Guideline NICE CATARACTS IN ADULTS

National Institute for Health and Care
Excellence
Final
Cataracts in adults:
management
Full guideline
NICE Guideline NG77

Methods, evidence and recommendations
October 2017
Final version
Commissioned by the National Institute for

Health and Care Excellence
Cataracts in adults: management
Contents
Disclaimer
Healthcare professionals are expected to take NICE clinical guidelines fully into account
when exercising their clinical judgement. However, the guidance does not override the
responsibility of healthcare professionals to make decisions appropriate to the circumstances
of each patient, in consultation with the patient and/or their guardian or carer.
Copyright
© NICE 2017. All rights reserved. Subject to Notice of rights.
ISBN 978-1-4731-2706-7
© NICE 2017. All rights reserved. Subject to Notice of rights.

Contents
Contents
Summary ........................................................................................................................... 10
1 Guideline committee membership and ICG technical team .................................... 11
1.1 Guideline committee............................................................................................ 11
1.2 Internal Clinical Guidelines Team ........................................................................ 12
2 Strength of recommendation ..................................................................................... 13
3 Methods ...................................................................................................................... 14
3.1 Evidence synthesis and meta-analyses ............................................................... 14
3.2 Evidence of effectiveness of interventions ........................................................... 14
3.2.1 Quality assessment .................................................................................. 14
3.2.2 Methods for combining intervention evidence .......................................... 14
3.2.3 Minimal clinically important differences (MIDs) ......................................... 14
3.2.4 GRADE for pairwise meta-analyses of interventional evidence ................ 15
3.3 Methods for combining direct and indirect evidence (network meta-analysis)
for interventions ................................................................................................... 15
3.3.1 Synthesis ................................................................................................. 16
3.3.2 Applying GRADE to network meta-analysis ............................................. 17
3.4 Association studies.............................................................................................. 18
3.4.1 Methods for combining association study evidence .................................. 18
3.4.2 Minimal clinically important differences (MIDs) ......................................... 18
3.4.3 Modified GRADE for association studies .................................................. 18
3.5 Non-comparative studies ..................................................................................... 19
3.5.1 Modified GRADE for non-comparative evidence ...................................... 19
3.6 Qualitative evidence ............................................................................................ 19
3.6.1 Methods for combining qualitative evidence ............................................. 19
3.6.2 CERQual for qualitative studies ............................................................... 20
3.7 Mixed-quantitative and qualitative evidence ........................................................ 20
3.8 Health economics ................................................................................................ 20
3.9 External collaborations ........................................................................................ 21
4 Summary of recommendations ................................................................................. 23
4.1 Recommendations summary ............................................................................... 23
4.2 Research recommendations summary ................................................................ 30
5 Patient information ..................................................................................................... 31
5.1 Patient information .............................................................................................. 32
5.1.1 Review questions ..................................................................................... 32
5.1.2 Introduction .............................................................................................. 32
5.1.3 Evidence review ....................................................................................... 32
5.1.4 Health economic evidence ....................................................................... 33
5.1.5 Evidence statements ................................................................................ 33
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5.1.6 Evidence to recommendations ................................................................. 34

5.1.7 Recommendations ................................................................................... 36
6 Indicators for referral ................................................................................................. 38
6.1 Indicators and thresholds for referral for cataract surgery .................................... 39
6.1.2 Introduction .............................................................................................. 39
6.1.3 Evidence review ....................................................................................... 39
6.1.8 Research recommendations .................................................................... 55
7 Preoperative assessment and biometry ................................................................... 56
7.1 Biometry techniques ............................................................................................ 58
7.1.1 Review question....................................................................................... 58
7.1.2 Introduction .............................................................................................. 58
7.1.3 Evidence review ....................................................................................... 59
7.1.8 Research recommendation ...................................................................... 65
7.2 Intraocular lens formulas ..................................................................................... 67
7.2.1 Review question....................................................................................... 67
7.2.2 Introduction .............................................................................................. 67
7.2.3 Evidence review ....................................................................................... 68
7.2.6 Evidence to recommendation ................................................................... 76
7.2.8 Research recommendations .................................................................... 79
7.3 Intraocular lens constant optimisation.................................................................. 80
7.3.1 Review question....................................................................................... 80
7.3.2 Introduction .............................................................................................. 80
7.3.3 Evidence review ....................................................................................... 81
7.4 Other considerations in biometry ......................................................................... 85
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7.4.1 Review question....................................................................................... 85

7.4.2 Introduction .............................................................................................. 85
7.4.3 Evidence review ....................................................................................... 85
7.5 Risk stratification and risk factors for increased cataract surgical complications .. 89
7.5.2 Introduction .............................................................................................. 89
7.5.3 Evidence review ....................................................................................... 90
8 Intraocular lens selection .......................................................................................... 97
8.1 Lens design ......................................................................................................... 98
8.1.2 Introduction .............................................................................................. 98
8.1.3 Evidence review ....................................................................................... 99
8.1.4 Health economic evidence ..................................................................... 102
8.1.5 Evidence statements .............................................................................. 102
8.1.6 Recommendations ................................................................................. 104
8.1.7 Research recommendations .................................................................. 104
8.2 Blue-light filtering vs ultraviolet-light filtering lenses ........................................... 106
8.2.1 Review question..................................................................................... 106
8.2.2 Introduction ............................................................................................ 106
8.2.3 Evidence review ..................................................................................... 106
8.3 Multifocal vs monofocal intraocular lenses......................................................... 109
8.3.1 Review question..................................................................................... 109
8.3.2 Introduction ............................................................................................ 109
8.3.3 Evidence review ..................................................................................... 110
8.3.6 Evidence to recommendations ............................................................... 114
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8.4 Optimal strategy to address pre-existing astigmatism ........................................ 117
8.4.1 Review question..................................................................................... 117
8.4.2 Introduction ............................................................................................ 117
8.4.3 Evidence review ..................................................................................... 117
9 Wrong lens implant errors ....................................................................................... 124
9.1 Wrong lens implant errors ................................................................................. 125
9.1.1 Review questions ................................................................................... 125
9.1.2 Introduction ............................................................................................ 125
9.1.3 Evidence review ..................................................................................... 125
10 Surgical timing and technique................................................................................. 132
10.1 Laser-assisted cataract surgery......................................................................... 132
10.1.1 Review question..................................................................................... 132
10.1.2 Introduction ............................................................................................ 132
10.1.3 Evidence review ..................................................................................... 133
10.2 Bilateral surgery ................................................................................................ 137
10.2.2 Introduction ............................................................................................ 137
10.2.3 Evidence review ..................................................................................... 138
11 Anaesthesia .............................................................................................................. 147
11.1 Type and administration of anaesthesia ............................................................ 148
11.1.1 Review question..................................................................................... 148
11.1.2 Introduction ............................................................................................ 148
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11.1.3 Evidence review ..................................................................................... 148

11.2 Sedation as an adjunct to local anaesthesia ...................................................... 157
11.2.1 Review question..................................................................................... 157
11.2.2 Introduction ............................................................................................ 157
11.2.3 Evidence review ..................................................................................... 157
11.3 Hyaluronidase as an adjunct to local anaesthesia ............................................. 160
11.3.1 Review question..................................................................................... 160
11.3.2 Introduction ............................................................................................ 160
11.3.3 Evidence review ..................................................................................... 160
11.4 General anaesthesia ......................................................................................... 163
11.4.1 Review question..................................................................................... 163
11.4.2 Introduction ............................................................................................ 163
11.4.3 Evidence review ..................................................................................... 163
12 Preventing and managing complications ............................................................... 165
12.1 Interventions to prevent retinal detachment in people with myopia .................... 166
12.1.1 Review question..................................................................................... 166
12.1.2 Introduction ............................................................................................ 166
12.1.3 Evidence review ..................................................................................... 166
12.2 Intraoperative pupil size management ............................................................... 168
12.2.1 Review question..................................................................................... 168
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12.2.2 Introduction ............................................................................................ 168

12.2.3 Evidence review ..................................................................................... 169
12.3 Interventions to reduce the impact of perioperative posterior capsule rupture ... 172
12.3.1 Review question..................................................................................... 172
12.3.2 Introduction ............................................................................................ 172
12.3.3 Evidence review ..................................................................................... 172
12.4 Capsular tension rings ....................................................................................... 175
12.4.1 Review question..................................................................................... 175
12.4.2 Introduction ............................................................................................ 175
12.4.3 Evidence review ..................................................................................... 175
12.5 Interventions to prevent endophthalmitis ........................................................... 179
12.5.1 Review question..................................................................................... 179
12.5.2 Introduction ............................................................................................ 179
12.5.3 Evidence review ..................................................................................... 180
12.5.8 Research recommendation .................................................................... 184
12.6 Interventions to prevent cystoid macular oedema .............................................. 185
12.6.1 Review question..................................................................................... 185
12.6.2 Introduction ............................................................................................ 185
12.6.3 Evidence review ..................................................................................... 186
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12.7 Managing cystoid macular oedema ................................................................... 192

12.7.1 Review question..................................................................................... 192
12.7.2 Introduction ............................................................................................ 192
12.7.3 Evidence review ..................................................................................... 192
12.8 Postoperative eye shields.................................................................................. 196
12.8.1 Review question..................................................................................... 196
12.8.2 Introduction ............................................................................................ 196
12.8.3 Evidence review ..................................................................................... 196
13 Postoperative assessment ...................................................................................... 198
13.1 Complications of surgery ................................................................................... 199
13.1.1 Review question..................................................................................... 199
13.1.2 Introduction ............................................................................................ 199
13.1.3 Evidence review ..................................................................................... 199
13.2 Details of postoperative assessment ................................................................. 205
13.2.2 Introduction ............................................................................................ 205
13.2.3 Evidence review ..................................................................................... 205
14 Glossary .................................................................................................................... 209
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Summary
Summary
A cataract is defined as any opacity in the crystalline lens of the eye. It can affect one or both
eyes. The changes to the transparency and refractive index of the lens result in various
levels of visual impairment. This impairment is associated with decreased quality of life
because it may restrict the person’s ability to carry out daily activities and function
independently, while increasing the risk of accidents and falls.
Cataracts most commonly affect adults as a result of biological ageing (age-related
cataracts) and may be classified according to the area of the lens that is affected (nuclear
sclerotic, cortical or posterior subcapsular cataracts). Cataracts can also occur in children,
and may be classified according to the age of onset (congenital or infantile/juvenile
cataracts). This guideline only covers cataracts in people who are 18 years or older.
Cataracts may occur secondary to hereditary factors, trauma, inflammation, metabolic or
nutritional disorders, and exposure to radiation. In addition, lifestyle factors such as tobacco
smoking and high alcohol intake are associated with an increased risk of developing age-
related cataracts. Most cataracts are progressive, although the decline in visual function may
be variable and unpredictable. The natural history of cataracts depends on the type and
severity of the cataract and the presence of comorbid ocular conditions. In severe, untreated
cases, cataracts can lead to significant reduction in vision, which is reversible with cataract
surgery, although some level of visual impairment may persist.
Cataract surgery has a high success rate in improving visual function, with low morbidity and
mortality. It is the most common operation performed in the NHS, with an ever growing need
as the population ages.
Cataract management usually involves a multidisciplinary team that includes
ophthalmologists, optometrists, nurses and technicians. Diagnosis is usually based on self-
reported symptoms and a series of tests performed by an optometrist, normally based in the
community. Symptoms may include blurred vision, difficulty seeing at night, sensitivity to light
or glare, seeing ‘halos’ around lights and double vision in a single eye. Diagnostic tests
include a visual acuity test, and slit-lamp and retinal examinations.
In adults with early age-related cataracts, non-surgical management may include prescription
of spectacles. Alternatively, adults with age-related cataracts may be referred for surgery by
an optometrist or a GP. The clinical threshold used to access cataract surgery varies across
NHS trusts in England. This has resulted in differences in access to cataract surgery,
because commissioning policies vary in scope and content and are not necessarily
consistent with research evidence or guidance provided by the Department of Health in
‘Action on cataracts’ and the Royal College of Ophthalmologists' ‘Cataract surgery
guidelines’.
Guidance on appropriate referral criteria for cataract surgery is needed to address patient
need and to optimise the allocation of NHS resources. In addition, an understanding of the
most clinically and cost-effective methods for undertaking cataract surgery, and
recommendations to minimise complications and surgical errors such as wrong intraocular
lens implants, are needed to further improve patient care.
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Guideline committee membership and ICG technical team
1 Guideline committee membership and ICG

technical team
1.1 Guideline committee
Mike Burdon (Guideline Chair)
Consultant Ophthalmic Surgeon, University Hospitals Birmingham NHS Foundation Trust
Keith Allman (co-opted expert member)

Consultant Anaesthetist, Royal Devon and Exeter NHS Foundation Trust
Kamal Bishai
General Practitioner, NHS West Essex CCG
Arthur Brill
Patient/carer member
Michael Glowala (co-opted expert member)

Theatre Manager, York Teaching Hospital NHS Foundation Trust
Kate Kotschy (Until July 2015)

Emily Lam (From July 2015)

Janet Marsden
Professor of Ophthalmology and Emergency Care, Faculty of Health, Psychology and Social
Care, Manchester Metropolitan University
Yvonne Needham
Senior Fellow, School of Health and Social Work, University of Hull
Ruth O'Dea (co-opted expert member, from March 2016)

Home Manager, Bemerton Lodge
Geoff Roberson
Professional Advisor, Association of Optometrists
Paul Rosen
Consultant Ophthalmic Surgeon, Oxford Eye Hospital, Oxford University Hospitals
Gillian Rudduck
Consultant Optometrist, Wirral University Teaching Hospital NHS Foundation Trust
Mary Russell (co-opted expert member, from March 2016)

Independence and Mobility Team, Royal National College for the Blind (Recently retired)
Nick Wilson-Holt
Consultant Ophthalmologist, Royal Cornwall Hospitals NHS Trust
Jennifer Yip
Consultant in Public Health, Public Health England & Clinical Associate Professor in Public
Health Ophthalmology, London School of Hygiene & Tropical Medicine
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Guideline committee membership and ICG technical team
For a full list of guideline development group and service delivery group declarations of
interest, see Appendix A.
1.2 Internal Clinical Guidelines Team

Daniel Davies (From March 2016 to June 2016)
Project Manager
Sue Ellerby
Consultant Clinical Adviser
Gareth Franklin
Medicines Adviser
Christopher Gibbons
Health Economist
Wesley Hubbard
Information Specialist
Holly Irwin (Until February 2016)

Project Manager
Aimely Lee (From September 2016 to February 2017)

Technical Analyst
Hugh McGuire (Until December 2015)

Technical Adviser
Vonda Murray (From February 2016 to March 2016)

Project Manager
Adam O’Keefe (From June 2016)

Project Manager
Joshua Pink (From February 2016)

Technical Adviser
Stephen Robinson (From April 2016)

Technical Analyst
Gabriel Rogers
Technical Adviser, Health Economics
Susan Spiers
Associate Director
Sharlene Ting (Until February 2016 and then February 2017 to March 2017)
Technical Analyst
Jeremy Wight (From December 2015 to April 2016)

Consultant Clinical Adviser
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Strength of recommendation
2 Strength of recommendation
Some recommendations can be made with more certainty than others. The Guideline
committee makes a recommendation based on the trade-off between the benefits and harms
of an intervention, taking into account the quality of the underpinning evidence. For some
interventions, the Guideline committee is confident that, given the information it has looked
at, most patients would choose the intervention. The wording used in the recommendations
in this guideline denotes the certainty with which the recommendation is made (the strength
of the recommendation).
For all recommendations, NICE expects that there is discussion with the patient about the
risks and benefits of the interventions, and their values and preferences. This discussion
aims to help them to reach a fully informed decision (see also ‘Patient-centred care’).
Interventions that must (or must not) be used

We usually use ‘must’ or ‘must not’ only if there is a legal duty to apply the recommendation.
Occasionally we use ‘must’ (or ‘must not’) if the consequences of not following the
recommendation could be extremely serious or potentially life threatening.
Interventions that should (or should not) be used – a

‘strong’ recommendation
We use ‘offer’ (and similar words such as ‘refer’ or ‘advise’) when we are confident that, for
the vast majority of patients, an intervention will do more good than harm, and be cost
effective. We use similar forms of words (for example, ‘Do not offer…’) when we are
confident that an intervention will not be of benefit for most patients.
Interventions that could be used

We use ‘consider’ when we are confident that an intervention will do more good than harm
for most patients, and be cost effective, but other options may be similarly cost effective. The
choice of intervention, and whether or not to have the intervention at all, is more likely to
depend on the patient’s values and preferences than for a strong recommendation, and so
the healthcare professional should spend more time considering and discussing the options
with the patient.
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Methods
3 Methods
This guideline was developed in accordance with the process set out in ‘Developing NICE
guidelines: the manual (2014)’. There is more information about how NICE clinical guidelines
are developed on the NICE website. A booklet, ‘How NICE clinical guidelines are developed:
an overview for stakeholders, the public and the NHS’ is available. In instances where the
guidelines manual does not provide advice, additional methods are used as described below,
organised by study type.
3.1 Evidence synthesis and meta-analyses

Where possible, meta-analyses were conducted to combine the results of studies for each
outcome. For continuous outcomes, where change from baseline data were reported in the
trials and were accompanied by a measure of spread (for example standard deviation), these
were extracted and used in the meta-analysis. Where measures of spread for change from
baseline values were not reported, the corresponding values at study end were used and
were combined with change from baseline values to produce summary estimates of effect.
These studies were assessed to ensure that baseline values were balanced across the
treatment groups; if there were significant differences at baseline these studies were not
included in any meta-analysis and were reported separately.
3.2 Evidence of effectiveness of interventions

3.2.1 Quality assessment
GRADE was used to assess the quality of evidence for the selected outcomes as specified in
‘The guidelines manual (2014)’. Where RCTs are available, these are initially rated as high
quality and the quality of the evidence for each outcome was downgraded or not from this
initial point. If non-RCT evidence was included for intervention-type systematic reviews then
these are initially rated as low quality and the quality of the evidence for each outcome was
downgraded or not from this point.
3.2.2 Methods for combining intervention evidence

Meta-analysis of interventional data was conducted with reference to the Cochrane
Handbook for Systematic Reviews of Interventions (Higgins et al. 2011).
Dichotomous outcomes were pooled on the relative risk scale (using the Mantel–Haenszel
method).
Random-effects models (der Simonian and Laird) were fitted for all syntheses, as a
conservative approach that reflected the underlying clinical heterogeneity of interventions (for
example, differences in surgical technique and lens choice even in otherwise similar studies),
regardless of whether such heterogeneity could be statistically identified.
Meta-analyses were performed in Cochrane Review Manager v5.3.
3.2.3 Minimal clinically important differences (MIDs)

The Core Outcome Measures in Effectiveness Trials (COMET) database was searched to
identify published minimal clinically important difference thresholds relevant to this guideline,
which were considered along with any other published MIDs found during the clinical
searches for the guideline, or any MIDs specified by the committee, and derived from their
clinical experience. For relative risks, the GRADE default MID interval for dichotomous
outcomes of 0.8 to 1.25 was used.
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Methods
Cataract surgery has benefits across a wide variety of different domains of vision, with
different people potentially benefiting in different ways. Examples would be improvements in
visual acuity, depth of focus or contrast sensitivity, or reductions in the severity of optical
abnormalities such as glare or halos. A person may gain a measurable benefit in one or
some of these domains, without accruing any meaningful benefits in others. On this basis,
the committee agreed that it would not be appropriate to specific quantitative MIDs for these
intermediate outcome measures, as applying a population level MID to a dataset where only
a proportion of people would be expected to benefit in that domain is likely to have the effect
of inappropriately viewing differences as not being meaningful, where they may be for the
proportion of people who do benefit.
The committee agreed, therefore, that wherever possible the focus would primarily be on
measures such as visual function, quality of life or patient satisfaction, which should hopefully
capture a more representative picture of the overall change. When decisions were made in
situations where MIDs were not available, the ‘Evidence to Recommendations’ section of that
review will make explicit the committee’s view of the expected clinical relevance of the
findings.
3.2.4 GRADE for pairwise meta-analyses of interventional evidence

The quality of the evidence for each outcome was downgraded where appropriate for the
reasons outlined in Table 1
Table 1: Rationale for downgrading evidence for intervention studies

GRADE criteria Reasons for downgrading quality
Risk of bias The quality of the evidence was downgraded if there were concerns about the
design or execution of the study, including concealment of allocation, masking,
loss to follow up using intervention checklists in the NICE guidelines manual
(2014)
Inconsistency The quality of the evidence was downgraded if, after appropriate pre-specified
sensitivity analyses were conducted, there were remaining concerns about
inconsistency of effects across studies: occurring when there is variability in
the treatment effect demonstrated across studies (heterogeneity).
This was downgraded either if important differences were found between
populations, interventions and/or comparators across studies include in a
meta-analysis, or if there was significant unexplained statistical heterogeneity,
assessed using the I2 statistic, where I2 ≥ 75% was categorised as serious
inconsistency.
Indirectness The quality of the evidence was downgraded if there were concerns about the
population, intervention and outcome in the included studies and how directly
these variables could address the specific review question.
Imprecision If MIDs (1 corresponding to meaningful benefit; 1 corresponding to meaningful
harm) were defined for the outcome, the outcome was downgraded once if the
95% confidence interval for the effect size crossed 1 MID, and twice if it
crossed both the upper and lower MIDs.
If an MID was not defined for the outcome, it was downgraded once if the 95%
confidence interval for the effect size crossed the line of no effect (i.e. the
outcome was not statistically significant).
3.3 Methods for combining direct and indirect evidence

(network meta-analysis) for interventions
Conventional pairwise meta-analysis involves the statistical combination of direct evidence
about pairs of interventions that originate from 2 or more separate studies (for example,
where there are two or more studies comparing A vs B).
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Methods
In situations where there are more than 2 interventions, pairwise meta-analysis of the direct
evidence alone is of limited use. This is because multiple pairwise comparisons need to be
performed to analyse each pair of interventions in the evidence, and these results can be
difficult to interpret. Furthermore, direct evidence about interventions of interest may not be
available. For example studies may compare A vs B and B vs C, but there may be no direct
evidence comparing A vs C. Network meta-analysis (NMA) overcomes these problems by
combining all evidence into a single, internally consistent model, synthesising data from
direct and indirect comparisons, and providing estimates of relative effectiveness for all
comparators and the ranking of different interventions.
3.3.1 Synthesis
Two separate frameworks and software packages were used for undertaking network-meta
analyses in this guideline, with the chosen method dependent on the specifics of the
question (for certain datasets, it may be possible to run the preferred analysis in one program
but not the other, or it may be particularly more efficient to use one package over another):
 Hierarchical Bayesian Network Meta-Analysis (NMA) was performed using WinBUGS
version 1.4.3. The models used reflected the recommendations of the NICE Decision
Support Unit's Technical Support Documents (TSDs) on evidence synthesis, particularly
TSD 2 ('A generalised linear modelling framework for pairwise and network meta-analysis
of randomised controlled trials'; see http://www.nicedsu.org.uk). The WinBUGS code
provided in the appendices of TSD 2 was used without substantive alteration to specify
synthesis models.
Results were reported summarising 10,000 samples from the posterior distribution of each
model, having first run and discarded 50,000 ‘burn-in’ iterations. Three separate chains
with different initial values were used.
Non-informative prior distributions were used in all models. Unless otherwise specified,
trial-specific baselines and treatment effects were assigned N(0,1000) priors, and the
between-trial standard deviations used in random-effects models were given U(0,5) priors.
These are consistent with the recommendations in TSD 2 for dichotomous outcomes.
Fixed- and random-effects models were explored for each outcome, with the final choice
of model based on deviance information criterion (DIC): if DIC was at least 3 points lower
for the random-effects model, it was preferred; otherwise, the fixed effects model was
considered to provide an equivalent fit to the data in a more parsimonious analysis, and
was preferred.
The network-meta analyses in sections 7.2 (biometry formulas) and 7.3 (biometry lens
constants) were conducted using this methodology.
 Frequentist NMAs were undertaken using the netmeta package in R v3.3.1. This uses a
graph-theoretical method which is mathematically equivalent to frequentist network meta-
analysis (Rücker 2012). Inconsistency was assessed using the overall I2 value for the
whole network, which is a weighted average of the I2 value for all comparisons where
there are multiple trials (both direct and indirect), and random-effects models were used if
the I2 value was above 50% (this was interpreted as showing the assumption of
consistent, shared underlying means was not met, and therefore a fixed-effects model
was inappropriate).
The network-meta analyses in sections 8.1 (lens design), 8.3 (multifocal vs monofocal
intraocular lenses), 11.1 (anaesthesia) and 12.6 (preventing cystoid macular oedema)
were conducted using this methodology.
Because different approaches and software had been applied, sensitivity analysis have
previously been undertaken to establish whether this might have led to any substantive
differences in output. Specimen dichotomous and continuous NMAs from the Bayesian
analysis were rerun in the frequentist framework and generated results that were materially
indistinguishable from the Bayesian version.
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Methods
3.3.2 Applying GRADE to network meta-analysis

A modified version of the standard GRADE approach for pairwise interventions was used to
assess the quality of evidence across the network meta-analyses undertaken. While most
criteria for pairwise meta-analyses still apply, it is important to adapt some of the criteria to
take into consideration additional factors, such as how each 'link' or pairwise comparison
within the network applies to the others. As a result, the following was used when modifying
the GRADE framework to a network meta-analysis. It is designed to provide a single overall
quality rating for an NMA, which can then be combined with pairwise quality ratings for
individual comparisons (if appropriate), to judge the overall strength of evidence for each
comparison.
3.3.2.1 Risk of bias

In addition to the usual criteria to assess the risk of bias or 'limitations' of studies for each
pairwise analysis within a network, the risk of bias was assessed for each direct comparison
and assessed to see how it would affect the indirect comparisons. In addition, there was an
assessment of treatment effect modifiers to see if they differed between links in the network.
For network meta-analyses with a large proportion of studies that were judged to be
susceptible to bias, some downgrading decision rules were applied:
 If 50% or more studies in the network were inadequate or unclear for a particular
parameter of quality, the outcome was downgraded by 1 level.
 As with pairwise meta-analyses, studies with differences in concomitant treatment
between groups, or which did not report concomitant treatment between groups (where
permitted), were treated with caution. Additionally, if there were differences in concomitant
treatment among the studies included in different links across the network, the overall
outcome was downgraded.
3.3.2.2 Inconsistency
Inconsistency was assessed for the heterogeneity of individual pairwise comparisons in the
network, and also between direct and indirect comparisons where both were available (that
is, where there were ‘loops’ in the network).
Heterogeneity across studies for each direct pairwise meta-analysis was assessed using I2.
This allowed for the assessment of heterogeneity within the included studies using the
following decision rules:
 If there was considerable heterogeneity for 1 link or more in a network, the outcome was
downgraded 1 level.
 If there was more than 1 link in the network with considerable, substantial or moderate
heterogeneity, consideration was given to downgrading 2 levels.
To assess for consistency in each pairwise comparison where both direct and indirect
evidence are available, the values of the direct and indirect estimates were compared to see
if they were similar.
The overall values of I2 (which combines heterogeneity between multiple studies of the same
comparison and inconsistency between direct and indirect comparisons) and tau were also
assessed to compare heterogeneity across the network.
3.3.2.3 Indirectness
As with pairwise meta-analyses, studies included in a network were assessed for how well
they fit the PICO (population, intervention, comparator, outcome) specified in the review
protocol.
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Methods
3.3.2.4 Imprecision
Imprecision was assessed for a number of variables:
 Sufficient head-to-head trials in the network.
 Sufficient number of studies to form the network (if there was a high proportion of ‘links’
formed with only 1 trial, the outcome was downgraded).
 Overall certainty/uncertainty of the effect estimates (size of confidence/credible intervals,
including for each drug compared with the reference option, and size of
confidence/credible intervals for the overall rankings within the network).
 For networks, imprecision was considered around both the direct and indirect effect
estimates.
3.4 Association studies

In this guideline, association studies are defined as those reporting data showing an
association of a predictor (either a single variable or a group of variables) and an outcome
variable, where the data are not reported in terms of outcome classification (i.e.
diagnostic/prognostic accuracy). Data were reported as hazard ratios (if measured over time)
or odds ratios (if measured at a specific time-point.
3.4.1 Methods for combining association study evidence

Hazard ratios were pooled using the inverse-variance method, and odds ratios were pooled
using the Mantel-Haenszel method. Adjusted odds ratios from multivariate models were only
pooled if the same set of predictor variables were used across multiple studies.
Random-effects models (der Simonian and Laird) were fitted for all syntheses, as a
conservative approach that reflected the underlying clinical heterogeneity of interventions (for
example, differences in surgical technique and lens choice even in otherwise similar studies),
regardless of whether such heterogeneity could be statistically identified.
Meta-analyses were performed in Cochrane Review Manager v5.3.
3.4.2 Minimal clinically important differences (MIDs)

For odds ratios and adjusted odds ratios, an MID interval of 0.8 to 1.25 was used. No MID
was specified for data reported as hazard ratios, and therefore the line of no effect was used.
3.4.3 Modified GRADE for association studies

GRADE has not been developed for use with predictive studies; therefore a modified
approach was applied using the GRADE framework. Data from cohort studies was initially
rated as high quality, and data from case-control studies as low quality, with the quality of the
evidence for each outcome then downgraded or not from this initial point.
Table 2: Rationale for downgrading evidence for association studies

Risk of bias Concerns about the design or execution of the study, including in how either
the predictor or outcome variables were assessed, or loss to follow up during
the study. These were identified using checklists in the NICE guidelines
manual (2014).
Inconsistency The quality of the evidence was downgraded if there were concerns about
inconsistency of effects across studies: occurring when there is variability in the
treatment effect demonstrated across studies (heterogeneity). This was
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Methods

assessed using the statistic, I2 where ; I2 < 50% was categorised as no
inconsistency, and I2 ≥ 50% was categorised as serious inconsistency
Indirectness Concerns about the population, intervention and outcome in the included
studies and how directly these variables could address the specific review
question.
Imprecision If MIDs (1 corresponding to a meaningful increase; 1 corresponding to a
meaningful decrease) were defined for the outcome, the outcome was
downgraded once if the 95% confidence interval for the effect size crossed 1
MID, and twice if it crosses both the upper and lower MIDs.
If an MID was not defined for the outcome, it was downgraded once if the 95%
confidence interval for the effect size crossed the line of no effect (i.e. the
outcome was not statistically significant).
3.5 Non-comparative studies

Throughout the guideline, wherever possible, data were always presented from comparative
studies, with non-comparative studies only considered when this was the only data available.
All non-comparative study designs (case series, audit data, surveys etc.) were analysed
under the same framework, regardless of the underlying question they sought to address.
3.5.1 Modified GRADE for non-comparative evidence

GRADE has not been developed for use with non-comparative studies; therefore a modified
approach was applied using the GRADE framework, with the approach summarised in Table
3.
Table 3: Rationale for downgrading evidence for non-comparative evidence

Risk of bias Concerns about the design or execution of the study, including participant
recruitment, retention and outcome measurement
Inconsistency Data from non-comparative studies were not pooled together at any stage, and
therefore it was not possible to assess inconsistency.
Indirectness Concerns about the population, intervention and outcome in the included
studies and how directly these variables could address the specific review
question.
Imprecision If the upper and lower limits of the 95% confidence interval were such that, if
they represented the true result, they would imply qualitatively different
conclusions (e.g. it is possible that either a moderate or small proportion of
people experience a given event), the outcome was downgraded one level.
If the mean estimate, the upper limit, and the lower limit of the 95% confidence
interval, were such that, if they represented the true result, they would all imply
qualitatively different conclusions (e.g. it is possible that either a small,
moderate or small proportion of people experience a given event), the outcome
was downgraded two levels.
3.6 Qualitative evidence

3.6.1 Methods for combining qualitative evidence
Where multiple qualitative studies were identified for a single question, information from the
studies was combined using a thematic synthesis. By examining the findings of each
included study, descriptive themes were independently identified and coded. Once all of the
included studies had been examined and coded, the resulting themes and sub-themes were
evaluated to examine their relevance to the review question, the importance given to each
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Methods
theme, and the extent to which each theme recurred across the different studies. The
qualitative synthesis then proceeded by using these ‘descriptive themes’ to develop
‘analytical themes’, which were interpreted by the reviewer in light of the overarching review
questions.
3.6.2 CERQual for qualitative studies

CERQual was used to assess the confidence we have in each of the identified themes.
Evidence from all qualitative study designs (interviews, focus groups etc.) was initially rated
as high confidence and the confidence in the evidence for each theme was then downgraded
from this initial point as detailed in Table 4 below.
Table 4: Rationale for downgrading evidence for qualitative questions

CERQual criteria Reasons for downgrading confidence
Methodological The extent to which there are problems in the design or conduct of the primary
limitations studies that contributed evidence to a review finding. Where the primary
studies underlying a review finding are shown to have important
methodological limitations, we are less confident that the review finding reflects
the phenomenon of interest.
Relevance Relevance is the extent to which the body of evidence from the primary studies
supporting a review finding is applicable to the context specified in the review
question. This may relate to, for example, the perspective or population
researched, the phenomenon of interest or the setting. Where the contexts of
the primary studies underlying a review finding are substantively different to the
context of the review question, we are less confident that the review finding
reflects the phenomenon of interest.
Coherence Coherence was addressed based on two factors:
 Between study – does the theme consistently emerge from all relevant
studies
 Theoretical – does the theme provide a convincing theoretical explanation for
the patterns found in the data
The outcome was downgraded once if there were concerns about one of these
elements of coherence, and twice if there were concerns about both elements.
Adequacy of data The outcome was downgraded if there was insufficient data to develop an
understanding of the phenomenon of interest, either due to insufficient studies,
participants or observations.
3.7 Mixed-quantitative and qualitative evidence

Where a review question identified both relevant quantitative and qualitative evidence, these
two types of evidence were analysed separately, using the relevant GRADE, modified
GRADE or CERQual criteria defined above.
3.8 Health economics

Literature reviews seeking to identify published cost–utility analyses of relevance to the
issues under consideration were conducted for all questions. In each case, the search
undertaken for the clinical review was modified, retaining population and intervention
descriptors, but removing any study-design filter and adding a filter designed to identify
relevant health economic analyses. Search strategies are provided in full in Appendix D. In
assessing studies for inclusion, population, intervention and comparator, criteria were always
identical to those used in the parallel clinical search; only cost–utility analyses were included.
Economic evidence profiles, including critical appraisal according to the Guidelines manual,
were completed for included studies; these are shown in Appendix J.
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Economic studies identified through a systematic search of the literature are appraised using
a methodology checklist designed for economic evaluations (NICE 2012; Appendix F). This
checklist is not intended to judge the quality of a study per se, but to determine whether an
existing economic evaluation is useful to inform the decision-making of the committee for a
specific topic within the guideline.
There are 2 parts of the appraisal process. The first step is to assess applicability (that is, the
relevance of the study to the specific guideline topic and the NICE reference case);
evaluations are categorised according to the criteria in Table 5.
Table 5 Applicability criteria

Level Explanation
Directly applicable The study meets all applicability criteria, or fails to meet one or
more applicability criteria but this is unlikely to change the
conclusions about cost effectiveness
Partially applicable The study fails to meet one or more applicability criteria, and
this could change the conclusions about cost effectiveness
Not applicable The study fails to meet one or more applicability criteria, and
this is likely to change the conclusions about cost
effectiveness. These studies are excluded from further
consideration
In the second step, only those studies deemed directly or partially applicable are further
assessed for limitations (that is, methodological quality); see categorisation criteria in Table
6.
Table 6 Methodological criteria

Level Explanation
Minor limitations Meets all quality criteria, or fails to meet one or more quality
criteria but this is unlikely to change the conclusions about cost
effectiveness
Potentially serious Fails to meet one or more quality criteria and this could change
limitations the conclusions about cost effectiveness
Very serious limitations Fails to meet one or more quality criteria and this is highly likely
to change the conclusions about cost effectiveness. Such
studies should usually be excluded from further consideration
Where relevant, a summary of the main findings from the systematic search, review and
appraisal of economic evidence is presented in an economic evidence profile alongside the
clinical evidence.
Original health economic modelling was available to support the Guideline Committee’s
decision making for the cataract surgery questions addressed in sections 6.1 and 10.2. The
Committee prioritised areas in which they felt that original analysis would be particularly
informative, on the grounds of uncertainty and variation in current practice and/or the
presence of complex trade-offs between the benefits, harms and costs of various courses of
action. In questions for which no published evidence was identified and original analysis was
not prioritised, the committee made a qualitative judgement about cost effectiveness by
considering potential differences in resource use and cost between the options alongside the
results of the review of evidence of clinical effectiveness.
3.9 External collaborations

A number of questions in this guideline were undertaken as a collaboration between the
NICE Internal Guidelines Team and the Cochrane Eyes and Vision Group. Data from
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relevant Cochrane reviews were supplied to the NICE team, and then either the full or
relevant subsection of the review included as part of the evidence base. The following
questions were undertaken as collaborations:
 What is the optimal strategy to facilitate simultaneous distance and near vision following
cataract surgery? (section 8.4)
 What is the effectiveness of laser-assisted phacoemulsification cataract surgery compared
with standard ultrasound phacoemulsification cataract surgery? (section 10.1)
 What is the effectiveness of prophylactic antiseptics (for example, topical iodine) and
antibiotics to prevent endophthalmitis after cataract surgery? (section 12.5)
 What is the effectiveness of prophylactic topical corticosteroids and/or NSAIDs to prevent
inflammation and cystoid macular oedema after phacoemulsification cataract surgery?
(section 12.6)
Details of the collaboration for each question are explained in the relevant chapters. Where
Cochrane reviews have been incorporated without substantive modification, the evidence is
presented as it was in the original Cochrane review. Where modifications have been made to
the published reviews (e.g. to standardise methodology with the rest of the guideline), these
are presented in the same format as the original reviews undertaken for this guideline, and
deviations from the data presented in the Cochrane reviews clearly specified.
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Summary of recommendations
4 Summary of recommendations
4.1 Recommendations summary
1. Give people with cataracts, and their family members or carers (as
appropriate), both oral and written information. Information should be
tailored to the person’s needs, for example, in an accessible format. For
more guidance on giving information to people and discussing their
preferences, see the NICE guideline on patient experience in adult NHS
services, particularly recommendations 1.2.12 and 1.2.13 on capacity and
consent.
2. At referral for cataract surgery, give people information about:
 cataracts:
 what cataracts are
 how they can affect vision
 how they can affect quality of life
 cataract surgery:
 what it involves and how long it takes
 possible risks and benefits
 what support might be needed after surgery
 likely recovery time
 likely long-term outcomes, including the possibility that people
might need spectacles for some tasks
 how vision and quality of life may be affected without surgery.
3. At the preoperative outpatient appointment, review and expand on the
topics in recommendation 2, and give people information about:
 the refractive implications of different intraocular lenses (see
recommendation 28)
 types of anaesthesia
 the person’s individual risk of complications during or after
surgery (for example, the risk of postoperative retinal detachment
in people with high myopia; also see recommendations 17 and
18)
 what to do and what to expect on the day of cataract surgery
 what to do and what to expect after cataract surgery
 what support might be needed after surgery
 medicines after surgery (for example, eye drops) and medicines
that people may be already taking (for example, anticoagulants).
 the refractive implications after previous corneal refractive
surgery, if appropriate (see recommendation 13)
 bilateral simultaneous cataract surgery, if appropriate (also see
recommendations 36 and 37).
4. On the day of surgery, before the operation, give people information
about:
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 their position on the list

 what to expect during and after surgery.
5. On the day of surgery, after the operation, give people information about:
 what visual changes to expect
 signs and symptoms of potential complications to look out for
 any restrictions on activities, for example, driving
 possible problems and who to contact
 emergency situations and who to contact
 eye drops
 pain management
 their next appointment and who they will see.
6. Base the decision to refer a person with a cataract for surgery on a
discussion with them (and their family members or carers, as appropriate)
that includes:
 how the cataract affects the person's vision and quality of life
 whether 1 or both eyes are affected
 what cataract surgery involves, including possible risks and
benefits
 how the person's quality of life may be affected if they choose not
to have cataract surgery
 whether the person wants to have cataract surgery.
7. Do not restrict access to cataract surgery on the basis of visual acuity.
8. Use optical biometry to measure the axial length of the eye for people
having cataract surgery.
9. Use ultrasound biometry if optical biometry:
 is not possible or
 does not give accurate measurements.
10. Use keratometry to measure the curvature of the cornea for people having
cataract surgery.
11. Consider corneal topography for people having cataract surgery:
 who have abnormally flat or steep corneas
 who have irregular corneas
 who have significant astigmatism
 who have had previous corneal refractive surgery or
 if it is not possible to get an accurate keratometry measurement.
12. For people who have not had previous corneal refractive surgery, use 1 of
the following to calculate the intraocular lens power before cataract
surgery:
 If the axial length is less than 22.00 mm, use Haigis or Hoffer Q.
 If the axial length is between 22.00 and 26.00 mm, use Barrett
Universal II if it is installed on the biometry device and does not
need the results to be transcribed by hand. Use SRK/T if not.
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 If the axial length is more than 26.00 mm, use Haigis or SRK/T.
13. Advise people who have had previous corneal refractive surgery that
refractive outcomes after cataract surgery are difficult to predict, and that
they may need further surgery if they do not want to wear spectacles for
distance vision.
14. If people have had previous corneal refractive surgery, adjust for the
altered relationship between the anterior and posterior corneal curvature.
Do not use standard biometry techniques or historical data alone.
15. Surgeons should think about modifying a manufacturer's recommended
intraocular lens constant, guided by learning gained from their previous
deviations from predicted refractive outcomes.
16. Consider using 50% of the first-eye prediction error in observed refractive
outcome to guide calculations for the intraocular lens power for second-
eye cataract surgery.
17. Consider using a validated risk stratification algorithm for people who
have been referred for cataract surgery, to identify people at increased
risk of complications during and after surgery.
18. Explain the results of the risk stratification to the person, and discuss how
it may affect their decisions.
19. To minimise the risk of complications during and after surgery, ensure that
surgeons in training are closely supervised when they perform cataract
surgery in:
 people who are at high risk of complications or
 people for whom the impact of complications would be especially
severe (for example, people with only 1 functional eye).
20. Explain to people who are at risk of developing a dense cataract that there
is an increased risk of complications if surgery is delayed and the cataract
becomes more dense.
22. Do not offer multifocal intraocular lenses for people having cataract
surgery.
23. Offer monovision for use after cataract surgery to people who have either
anisometropia or monovision preoperatively and would like to remain with
it.
24. Consider on-axis surgery or limbal-relaxing incisions to reduce
postoperative astigmatism.
25. Before the preoperative biometry assessment, ensure that the person’s
correct medical notes are used by confirming the person’s:
 name
 address and
 date of birth.
26. Immediately after the preoperative biometry assessment:
 check that the biometry results include the person’s name,
address, date of birth and hospital number
 either:
 use electronic data transfer to upload the biometry results to an
electronic health record or
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 securely fix the printed biometry results to the person’s medical

notes
 do not transcribe the results by hand.
27. At the preoperative assessment:
 discuss the refractive implications of different intraocular lenses
with the person
 base the choice of intraocular lens on the person’s chosen
refractive outcome
 record the discussion and the person’s choices in their medical
notes.
28. The person’s medical notes, including biometry results, must be available
in theatre on the day of the cataract surgery.
29. Use a checklist based on the World Health Organization (WHO) surgical
safety checklist, modified to include the following cataract surgery checks,
to ensure that:
 the person’s identity has been confirmed and matches
information in:
 the consent form
 the biometry results and
 the person’s medical notes
 the eye to be operated on has been checked and clearly marked
 there is only 1 intraocular lens in the theatre, that matches the
person’s selected lens type and prescription
 at least 1 additional identical intraocular lens is in stock
 alternative intraocular lenses are in stock in case the selected
lens needs to be changed if there are complications during
surgery
 at least 2 members of the team, including the surgeon, have
previously checked the appropriateness, accuracy and
consistency of all:
 formulas
 calculations and
 intraocular lens constants.
30. Before giving the person anaesthetic, ensure that:
 there is only 1 intraocular lens in the theatre, that matches the
person’s selected lens type and prescription
 alternative intraocular lenses are in stock in case the selected
lens needs to be changed if there are complications during
surgery.
31. Immediately before the operation, the surgeon should:
 confirm the person’s identity and ensure that the correct medical
notes are being used, especially if using electronic patient
records
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 refer to the printed biometry results, not to transcribed

information in the person’s medical notes
 refer to the person’s medical notes to check which refractive
outcome they preferred
 verify that the correct intraocular lens has been selected and is
available in theatre.
32. If a wrong lens is implanted, refer to NHS England’s Never Events policy,
and together with the whole multidisciplinary team:
 undertake a root-cause analysis to determine the reasons for the
incident
 establish strategies and implementation tools to stop it from
happening again.
33. Only use femtosecond laser-assisted cataract surgery as part of a
randomised controlled trial that includes collection of resource-use data,
comparing femtosecond laser-assisted cataract surgery with ultrasound
phacoemulsification.
34. Offer second-eye cataract surgery using the same criteria as for the first-
eye surgery (see section 6 for referral for cataract surgery).
35. Consider bilateral simultaneous cataract surgery for
 people who are at low risk of ocular complications during and
after surgery or
 people who need to have general anaesthesia for cataract
surgery but for whom general anaesthesia carries an increased
risk of complications or distress.
36. Discuss the potential risks and benefits of bilateral simultaneous cataract
surgery with people, which should include:
 the potential immediate visual improvement in both eyes
 how it will not be possible to choose a different intraocular lens
based on the outcome in the first eye
 the risk of complications in both eyes during and after surgery
that could cause long-term visual impairment
 the likely need for additional support after the operation.
37. Offer sub-Tenon’s or topical (with or without intracameral) anaesthesia for
people having cataract surgery.
38. If both sub-Tenon’s and topical (with or without intracameral) anaesthesia
are contraindicated, consider peribulbar anaesthesia.
39. Do not offer retrobulbar anaesthesia for people having cataract surgery.
40. Consider sedation, administered by an experienced ophthalmic
anaesthetist, as an adjunct to anaesthesia for people if, for example:
 they have high levels of anxiety
 they have postural or musculoskeletal problems
 surgery is expected to take longer than usual.
41. Consider hyaluronidase as an adjunct to sub-Tenon’s anaesthesia,
particularly if trying to stop the eye moving during surgery.
42. Consider intracameral phenylephrine to increase pupil size in people at
risk of floppy iris syndrome.
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43. When dealing with posterior capsule rupture, follow a protocol that covers:
 removing vitreous from the wound and anterior chamber
 minimising traction on the retina
 removing lens fragments in the posterior chamber or vitreous
cavity
 removing soft lens matter
 implications for any lens insertion.
44. Do not use capsular tension rings in routine, uncomplicated cataract
surgery.
45. Consider using capsular tension rings for people with pseudoexfoliation.
46. Use preoperative antiseptics in line with standard surgical practice.
47. Use intracameral cefuroxime during cataract surgery to prevent
endophthalmitis.
48. Use commercially prepared or pharmacy-prepared intracameral antibiotic
solutions to prevent dilution errors.
49. Consider topical steroids in combination with non-steroidal anti-
inflammatory drugs (NSAIDs):
 after cataract surgery for people at increased risk of cystoid
macular oedema, for example, people with diabetes or uveitis
 to manage cystoid macular oedema.
50. Offer topical steroids and/or NSAIDs after cataract surgery to prevent
inflammation and cystoid macular oedema.
51. Offer eye protection for people whose eye shows residual effects of
anaesthesia at the time of discharge after cataract surgery.
52. Commissioners and service providers should ensure that the following are
in place:
 Processes that identify complications after surgery and ensure
that there is prompt access to specialist ophthalmology services.
 Processes to ensure that the UK Minimum Cataract Dataset for
National Audit is completed.
 Arrangements so that healthcare professionals discuss second-
eye cataract surgery with people who have a cataract in their
non-operated eye.
53. Consider collecting patient visual function and quality-of-life data for entry
into an electronic dataset.
54. Do not offer in-person, first-day review to people after uncomplicated
cataract surgery.
55. At the first appointment after cataract surgery, give people information
about:
 eye drops
 what to do if their vision changes
 who to contact if they have concerns or queries
 when it is appropriate to get new spectacles and how to do so
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 second-eye cataract surgery if there is a cataract in the non-

operated eye
 arrangements for managing ocular comorbidities.
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4.2 Research recommendations summary

1. What is the association between preoperative vision- and health-related
quality of life, and postoperative vision-related quality of life, health-related
quality of life, and self-reported postoperative improvement?
2. What vision-specific quality-of-life measures best capture visual changes
in a population with cataracts?
3. What is the effectiveness and cost effectiveness of biometry techniques in
adults undergoing phacoemulsification cataract surgery with a history of
corneal refractive surgery?
4. How effective are newer intraocular lens formulas (for example, Barrett,
Olsen, T2) compared with standard formulas for phacoemulsification
cataract operations on eyes without a history of corneal refractive surgery,
especially for long and short axial lengths?
5. What is the effectiveness of different intraocular lens formulas for eyes
after prior corneal refractive surgery, as measured in a prospectively
collected multi-centre study?
6. What is the most effective material for square-edge lenses for preventing
posterior capsule opacification and improving postoperative vision in
cataract surgery?
7. What are the long-term outcomes of different choices of intraocular lens
material following cataract surgery?
8. What are the long-term rates of and reasons for lens explantation after
cataract surgery?
9. What is the effect of differences in contrast sensitivity and depth of focus
on overall visual function and quality of life?
10. What is the long-term effectiveness of blue light filtering IOLs in reducing
the incidence and/or progression of age-related macular degeneration?
11. What is the effectiveness of different approaches to monovision (the
degree of anisometropia) versus standard monofocal lenses?
12. What is the cost effectiveness of toric lenses compared with on-axis or
limbal-relaxing incision surgery, or non-toric lenses with no further
intervention, in an NHS context, taking account of the whole care pathway
cost implications from pre- to postoperative phases, stratified by the
preoperative level of astigmatism?
13. What is the effectiveness and cost effectiveness of limbal relaxing
incisions (in combination with any intraocular lens type) to reduce
postoperative astigmatism?
14. What is the long-term effectiveness of capsular tension rings in people
with pseudoexfoliation undergoing cataract surgery?
15. What is the effectiveness of postoperative antibiotic drops to reduce rates
of endophthalmitis after cataract surgery?
16. What is the most effective postoperative medical management for cystoid
macular oedema?
17. What is the risk of postoperative retinal detachment in people with high
myopia?
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Patient information
5 Patient information
Providing services that reflect the needs and preferences of patients, their families and their
carers is one of the core principles that define NHS values, as outlined in the NHS
Constitution. Patients, with their families and carers where appropriate, should be involved in
and consulted on all decisions about their care and treatment. Whilst no-one could disagree
with this code of practice, the practice itself can sometimes suffer from a lack of time,
resources and accessible information.
A cataract operation can be a daunting experience for patients, most of whom are older,
some with other medical conditions, which can create additional concerns for both clinician
and patient. Clinicians should engage in collaborating with the patient in their care, ensuring
they provide care that is patient centred, tailored and co-ordinated to the needs of the
individual. Throughout the patient journey, from diagnosis, to the operation and after care,
there should always be opportunities and time for questions and information.
Patient centred information is essential in supporting individuals to develop the knowledge
and confidence they need to make informed decisions about their health and healthcare.
This includes clear written information which outlines the individual steps of the operation as
well as pre and postoperative care.
Adequate explanation of the risks and benefits for the individual patient, ideally including
treatment options and expertise offered by the surgeon, will assist the patient / carer in their
decision-making regarding surgery. Clear explanations can allay anxiety, increase
understanding and in turn secure patient cooperation and compliance. This helps them
prepare preoperatively, during the operation, and in organising after care arrangements,
such as organising a family carer or someone to assist in returning home after the operation.
A realistic discussion between the surgical team and the patient preoperatively about likely
postoperative outcomes including vision, quality of life (both visual and general, where they
can be reasonably predicted), driving ability and probable timescale involved, whilst allowing
opportunities for patient to ask questions, should go some way towards ensuring patients
have realistic expectations, leading to greater satisfaction after surgery.
Most importantly of all, patients should always be treated with dignity, compassion and
respect.
Though there is little evidence to support specific interventions to improve patient centred
care in cataract surgery, common sense should prevail; surgeons, nurses and optometrists
should commit to consultations which are a mutual process of information sharing and joint
decision making in order to ensure the best clinical outcomes that are satisfactory for both
parties.
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Patient information
5.1 Patient information

5.1.1 Review questions
 What information do people with cataracts and their carers find useful, and what format do
they prefer it to be provided in?
 What information on cataract surgery do people and their carers find useful when deciding
whether surgery is appropriate for them, and before, during and after any operation(s)
they elect to undergo? What format do they prefer it to be provided in?
5.1.2 Introduction
In order to inform the content, utility and applicability of literature on cataracts and/or cataract
surgery, the aim of this review was to determine the information needs of:
 People who are diagnosed with a cataract and their carers; and
 People considering, about to undergo, or who have recently undergone cataract surgery
and their carers
The review focused on identifying studies that fulfilled the conditions specified in Table 7. For
full details of the review protocols, see Appendix C.
Table 7: PICO inclusion criteria for information needs for people with cataracts and
their carers
Population Adults (18 years and over) diagnosed with non-trauma related cataracts or
their carers
Information needs Any information needs identified in the literature that are specific to people
with cataracts and their carers
Factors of interest Themes surrounding patients’ or carers’ educational or information needs
such as:
 information on prognosis
 self-management
 treatment options
 self-management following surgery
 risks of complications
Qualitative surveys or interviews were considered to be the most appropriate study designs
to derive patient and carer information needs. Papers were excluded if they:
 were non-qualitative research, narrative reviews, commentaries, editorials/letters, opinion
pieces or case studies/reports
 included animals, healthy eyes, other ocular conditions besides cataracts or mixed
primary population of people with different eye pathologies.
 were not published in the English language.
For flow charts of study inclusion and exclusion, see Appendix K. For the list of excluded
studies with reasons, see Appendix F.
5.1.3 Evidence review

An overarching systematic search was conducted to inform the review questions on patient
information (see Appendix D), which identified 4,314 references. Due to the low volume of
relevant evidence obtained, the inclusion criteria for including studies from that search were
broadened to also include studies where qualitative data had been collected, but then
quantitatively analysed (e.g. studies reporting the proportion of people expressing a certain
opinion). The references were screened on their titles and abstracts and full papers of 18
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references were obtained and reviewed against the inclusion and exclusion criteria in the
review protocols (see Appendix C).
Overall, 15 studies were excluded as they did not meet the eligibility criteria, for reasons
such as not being a qualitative design or not reporting any outcomes of interest. Of the
remaining 3 studies that did meet the eligibility criteria, 1 was a focus group study, 1 was a
questionnaire study and 1 was a survey study.
No additional relevant studies were identified in the update searches undertaken at the end
of the guideline development process.
5.1.3.1 Description of included studies

One prospective survey study (Tan et al., 2008) investigated 100 patients’ preferences for
information and discussion prior to routine cataract surgery. All patients had already been
given standard information, including written information, at the time of listing for surgery.
Age ranged between 22 to 99 years old (mean age 74.7 years), with 70% being in their 70s
and 80s and 51% were male.
One study (Elder & Suter, 2004) administered a questionnaire to 190 patients before cataract
surgery to clarify what preoperative information patients wanted before a patient can be said
to have made an ‘informed decision’. The average age was 75.49 years and 59.7% were
female. Two-thirds of patients were to undergo their first cataract operation.
One study (Nijkamp et al., 2002) conducted 4 focus groups with 27 patients (5–8 patients per
group) to identify factors that are related to fear among patients who need to undergo
cataract surgery. Age ranged between 50 to 87 years (mean age 72.2 years) and 56% were
women.
Full details of the included studies are found in the evidence tables (see Appendix E), with
GRADE tables for quantitative data and CERQual tables for qualitative data given in
Appendix G.
5.1.4 Health economic evidence

A literature search was conducted jointly for all review questions in this guideline by applying
standard health economic filters to a clinical search for cataracts (see Appendix D). A total of
4,306 references was retrieved, of which none were retained for this review question. Health
economic modelling was not prioritised for this review question.
5.1.5 Evidence statements
5.1.5.1 Qualitative evidence

One focus group study exploring factors related to fear in 27 patients identified the following
themes relating to information provision for people undergoing cataract surgery (moderate
confidence evidence base):
 At home after diagnosis:
o Importance of patient information and reassurance.
o Importance of a positive doctor–patient relationship.
o Importance of positive social support.
o People undergoing second-eye surgery were more relaxed than those
undergoing first-eye surgery.
 Preparation for surgery at hospital;
o Fears could be reduced by providing comprehensive information about
anaesthesia and the operation itself.
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o People varied considerably in the amount of information they wanted before

surgery.
o Oral information was preferred over written information.
 Day of surgery:
o Trust was boosted by reassuring comments from the ophthalmologist during
surgery.
o People reported feeling fear or distress if they experienced unexpected
sensations of pain or discomfort during surgery.
 Postoperative visits:
o People were confused by unclear, incomplete or contradictory patient
information, and felt that unambiguous guidance about postoperative
restrictions would generate reassurance.
 Recovery at home:
o If not properly informed, patients worried about deteriorations in visual acuity
over the recovery period.
5.1.5.2 Quantitative evidence

Moderate-quality evidence from 1 survey of 100 participants found that, in addition to
receiving standard information about cataract surgery at the time of listing for surgery, 32 did
not wish to know “anything at all” about risks and would prefer to leave decision-making to
their ophthalmologists; 22 were interested only in knowing their overall chance of visual
improvement; and 46 welcomed a discussion of possible complications.
Moderate-quality evidence from 1 questionnaire study of 190 participants found that, before
cataract surgery, the most important information was the chance of visual improvement after
surgery, followed by when vision would improve; the overall risk of losing vision from the
surgery; the consequences of not having the operation and the types of serious
complications.
Moderate-quality evidence from 1 questionnaire of 190 participants found that the majority of
people preferred that preoperative information be provided in both a verbal and written
format.
5.1.5.3 Health economic evidence

No health economic evidence was identified for this review question.
5.1.6 Evidence to recommendations

Relative value of different The committee stated that themes surrounding patients’ or carers’
outcomes educational or information needs before and after cataract surgery
would all be relevant outcomes. They agreed that whilst qualitative
data were the most relevant for addressing this question,
quantitatively analysed data (such as the proportions of people who
wanted to receive certain types of information) would also be of
value.
Trade-off between The committee agreed that the quantitative evidence presented
benefits and harms clearly demonstrated that a large majority of people had a preference
for being given both verbal and written information, and agreed it was
appropriate to make an overarching recommendation to this effect
across the whole patient information section. They also agreed it
would be appropriate at this point to cross-refer to the general NICE
guidance on patient experience, which gives guidance on making
information accessible to patients and their carers.
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The committee agreed that both the quantitative and qualitative

evidence presented showed a clear structure of different stages at
which information was necessary. This began at the time of initial
diagnosis/referral; then at the point where people are being assessed
for surgery; on the day of surgery (both before and after surgery); and
finally during the postoperative follow-up period. The committee
agreed people’s information needs would change as they passed
through this trajectory. It also noted that there was considerable
heterogeneity in the amount of information people wanted to receive
(particularly around risks) but agreed it was always appropriate that
information should be available, even if the person decides they do
not want to receive all of it at that stage.
The committee agreed it would not be possible or appropriate to list
all the information that should be given to people at each stage,
particularly as this will differ between individuals, but agreed it was
appropriate to set minimum levels that should always be provided.
The specific items included in this minimum list were derived from
three sources: 1) items identified from the quantitative evidence as
being important to a large proportion of people; 2) items identified
through the qualitative evidence as being sources of distress if such
information was not provided; 3) committee consensus, where it was
agreed items would always form part of good practice for discussions
with individuals. Additionally, where other review questions in this
guideline (such as those on biometry in people with corneal refractive
surgery, or bilateral simultaneous cataract surgery) had identified
specific issues around patient information needs, it was agreed that it
would be appropriate to cross-refer to those sections here, to ensure
that there was coherency across the recommendations made for
patient information.
The committee agreed that, at the point of referral, the main
information needs were general (what cataracts are, how they may
affect people, how they can be treated), but that, as a person moved
in to more specialist care, they should receive more detailed
information about their specific risks and potential benefits from
surgery to help guide their decision-making. This conversation should
also include information about what they will need to do to prepare for
surgery, and the expected post-surgical pathway and recovery
pattern.
Specific information needs were identified for the day of surgery itself,
both before (when people should be informed what to expect during
the procedure so as to minimise any possible distress), and
afterwards (when detailed information should be provided about both
what to do and what to expect in the post-surgical period).
Consideration of health No health economic evidence was identified for this review question
benefits and resource and economic modelling was not prioritised. The committee agreed
use that none of the items listed should result in it being necessary to
increase the total contact time between staff and patients/carers, and
therefore there would not be expected to be any increase in resource
use.
Quality of evidence The committee agreed that the overall quality of the evidence was
moderate. They agreed that the evidence presented from a 2006
Dutch study was applicable to the UK, as neither the difference in
setting nor date would be expected to have a substantial impact on
the findings of the research.
Other considerations Recommendations on the information needs of people during the
postoperative recovery period are included in section 13.2 rather than
this section, but the committee did also make use of the evidence
from this section when drafting those recommendations.
The committee agreed that the subgroup of people who lacked
capacity to be involved in these discussions themselves required
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Patient information
specific consideration. They therefore agreed it was appropriate that,

when referring to the NICE guideline on patient experience, that
particular reference should be given to the recommendations on
patient capacity and consent. Additionally, the committee was aware
that the NICE guideline on dementia is currently being updated, and
the scope for that guideline contains making recommendations on
managing comorbidities (including ocular comorbidities) in people
living with dementia. The committee agreed it was appropriate to
draw attention to this upcoming guidance in the form of a footnote to
this recommendation.
The committee also noted that people with cataracts may need
written information to be given in modified formats (e.g. large print),
tailored to their particular visual problems. The committee agreed
these issues are appropriately covered in the NICE guideline on
patient experience in adult NHS services, and therefore no specific
recommendation was necessary.
5.1.7 Recommendations
1. Give people with cataracts, and their family members or carers (as appropriate),
both oral and written information. Information should be tailored to the person’s
needs, for example, in an accessible format. For more guidance on giving
information to people and discussing their preferences, see the NICE guideline on
patient experience in adult NHS services, particularly recommendations 1.2.12 and
1.2.13 on capacity and consent. For guidance on eye tests for people living with
dementia, see sensory impairment in the NICE guideline on dementia.
2. At referral for cataract surgery, give people information about:

 cataracts:
 what cataracts are
 how they can affect vision
 how they can affect quality of life
 cataract surgery:
 what it involves and how long it takes
 possible risks and benefits
 what support might be needed after surgery
 likely recovery time
 likely long-term outcomes, including the possibility that people might
need spectacles for some tasks
 how vision and quality of life may be affected without surgery.
3. At the preoperative outpatient appointment, review and expand on the topics in

recommendation 2, and give people information about:
 the refractive implications of different intraocular lenses (see
recommendation 27)
 types of anaesthesia
 the person’s individual risk of complications during or after surgery (for
example, the risk of postoperative retinal detachment in people with high
myopia; also see recommendations 17 and 18)
 what to do and what to expect on the day of cataract surgery
 what to do and what to expect after cataract surgery
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 what support might be needed after surgery

 medicines after surgery (for example, eye drops) and medicines that
people may be already taking (for example, anticoagulants).
 the refractive implications after previous corneal refractive surgery, if
appropriate (see recommendation 13)
 bilateral simultaneous cataract surgery, if appropriate (also see
recommendations 35 and 36).
4. On the day of surgery, before the operation, give people information about:
 their position on the list
 what to expect during and after surgery.
5. On the day of surgery, after the operation, give people information about:
 what visual changes to expect
 signs and symptoms of potential complications to look out for
 any restrictions on activities, for example, driving
 possible problems and who to contact
 emergency situations and who to contact
 eye drops
 pain management
 their next appointment and who they will see.
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Indicators for referral
6 Indicators for referral

Cataract surgery is the most commonly performed elective surgery in the UK, with over
400,000 operations performed in England each year over recent years. The clinical and cost
effectiveness of cataract surgery (at a population level) is well established in both people with
and without ocular comorbidities. In spite of this, there is concern that there is wide variation
across the country in commissioning policies for cataract surgery. In some areas, restriction
of access to cataract surgery has been introduced by referral thresholds, based only on
visual acuity. In England this has led to a reported threefold variation in the number of people
having cataract surgery between different areas.
Whilst cataracts are an almost inevitable consequence of ageing, the time at which cataract
surgery is performed can vary depending on the visual needs and social circumstances of
the individual. In the UK, a majority of patients with cataracts are first diagnosed by their
community optometrist, either during a routine check, or on presentation with a visual
problem. The decision to refer for surgery requires a careful, informed conversation between
clinician and patient, and includes consideration of the surgery itself. A referral to the hospital
eye service is often made through the GP after a recommendation from an optometrist, or
directly from optometrists. Only patients who would be likely to agree to and benefit from
surgery should be referred, to maximise the number of referrals who go on to have surgery,
and therefore the efficiency of the hospital eye service.
Limited capacity in the NHS and rising demand from an ageing population has led to
prioritisation initiatives in commissioning bodies, some of which are based on clinical criteria
and may not consider quality of life factors. However, the variation in prioritisation criteria can
lead to inequalities of access, and therefore it is important to understand the evidence base
behind any indicators or clinical thresholds for referral.
Visual acuity, both for near and distance, is the most commonly used and most easily
quantifiable indicator of visual function. However, in people with a cataract, sole dependency
on visual acuity can underestimate visual disability as it does not take into account other
symptoms of cataracts, such as glare or reduced contrast sensitivity, which have the
potential to significantly impact on a person’s quality of life. For example, a patient with a
posterior sub-capsular cataract in one eye might have visual acuity of 6/6 but have disabling
glare symptoms, preventing driving in bright sunlight and at night.
In many areas of England, priority is given to first-eye surgery, with restrictions on access to
second-eye surgery for people who have already had 1 cataract removed. Again, it is
important to understand the evidence base behind these decisions, and whether they are
clinically justified.
Ultimately, the decision for referral and surgery (for both first- and second-eye surgery) lies in
an informed discussion between clinician and patient, and necessitates a balance between
clinical measures such as distance visual acuity and other indicators of visual function,
clinical need for a clear fundus view (such as for diabetic retinopathy screening or the
management over other ocular comorbidities), and also individual requirements for activities
such as driving.
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6.1 Indicators and thresholds for referral for cataract surgery

 What are the indicators for referral for cataract surgery?
 What are the optimal clinical thresholds in terms of severity and impairment for referral for
cataract surgery?
6.1.2 Introduction
The aim of this review was to identify the indicators and thresholds for referral for cataract
surgery. The review focused on identifying studies that fulfilled the conditions specified in
Table 8. For full details of the review protocol, see Appendix C. The main outcomes for this
review were visual acuity, visual function and quality of life after surgery.
Table 8: PICO inclusion criteria for indicators and thresholds for referral for cataract
surgery
Adults (18 years and over) undergoing phacoemulsification cataract surgery
Population for non-trauma related cataracts
Interventions  Prioritisation criteria/appropriateness frameworks/scores/referral policies
 Preoperative visual function, acuity and health-related quality of life
Outcomes  Indicators for referral for cataract surgery
 Conversion rate
 Visual acuity
 Visual function
 Road traffic accidents
 Falls
 Health-related quality of life
 Resource use and costs
Papers were excluded if they:

 were narrative reviews, case studies/reports, commentaries, editorials/letters or opinion
pieces.
primary populations of people with different eye pathologies
 reported studies conducted entirely in non-OECD countries

In total, 10,956 references were found from a combined database search for both review
questions, and full-text versions of 85 citations that seemed potentially relevant to this topic
were retrieved and screened. Eight observational studies (prospective and retrospective
cohorts) were included (Bellan et al., 2005; Choi et al., 2008; Frost et al., 2001; Gutierrez et
al., 2009; Lash et al., 2006; Lundstrom et al., 2006; Quintana et al., 2009; Tobacman et al.,
2003) for indicators for referral. Five studies (4 prospective cohorts and 1 systematic review)
were included (Bilbao et al., 2009; Black et al., 2009; Kuoppala et al., 2012; Kessel L et al.,
2012; Monestam et al., 1999) for clinical thresholds.
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The design of included studies is summarised in Table 9 and Table 10. Full details and
results are found in the evidence tables (see Appendix E). It was not possible to pool the
results of individual studies together due to considerable heterogeneity both in the
populations and settings of the studies, and in the referral criteria and thresholds examined,
and therefore the results for each study are presented individually.
Table 9: Summary of included studies – indicators for referral

Study & location Population Methods
Bellan (2005) 149 people on Manitoba cataract Cataract surgery followed by
Canada waiting list who indicated no assessment of the benefit from
Prospective cohort impairment according to VF14 surgery according to VF14
questionnaire questionnaire.
Choi (2008) 222 people referred for cataract Rating of patients based on the
Korea surgery RAND/UCLA ratings.
Retrospective cohort
Frost (2001) 2,647 people referred for cataract Grouping individuals on suitability
England surgery and requirement for surgery
Gutierrez (2009) 4,336 people referred for cataract Rating of patients based on the
Spain surgery RAND/UCLA ratings.
Prospective cohort
Lash (2006) 412 referrals for cataract surgery Referrals outcomes assessed in
England terms of listing rate and reasons for
Prospective cohort not listing.
Lundstrom (2006) 307 cataract surgery patients Using the NIKE clinical tool to
Sweden allocate into indication for surgery
Prospective cohort groups.
Quintana (2009) 4,335 people referred for cataract Grouping patients using a newly
Spain surgery developed explicit appropriateness
Prospective cohort criteria for surgery.
Tobacman (2003) 793 people referred for cataract Rating of patients based on the
USA surgery RAND/UCLA ratings.
Table 10: Summary of included studies – thresholds for referral

Bilbao (2009) 4,356 cataract surgery patients Grouping patients according to
Spain baseline visual acuity
Prospective cohort
Black (2009) 745 cataract surgery patients Grouping patients according to
UK baseline visual function
Prospective cohort
Kessel (2016) 8 studies Systematic review
Denmark
Systematic review
Kuoppala (2012) 90 cataract surgery patients Grouping patients according to
Finland baseline visual acuity and visual
Prospective cohort function.
Monestam (1999) 453 cataract surgery patients Grouping patients using criteria
Sweden based on visual acuity
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Prospective cohort
6.1.4.1 Systematic review of published cost–utility analyses

standard health economic filters to a clinical search for cataracts. A total of 4,306 references
were retrieved, of which 2 were included for this review question. Summary results for the
published studies are included here, with detailed analysis and evidence tables available in
Appendix J. This question was also prioritised by the committee for original health economic
analysis.
Naeim et al. (2006) conducted an economic evaluation alongside an RCT that enrolled 250
patients with bilateral cataracts eligible for first-eye surgery in whom the predicted probability
of improvement in visual function was low. The trial randomised participants to surgery or
watchful waiting. The primary outcome measure was the self-reported change in visual
function measured using the Activities of Daily Vision Survey (ADVS). The Health Utility
Index 3 (HUI-3) instrument was also used to collect data on the health-related quality of life
(HRQoL) of participants at enrolment and at the 6-month post-surgery/post-enrolment
endpoint.
The Cataract Surgery Index (CSI) was used to assess how likely patients were to benefit
from surgery. Patients with a CSI score of 10 points or more are considered to have a low
probability (<30%) of improving with surgery. The economic analysis was conducted from a
co-payer perspective, which assumed that the costs of spectacles, medication and surgery
were shared between the patient and the provider, and non-healthcare-related costs to the
patient such as travelling to appointments and loss of working days were also incorporated
into the analysis. Results are presented as simple (not incremental) cost and QALY gains for
surgical intervention for the entire surgical cohort and for three scoring brackets of the CSI.
The cost-effectiveness of surgery was $38,288/QALY. In the subgroup of patients with a CSI
score > 11 (< 20% probability of improvement), the cost-effectiveness of cataract surgery
was $53,500/QALY. A sensitivity analysis suggests that, if costs increase by 50% or QALY
gains reduce by 25%, surgery is not cost effective at a threshold of $50,000 per QALY
(although it should be cautioned that this was not an incremental analysis and the threshold
is not being applied here to incremental costs and QALYs). The analysis only considers the
benefits of surgery as reported at 6 months post intervention.
Rasanen et al. (2006) considered the HRQoL assessment of patients undergoing cataract
surgery as a method of prospectively identifying those patients most likely to benefit from the
procedure. Three cohorts of patients with bilateral cataract were included: 87 patients in
which the first eye was to be operated, 73 in which both eyes were to be operated, and 59
patients who had a history of unilateral cataract removal. The average age (all patients) was
71 years (SD 11 years). HRQoL was measured immediately before and 6 months after
surgery using the 15D instrument, which has a Finnish-societal preference-based valuation.
The analysis used a secondary care provider payer perspective, with direct medical costs
taken from a Finnish clinical patient administration database. It is possible to calculate ICERs
by comparing the costs and QALYs between the first eye only and the bilateral surgery group
to create a second-eye vs unilateral surgery comparison (see Table 11).
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Table 11 Base-case results from Rasanen et al.

First-eye Both eyes Incremental
Costs QALY Costs QALY Costs QALY ICER
Mean € 1,318.00 0.1605 € 2,289.00 0.4464 € 971.00 0.2859 € 3,396.29
The third cohort, who had a history of first eye surgery and awaiting second eye-surgery,
experienced QALY losses after surgery of on average -0.0219. The reasons for this are
unclear but the authors suggest that it may be due to patient characteristics. Postsurgical
visual acuity data were not included in the study, making further investigation difficult.
6.1.4.2 De novo economic model
Methods
An Excel model was developed that compares 3 strategies: no surgery, immediate surgery,
and delaying surgery until visual acuity (VA) reaches a specified threshold. The delayed
surgery arm allows for the simulation of different VA thresholds so that the impact on cataract
surgery cost effectiveness can be examined. The model differentiates between first and
second operated eyes, incorporates visual acuity changes over time in eyes both pre- and-
postoperatively, and includes risk factors which influence the visual acuity outcome of
surgery. The model includes the cost of surgery including outpatient care, explicit costs of
measures to treat and monitor endophthalmitis, posterior capsule opacification (PCO),
posterior capsule rupture (PCR) and retinal detachment, and the NHS and PSS costs of
support services for people with low vision. Additional background costs associated with
increased health service use post-surgery, as detailed by Sach et al. 2010, are included in a
sensitivity analysis. A full description of the parameterisation of the model is given in
Appendix J.
In this analysis, it was necessary to build a model which might identify the particular
characteristics of people with cataracts that can change the expected balance between
benefits, harms and costs (see appendix J for the full rationale). The model is not designed
to generate ICERs that suggest whether surgery is or is not cost effective. Instead, the model
takes into account the available evidence on multiple risk factors and other patient
characteristics and generates an estimate of the minimum magnitude of change in HRQoL
that would be required to make cataract surgery cost effective, for a person – or a population
of people – with specified characteristics.
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Figure 1 Model structure for first eyes

Eye 1 Eye 2
Asymptomatic Symptomatic Asymptomatic Symptomatic
cataract cataract cataract cataract
Symptomatic Symptomatic
on waiting list on waiting list
Immediate
surgery
Surgery Surgery
No visual loss Visual loss No visual loss Visual loss

No PCR No PCR No PCR No PCR

PCR PCR PCR PCR
Eye 1 Eye 2
Delayed
surgery
Surgery Surgery


PCR PCR PCR PCR
Eye 1 Eye 2
No
surgery
Surgery Surgery


PCR PCR PCR PCR
Block red arrows show states in which patients can potentially start the model. ‘Surgery’ is not a state, but an
event resulting in transition to postsurgical states.
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Figure 2 Model structure for second-eyes

Eye 1 Eye 2
Second eye
Immediate
Surgery Surgery


PCR PCR PCR PCR
Eye 1 Eye 2
Second eye
Delayed
Surgery Surgery


PCR PCR PCR PCR
Eye 1 Eye 2
Second eye
No surgery
Surgery Surgery


PCR PCR PCR PCR
Block red arrows show states in which patients can potentially start the model. ‘Surgery’ is not a state, but an
event resulting in transition to postsurgical states.
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Figure 1 depicts how the general model structure is deployed in the 3 strategies simulated for
the first-eye surgery decision problem.
 In the case of immediate surgery, everyone joins the waiting list for first-eye surgery from
the outset. The second eye of these people may be symptomatic (in which case it will also
be assigned to the ‘waiting list’ state, and will receive surgery in the same 3-month cycle
as the first eye, or asymptomatic (in which case, it is subject to a probability of developing
symptoms as the model progresses).
 In the case of delayed surgery, the case will be identical to immediate surgery for anyone
presenting with both eyes at or below the acuity threshold determining access. However, if
one or both eyes have acuity better than the threshold, they will remain in the
‘symptomatic cataract’ state until their sight deteriorates to the required degree, at which
point they will join the waiting list for surgery. For the second eye, transition from
‘asymptomatic cataract’ directly to the waiting list is possible if the level of acuity
impairment in the eye had already crossed the threshold before the cataract became
symptomatic.
 In the case of no surgery, the first eye always remains symptomatic until death. The
second eye may start as symptomatic or develop symptoms over time; in either event, as
with the first eye, it remains symptomatic until death.
The model structure for second-eye surgery is similar, with some slight modifications. It is
shown in Figure 2. Regardless of strategy, the first (pseudophakic) eye represents a
weighted average of possible outcomes from the initial surgery, with probabilities of each
assumed to reflect the average observed across the population. No subsequent transitions
are modelled for the first eye (though this does not mean that no deterioration of acuity is
simulated for people with ‘good visual outcomes’; this categorisation simply reflects the short-
term result of the historical surgery). The ‘asymptomatic cataract’ state is no longer possible
for the second eye, as this decision problem envisages people in whom second-eye surgery
is being considered, who must have some degree of cataract-related impairment in the eye
in question.
 In the case of immediate surgery, everyone joins the waiting list for second-eye surgery
from the outset.
 In the case of delayed surgery, second eyes which meet the acuity threshold will also
join the waiting list immediately. However, eyes that have acuity better than the threshold
will remain in the ‘symptomatic cataract’ state until their sight deteriorates to the required
degree, at which point they will join the waiting list.
 In the case of no surgery, no transitions occur: the first eye remains in its assigned
postsurgical category and the second eye remains symptomatic until death.
We based our modelled cohort on the large Royal College of Ophthalmologists’ National
Ophthalmology Database (RCOphth NOD) study of cataract surgery. Multivariable models
using the RCOphth NOD dataset have been published which can be used to calculate the
probability of good or poor visual outcome based on patient and eye-related factors. Sparrow
et al. (2012) developed a logistic regression model to assess candidate indicators for poor
(doubling of visual angle or worse) visual outcome. The model incorporated data from 12
NHS trusts, totalling 406 surgeons across 55,567 cataract operations undertaken between
2001 and 2006, for which postoperative VA outcomes were known for 40,758 (73.3%). All of
the models adjusted for preoperative baseline VA as a continuous variable, and for inter-eye
correlation by adjusting for paired eyes. The models incorporated the following covariates:
 age
 sex
 any ocular comorbidity
 age-related macular degeneration
 glaucoma
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 diabetic retinopathy
 brunescent/white cataract
 high myopia
 corneal pathology
 amblyopia
 uveitis/synechiae
 no fundal view/vitreous opacities
 pseudoexfoliation/phacodonesis
 previous vitrectomy
 previous retinal detachment surgery
 axial length (quintiles)
 pupil size
 inability to co-operate
 unable to lie flat
 any alpha blocker
 tamsulosin, doxazosin, alfuzosin, indoramin, prazosin, terrazosin
 surgeon grade
 and PCR during surgery
Because of the large number of independent variables the models were limited to a main
effects approach, and were generated using forward and backwards stepwise methods. The
best-fitting visual loss model was one which included older age, short axial length, presence
of ocular comorbidity, diabetic retinopathy, small pupil size and PCR during surgery as risk
factors. We incorporated this model of clinically significant visual loss into our analysis.
The guideline committee advised that, from a purely pathological point of view, the modelled
population should be assumed to have bilateral cataracts (except in the case of unilateral
pseudophakia). However, it emphasised that this is not necessarily the same thing as
bilateral symptomatic cataracts; rather, it is the case that a cataract can always be detected
in the fellow eye of anyone with at least one symptomatic cataract.
The model uses a patient perspective for outcomes and an NHS and PSS perspective for
costs, in line with Developing NICE guidelines (2014). The model includes 6 dimensions of
data: baseline HRQoL, visual acuity in each eye, age, the probability of PCR, and the
probability of visual loss. The possible combinations of these values runs into the several
million, and therefore it is both sensible from the point of view of developing results that are
useful to making recommendations, and desirable from a computational workload
perspective, to rationalise these data by categorisation. The cross-categorisation across 6
domains results in a matrix of 2,916 unique scenarios, each representing some combination
of age, VA in the index eye, VA in the fellow eye, baseline HRQoL, risk of visual loss, and
risk of PCR. It may be useful to imagine this matrix as generating a very large number of
subgroup analyses, with the model calculating a categorical value of utility-gain for each of
the cells in the matrix, which represent each possible combination of variables (the
subgroups). For baseline HRQoL, we use natural breaks to characterise low, moderate and
good categories as 0.4/ 0.6/ 0.8. For utility gains, we started with the EQ-5D as a template
and developed the following categories accordingly:
 A very small change is any change less than moving a full category (i.e. less than the
EQ-5D can measure in an individual case)
 A small change is less than the smallest change possible when moving from a level 3 to a
level 2, but greater than the smallest change possible when changing from a level 2 to a
level 1
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 A moderate change is greater than this but less than the smallest change possible when
either:
a) moving from a 3 > 1
OR
b) moving from 2->1 in at least TWO separate categories.
 A large change is any change larger than this
These criteria equate to utility ranges of:
 Very small = 0.00–0.03
 Small = 0.03–0.06
 Moderate = 0.06–0.10
 Large = >0.10
The full results matrices are published in Appendix J, subappendix Jd.
Results
The model suggests that, in an overwhelming majority of scenarios, immediate first-eye
cataract surgery is cost effective compared with no surgery, even if it confers no
immediate HRQoL gain. This is because immediate surgery avoids future QALY losses and
costs incurred by leaving the cataract(s) to progress until death. There are very few
exceptions to this rule, all of which involve people aged 90 who have no impairment of BCVA
(6/6 vision) in the eye for which surgery is contemplated. If such people have either very
good or very poor vision in their other eye, and they are at high risk of both PCR and visual
loss, they would only be candidates for cost effective surgery if it confers an improvement in
their HRQoL that can be classified as at least 'very small' (see appendix J for illustrative
definitions).
When comparing immediate with delayed surgery, most people are predicted to benefit from
immediate surgery even if it confers no HRQoL gain and, in those cases where a gain of
HRQoL is necessary to justify the slightly higher cost of immediate surgery, this benefit only
has to be of 'very small' magnitude. However, compared to the immediate vs no surgery
comparison, there are a greater proportion of scenarios in which this kind of expectation is
necessary:
 In 90-year-old patients, when BCVA in the index eye is unimpaired (6/6) and the risk of
PCR and/or a poor visual outcome is high
 In younger patients, the scenarios in which a (very small) gain in HRQoL is needed are all
those in which fellow-eye vision is 6/12. In these cases, it is most important to achieve an
immediate gain in HRQoL when the risk of poor visual outcome is lowest; conversely,
when the risk is high, no such gain is necessary. This is because, in this case, the risk
only increases as the patient ages; therefore, delaying surgery until they meet a threshold
is counterproductive.
For second-eye cases, immediate cataract surgery is shown to be cost effective compared
with no surgery in most scenarios, even if it confers no immediate HRQoL gain. This is
because, as with the first-eye surgery, immediate surgery avoids future QALY losses and
costs incurred by leaving the cataract(s) to progress until death. Compared with the first eye,
there are slightly more scenarios in which HRQoL gain is necessary to produce an ICER
lower than £20,000 / QALY; however, in common with the first eye, all these relate to people
aged 90. In most cases, these scenarios also feature a high risk of visual loss. A very similar
pattern is shown when comparing no surgery with delayed surgery with an acuity threshold of
6/12: most people are predicted to benefit from immediate surgery even if it confers no
HRQoL gain and, in those cases where a gain of HRQoL is necessary to justify the slightly
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higher cost of immediate surgery, this benefit only has to be of 'very small' magnitude. All
these scenarios relate to 90-year-olds and most feature a high risk of visual loss.
Whilst it was not possible, because of structural constraints, to run any probabilistic
sensitivity analyses for the model, some deterministic sensitivity analyses were run. These
included simulating a more rapid deterioration of VA in people with cataract; including wider
NHS costs that would typically fall outside of the NICE reference case; and modelling an
alternative acuity threshold of 6/9 in the delayed surgery arm. The model behaved as
expected in these scenarios, with faster progression making immediate surgery more cost
effective in all cases, regardless of risk factors. Including wider costs, or changing the acuity
threshold to 6/6 increased the margin by which cataract surgery, in either eye, has to
improve HRQoL for 90 year old patients with higher risk profiles. A full description of the
sensitivity analyses is given in appendix J.
Conclusion
For the majority of patients with symptomatic cataract, it is clearly optimal to offer surgery,
and it is not cost effective to delay this until a VA threshold is met. This is true whether for
first- or second-eye surgery. For some combinations of characteristics (typically relating to
older patients with a high risk of perioperative visual loss), an expectation of improved quality
of life is necessary to make surgery cost effective but, in all such cases, the magnitude of
anticipated gain need only be 'very small' to justify immediate surgery.
6.1.5.1 Indicators for referral
6.1.5.1.1 Visual acuity

Low- to high-quality evidence from 4 cohort studies containing 8,452 participants found that
people categorised as needing cataract surgery more, using different assessment tools,
obtained a greater improvement in visual acuity compared with those categorised as needing
surgery less, but could not identify any subgroups in which no gain from surgery was
observed:
 High-quality evidence from 1 prospective cohort study containing 3,126 participants found
that people rated either necessary or appropriate for cataract surgery had a significantly
larger visual acuity gain 6 weeks postoperatively than people rated uncertain or
inappropriate.
 High-quality evidence from 1 prospective cohort containing 3,126 participants found that
people rated either necessary or appropriate for cataract surgery had a clinically
meaningfully higher probability of achieving an improvement in visual acuity of at least the
study’s defined minimal clinically important difference than people rated uncertain or
inappropriate.
that people rated as high priority for cataract surgery had a significantly larger visual
acuity gain 6 weeks postoperatively than people rated low priority.
 Moderate-quality evidence from 1 retrospective cohort study containing 222 participants
found that people rated either crucial or appropriate for cataract surgery had a significantly
larger visual acuity gain (LogMAR) 1 year postoperatively than people rated uncertain or
inappropriate.
 Low-quality evidence from 1 retrospective cohort study containing 768 participants found
that people rated either crucial or appropriate for cataract surgery had a clinically
meaningfully higher probability of improvements in visual acuity 4 months postoperatively
than people rated uncertain or inappropriate.
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6.1.5.1.2 Visual function

Moderate- to high-quality evidence from 3 cohort studies containing 7,684 participants found
that people categorised as needing cataract surgery more, using different assessment tools,
obtained a greater improvement in visual function (as measured with the VF-14 tool),
compared with those categorised as needing surgery less, but could not identify any
subgroups in which no gain from surgery was observed:
that people rated either necessary or appropriate for cataract surgery had a significantly
larger visual function gain 3 months postoperatively than people rated uncertain or
inappropriate.
that people rated either necessary or appropriate for cataract surgery had a clinically
meaningfully higher probability of achieving an improvement in visual function of at least
the study’s defined minimal clinically important difference than people rated uncertain or
inappropriate.
that people rated as high priority for cataract surgery had a significantly larger visual
function gain 6 weeks postoperatively than people rated low priority.
 Moderate-quality evidence from 1 retrospective cohort study containing 222 participants
found that people rated either crucial or appropriate for cataract surgery had a significantly
larger visual function gain 1 year postoperatively than people rated uncertain or
inappropriate.
6.1.5.1.3 Satisfaction
Moderate-quality evidence from 1 prospective cohort study containing 105 participants found
that, of the people who scored the maximum of 100 on their preoperative VF-14 form, a
substantial number were found to have subjective complaints about their vision.
6.1.5.2 Optimal clinical thresholds for referral

High-quality evidence from 1 prospective cohort study containing 4,356 participants found
that people with worse preoperative visual acuity (worse than 6/60) had larger gains in
postoperative visual acuity than those with better preoperative visual acuity (better than
6/12).
Very low-quality evidence from a meta-analysis of 3 cohort studies containing 368,644
participants could not differentiate proportions of people with improved postoperative visual
acuity between those with better and worse preoperative visual acuity.
Low-quality evidence from 1 prospective cohort study containing 93 participants found that
people satisfying a visual acuity criterion for surgery had clinically meaningfully higher odds
of postoperative visual acuity improvement.
Low-quality evidence from 1 prospective cohort study containing 453 participants could not
differentiate self-reported improvement indices between people with better and worse
preoperative visual acuity.

High-quality evidence from 1 prospective cohort study containing 4,356 participants found
that people with worse preoperative visual acuity (worse than 6/60) had larger gains in
postoperative visual function than those with a preoperative visual acuity (better than 6/12).
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Low-quality evidence from a meta-analysis of 2 studies containing 5,569 participants found

there was no meaningful difference in the proportions of people with improved postoperative
visual function between those with better and worse preoperative visual acuity.
Moderate quality evidence from 1 prospective cohort study containing 93 participants found
that people satisfying a visual function criterion for surgery had clinically meaningfully higher
odds of postoperative visual function improvement.
6.1.5.2.3 Operation success

Moderate-quality evidence from 1 prospective cohort study containing 745 participants found
there was no meaningful difference in proportions of people describing the results of their
operation as ‘good’ or ‘excellent’ between those with preoperative VF-14 scores <94.5 and
≥94.5, or between those with preoperative VF-14 scores <87.8 and ≥87.8
6.1.5.3.1 Published cost–utility analyses

One partially applicable CUA with serious limitations suggests that cataract surgery may be
cost effective even when there is low expectation of visual acuity gain. The degree of
uncertainty in this finding is significant, and no incremental analysis was performed. One
partially applicable CUA with serious limitations suggests that, based on a prospective
assessment of possible HRQoL gain following surgery, cataract surgery may be cost
effective if the patient has bilateral cataracts and the intention is to operate on both eyes, but
uncertainty in these findings is significant.
6.1.5.3.2 Original model

One directly applicable original health economic analysis with potentially serious limitations
suggests that:
1) Offering first-eye cataract surgery is cost effective compared with no surgery in
almost all cases even if it confers no immediate HRQoL gain, because future costs of
low vision and QALY losses are prevented.
2) When compared with delayed surgery (waiting until the first-eye acuity drops to 6/12),
most people are predicted to benefit from immediate surgery even if it confers no
immediate HRQoL gain, although there are more cases where a ‘very small’ gain of
HRQoL is necessary to justify the slightly higher cost of immediate surgery.
For second eyes:
1) Cataract surgery is cost effective compared with no surgery in most scenarios even if
it confers no immediate HRQoL gain.
2) Compared with delayed surgery, most people derive cost-effective benefit from
immediate surgery even if it confers no HRQoL gain and, in older, higher-risk cases
where a gain of HRQoL is necessary to justify the slightly higher cost of immediate
surgery, this benefit only has to be of 'very small' magnitude (see Appendix J).
The model results were somewhat sensitive to the inclusion of ‘unrelated’ costs after surgery
for first and second eyes, and the assumed rate at which visual acuity declines in
symptomatic eyes.

Relative value of different The committee agreed that, whilst visual acuity is still commonly used
outcomes to decide whether cataract surgery is needed, it is a crude measure
that will often fail to detect other vision problems that may justify
surgery (for example, glare, loss of colour vision). The committee
agreed that the best possible decision-making aids would be
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measures of pre- and postoperative vision-related quality of life,

which could be used to quantify the impact of surgery for the person,
and identify any groups of people who do not gain in quality of life
after surgery. However, it noted that most existing prioritisation
criteria were based primarily on visual acuity and visual function
(usually measured using the VF-14), which capture only part of the
impact of a cataract on quality of life.
Trade-off between The committee noted 2 primary harms that could result if there was
benefits and harms an increase in the number of people being referred for surgery.
Firstly, increased referral rates could lead to people without
significant visual problems having surgery and subsequently
experiencing a reduced quality of life where the benefits of surgery
are not enough to balance the risks. The committee discussed this
scenario and agreed that this is unlikely to be problematic provided
people were appropriately informed about the risks as well as
benefits of surgery.
Secondly, if a significant increase in the number of people having
surgery occurred, this could put pressure on capacity in the system.
The committee discussed this and agreed that, whilst it was possible
there could be a small increase in numbers in the short term, this
would be unlikely to lead to significant long-term changes as most
people referred earlier would have been likely to have their condition
worsen to the point of needing surgery later, and therefore this would
only be a change in the timing of the surgery, not in the overall
number of procedures taking place. The only exception to this would
potentially be in particularly elderly individuals, where the expected
rate of mortality before reaching the threshold may mean a
meaningful proportion of people never have surgery. Committee
members also noted that it was their experience that many surgeons
at present were not following thresholds for visual acuity unless they
were strictly policed, and that this practice would lower the risk of a
sudden influx of new people having surgery.
The committee also noted that, when undertaking watchful waiting of
patients, complication rates increase with increasing severity of
cataract. It noted that, whilst not everyone gets worse (as many are
stable), for those who do, this effect can be substantial and increases
the risks of surgery.
In the absence of the ideal data, the committee agreed that the
emphasis should be placed on patient–healthcare professional
discussions regarding the effect the cataract is having on the
person’s quality of life. The committee agreed that such discussions
should be used to inform people with cataracts of the risks as well as
the benefits of surgery. A willingness on behalf of the person with
cataracts to proceed with surgery following such a discussion
provides evidence that the person’s visual problems are having a
significant impact on their quality of life to the extent that they felt that
the potential benefits of surgery outweigh the risks. The committee
agreed that a structured discussion should, at minimum, contain how
the cataract is currently affecting the person’s quality of life, the risks
and benefits of surgery, and what may be expected to happen if the
person chooses not to have surgery.
Consideration of health The committee considered that the published economic evidence
benefits and resource presented had underestimated the costs associated with some key
use parameters. It noted that both studies underestimated the costs of
endophthalmitis, which could require several follow-up appointments
and so incur further costs. No studies reflected the possibility that
progression of infection can lead to eye removal, which although rare
would incur significant HRQoL losses. However, the committee also
discussed that endophthalmitis case numbers could have reduced
since 2006/7 due to the common use of prophylactic antibiotics, and
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that this would need to be reflected in the appropriate transition

probabilities in any new models. The cost of this prophylactic
treatment has also reduced over time because of the wider
availability of eye-drop formulations.
The committee discussed the characteristics of the patient cohorts
included in the models, noting that in both studies there was no
consideration of the need to use general anaesthesia for some
patients, which would increase the cost of the procedure for more
complex cases – some of the same cases with low predicted
probability of improvement in the Naeim (2007) study.
The committee recognised that adverse events in cataract surgery
involves a complex interplay of risks, with some complications
increasing the likelihood of future complications. For example,
patients who experience a posterior capsule rupture (PCR) during
surgery are more likely to experience a retinal detachment, and
retinal detachment is more likely in endophthalmitis, which is itself
more likely in patients who have experienced PCR. The risk
assessment of patients before surgery with regard to these adverse
events may result in a decision to delay surgery, and no published
models considered this possibility.
The committee was presented with an original economic analysis that
estimates the magnitude of utility gain needed for cataract surgery to
be cost effective given multiple risk-factors for visual loss. The model
compared three strategies – no surgery, immediate surgery, and
delayed surgery (to a 6/12 acuity threshold). In the majority of model
simulations, cataract surgery for first- or second-eye surgery was cost
effective compared with no or delayed surgery even if it does not
generate immediate HRQoL benefit, as future costs and QALY losses
were avoided by performing surgery. Because the model generates a
large series of matrices for each strategy, the committee also
reviewed several exemplar output profiles which illustrated the
categorisation of risk levels for visual loss and PCR, and also
categories of baseline HRQoL.
The committee discussed that the model was not a decision-making
tool for individual cases and that it was inappropriate to use the
matrices generated by the model to cross-check with individual
patient data when deciding to refer for surgery. Rather, the model
was good evidence to support a commissioning strategy that is not
based on visual acuity thresholds, but that takes into account the
relative benefits, risks, harms and costs of offering surgery. To that
end, the committee noted that, for the vast majority of cases in the
simulated cohort (even those examples with many risk factors for
poor visual outcome), immediate referral for surgery once cataract is
symptomatic only required very small gains in HRQoL in order to be
cost effective. This was independent of whether the surgery is for the
first eye or the second eye. The committee was presented with some
examples of where surgery required some degree of immediate
HRQoL benefit in order to be the cost effective strategy compared to
delayed surgery and noted, for example, that this was the case for
older (90yrs) patients with high risk of PCR and visual loss. However,
in these cases, the committee agreed that delayed surgery would still
not be justified, because the lower life expectancy of 90-year-olds
means that a nontrivial proportion of the cohort will die before they
would qualify for surgery, meaning that they experience avoidable
morbidity from their cataract before death as a result of the threshold.
The committee noted that one issue with the modelling approach was
that some combinations of factors created by the model were unlikely
in a clinical setting – for example, in a person of 90yrs of age with 6/6
vision in the index eye and worse acuity in the fellow eye, the fellow
eye would become the index eye and be operated on first. However,
the committee noted that these examples still had value in illustrating
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that surgical thresholds are not optimal, given that even 6/6 eyes
benefitted from surgery because future QALY losses and costs of low
vision were prevented.
The committee concluded that visual acuity thresholds, or limits on
second-eye surgery, were likely to incur avoidable QALY losses in
most cases, and could be shown to increase longer-term costs by
raising the demand for low vision services. The committee therefore
agreed it was appropriate to make a clear recommendation that
visual acuity thresholds should not be used as a criterion to restrict
access to cataract surgery. The committee agreed it was appropriate
to distinguish between effects on overall vision (which are an
important part of the decisions making process) and visual acuity,
which was been shown not to be effective as a decision-making
criteria.
The committee discussed the likely resource and capacity impacts of
recommending immediate referral, particularly the increased demand
for surgery and associated pressures on capacity. The consensus of
the group was that this would likely be a short-term increase in
demand as those people with visual acuity below thresholds (in trusts
where they currently apply) would move to waiting lists, but that after
that initial increase there would be a return to a steady state. The
original model was not designed to provide a dynamic simulation of
these potential concerns.
The committee discussed the difficulty inherent in contextualising the
categorical utility-gain estimates generated by the model with
reference to HRQoL instruments such as EQ-5D and VFQ-UI and
agreed there was a need for future research into how HRQoL
changes can be best captured in people with cataract. A research
recommendation was therefore made to look at validating quality of
life instruments in a population undergoing cataract surgery.
The committee noted that this work represented a step forward in
understanding the costs involved in cataract surgery and its most
common complications.
With reference to the model parameters, the committee agreed that
the model represented a detailed costing of cataract surgery, which
improved on other models with NHS contexts. Some rare, but
potentially high-cost complications which can have life-long effects,
such as rare cases of blindness caused by haemorrhage, or
iatrogenic glaucoma as a consequence of unresolved CMO, or
exceptional cases of endophthalmitis which require evisceration of
the eye, could not be included because of data availability. The
committee discussed that, while these events did indeed incur
additional costs which could be described, they were difficult to
predict and so rare that, from a whole-population standpoint, their
impact on the cost effectiveness of surgery would likely be
insignificant.
The natural history of cataract was discussed at length with the
group, particularly the very limited evidence base from which to draw
data on how visual acuity changes over time in patients with
symptomatic cataract, and how surgery might change this trajectory.
Despite these limitations, the committee agreed that the model
represents a step forwards in attempting to model visual acuity
changes pre-and postoperatively in pseudophakic and phakic eyes,
and therefore the lifetime visual consequences of the different
strategies considered. The committee agreed that it was appropriate
to consider the visual acuity change rates used in the model as
representing likely extreme scenarios, and that, whilst the true rate of
decline could not reliably be defined without larger, long-term
datasets and incorporation of cataract morphology data, it was
reasonable to assume it was somewhere within the range modelled.
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Moreover, the base-case value used was at the conservative end of

the spectrum; if the true average rate of decline is faster, surgery
would only become even more cost effective.
Quality of evidence The committee noted that the evidence presented was largely in line
with current clinical opinion. It noted that no relevant studies were
identified to inform a distinct tool or set of criteria that could be used
to determine a threshold for cataract surgery. In particular, whilst
many papers found that people rated less appropriate for surgery had
smaller gains after surgery, even in the least appropriate group there
were still statistically significant postoperative gains.
It agreed that the evidence did not support the use of visual acuity
measurements as a threshold indicator for surgery. No studies were
able to identify a group of patients by visual acuity at baseline who
did not improve after surgery.
The committee discussed and agreed that the various prioritisation
tools presented were often primarily dependent on a visual acuity
threshold. It noted that consideration of the risk–benefit transaction
involved in offering surgery was missing (for example: a person
ranked ‘appropriate’ using the tool may decide, after consultation,
that they did not want to go ahead with the procedure, whilst a person
ranked ‘inappropriate’ may have other vision problems not fully
captured by the tool which mean they would benefit from and want
surgery).
The committee agreed that the VF-14 tool does not appear to be
accurate in determining whether someone requires surgery. It
suggested that this may reflect the fact that the validation cohort for
the VF-14 tool was undertaken long before phacoemulsification
surgery was available. The committee noted that the outcomes of
surgery are now very different compared with when the tool was
validated and this may account for its lack of sensitivity, particularly at
the top end of the scale. It noted that even people with the best
possible preoperative score on the VF-14 consistently reported
postoperatively that their preoperative symptoms were sufficient to
justify surgery.
The committee noted that the majority of the evidence only consisted
of 2 outcome measurements, one before and one after surgery, and
that this left gaps in the evidence base. In particular, there was no
measurement of how the benefits of surgery persist over time and no
data on outcomes for people not having surgery, such as any decline
in their vision or quality of life before surgery at a later time point.
Other considerations The committee agreed that, on first inspection, it may appear
somewhat counterintuitive that there are tools which are able to
identify groups of people who will gain more from surgery than
others, but that surgery is still cost-effective in all the subgroups.
However, the committee agreed this was because the current tools
are not sensitive enough to be able to detect specific small subsets of
people who may exist where the costs and harms of surgery
outweigh the benefits.
The committee noted that, in certain places in the country, there are
issues with a lack of access to optometry services, and this could
result in people who would benefit from surgery not being identified.
However, this was agreed to be a broader structural problem, and not
one that could be fixed or improved by any recommendations around
the thresholds used for referral.
The committee also noted that, whilst evidence was presented linking
preoperative visual acuity and visual function to postoperative visual
acuity and visual function, no such data were available on the more
relevant question of the link between preoperative quality of life and
postoperative quality of life. Therefore, the committee agreed to make
a research recommendation in this area.
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6. Base the decision to refer a person with a cataract for surgery on a discussion
with them (and their family members or carers, as appropriate) that includes:
 how the cataract affects the person's vision and quality of life
 whether 1 or both eyes are affected
 what cataract surgery involves, including possible risks and benefits
 how the person's quality of life may be affected if they choose not to
have cataract surgery
 whether the person wants to have cataract surgery.
7. Do not restrict access to cataract surgery on the basis of visual acuity.
6.1.8 Research recommendations
1. What is the association between preoperative vision- and health-related quality of

life, and postoperative vision-related quality of life, health-related quality of life,
and self-reported postoperative improvement?
Why this is important

In contrast to the data linking preoperative visual acuity and visual function with
postoperative visual acuity and visual function, there is a lack of evidence on the association
between preoperative vision- and health-related quality on postoperative outcomes and
levels of satisfaction for people having cataract surgery. This makes it difficult either to
identify those groups of individuals who may achieve the largest gains from surgery, or to
provide people with accurate information about what their potential gains may be. Robust
information around the link between preoperative patient characteristics and outcomes would
be useful both for prioritisation of surgery, and to help better inform individuals about the
levels of gain they may individually expect to get from surgery.
2. What vision-specific quality-of-life measures best capture visual changes in a

population with cataracts?

Although visual acuity is still commonly used to decide whether cataract surgery is needed, it
is a crude measure that will often fail to detect other vision problems that may justify surgery
(for example, glare and loss of colour vision). The best possible decision-making aids would
be measures of preoperative and postoperative vision-related quality of life, which could then
be used to identity groups of people who do not have an improvement in quality of life after
surgery. However, most prioritisation criteria are based primarily on visual acuity and visual
function (usually measured using the VF-14), which capture only part of the impact of a
cataract on quality of life. The development and validation of suitable vision-specific, quality-
of-life measures would aid the decision-making process for cataract surgery, and help to
accurately quantify the quality of life gains that may be expected from surgery. Particular
consideration should be given to people with learning disabilities/cognitive impairment, or any
other groups who may find it more difficult to self-report their own symptoms or quality of life.
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Preoperative assessment and biometry
7 Preoperative assessment and biometry

The current methods to remove a cataract are now very reliable with great reproducibility. A
key component of determining a successful outcome is the ability to calculate the power of
the lens implant used to replace the natural lens.
The refractive power of the human eye is dependent on three factors, the power of the
cornea, the power of the lens (and where it will sit in the eye) and the length of the eye.
During cataract surgery a replacement intraocular lens (IOL) is inserted. By knowing the
power of the cornea and the axial length of the eye, it is possible to calculate the power of
this replacement lens to give the desired refractive outcome.
Biometry is the process of measuring the corneal power and length of the eye. Inaccuracy in
either of these measurements will lead to an unpredicted postoperative refractive error.
Corneal power accounts for about 2/3 the total power of the eye and errors in calculation will
have a significant effect on the refractive outcome. Corneal power is calculated from
measurements made by a keratometer or by a corneal topographer. The calculation of
corneal power is based on the curvature (steepness) of the cornea. In keratometry,
assumptions are made of a fixed relationship between the front and back corneal surfaces
and its uniform spherical shape when making this calculation. This relationship between
corneal surfaces is particularly altered during corneal refractive surgery. Some corneal
topographical methods measure the anterior and posterior radii of corneal curvature as well
as corneal thickness and use these to calculate corneal power.
The accuracy of axial length measurement is crucial in IOL power calculations. A 1mm error
in measurement can lead to an equivalent power error of 3.00D. The axial length of the eye
may be measured by ultrasound (contact or immersion) or by optical means.
Ultrasonography Amplitude scan (A-scan) measures the time taken for an ultrasonic pulse to
travel from the cornea to the retina and from this calculates the distance travelled between
the two points. Optical methods use partial coherence laser tomography, and use the
interferometry principle to calculate distance from the cornea to the retina.
Once the measurements of the eye have been made, the power of the replacement
intraocular lens can be calculated. The formulas for these calculations are generally
incorporated into the biometry equipment software and include one or more constants which
are specific for a particular lens. They are supplied by the lens manufacturer but may be
refined or optimised by a surgeon, taking into account their previous surgical results.
The accuracy and consistency of biometry is dependent on the operator, the individual
equipment and the appropriateness of the formulas used, all of which contribute to accuracy
and therefore to the refractive outcome of surgery
Optimal biometry is critical to the success of the cataract surgery in terms of the actual
refractive outcome being congruent with the required refractive outcome. It is critical
therefore that the person undertaking the biometry is competent to undertake the procedure,
and a competence framework has been developed by the ophthalmic professional
organisations and is available from: https://www.rcophth.ac.uk
Risk Stratification
Risk stratification is a tool for identifying or predicting which patients are at high risk of
complications, in this case in cataract surgery. By analysing a large database of patients
undergoing cataract surgery and the incidence of complications and their outcomes, it has
been possible to determine which patient characteristics and what preoperative co-
morbidities are likely to be associated with per- and postoperative complications and a poor
visual outcome.
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Risk stratification tools can be used to alert the surgeon to potential complications and poor
outcomes and therefore be able to more accurately counsel the patient and arrange for the
cataract surgery to be performed by surgeons with the appropriate skills.
Risk stratification is also an important component of surgical audit, allowing more accurate
assessment and benchmarking of outcomes.
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7.1 Biometry techniques

7.1.1 Review question
 What is the effectiveness of different techniques for undertaking biometry?
7.1.2 Introduction
The review focussed on identifying studies that fulfilled the conditions specified in Table 12.
For full details of the review protocol, see Appendix A. The main outcome for this review
question was the predictive accuracy of the different techniques, assessed by deviations
from the predicted refractive outcome expressed as a spherical equivalent. As suggested by
Gale et al. (2009), a benchmark standard of 85% of individuals achieving a final spherical
equivalent within 1.00 dioptre of the predicted refraction and 55% of individuals within 0.50
dioptres was used to evaluate the clinical relevance of the review findings.
Table 12: PICO inclusion criteria for the review question on biometry techniques
Population Adults (18 years and over) undergoing biometry prior to phacoemulsification
cataract surgery with intraocular lens implantation
Interventions Ultrasound biometry vs. optical biometry (axial length)
and  Immersion ultrasound. Examples: immersion ultrasound A-scan (Canon KU-1
comparators IOL measurer), immersion B-guided
 Contact/applanation ultrasound (contact A-mode). Examples: Grieshaber
Biometric System, VPLUS A/B scanner
 Optical biometry. Examples: partial coherence laser interferometry (optical or
ocular) coherence biometry, laser Doppler interferometry, IOLMaster (Carl
Zeiss), Lenstar LS900, optical low-coherence reflectometry (OLCR) optical
biometer, laser interference biometry
Keratometry vs. topography (corneal curvature)

 Manual keratometry
 Automated keratometry
Examples: IOLMaster, autokeratometer/Topcon KR-7100, partial coherence
interferometry keratometer, videokeratography
 Topography. Examples: Pentacam Scheimpflug, Orbscan Topography System
Outcomes  Deviation from predicted refractive outcome expressed as a spherical equivalent
 Resource use and cost
Randomised controlled trials (RCTs) comparing different biometry and keratometry

techniques in adults undergoing phacoemulsification cataract surgery to predict the accuracy
of postoperative refraction were included. Papers were excluded if they:
 were guidelines/health technology assessment reports, narrative reviews, case
studies/reports/series, reliability studies, diagnostic accuracy studies, non-comparative
studies
 focused on combination surgical procedures, that is cataract surgery in tandem with other
surgical procedures (for example, phacotrabeculectomy, canaloplasty, Descemet's
stripping automated endothelial keratoplasty)
 compared biometry techniques with no biometry only or standard care that was not
specified
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Protocol deviation
Only one RCT published in 1995 comparing standard keratometry and corneal topography
on 46 people undergoing phacoemulsification cataract surgery was identified (Antcliff et al.,
1995). The Guideline committee noted that keratometry techniques are routinely used as
current standard practice in the NHS, while topography which requires greater expertise
(training) and time is used in specific circumstances, such as for individuals with a history of
corneal refractive surgery that results in an increased risk of postoperative refractive errors
stemming from difficulties in estimation of corneal power. Therefore, the committee agreed
that it would be useful to further consider observational evidence comparing keratometry
techniques and topography only within this specific subgroup. Two observational studies
comparing keratometry with topography in individuals with a history of corneal refractive
surgery undergoing phacoemulsification cataract operations were identified.

In total, 18,080 references were found for a combined database search for all 4 related
review questions on biometry and postoperative refractive errors, with 315 articles ordered
for full-text review. Five unique RCTs were identified for the comparison of ultrasound and
optical biometry (Fontes et al., 2011; Kolega et al., 2015; Naicker et al., 2015; Rajan et al.,
2002; Raymond et al., 2009). One RCT was identified for the comparison of keratometry and
topography (Antcliff et al., 1995), while two retrospective case series were identified for this
comparison in the specific subgroup of individuals undergoing phacoemulsification cataract
surgery with a history of corneal refractive surgery.

Details of the included studies are found in the evidence tables (see Appendix C).
7.1.3.1.1 Ultrasound (immersion and contact) and optical biometry to measure axial length
The 5 RCTs including a total of 588 participants (629 eyes; range n=40 to 200) were carried
out in England (Rajan et al., 2002), Australia (Raymond et al., 2009), Croatia (Kolega et al.,
2015), Brazil (Fontes et al., 2011) and Malaysia (Naicker et al., 2015). Only 1 trial included
multiple eyes per participant (Fontes et al., 2011). Baseline characteristics of participants
across all studies included mean ages ranging from 67 to 74 years (only age range of 60 to
84 years was reported by Kolega et al., 2015), similar distributions of male and female (57%
to 60% female were reported in 4 studies; not reported by Rajan et al., 2002) and mean axial
lengths ranging from 23.22mm to 23.45mm (reported in 3 studies; Naicker et al., 2015
specifically excluded people with axial lengths <20mm or >25mm while Kolega et al., 2015
provided no details of this characteristic). With the exception of the study conducted by
Raymond et al. (2009), the other 3 trials specifically excluded participants with ocular
pathologies that may result in poor visual prognosis. Only Naicker et al. (2015) provided
information on specific diagnosis using the Lens Opacities Classification System III (LOCS
III), while Raymond et al. (2009) provided details of the types of cataracts that were observed
in the sample.
Four trials randomised participants to partial coherence laser interferometry (IOLMaster;
Fontes et al., 2011; Kolega et al., 2015; Rajan et al., 2002; Raymond et al., 2009), while
Naicker et al. (2015) examined optical low-coherence reflectometry (Lenstar) in its optical
biometry group. Two studies examined immersion ultrasound biometry (Fontes et al., 2011;
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Naicker et al., 2015), while the other 3 trials focused on applanation or contact ultrasound
biometry (Kolega et al., 2015; Rajan et al., 2002; Raymond et al., 2009). Only Kolega et al.
(2015) did not provide details of the preoperative assessments/assessors. The remaining 4
RCTs highlighted that the persons undertaking the biometry were experienced, with only
Naicker et al. (2015) quantifying the years of experience as a clinical technician (4 years);
other studies specified experienced biometrist (Rajan et al., 2002), experienced
ophthalmologist (Fontes et al., 2011) and senior orthoptist (Raymond et al., 2009). With the
exception of the study conducted by Raymond et al. (2009), these other 3 trials used the
same individual to assess both biometry techniques.
Keratometric measurements were standardised in 2 studies (Naicker et al., 2015; Raymond
et al., 2009). Rajan et al. (2002) and Kolega et al. (2015) used the Javal keratometer and
Righton Speedy-K type automated keratometer respectively for the ultrasound group only,
while Fontes et al. (2011) did not provide any details of keratometric measurements. Four
studies used the same formula for both biometry techniques (Hoffer Q – Naicker et al., 2015;
SRK-T and same intraocular lens (IOL) constant – Rajan et al., 2002; Holladay I – Fontes et
al., 2011, Holladay II – Kolega et al., 2015), while Raymond et al. (2009) used the SRK-T
formula and manufacturer-recommended constant for the optical group and the SRK-II
formula and IOL manufacturer-recommended constant for the ultrasound group. Four studies
did not provide any details of IOL constant selection and/or optimisation (Fontes et al., 2011;
Kolega et al., 2015; Naicker et al., 2015; Rajan et al., 2002).
All phacoemulsification cataract surgery was undertaken by the same surgeon for 3 studies,
while 2 and 12 different surgeons performed operations in the studies conducted by Kolega
et al. (2015) and Raymond et al. (2009) respectively. Postoperative refractive assessment
varied from up to 2 weeks (Fontes et al., 2011), 5 weeks (Raymond et al., 2009), 6 weeks
(Kolega et al., 2015) and 2 months (Naicker et al., 2015; Rajan et al., 2002). Only 2 studies
provided details of the methods employed to assess postoperative refraction: autorefractor
confirmed with subjective refraction (Rajan et al., 2002) and mixture of subjective refraction
and autorefractor conducted by community ophthalmologists and optometrists as per
standard practice (Raymond et al., 2009).
The quality of the evidence ranged from very low to low (see Appendix D for the GRADE
tables and Appendix E for the forest plots).
7.1.3.1.2 Keratometry (manual and automated) and topography to measure corneal curvature
One RCT comparing standard keratometry (details not provided) and topography (3mm zone
keratometric equivalent readings using the Eyesys Corneal Analysis System) in 46
participants (46 eyes) undergoing phacoemulsification cataract surgery with no specified
history of corneal refractive surgery was carried out in England (Antcliff et al., 1995).
Individuals who had fundal lesions sufficient to reduce postoperative acuity and accuracy of
refraction or were unable to undergo the keratometry techniques were excluded. Reported
baseline characteristics were limited to mean age of 74 years (range 32 to 92) and proportion
of women (34; 73.9%). Biometry measurements for all patients were standardised using the
A-scan biometer and the SRK-II formula was used to calculate the IOL power. No further
details of the preoperative assessment were provided. Two surgeons performed
uncomplicated phacoemulsification cataract surgery with implantation of the same type of
5mm posterior chamber lens in the capsular bag. Postoperative refraction was carried out 3
months after surgery by a “masked” investigator but no further details were provided. The
quality of the evidence was low (see Appendix D for the GRADE tables and Appendix E for
the forest plots).
Two retrospective case series conducted in the USA (Canto et al., 2013) and South Korea
(Kim et al., 2013) compared automated keratometry (IOLMaster) and topography (TMS or
Pentacam) in a total of 80 people (93 eyes) with a history of corneal refractive surgery who
had phacoemulsification cataract surgery. Kim et al. (2013) specifically included people who
had corneal refractive surgery for myopia. The mean ages were 52.4 and 60 years, with a
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greater proportion of men included in Canto et al. (2013)’s study (n=22/33) compared with an
even distribution of men and women in the Kim et al. (2013) study (22 men and 25 women).
The mean duration between refractive and cataract surgery was reported by Kim et al.
(2013) to be 8.67 years (SD 5.45, range 1 to 16). The mean axial length was only reported
by Kim et al. (2013) to be 27.75 mm (SD 2.19). Biometry measurements were only
standardised by Canto et al. (2013) using the IOLMaster, while Kim et al. (2013) used
immersion ultrasound for the keratometry group and the IOLMaster for the topography group.
The SRK/T formula was used for all groups in both studies, but neither study provided details
of IOL constant optimisation. Uneventful phacoemulsification cataract surgery was performed
by 8 surgeons with 4 IOL models in Canto et al. (2013), while 1 surgeon and 1 IOL model
were reported in the study by Kim et al. (2013). Canto et al. (2013) did not provide details of
the timing of the postoperative refraction assessment, while Kim et al. (2013) noted that
these measurements were undertaken 2 months following surgery. The quality of the
evidence was very low (see Appendix D for the GRADE tables and Appendix E for the forest
plots).

7.1.5.1 Ultrasound (immersion and contact) and optical biometry to measure axial length
Low-quality evidence from 5 RCTs containing 588 participants found no statistically
significant between group differences in mean absolute prediction errors for ultrasound
(including separate subgroup analyses for immersion and contact) compared with optical
biometry in people undergoing phacoemulsification cataract surgery. Similarly, no statistically
significant between group differences were observed in the proportion of individuals
achieving postoperative refraction within various predicted ranges (<0.50 dioptres, <1.00
dioptre, <1.50 dioptres and <2.00 dioptres). Both the ultrasound and optical biometry groups
demonstrated similar levels of achieving the standard benchmarks for individuals attaining a
final spherical equivalent within 1.00 dioptre of the predicted refraction (90.7% with
ultrasound biometry vs. 93.6% with optical biometry) and within 0.50 dioptres (68.2% with
ultrasound biometry vs. 72.7% with optical biometry).
7.1.5.2 Keratometry (manual and automated) and topography to measure corneal curvature
Very low- quality evidence from 1 RCT containing 46 participants found no statistically
significant between group differences in mean absolute prediction errors for standard
keratometry compared with corneal topography in people undergoing phacoemulsification
cataract surgery. Statistically significant between group differences were observed in the
proportion of individuals achieving postoperative refraction within 0.50 dioptres of the
predicted refraction (34.8% with standard keratometry vs. 69.6% with corneal topography).
Overall, very low-quality evidence from 2 retrospective case series containing 186
participants showed smaller mean prediction errors and/or greater proportions of individuals
within 0.50 dioptres of the predicted refraction in the topography group compared with the
automated keratometry group in people undergoing phacoemulsification cataract surgery
with a history of corneal refractive surgery. However, the direction of effect and/or whether
statistically significant between group differences were observed depended upon the type of
topography machine (e.g. Scheimpflug or Orbscan), topography reading (e.g. true net
corneal power, equivalent K, 2.0mm or 4.0mm diameter central zone of the total mean
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power, simulated K), formulas (e.g. SRK-T, Haigis-L, American Society of Cataract and
Refractive Surgery estimation) and point estimate (e.g. mean prediction errors, mean
absolute prediction errors) used.


Relative value of different The Guideline committee agreed that the critical outcome for decision
outcomes making was deviation from predicted refractive outcome, while
resource use and costs were considered to be important.
The committee noted that tolerances in axial length and corneal
curvature measurement and formulas may impart a total refractive
error of up to 1.00 dioptre. The committee noted that axial length is a
major contributor to prediction errors such that for every 1.0mm
measurement error, 3.00 dioptres refractive outcome error is
introduced. However, the ratio for keratometry is 1:1, such that for
every 1.00 dioptre corneal curvature error, 0.90 to 1.00 dioptres
refractive outcome error is introduced.
Trade-off between The committee noted that optical biometry is commonly used in
benefits and harms routine NHS standard practice as it is user-friendly, convenient, fast,
does not require direct contact with the individual’s eye and
generates the results immediately. In addition, commonly used
optical biometry machines have the capability of providing both axial
length and keratometry measurements so additional corneal
curvature measuring devices are not required. However, the
committee noted that optical biometry is not appropriate in some
individuals, for example, those with dense cataracts, and in those
cases ultrasound biometry becomes necessary. The committee noted
that in current UK practice, optical biometry machines may be used to
measure keratometric readings, even in these situations where
ultrasound biometry is required to measure axial lengths.
In contrast, ultrasound biometry procedures are more complicated,
requiring experienced technicians to minimise measurement errors
resulting from for example, excessive corneal indentations that
artificially shortens the length of the eye, or off-axis readings. Contact
ultrasound biometry also requires an anaesthetic to be administered
with a small risk of infection and abrasion, while immersion
ultrasound biometry requires an eye water bath. However, the
committee noted that ultrasound biometry is convenient as the
machine is portable and therefore can be useful in tandem with hand-
held keratometers for individuals with limited mobility or reduced
ability to comply (for example, reduced cognitive function). The
committee noted that owing to the limited availability of expertise in
ultrasound biometry in the NHS, there may be delays in undertaking
the assessment and obtaining the results, particularly if the individual
has to be referred to another centre.
The committee highlighted that ultrasound and optical biometry may
give different results, and this needs to be taken in to account when
calculating the intraocular lens power. No statistically significant
differences in absolute prediction errors were observed for ultrasound
and optical biometry, irrespective of the type of ultrasound biometry
(although the committee recognised that specific studies only
comparing immersion and contact ultrasound biometry were
excluded). The committee also noted that both ultrasound and optical
biometry showed proportions of individuals exceeding the standard
benchmarks for attaining a final spherical equivalent within 0.50
dioptres and 1.00 dioptre of the predicted refraction.
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The committee noted that automated keratometry is currently used in

NHS standard practice to assess corneal curvature measurements in
routine cataract surgery patients with regular corneas. However,
keratometry may not be appropriate for some individuals. Therefore,
corneal topography is a useful adjunct in patients with irregular
corneas or a history of corneal refractive surgery. The committee also
noted that corneal topography may be useful in circumstances where
the cornea is abnormally flat (<41.00 dioptres) or steep (>47.00
dioptres) or if there is significant astigmatism (delta K >2.50 dioptres)
to assist in planning of incision techniques.
The committee agreed that there is a significant cost attached to the
machinery for corneal topography, particularly in light of its relatively
infrequent use in biometry. Moreover, a high level of skill is required
to undertake corneal topography, the equipment may not be available
in all ophthalmology departments and measurements take longer,
requiring expertise in interpreting the data. The committee also noted
that machines and techniques measure different points on the eye
and use different readings.
Consideration of health For optical biometry, the main cost relates to the cost of the
benefits and resource equipment, which is already in situ in NHS clinics. In addition, cost is
use offset by the volume of use and throughput, and the lower staff time
and experience required.
For ultrasound biometry, the main costs relate to higher staff time and
experience required, because ultrasound biometry equipment is
widely available in all departments. Access to ultrasound biometry-
experienced technicians is rapidly declining as optical biometry
becomes ubiquitous. The impact of this is resource limitation and the
need to refer individuals to clinics that still have staff with the
expertise to undertake ultrasound biometry. The committee agreed
that ultrasound biometry should be available and able to be used in
ophthalmic units to ensure that people with physical or cognitive
impairment are not unfairly disadvantaged because they cannot
travel to another unit where the service is offered.
The committee noted that the evidence indicates that both ultrasound
and optical biometry are effective. However, given the practical
advantages of optical biometry, the most efficient way of
implementation is as currently observed in standard NHS practice,
where optical biometry is routinely used, and ultrasound biometry
used in special circumstances. In spite of this, the committee agreed
that it was important to maintain competence in ultrasound biometry
within the NHS, for use in situations where optimal biometry is either
not practical to do, or does not provide accurate results.
The committee noted that the main costs attached to corneal
topography is in the acquisition cost of the machine and the
requirement for highly skilled and experienced staff to operate the
equipment and interpret the results.
Quality of evidence The committee noted that only 5 relevant randomised controlled trials
were identified for the comparison on ultrasound vs. optical biometry.
It noted that there was a larger body of evidence consisting of
comparative case series that may provide further evidence for this
comparison, but agreed that given the potential confounding factors
of the observational studies, the best study design to consider the
effectiveness of the different biometry techniques was the
randomised controlled trial. The committee agreed that the overall
quality of evidence was low because of the risk of bias associated
with the limited reporting in the studies, and the lack of
generalisability on the use of ultrasound biometry in the studies
compared with standard NHS clinical practice. It noted that all studies
used 1 experienced practitioner/technician to undertake all the
ultrasound biometry measurements and therefore, inter-observer
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reliability would not be captured. It agreed that the accuracy and

reliability of ultrasound biometry is heavily dependent on technicians’
experience and therefore was not confident that the observed
findings would be reproducible in current NHS clinical practice, where
ultrasound biometry is no longer routinely used, which has
implications on staff training and expertise.
The committee discussed the evidence and noted that the
randomisation methods used in Fontes et al. (2011) were unclear and
that the 2 groups were of very different sizes, suggesting the
possibility of biased allocation. The minimum age in the optical
biometry group was reported to be 11 years and while it was likely to
be different pathology (e.g. congenital cataracts), there was
agreement that this would have little impact on this particular review
question as the eye at that age is at a mature size. Moreover, it was
noted that the overall mean age for the optical biometry group was 70
years with a small standard deviation, suggesting that it is likely to be
1 or 2 outliers, which should not considerably affect the results. The
committee also noted that the study applied the Holladay I formula
which is not considered optimal in current UK practice but agreed that
since both biometry groups used the same formula, the overall
findings should not be affected.
The committee discussed the issue of confounding with non-
standardised keratometry, given that keratometric readings are also
required in intraocular lens formulas. Rajan et al. (2002) did not
undertake standardised keratometry and Fontes et al. (2011) did not
report any details on keratometry measurements.
The committee noted the generally small studies (1 randomised
controlled trial and 2 retrospective case series) that were identified for
the comparison on keratometry vs. topography. It agreed that the
evidence was very low quality. Specifically for the randomised
controlled trial, it noted the high risk of bias from the lack of reporting
of specific methods, large imprecision in the point estimates and the
limited generalisability given that the study was published in 1995
such that clinical practice, keratometry and topography technology
have progressed.
The committee discussed the evidence from the 2 retrospective
studies that included the specific subgroup of individuals with a
history of corneal refractive surgery undergoing phacoemulsification
cataract surgery. The committee agreed that the evidence was very
low quality noting its retrospective nature, and that practice may have
changed over time. In addition, the committee agreed that mixed
populations containing individuals with different types of refractive
surgeries (e.g. laser-assisted in situ keratomileusis, photorefractive
keratectomy, radial keratotomy) for varying indications (e.g. myopia,
hyperopia) should not be pooled as different surgical techniques
would impact upon measurements due to altered corneal shape and
stability of keratometry (e.g. individuals with a history of radial
keratotomy have diurnal fluctuations in corneal curvature
measurements). Moreover, the indication of surgery would typically
determine the appropriate intraocular lens formula that should be
used. The committee also noted the variability in observed effect
depending upon the type of topography machine, topography
reading, formulas and point estimate used in the analysis. It agreed
that it was difficult to determine the effectiveness of keratometry vs.
topography given these confounding issues.
The committee also noted that there was variation between the
studies in the intraocular lens formulas and constants that were used.
However, because the techniques used were the same within each
study (and therefore comparative data from a study are done using a
consistent technique), the committee did not believe this was likely to
be a source of considerable bias.
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As a result of the particular poor quality evidence base on the optimal

biometry techniques in people who have had previous corneal
refractive surgery, the committee agreed it was appropriate to make a
research recommendation for this group of patients.
Other considerations The committee noted that there is no true gold standard for biometry
(axial length) and keratometry (corneal curvature), but agreed that all
instruments should undergo calibration checks as per manufacturer’s
recommendations. The committee agreed that, in patients with a
history of corneal refractive surgery, the specific machine used to
measure corneal curvature is less relevant than choosing the most
appropriate and effective method. Because of the wide range of
methods offered to estimate the corneal power used to calculate
intraocular lens power following corneal refractive surgery, it is
general practice to use a consensus of several methods to obtain an
average. The predictability of cataract outcome after corneal
refractive surgery is less than that in previously untreated eye and the
patients should be counselled accordingly preoperatively. The
committee emphasised the importance of personalisation based on
specific equipment and techniques used and other related issues
such as, surgeon factors.
The committee noted that as part of routine practice, both eyes are
normally assessed in the same visit to validate biometry readings. It
noted that although optical biometry readings are directly transferred
by some instruments into intraocular lens calculation programmes,
there is a possibility of transcription errors for both techniques
depending on the operating protocols used in individual clinics.
8. Use optical biometry to measure the axial length of the eye for people having
cataract surgery.
9. Use ultrasound biometry if optical biometry:

 is not possible or
 does not give accurate measurements.
10. Use keratometry to measure the curvature of the cornea for people having
cataract surgery.
11. Consider corneal topography for people having cataract surgery:

 who have abnormally flat or steep corneas
 who have irregular corneas
 who have significant astigmatism
 who have had previous corneal refractive surgery or
 if it is not possible to get an accurate keratometry measurement.
7.1.8 Research recommendation
3. What is the effectiveness and cost effectiveness of biometry techniques in adults

undergoing phacoemulsification cataract surgery with a history of corneal
refractive surgery?
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The number of individuals undergoing corneal refractive surgery is increasing, and a
significant number of these individuals will eventually develop age-related cataracts. The
corneal changes resulting from different types of refractive surgeries provide a challenge in
undertaking accurate biometry assessments, and may result in worse visual outcomes of
surgery in this population compared with people without prior corneal refractive surgery.
Robust evidence from randomised controlled trials is needed to inform the appropriate
techniques that should be used in undertaking biometry including equipment, readings and
formulas.
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7.2 Intraocular lens formulas

 What are the most appropriate formulas to optimise intraocular lens biometry calculation?
7.2.2 Introduction
The evolution of theoretical intraocular lens (IOL) formulas, based on geometrical optics, is
universally accepted as an essential factor contributing to the improvement of predictability of
the refractive outcome with modern cataract surgery. Implicit to the third generation formulas
is the variation of the effective lens position (ELP), previously referred to as anterior chamber
depth (ACD), with corneal power and, in particular, the axial length of the patient’s eye.
Fourth generation formulas such as Olsen and Holladay II have further improved ELP
accuracy by adding variables including lens thickness. Parallel with refinement of IOL
formulas has been improvement of biometry measurements, particularly axial length, with
devices employing infra-red laser interferometry such as the ‘IOLMaster’ and ‘Lenstar’.
In 2010, the Royal College of Ophthalmologists published cataract surgery guidelines
recommending the most appropriate IOL formulas, available at that time, for given axial
length. Although these guidelines were widely acknowledged, the National Biometry audit
demonstrated lack of awareness of and poor compliance with these recommendations, and
also emphasised the importance of customising A constants (a measure of lens power) to
minimise prediction error.
Increasingly, patients undergoing cataract surgery are likely to have a history of corneal
refractive laser surgery such as laser-assisted in situ keratomileusis (LASIK) and laser-
assisted sub-epithelial keratomileusis (LASEK). This is important because such surgeries
alter the relationship between the anterior and posterior corneal curvature and thereby
renders inaccurate the basic assumptions regarding the power of the central cornea in IOL
formulas. As a result, there is a risk of unpredictable under correction of the corneal power in
people with myopia, which will result in the eye being hyperopic after cataract surgery.
The aim of this review was to determine the most appropriate IOL formulas that should be
used in different circumstances in order to optimise intraocular lens calculation. The
Guideline committee prioritised the following circumstances:
 ‘Virgin’ eyes without a history of corneal refractive surgery within various ranges of axial
lengths, categorised (RCOphth, 2010) into:
o Short: less than 22.00mm
o Average length: 22.00 to 24.50mm
o Medium long: 24.50 to 26.00mm
o Very long: more than 26.00mm
 People with a history of corneal refractive surgery, categorised into:
o Refractive error: myopia vs. hypermetropia
o Surgical procedure: laser-assisted in situ keratomileusis (LASIK), laser-assisted sub-
epithelial keratomileusis (LASEK), photorefractive keratectomy (PRK) vs. radial
keratotomy (RK)
The review focused on identifying studies that fulfilled the conditions specified in Table 13.
For full details of the review protocol, see Appendix C. The main outcome for this review
question was the predictive accuracy of the different IOL formulas, assessed by deviations
from the predicted refractive outcome expressed as a spherical equivalent. As suggested by
Gale et al. (2009), a benchmark standard of 85% of individuals achieving a final spherical
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Table 13: PICO inclusion criteria for the review question on intraocular lens formulas
Interventions Formulas used in intraocular lens biometry calculations
Examples: Haigis, Hoffer Q, Holladay 2, Sanders/Retzlaff/Kraff (SRK/T), Barrett
Universal II, Olsen
Excluded: Binkhorst II, Holladay 1, SRK I, SRK II
Comparators All formulas vs. each other
No relevant randomised controlled trials (RCTs) comparing different IOL formulas in adults
undergoing phacoemulsification cataract surgery to predict the accuracy of postoperative
refraction were identified. Papers were excluded if they:
studies
 focused on combination surgical procedures – that is, cataract surgery in tandem with
other surgical procedures (for example, phacotrabeculectomy, canaloplasty, Descemet's
 did not provide adequate information to assess the status of ocular comorbidities or
previous ocular surgeries
 did not provide separate subgroup data of axial lengths in virgin eyes
Protocol deviation
Given that no relevant RCTs were identified, the search was expanded to include
comparative observational studies. Eighteen relevant observational studies that compared
the predictive accuracy of different IOL formulas in a range of axial lengths of virgin eyes
undergoing phacoemulsification cataract surgery were identified. Six observational studies in
eyes with a history of corneal refractive surgery were included. Since these studies were in
the form of intra-person comparisons (where every tested formula was calculated for each
individual in the study), it was agreed the usual concerns associated with using non-
randomised data were not relevant here, and therefore observational studies were started as
being high-quality evidence in the GRADE framework, and downgraded from that point.

for full-text review. Fourteen observational studies on virgin eyes undergoing
phacoemulsification cataract surgery were included (Aristodemou et al., 2011; Bang et al.,
2011; Carifi et al., 2015; Day et al., 2012; El-Nafees et al., 2010; Eom et al., 2014; Mitra et
al., 2014; Moschos et al., 2014; Percival et al., 2002; Petermeier et al., 2009; Srivannaboon
et al., 2013; Tsang et al., 2003; Wang and Chang, 2013; Wang et al., 2011). Six comparative
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68
observational studies on eyes with a history of corneal refractive surgery undergoing

subsequent phacoemulsification cataract operations were included. All studies included
people with myopic LASIK/LASEK or PRK (Fam and Lim, 2008; Huang et al., 2013; Kim et
al., 2013; Saiki et al., 2013; Savini et al., 2010; Xu et al., 2014). The formulas used for eyes
with prior corneal refractive surgery were categorised as historical data methods (where
information on patient history is used as part of the calculation) and no historical data
methods (where patient history is not used as part of the calculation).
At the update searches, 13 full text articles were evaluated and 4 comparative case series on
virgin eyes undergoing phacoemulsification cataract surgery were included (Cooke and
Cooke, 2016; Doshi et al., 2017; Kane et al., 2016; Ozcura et al., 2016).

Details of the included studies are found in the evidence tables (see Appendix E).
7.2.3.1.1 Virgin eyes without a history of corneal refractive surgery

Of the 18 identified studies, 17 provided usable data (exception Tsang et al., 2003). All
studies were comparative case series, 15 retrospective and 3 prospective (Doshi et al., 2017;
El-Nafees et al., 2010; Srivannaboon et al., 2013). All studies with the exception of
Petermeier et al. (2009) stated that the phacoemulsification cataract surgery was uneventful
or people with intraoperative/postoperative complications had been excluded. Table 14
provides a summary of the key study characteristics.
7.2.3.1.2 People with a history of corneal refractive surgery

All studies were comparative case series, 5 retrospective and 1 prospective (Huang et al.,
2013) including eyes with a history of myopic LASIK/LASEK/PRK. All studies with the
exception of Fam and Lim (2008) stated that the phacoemulsification cataract surgery was
uneventful. Table 14 provides a summary of the key study characteristics.
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69
ISBN 978-1-4731-2706-7
Table 14: Summary of key characteristics of included studies for virgin eyes without a history of corneal refractive surgery
Study & Axial length
location Population Preoperative biometry Types of intraocular lens subgroup
Aristodemou 8,108 eyes IOLMaster Separate results reported: <22.00mm
2011 Postoperative corrected distance visual acuity (CDVA) IOL constant optimised o Sofport Advanced Optics 22.00-24.50mm
England of at least 6/12 L161AO 24.50-26.00mm
Excluded: corneal astigmatism >3.00D, concurrent o Akreos Fit >26.00mm
additional surgical procedures
Bang 2011 53 eyes IOLMaster Combined results reported: >26.00mm
USA Postoperative CDVA of at least 20/40 IOL constant optimisation o MA60MA
Excluded: history of amblyopia, severe macular not reported o MA50BM
damage
o SA60AT
Carifi 2015 28 eyes IOLMaster SA60AT <22.00mm
England Excluded: combined surgical procedures, previous IOL constant optimised
intraocular surgery, intraoperative complications, any (ULIB)
corneal pathology, marked lens opacities,
postoperative CDVA worse than 20/40
70
Cooke 2016 1079 eyes IOLMaster Acrysof SN60WF ≤22.00mm

USA Postoperative CDVA of at least 20/25 Lenstar ≥26.00mm
Excluded: additional ocular surgery, history of contact IOL constant optimised
lens wear, intraoperative complications, ocular or
systemic disease that might have prevented obtaining
good preoperative measurements, unexpected
refractions, second eye surgery
Day 2012 163 eyes IOLMaster Separate and combined <22.00mm
England Excluded: previous corneal refractive surgery Data available for IOL results reported:
constant optimised and not o Akreos AO
optimised o Akreos Adapt
o Corneal ACR6D
o Oculentis Lentis L302-1
Doshi 2017 80 eyes Immersion ultrasound and Not reported <22.00mm
India Postoperative best corrected visual acuity (BCVA) of IOLMaster >24.50mm
6/12 or better IOL constant optimised
Excluded: people with psychiatric illness, traumatic
cataract, several corneal degeneration, corneal
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opacity, vitreous degeneration and other vitreous
pathology, diabetic retinopathy, developmental and
acquired retinal diseases, squint and high corneal
astigmatism
El-Nafees 53 eyes Ultrasound biometry I-Medical 25.50-31.40mm
2010 Excluded: previous ocular surgery, combined surgical IOL constant optimisation
Egypt procedures, eventful cataract surgeries, corneal not reported
surface irregularities
Eom 2014 75 eyes IOLMaster Acrysof IQ <22.00mm
South Korea Excluded: history of traumatic cataracts, previous IOL constant optimised
ocular surgery, complicated cataract surgery, sulcus-
fixated lenses, postoperative complications
Kane 2016 3241 eyes IOLMaster Acrysof IQ SN60WF <22.00mm
Australia Postoperative CDVA better than 6/12 IOL constant optimised 22.00-24.50mm
Excluded: corneal astigmatism >3.00D, complicated 24.50-26.00mm
cataract surgery, additional procedures during cataract >26.00mm
surgery, postoperative complications
71
Mitra 2014 43 eyes Ultrasound biometry Not reported 24.50-26.50mm

India Excluded: pre-existing astigmatism >3.00D, corneal IOL constant optimisation
scar, keratoconus, complications affecting refractive not reported
status
Moschos 2014 69 eyes Ultrasound biometry SN60WF <22.00mm
Greece Postoperative best corrected visual acuity (BCVA) of IOL constant optimised
20/40 or better
Excluded: preoperative BVCA of 20/200 or worse,
corneal abnormalities, previous intraocular or corneal
surgery, history of ocular injury or uveitis
Ozcura 2016 485 eyes Ultrasound biometry Not reported ≤22.00mm
Turkey Postoperative visual acuity of 20/40 or better IOL constant optimisation 22.00-25.00mm
Excluded: combined procedures, postoperative not reported ≥25.00mm
astigmatism >2.00D
Percival 2002 500 eyes Ultrasound biometry Centerflex <22.00mm
England Excluded: surgical complications preventing in-the-bag IOL constant optimised 22.00-24.50mm
implantation, corneal pathology, extreme dementia 24.50-26.00mm
>26.00mm
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Petermeier 50 eyes IOLMaster Separate results reported for >26.00mm
2009 Excluded: pathology affecting accuracy of biometry (for Data available for IOL MA60MA based on
Germany example, retinal detachment, corneal scars), severely constant optimised and not o positive dioptre
reduced visual acuity (hand movements or worse), optimised o negative dioptre
unable to participate in refraction because of
o zero dioptre
glaucoma, amblyopia or myopic degeneration
Srivannaboon 163 eyes IOLMaster and ultrasound Hoya PY60AD <22.00mm
2013 Excluded: other ocular diseases, previous ocular biometry 22.00-24.50mm
Thailand surgery IOL constant optimised >24.50mm
(ULIB)
Wang 2013 200 eyes IOLMaster SA60AT <22.00mm
Taiwan Excluded: ocular pathology, operative complications IOL constant optimised 22.00-26.00mm
>26.00mm
Wang 2011 106 eyes IOLMaster IOLs combined in the 25.01-30.78mm
USA Postoperative CDVA of 20/30 or better Axial length optimised following groups:
Excluded: previous ocular surgery, intraoperative or o MA60MA/MA60AC
postoperative complications o SA60AT/SN60AT/SN60T
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o SN60WF
Table 15: Summary of key characteristics of included studies for eyes with a history of myopic LASIK/LASEK/PRK
ISBN 978-1-4731-2706-7
Postoperative
Study & location Population Biometry/Types of intraocular lens assessment Formulas/methods
Fam 2008 37 eyes Biometry: not reported 1 month Historical data methods: SRKT Clinical
Singapore/Malaysia Myopic LASIK or IOL constant optimisation: implanted IOL A- history, Hoffer Q DK, Holladay 2 DK, SRKT
6 centres/number PRK constant DK, SRKT Feiz-Mannis, SRKT Ladas-Stark
of surgeons not Mean AL: 26.63mm IOL: not reported
reported
Huang 2013 46 eyes Biometry: IOLMaster Manifest No historical data methods: Haigis-L,
USA Myopic LASIK, IOL constant optimisation: personalised refraction: 1 Shammas-PL
2 centres/5 LASEK or PRK Haigis constants for Haigis-L only month
surgeons Mean AL: not IOL: Alcon SN60AT, SA60AT, SN60WF,
reported SN6AT3/4; AMO ZA9003, ZCB00
Kim 2013 47 eyes Biometry: IOLMaster, immersion ultrasound Manifest No historical data methods: Haigis-L, SRKT
South Korea Myopic LASIK or IOL constant optimisation: not reported refraction: 2 K
1 centre/1 surgeon PRK IOL: Alcon SN60AT months
Mean AL: 27.75mm
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Saiki 2013 28 eyes Biometry: IOLMaster (AL and ACD), UD- Manifest No historical data methods: SRKT TNP,
Japan Myopic LASIK 6000 ultrasound scanner (ACD) refraction: 1 SRKT A-P, BESSt, SRKT C-P, SRKT DK,
Number of centres Mean AL: 26.19mm Keratometry: IOLMaster, ARK10000, month Camellin-Calossi, Haigis-L, Shammas-PL
or surgeons not Scheimpflug, ARK-730A autokeratometer, Historical data methods: Double-K, Feiz-
reported Pentacam Mannis, Masket, Modified Masket
IOL constant optimisation: ULIB optimised
lens constants
IOL: not reported
Savini 2010 28 eyes Topography: TMS-2, Keratron, CM02, Spherical No historical data methods: Shammas-PL
Italy Myopic LASIK or EyeSys System 3000 (simulated K used) equivalent: 1 Historical data methods: Clinical history,
Number of centres PRK IOL constant optimisation: implanted IOL A- month SRKT DK Awwad, Camellin-Calossi, SRKT
not reported/12 Mean AL: 27.84mm constant, not optimised Diehl, SRKT DK, SRKT Feiz-Mannis, SKRT
surgeons IOL: not reported Feiz-Mannis nomogram, SRKT SK Ferrara,
SRKT Ladas-Stark, SRKT Latkany, SRKT
Masket, SRKT SK Rosa, SRKT DK Savini,
SRKT DK Seitz/Speicher, SRKT DK
Seitz/Speicher/Savini, SRKT DK Shammas
Postoperative
ISBN 978-1-4731-2706-7
Study & location Population Biometry/Types of intraocular lens assessment Formulas/methods

Xu 2014 37 eyes Biometry: immersion ultrasound A-scan 12 weeks No historical data methods: SRKT K, SRKT
China Myopic LASIK, (AL) TNP, Hoffer Q K, Hoffer Q TNP
Number of centres LASEK or PRK Topography: Pentacam Scheimpflug
not reported/1 Mean AL: 29.52mm IOL constant optimisation: not reported
surgeon IOL: not reported
ALaxiallength, IOLintraocular lens, LASEKlaser-assisted sub-epithelial keratomileusis, LASIKlaser-assisted in situ keratomileusis, PRKphotorefractive
keratectomy, DKdouble-K, SKsingle K, Ksimulated K (IOLMaster), TNPtrue net power
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7.2.5.1 Virgin eyes without a history of corneal refractive surgery
7.2.5.1.1 Axial lengths less than 22.00mm

Evidence from 5 network meta-analyses and 1 pairwise comparison including data from up to
11 case series showed that the SRK/T formula had the lowest predictive accuracy for
intraocular lens power calculations as assessed by mean absolute error and proportion of
people achieving predicted target within 0.25, 0.50, 1.00 and 2.00 dioptres. Haigis and Hoffer
Q formulas showed the highest predictive accuracy with lowest imprecision as assessed by
mean absolute error and proportion of people achieving predicted target within 0.25, 0.50
and 2.00 dioptres. The overall quality was assessed to be very low to moderate (see
Appendix G for the GRADE tables and Appendix H for the results of the network meta-
analyses).
7.2.5.1.2 Axial lengths 22.00-24.50mm

Evidence from 5 network meta-analyses including data from up to 4 case series showed that
the Barrett Universal II and SRK/T formulas were similarly effective in terms of predictive
accuracy of intraocular lens power calculations as assessed by mean absolute error and
proportion of people achieving predicted target within 0.25, 0.50, 1.00 and 2.00 dioptres. The
overall quality was assessed to be moderate to high (see Appendix G for the GRADE tables
and Appendix H for the results of the network meta-analyses).
7.2.5.1.3 Axial lengths 24.50-26.00mm

Evidence from 5 network meta-analyses including data from up to 6 case series showed that
the Barrett Universal II formula was most effective in terms of predictive accuracy of
intraocular lens power calculations as assessed by the proportion of people achieving
predicted target within 0.25, 0.50, 1.00 and 2.00 dioptres. SRK/T formula was effective in
terms of predictive accuracy of intraocular lens power calculations as assessed by the
proportion of people achieving predicted target within 2.00 dioptres. The overall quality was
assessed to be low to moderate. The overall quality was assessed to be very low to high
(see Appendix G for the GRADE tables and Appendix H for the results of the network meta-
analyses).
7.2.5.1.4 Axial lengths greater than 26.00mm

8 case series showed that the SRK/T and Haigis formulas had the highest predictive
accuracy for intraocular lens power calculations as assessed by the proportion of people
achieving predicted target within 0.25, 0.50 and 2.00 dioptres. The overall quality was
assessed to be low to moderate (see Appendix G for the GRADE tables and Appendix H for
the results of the network meta-analyses).
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7.2.5.2 Eyes with a history of myopic LASIK/LASEK/PRK
7.2.5.2.1 Historical and no historical data methods

5 case series showed that it was not possible to distinguish between the formulas tested, as
assessed by mean absolute error, mean prediction error, or the proportions of people
achieving predicted target within 0.50 and 1.00 dioptres. The Haigis-L formula was more
effective than the SRK/T formula, as assessed by the proportions of people achieving
predicted target within 1.50 and 2.00 dioptres. The overall quality was assessed to be very
low to low (see Appendix G for the GRADE tables and Appendix H for the results of the
network meta-analyses).
7.2.5.2.2 No historical data methods

Evidence from 4 network meta-analyses including data from 4 case series showed that it was
not possible to distinguish between the formulas tested, as assessed by the proportions of
people achieving predicted target within 0.50 and 1.00 dioptres. The overall quality was
assessed to be very low (see Appendix G for the GRADE tables and Appendix H for the
results of the network meta-analyses).
7.2.5.2.3 Historical data methods

Data from 2 network meta-analyses and 1 pairwise comparison including data from up to 2
case series showed that it was not possible to distinguish between the formulas tested, as
assessed by mean absolute error or the proportion of people achieving predicted target
within 2.00 dioptres. The SRK/T formula had the lowest predictive accuracy, as assessed by
the proportion of people achieving predicted target within 0.50 and 1.00 dioptres. The overall
quality was assessed to be very low (see Appendix G for the GRADE tables and Appendix H
for the results of the network meta-analyses).

7.2.6 Evidence to recommendation

Relative value of different The Guideline committee agreed that the critical outcome for
outcomes decision-making was deviation from predicted refractive outcome,
though resource use and costs were also considered to be important.
The committee agreed that, of the different refractive outcomes
presented, the proportion of people with 0.5 dioptres was likely to be
the most relevant, as this was the clinically relevant outcome for
which the largest amount of data was available (smaller errors are
unlikely to have a meaningful impact on patients’ vision; larger ones
are uncommon events regardless of formula).
The committee highlighted the importance of selecting appropriate
intraocular lens (IOL) formulas depending on the axial length of the
eye and in specific circumstances where a history of corneal
refractive surgery are likely to impact upon the shape of the cornea,
such that resulting keratometry and/or topography measurements
would require adjustments when applied to standard formulas.
Trade-off between The committee agreed that the SRK/T formula was the most
benefits and harms appropriate to use as the reference category in the analyses (where it
was available), as it was the formula used most commonly across the
different trials and outcome measures, and is one that is in use in
clinical practice.
The committee noted that individual IOL formulas used a range of
variables in addition to IOL constants, with the simplest including only
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2 measurements, that is, axial length and keratometric reading (for
example, Hoffer Q, SRK/T), while others included 7 variables (for
example, Holladay 2 uses axial length, keratometry, preoperative
anterior chamber depth and refraction, lens thickness, age and
horizontal white-to-white measurement). However, the committee
agreed that these formulas were comparable when considered as
complex interventions and noted that all required measurements
including those for the Holladay 2 (with the exception of lens
thickness) can be obtained using standard modern biometry
machines. The committee noted the recently published Super
Formula which uses other formulas (Haigis, Hoffer Q, Holladay 1 with
and without Wang-Koch adjustment).
The committee noted the general high levels of statistical imprecision
observed across all the formulas and outcomes. For eyes without a
history of corneal refractive surgery, the main results of the evidence
synthesis were that the SRK/T formula performs poorly in eyes with
short axial lengths (those less than 22.00mm) in contrast to eyes with
very long axial lengths (those greater than 26.00mm), and the Hoffer
Q performs poorly in eyes with very long axial length (greater than
26.00mm). The Haigis formula was among the best options for 3 of
the 4 axial length subgroups.
Eyes with short axial lengths
For eyes with short axial lengths, the Hoffer Q formula was similarly
effective to the Haigis in predictive accuracy. Barrett Universal II and
SRK/T formulas were the best options for eyes with average or
medium long axial lengths. While several newer formulas showed
trends towards better predictability, the committee was hesitant to
recommend these formulas because of the high levels of statistical
imprecision and small study samples. Therefore, it agreed it would be
more appropriate to make a research recommendation looking at the
effectiveness of these newer formulas in larger studies.
The committee noted that, for eyes with a history of corneal refractive
surgery, the absolute levels of prediction error were worse than in
eyes without previous surgery. For example, across all studies and
formulas, in the non-surgery group, for axial lengths between 22.00
and 24.50mm, 70.1% of the prediction errors were less than 0.50
dioptres, while in eyes with prior surgery, only 31.1% of the prediction
errors were less than 0.50 dioptres. The committee therefore agreed
it was appropriate to make a research recommendation looking at the
most appropriate formulas to use in people with prior corneal
refractive surgery.
Eyes with a history of corneal refractive surgery
For eyes with a history of corneal refractive surgery, it was not
possible to identify formulas that provided consistently better results
than others, as there was considerable uncertainty and heterogeneity
in the evidence base. The formulas used across multiple studies
produced very different levels of accuracy in different studies, and the
committee was not able to identify aspects of the study design or
patient population that would adequately explain these levels of
heterogeneity. The committee noted, however, that there was a
pattern of formulas which did make adjustments performing better
than those based on clinical history alone, implying that making an
adjustment is better than not doing so, even if it was not possible to
recommend which particular adjustment should be made. The
committee also agreed that, given the clear evidence that predictions
were less accurate in this group, this information should be
communicated to patients before surgery, to ensure they are fully
informed and have realistic expectations of the benefits they are likely
to receive from surgery.
77
Consideration of health No health economic evidence was found for this review question, and
benefits and resource it was not prioritised for de novo modelling work. However, the
use committee noted that various IOL formulas are available as a
standard package within more recent biometry machines (which the
committee confirmed were widely in use), but some of the newer
formulas may require additional proprietary licenses, although this
does not apply to those formulas which are recommended here. The
committee did not consider the recommendations made would have
significant resource implications.
Quality of evidence The committee noted the lack of randomised controlled trials
examining the effectiveness of different IOL formulas.
The committee agreed that it may have been useful to consider
narrower ranges of axial lengths in order to identify critical thresholds
for the appropriate use of different IOL formulas. However, the
committee noted that only 1 large UK-based study provided this level
of detailed evidence (Aristodemou et al. 2011) for the Hoffer Q and
SRK/T formulas, and that the reported findings for axial length
subgroups in increments of 0.5 to 1.0mm were congruent with the
overall network meta-analysis results observed for the 4 prioritised
axial length classes. The committee also highlighted that focusing on
narrower bands of axial lengths would impact upon the statistical
power and precision of the findings.
The committee agreed that strict selection criteria excluding studies
that did not specify phacoemulsification cataract surgery or did not
provide adequate information to assess the status of ocular
comorbidities or previous ocular surgeries and/or separate subgroup
data of axial lengths in virgin eyes were necessary to ensure that the
included studies were adequately homogeneous to be included in a
network meta-analysis. However, the committee recognised that this
meant 2 specific papers that have been relied on in other guidelines
were excluded (MacLaren et al. 2007 and Narvaez et al. 2006). The
committee noted that the sensitivity analyses based on the type of
biometry undertaken and the use of IOL constant optimisation also
showed little variation compared with the overall findings of all
included studies.
The committee agreed that the overall quality of evidence was very
low to moderate, and noted that the evidence for people with prior
corneal refractive surgery was of particularly low quality, consisting
mainly of small retrospective studies (and with no evidence at all in
eyes post radial keratotomy). The committee also noted that the
formulas assessed in the included papers had all been derived from
retrospective analyses, and none had been subject to prospective
testing.
The committee noted that, in some analyses, the ordering of
effectiveness of the interventions differed between the analyses
looking at mean absolute error and those looking at the proportion of
people within 0.5D. They agreed this was likely to be because the
mean difference results were being skewed by a small proportion of
people having very large errors in prediction. The committee agreed
the within 0.5D evidence was more appropriate for decision making,
as once an error reaches a certain level the clinical outcome (of lens
explantation and new lens insertion) is the same, regardless of the
magnitude of the error.
Other considerations The committee agreed that, given the lack of distinction in predictive
accuracy of different IOL formulas for axial lengths ranging from
22.00 to 24.50mm and 24.50 to 26.00mm, it would be useful to group
these bandings in the recommendations.
78
12. For people who have not had previous corneal refractive surgery, use 1 of the
following to calculate the intraocular lens power before cataract surgery:
 If the axial length is less than 22.00 mm, use Haigis or Hoffer Q.
 If the axial length is between 22.00 and 26.00 mm, use Barrett Universal
II if it is installed on the biometry device and does not need the results to
be transcribed by hand. Use SRK/T if not.
 If the axial length is more than 26.00 mm, use Haigis or SRK/T.
13. Advise people who have had previous corneal refractive surgery that refractive
outcomes after cataract surgery are difficult to predict, and that they may need
further surgery if they do not want to wear spectacles for distance vision.
14. If people have had previous corneal refractive surgery, adjust for the altered
relationship between the anterior and posterior corneal curvature. Do not use
standard biometry techniques or historical data alone.
4. How effective are newer intraocular lens formulas (for example, Barrett, Olsen, T2)
compared with standard formulas for phacoemulsification cataract operations on
eyes without a history of corneal refractive surgery, especially for long and short
axial lengths?

Appropriately applied intraocular lens (IOL) formulas are paramount to improving predictive
accuracy and patient satisfaction following cataract surgery and IOL implantation. Despite
significant technological advancement in ophthalmology, it is widely recognised that many of
the currently used IOL formulas were developed more than 20 years ago. Newer formulas
are being published but there is a dearth of evidence comparing their effectiveness to
standard formulas in people without a history of corneal refractive surgery. Methodologically
robust randomised controlled trials are needed to address this research gap.
5. What is the effectiveness of different intraocular lens formulas for eyes after prior
corneal refractive surgery, as measured in a prospectively collected multi-centre
study?

Appropriately applied intraocular lens (IOL) formulas are paramount to improving predictive
accuracy and patient satisfaction following cataract surgery and IOL implantation. There are
particular challenges in accurate prediction in people with a history of corneal refractive
surgery, and there is a lack of evidence for the most effective formulas to use in this group,
with a total absence of large, prospective studies. Methodologically robust randomised
controlled trials are needed to address this research gap.
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7.3 Intraocular lens constant optimisation
 What is the effectiveness of strategies used to select intraocular lens constants in order to
optimise biometry calculation?
7.3.2 Introduction
The aim of this review was to determine the effectiveness of strategies used to select
intraocular lens (IOL) constants in order to optimise biometry calculation.
question was the predictive accuracy of the different optimisation strategies, assessed by
deviations from the predicted refractive outcome expressed as a spherical equivalent. As
suggested by Gale et al. (2009), a benchmark standard of 85% of individuals achieving a
final spherical equivalent within 1.00 dioptre of the predicted refraction and 55% of
individuals within 0.50 dioptres was used to evaluate the clinical relevance of the review
findings.
Table 16: PICO inclusion criteria for the review question on intraocular lens constant
optimisation
Interventions Different optimisation methods of intraocular lens constants vs. each other
and Examples: surgeon-specific lens constants, axial length-specific lens constants,
comparators keratometry-specific lens constants
No randomised controlled trials (RCTs) comparing different strategies to optimise IOL

constants in adults undergoing phacoemulsification cataract surgery to predict postoperative
refraction were identified. Papers were excluded if they:
studies
 focused on combination surgical procedures that is, cataract surgery in tandem with other
Protocol deviation
Given that no relevant RCTs were identified, the search was expanded to include
comparative observational studies. Nine relevant retrospective comparative case series that
compared the predictive accuracy of different IOL constant optimisation strategies in virgin
eyes without a history of corneal refractive surgery undergoing phacoemulsification cataract
operations were identified. Since these studies were in the form of intra-person comparisons
(where both optimisation and non-optimisation were considered for each individual in the
80
study), it was agreed the usual concerns associated with using non-randomised data were
not relevant here, and therefore observational studies were started as being high-quality
evidence in the GRADE framework, and downgraded from that point.

for full-text review. Nine observational studies on virgin eyes undergoing phacoemulsification
cataract surgery were included (Aristodemou et al., 2011; Charalampidou et al., 2010; Day et
al., 2012; Eom et al., 2013; Fam et al., 2009; Lee et al., 2015; Petermeier et al., 2009;
Sharma et al., 2014; Wang et al., 2011).

All 9 identified studies were retrospective comparative case series with sample sizes ranging
from 50 to 8,108 eyes. With the exception of Petermeier et al. (2009), all studies stated that
the phacoemulsification cataract surgery was uneventful or those with intraoperative/
postoperative complications had been excluded. All studies used optical biometry to
undertake preoperative assessments (IOLMaster in 8 studies and Lenstar in Lee et al. 2015).
One study (Aristodemou et al., 2011) tailored the use of IOL formula based on the individual
eye’s axial length. An extensive range of IOL constant optimisation methods was examined
including the use of User Group for Laser Interference Biometry (ULIB) website to download
IOL constants or personalise constants, back-calculating to achieve a prediction error of
zero, using optimised axial length and/or keratometry readings, using IOL constants derived
from biometry machines (IOLMaster, Lenstar), use of manufacturers’ IOL constants,
traditional A constants and optimising the axial length compared with using the IOLMaster
axial lengths. Further details of the reported methods for optimisation are found in the
evidence tables (see Appendix E).
7.3.3.2 Evidence review strategy

Separate data for excluded IOL formulas (that is, Binkhorst II, Holladay 1, SRK I and SRK II)
reported in studies were not extracted or analysed. Where a study included multiple IOLs
and reported both separate data for each IOL and combined data, the individually reported
IOL data were preferentially used. Where a study reported results for multiple IOL formulas,
the IOL formula that is recommended for the mean axial length of that study was
preferentially extracted and analysed (see section 7.2 on intraocular lens formulas). Where a
study reported several versions of the optimisation method, for example, using the entire
sample to calculate individualised IOL constants vs. using half the sample and extrapolating
to the full population; or the use of 3 optimised constants vs. 2, the option that would more
likely provide the optimal optimisation was preferentially selected, that is, total sample
individualised and 3 optimised constants.

81
7 retrospective case series suggested that the use of standard IOL constants may be
suboptimal in maximising the predictive accuracy of intraocular lens power calculations as
assessed by mean absolute error and proportion of people achieving predicted target within
0.25, 0.50, 1.00 and 1.50 dioptres. The proportions of individuals achieving postoperative
refraction within 0.50 and 1.00 dioptres were lower in groups using standard IOL constants
(46.3% and 83%) compared with optimised constants (75.2% and 94.1%) in 5 and 6 low-
quality retrospective case series (8,698 and 8,749 eyes) respectively. The overall quality was
assessed to be low (see Appendix G for the GRADE table and Appendix H for the results of
the network meta-analyses).
7 retrospective case series showed that, of the 7 different IOL constant optimisation methods
assessed, none were significantly better than each other in improving predictive accuracy of
intraocular lens power calculations. Two methods, surgeon’s personalisation using the Users
Group for Laser Interference Biometry (ULIB) framework and optimising individual IOL
constants by back-calculating the prediction error to zero showed trends of being effective in
improving the proportion of eyes achieving the predicted target within 1.00 and 0.25 dioptres
respectively. The overall quality was assessed to be low (see Appendix G for the GRADE
table and Appendix H for the results of the network meta-analyses).


The committee noted that intraocular lens (IOL) constant optimisation
was one of several strategies to improve postoperative refractive
outcomes, involving adjustments specific to the IOL and individual
surgeons. They highlighted that IOL manufacturers’ tolerance for lens
accuracy is variable and can range from 0.25 to 0.40 dioptres
tolerance. Surgeon variables include the size and method of
insertions such that small variations can result in systematic
differences in postoperative refractive outcomes. The committee
emphasised the importance of personalisation based on specific
biometry equipment and techniques used, multiple preoperative
assessment staff and other related issues such as surgeon factors.
Trade-off between The committee noted that, historically, it was difficult to obtain audit
benefits and harms data of prediction errors that can be used to inform IOL constant
optimisation, as there were no robust mechanisms for returning
postoperative outcome data, particularly where patients were
discharged for postoperative refraction by community optometrists.
However, such data are currently much more accessible with the
availability of automated biometry with electronic storage of results.
The committee agreed that the time taken to submit audit information
is not overly onerous and therefore it would be useful to encourage
departments to undertake such practice, to facilitate quality data sets
that can be used to improve the accuracy of IOL constant
optimisation. The committee recognised that this practice would need
to be maintained as IOLs change over time.
The committee noted that, generally, UK surgeons and departments
do not formally calculate optimised constants, but rather use informal
processes, for example, surgical teams apply adjustments (over- or
82
under-estimates) based on reflection of their experience, type of IOL
used (for example, standard vs. multifocal) and patient preference
(for example, to be over- rather than under-corrected).
The committee agreed that, overall, the evidence synthesis was
suggestive that, compared with standard IOL constants, optimisation
of IOL constants is likely to improve the predictive accuracy of
postoperative refractive outcomes. However, this finding was subject
to substantial statistical uncertainty: although there was a trend
towards improved accuracy in all outcomes, credible intervals from
the network meta-analyses tended to be very wide and only 1
comparison produced results that satisfied conventional definitions of
statistical significance (adjusting the prediction error to zero for the
proportion of eyes within 0.25 dioptres of the predicted postoperative
refraction). The committee understood that this uncertainty was
substantially caused by statistical heterogeneity in the underlying
evidence, leading to large random-effects terms in the synthesis
models. In particular, it was notable that the 2 trials that examined
comparable strategies for calibrating prediction error to zero
(Aristodemou et al., 2011 and Day et al., 2012) gave incongruent
results, with substantial and significant accuracy gains in
Aristodemou et al. (2011) but not in Day et al. (2012). The committee
discussed that this discrepancy may have arisen because Day et al.
(2012) was a small study restricted to eyes with short axial lengths
(less than 22.00mm), whereas Aristodemou et al. (2011) was a much
larger study including eyes of all sizes. The effect of this discrepancy
was to ‘dilute’ the strongly significant gains demonstrated in the
larger, more representative study, as the synthesis models had to
estimate a broad, uncertain distribution of effects in order to fit the
heterogeneous data. The committee therefore concluded that Day et
al. (2012) had a disproportionate effect in the network meta-analyses,
and considered putting additional weight on the findings of
Aristodemou et al. (2011), due to the study’s greater power and more
inclusive population.
For these reasons, the committee arrived at the view that surgeons
should consider personalising their IOL constants. The evidence was
not sufficiently unambiguous to make a firm (‘offer’) recommendation,
but there was no prospect of patient harm resulting from the
approach, and it should not be onerous for surgeons to incorporate
this step into their audit routines (that is, the anticipated opportunity
cost – in terms of surgeon time – is negligible).
However, the committee agreed that no specific distinction could be
made on the best optimisation strategy, given that all the credible
intervals overlapped each other across all the assessed outcomes
(mean absolute error and proportion of eyes within 0.25, 0.50 and
1.00 dioptres). Therefore, the committee agreed a recommendation
that urges surgeons to consider personal optimisation, but leaves the
specific strategy to the individual’s discretion.
benefits and resource it was not prioritised for de novo modelling work. The committee did
use not consider the recommendation made would have significant
resource implications.
Quality of evidence The committee noted the lack of randomised controlled trials
examining the effectiveness of different IOL constant optimisation
strategies. They highlighted that all the identified studies were
retrospective in design such that assumptions were made that the
preoperative data were accurate. The postoperative refractive
outcome was used to back-calculate the likely outcomes given that
various optimisation strategies had been applied. The committee
noted that, with the exception of 1 large UK based study, the studies
were small.
83
The committee noted that 3 studies specifically stated that an
autorefractor had been used to assess the postoperative refractive
outcome. This is different to clinical practice in that auto-refraction is
used as a baseline measurement and does not guide lens
selection/corrective lens prescription. However, the committee
agreed that, due to lack of detailed reporting, it was unclear as to
whether other studies had only assessed subjective refraction
postoperatively.
The committee noted the general lack of descriptive detail of the
optimisation methods applied in most of the studies, particularly
ambiguity regarding the use of the Users Group for Laser
Interference Biometry (ULIB) framework, which made it difficult to
implement in clinical practice. The committee noted that, in many
instances, the comparator arms may have also involved the use of
optimised constants (for example, IOL constants available from
optical biometry machines) but, because of the limited detail provided
by the studies, it was unclear whether optimisation occurred.
However, it agreed that these comparator arms could be grouped
together in 1 category of standard IOL constants since it was clear
that an optimisation strategy was being applied in the other arms, and
given the retrospective nature of the study designs, all optimisation
methods were compared with the original calculations undertaken on
the same optical biometry machine.
While the committee recognised that various confounding factors (for
example, type of IOL and IOL formulas) were kept constant within
studies, and that sensitivity analyses undertaken involving the
removal of the study on light-adjustable lens had not affect the overall
findings, it agreed that this specific study (Conrad-Hengerer et al.
2011) should be excluded from the evidence base because refraction
could not be determined as being stable or accurate at the point of
measurement.
The committee agreed that the remaining 9 studies were adequately
homogeneous to be included in a network meta-analysis and that the
overall quality of evidence was low to moderate. They agreed that
whilst the exclusion of participants with complications during surgery
is likely to have led to overestimates in the effectiveness of biometry
overall, there was no reason to believe this will have led to
differences in the comparative effectiveness of the approaches.
Other considerations No other considerations were identified for this review question.
15. Surgeons should think about modifying a manufacturer's recommended

intraocular lens constant, guided by learning gained from their previous
deviations from predicted refractive outcomes.
84
7.4 Other considerations in biometry
 What other factors should be considered such as, who should undertake biometry and
when should preoperative biometry be assessed?
7.4.2 Introduction
The aim of this review was to identify other factors that should be considered to minimise the
risk of biometry errors and postoperative refractive errors and in particular the following:
 who should undertake biometry
 when should preoperative biometry be assessed
 second eye prediction refinement.
question was the predictive accuracy of the different methods, assessed by deviations from
the predicted refractive outcome expressed as a spherical equivalent. As suggested by Gale
et al. (2009), a benchmark standard of 85% of individuals achieving a final spherical
Table 17: PICO inclusion criteria for the review question on other factors
Interventions  Who should undertake biometry
 When should preoperative biometry be assessed
 Second eye prediction refinement
Randomised controlled trials (RCTs) and observational studies comparing different methods
of reducing the risk of biometry errors and postoperative refractive errors in adults
undergoing phacoemulsification cataract surgery were included. Papers were excluded if
they:
studies/reports, case series with less than 10 people, reliability studies, diagnostic
accuracy studies, non-comparative studies
 focused on combination surgical procedures that is, cataract surgery in tandem with other

for full-text review. Four unique observational studies were included (Aristodemou et al.,
85
2011; Covert et al., 2010; Jabbour et al., 2006; Jivrajka et al., 2012), all focusing on second
eye prediction refinement, that is using the first eye prediction error to adjust the intraocular
lens (IOL) calculation for the second eye. Since these studies were in the form of intra-
person comparisons (where every tested strategy was calculated for each individual in the
study), it was agreed the usual concerns associated with using non-randomised data were
not relevant here, and therefore observational studies were started as being high-quality
evidence in the GRADE framework, and downgraded from that point. No relevant studies
were identified for the other two listed factors, that is, staffing and timing of preoperative
assessments.

Details of the included studies are found in the evidence tables (see Appendix E).
7.4.3.1.1 Second eye prediction refinement

The 4 case series including a total of 2,291 participants (4,582 eyes; range n=97 to 1,867)
undergoing bilateral sequential phacoemulsification cataract surgery were carried out in the
UK (Aristodemou et al., 2011), USA (Covert et al., 2010; Jivrajka et al., 2012) and Germany
(Jabbour et al., 2006). All but 1 study (Jivrajka et al., 2012) specifically stated that the
surgery was conducted in 1 hospital. Timing between the first and second eye surgeries was
not reported by Aristodemou et al. (2011), while Covert et al. (2010) reported a mean of 36.7
days, Jabbour et al. (2006) reported a median of 3 months and Jivrajka et al. (2012) provided
a range of 1 to 3 months. All but 1 study (Jivrajka et al., 2012) used a retrospective design to
develop and/or test various correction factors based on the first eye prediction error. One
study did not report any baseline characteristics (Aristodemou et al., 2011). Two studies
reported mean age, one specifically at the time of first eye surgery (69.9 years, Covert et al.,
2010) and the other was unclear in terms of timing (77.57 years, Jivrajka et al., 2012). Three
studies reported similar distributions of female patients (51% in Jivrajka et al., 2012 to 64% in
Jabbour et al., 2006), mean axial lengths ranging from 23.15mm (Jabbour et al. 2006) to
24.0mm (Covert et al., 2010) and mean keratometric readings ranging from 43.48 dioptres
(Jabbour et al., 2006) to 44.00 dioptres (Covert et al., 2010). Two studies specifically
excluded people who had corneal astigmatism >3.00 dioptres (Aristodemou et al., 2011;
Jabbour et al., 2006). All studies applied exclusion criteria based on concurrent procedures
and/or ocular comorbidities. No studies provided information on specific diagnosis.
All but 1 study undertook biometry and keratometry measurements using the IOLMaster;
Jabbour et al. (2006) used 2 ultrasound biometers and 2 identical Bausch & Lomb
keratometers. Only 2 studies provided some information on the biometry assessors; Covert
et al. (2010) noted that a trained ophthalmic technician carried out measurements, while
Jabbour et al. (2006) highlighted that readings were taken by 2 different operators. All
studies used different formulas. Aristodemou et al. (2011) used the Hoffer Q, Holladay I and
SRK/T formulas based on the axial lengths of paired eyes, Covert et al. (2010) used the
SRK-II and Holladay (1998) formulas, Jabbour et al. (2006) used the SRK/T and axial length
vergence formulas while Jivrajka et al. (2012) used the Haigis formula.
All phacoemulsification cataract surgery was undertaken by the same surgeon for 3 studies,
Aristodemou et al. (2011) did not provide any details. Only 3 studies reported timing of
postoperative refractive assessment which varied from at least 4 weeks (Aristodemou et al.,
2011; Covert et al. 2010) up to 8 weeks (Jivrajka et al., 2012). All but 1 study (Jivrajka et al.,
2012) reported that subjective refraction was used at postoperative assessment.
All but 1 study (Jabbour et al., 2006) found that 50% was the optimal correction factor to take
into consideration when applying the first eye prediction error.
86
The quality of the evidence ranged from very low to low (see Appendix G for the GRADE
tables and Appendix H for the meta-analysis results).

7.4.5.1 Second eye prediction refinement

Very low-quality evidence from 1 retrospective case series of 412 people found a small
statistically significant between group difference in mean absolute prediction errors in favour
of the 50% adjusted 2nd eye prediction group compared with the unadjusted 2nd eye
prediction group.
Statistically significant between group differences were only observed in the proportion of
individuals achieving postoperative refraction within 0.50 dioptres (80.3% with 50% adjusted
2nd eye prediction vs. 73.3% with unadjusted 2nd eye prediction) in 2 low-quality retrospective
case series. No statistically significant differences were observed in the proportion of
individuals achieving postoperative refraction within 1.00 dioptre (3 low quality case series;
96.3% with 50% adjusted 2nd eye prediction vs. 94.7% with unadjusted 2nd eye prediction).


Trade-off between The committee discussed the implications of using first eye prediction
benefits and harms error to inform calculations of intraocular lens power of the second
eye in terms of adequate timing between the first and second eye
surgeries to ensure that the refractive error of the first eye had
stabilised. The committee noted that individuals undergoing bilateral
simultaneous cataract surgery may be disadvantaged by
recommending that second eye prediction is adjusted based on first
eye prediction. However, the committee agreed that given the
potential benefit of improved prediction of the second eye and
subsequent improved patient outcomes such as satisfaction, the use
of first eye prediction error to inform second eye prediction should be
considered by healthcare professionals where appropriate, such as in
cases where first eye prediction error does not result in ‘refractive
surprise’ or require lens exchange.
The committee agreed that, although the evidence base was of low
quality, it did suggest that second eye prediction adjustment did lead
to improved refractive outcomes, and it was highly unlikely there
would be any negative outcomes that could result from doing so
which would counterbalance these small gains.
87
Consideration of health No relevant health economic evidence was identified and de novo
benefits and resource health economic modelling was not prioritised for this review
use question.
Quality of evidence The committee noted that no relevant studies were identified to
inform who should undertake biometry or when the preoperative
biometry assessment should take place.
The committee agreed that the evidence for the use of first eye
prediction errors to inform second eye prediction refinement was
generally of low quality because the majority of studies (3 out of 4)
were retrospective in design, applying theoretical calculations, with
no consideration of practical, clinical and individual implications such
as anisometropia. However, the committee noted that the only small
prospective study on 97 people showed similar evidence of beneficial
effect of using 50% adjusted first eye prediction error to inform
calculations of intraocular lens power of the second eye.
The committee also noted that in 1 retrospective study, 50% adjusted
refinement was shown to be beneficial even in situations where the
intraocular lens constants in the formula were already optimised.
The committee agreed that it would be useful to provide a clinical
guide on the maximum threshold level of prediction error from the first
eye for use in second eye prediction, in order to minimise the risk of
anisometropia. However, the committee noted that the evidence
reviewed did not facilitate recommendation with this detailed
information.
Other considerations The committee noted that currently individuals are routinely refracted
postoperatively at 4-6 weeks but the outcome data are not
necessarily provided to ophthalmology departments to enable
consideration of adjustment for second eye surgery intraocular lens
calculations.
The committee noted that there is evidence to suggest that there is
limited uptake of guidelines on the appropriate use of formulas, and
therefore a recommendation to adjust second eye prediction based
on first eye prediction errors would be useful in improving patient
care.
The committee noted that a range of professionals may undertake
biometry but it is exceedingly important that staff are appropriately
trained and experienced.
16. Consider using 50% of the first-eye prediction error in observed refractive
outcome to guide calculations for the intraocular lens power for second-eye
cataract surgery.
88
7.5 Risk stratification and risk factors for increased cataract
surgical complications
 What is the effectiveness of risk stratification techniques to reduce surgical complications?
 What are the risk factors associated with increased surgical complications in cataract
surgery?
7.5.2 Introduction
The aim of this review was to determine the effectiveness of preoperative risk stratification
techniques, and the identification of risk factors associated with an increase in surgical
complications. The reviews for these two separate issues focused on identifying studies that
fulfilled the conditions specified in Table 18 and Table 19, respectively. For full details of the
review protocol, see Appendix C. The main outcomes for this review were surgical
complication rates.
Table 18 PICO for effectiveness of preoperative risk stratification techniques

Population with intraocular lens implantation
Interventions  Preoperative risk stratification systems
 Prioritised factors in ophthalmic risk stratification:
 Pupil size
 Density of lens
 Age and mobility of patients
 Ocular comorbidities e.g. macular degeneration, Fuch’s, Corneal endothelial
dystrophies, glaucoma, uveitis, pseudoexfoliation, big eyes, small eyes
 Systemic comorbidities e.g. diabetes, hypertension, dementia and other mental
illnesses
 Tamsulosin and warfarin (anticoagulants) use
Outcomes  Surgical complications rates

pieces.
 were studies on procedural safety surgical checklists e.g. WHO, case reports/case studies
Table 19 PICO for risk factors that are associated with surgical complications
Prognostic  Pupil size
factors  Density of lens
 Age and mobility of patients
 Ocular comorbidities e.g. macular degeneration, Fuch’s, Corneal endothelial
dystrophies, glaucoma, uveitis, pseudoexfoliation, big eyes, small eyes
89
 Systemic comorbidities e.g. diabetes, hypertension, dementia and other mental
illnesses
 Tamsulosin and warfarin (anticoagulants) use
Outcomes  Surgical complications rates

pieces
 were studies on procedural safety surgical checklists e.g. WHO, case reports/case studies

In total, 9,823 references were found from a combined database search for both review
questions, and full-text versions of 67 citations that seemed potentially relevant to this topic
were retrieved and screened at full-text. Four observational studies were included for risk
stratification (Blomquist et al., 2010; Muhtaseb et al., 2004; Osbourne et al., 2006 and
Tsinopoulos et al., 2013). Twelve studies (11 observational studies and 1 systematic review)
were included for risk factors (Artzen et al., 2009; Beatty et al., 1998; Blomquist et al., 2012;
Briszi et al., 2012; Chatziralli et al., 2011; Chen et al., 2010; Gonzalez et al., 2014; Keklikci et
al., 2009; Ling et al., 2004; Narendran et al., 2009; Robbie et al., 2006 and Rutar et al.,
2009).

Summaries of the included studies for the review questions are given in Table 20 and Table
21, with full evidence tables available in Appendix E and GRADE tables available in
Appendix G.
Table 20 Summary of included studies – risk stratification techniques

Blomquist (2010) 1,833 cataract surgery Rating risk of complications in patients based on
USA patients the Najjar-Awwad risk stratification score.
Muhtaseb (2004) 1,000 cataract surgery Patients allocated into risk groups based on the
UK patients Muhtaseb risk stratification score.
Prospective cohort
Osbourne (2006) 11,913 cataract Rating risk of complications in patients based on
UK surgery patients the Muhtaseb and Habib risk stratification scores.
Case-control study
90
Tsinopoulos (2013) 953 (1,109 eyes) Rating risk of complications in patients based on
Greece cataract surgery the Muhtaseb risk stratification score.
Randomised patients
controlled trial
Table 21 Summary of included studies – risk factors for surgical complications

Artzen (2009) 655 cataract surgery Comparison of capsule complications to case-
Sweden patients controls
Case-control study
Beatty (1998) 99 cataract surgery Comparison of suprachoroidal haemorrhage to
UK patients case-controls
Case-control study
Blomquist (2012) 2,434 cataract surgery Comparison of patients with and without
USA patients intraoperative complications
Briszi (2012) 600 cataract surgery Correlating patient characteristics risk factors to
Germany patients intraoperative complications
Chatziralli (2011) 17 studies (17,588 Systematic review of risk factors for intraoperative
Greece eyes) floppy iris syndrome
Systematic review
Chen (2010) 59 people (81 eyes) Comparison of prophylactic lidocaine-epinephrine
USA cataract surgery to none on floppy-iris syndrome
Retrospective cohort patients
Gonzalez (2014) 4,335 cataract surgery Correlating patient characteristics risk factors to
Spain patients intraoperative and postoperative complications
Prospective cohort
Ling (2004) 558 cataract surgery Comparison of suprachoroidal haemorrhage to
UK patients case-controls
Case-control
Narendran (2009) 55,567 cataract Correlating patient characteristics risk factors to
UK surgery cases intraoperative complications
Prospective cohort
Robbie (2006) 1,441 cataract surgery Correlating patient age to intraoperative
UK patients complications
Prospective cohort
Rutar (2009) 320 eyes of cataract Correlating patient characteristics risk factors to
USA surgery patients intraoperative complications

4,306 references were retrieved, of which 0 were retained for this review question. Health
91
7.5.5.1 Risk stratification techniques

Moderate-quality evidence from 1 retrospective cohort study of 1,883 participants found that
those with a cataract risk score of >6 as determined using the Najjar–Awwad risk
stratification algorithm have a clinically meaningfully increased risk of complications during
cataract surgery.
Low- to high-quality evidence from 1 case-control study of 11,913 participants and 1
prospective cohort study of 1000 participants found that those with increasing potential
complication scores as determined using the Muhtaseb risk stratification algorithm had
clinically meaningfully higher odds of developing complications during cataract surgery.
Low-quality evidence from 1 case-control study of 11,913 participants found that those with
increasing potential complication scores as determined using the Habib risk stratification
algorithm had clinically meaningfully higher odds of developing complications during cataract
surgery.
Very low- to low-quality evidence from 1 RCT of 953 participants could not distinguish rates
of posterior capsule rupture or rates of all intraoperative complications between those in the
risk stratified or unstratified arms of the trial.
Low-quality evidence from 1 RCT of 953 participants found, in the subgroup of participants
operated on by trainee resident surgeons, clinically meaningfully lower odds of adverse
events in the risk stratified as opposed to unstratified arm of the trial.
7.5.5.2 Risk factors
7.5.5.2.1 Risk of suprachoroidal haemorrhage

Low- to very low-quality evidence from 1 case-control study of 558 participants found those
with a posterior capsule rupture, using cardiovascular drugs, with glaucoma, with increased
preoperative intraocular pressure and those who undergo conversion from
phacoemulsification to extracapsular cataract extraction during surgery had higher odds of
developing a suprachoroidal haemorrhage during cataract surgery.
Very low-quality evidence from 1 case-control study of 99 participants could not differentiate
preoperative intraocular pressure between those who did and did not develop a
suprachoroidal haemorrhage during cataract surgery.
7.5.5.2.2 Risk of floppy iris syndrome

Low- to moderate-quality evidence from 1 retrospective cohort study of 59 participants found
that those with a preoperative pupil diameter of ≤ 6.5 mm had higher odds of developing
floppy iris syndrome during cataract surgery, but could not differentiate the odds between
those receiving or not receiving prophylactic intracameral lidocaine-epinephrine.
Moderate- to high-quality evidence from 1 systematic review of 17,588 eyes found that
people with hypertension had higher odds of developing floppy iris syndrome during cataract
surgery, but could not differentiate the odds for people with diabetes mellitus.
Moderate-quality evidence from 1 systematic review of 17,588 eyes found that people using
tamsulosin had higher odds of developing floppy iris syndrome during cataract surgery.
Moderate- to high-quality evidence from 1 systematic review of 17,588 eyes found that
people using alfuzosin, terazosin or doxazosin had higher odds of developing floppy iris
syndrome during cataract surgery.
92
7.5.5.2.3 Risk of posterior capsule rupture, vitreous loss or both
Moderate-quality evidence from 1 prospective cohort study of 55,567 participants found that
those with the following preoperative characteristics had higher odds of developing posterior
capsule rupture during cataract surgery:
 Glaucoma
 Diabetic retinopathy
 Brunescent / white cataract
 No fundal view / vitreous opacities
 Pseudo exfoliation / phacodonesis
 Pupil size (small)
 Axial length ≥ 26.0mm
Low- to moderate-quality evidence from 1 prospective cohort study of 55,567 participants
found that, when compared with those operated on by a consultant, people who were
operated on by the following surgical grade had higher odds of developing posterior capsule
rupture during cataract surgery:
 Fellow
 Specialist registrar
 Senior house officer
but could not differentiate the odds for associate specialist or staff grade surgeons.
Low- to moderate-quality evidence from 1 prospective cohort study of 55,567 participants
found that, when compared with those aged under 60 at the time of surgery, people over 70
had higher odds of developing posterior capsule rupture during cataract surgery, but could
not differentiate the odds for ages 60–69.
Moderate-quality evidence from 1 prospective cohort study of 55,567 participants found that
people who used doxazosin or were unable to lie flat for the operation had higher odds of
developing posterior capsule rupture during cataract surgery.
7.5.5.2.4 Risk of developing intraoperative complications

Low-quality evidence from 1 prospective cohort study of 1,441 participants could not
distinguish rates of intraoperative complications between those in different age groups.
Very low- to moderate-quality evidence from 1 retrospective cohort study found that people
with preoperative white cataract or dense nuclear sclerosis had higher odds of developing
intraoperative complications during cataract surgery but could not differentiate the odds for
the following characteristics:
 Small pupil (< 6.0 mm)
 Anterior chamber depth < 2.5 mm
 Axial length > 26.0 mm
 Pseudoexfoliation syndrome
 Posterior synechia
 Restless patient
Moderate-quality evidence from 1 retrospective cohort study of 2,434 participants found that
those with the following preoperative conditions had higher odds of developing intraoperative
complications during cataract surgery:
 Worse corrected distance visual acuity (logMAR)
 Prior pars plana vitrectomy
93
 Dementia
 Zonular dehiscence
Very low-quality evidence from 1 retrospective cohort study of 320 participants could not
distinguish rate of intraoperative complications between those with better and worse
preoperative visual acuity.
Low- to very low-quality evidence from 1 prospective cohort study of 4,335 participants found
that those with a preoperative visual acuity more than 1 logMAR had higher odds of
developing intraoperative complications during cataract surgery than people with a
preoperative visual acuity less than or equal to 0.3 logMAR.
Very low-quality evidence from 2 case-control studies of 1,255 participants found that having
a preoperative white cataract increased the odds of developing intraoperative complications
during cataract surgery.
Very low-quality evidence from 1 case-control study of 655 participants found that those with
preoperative characteristics of phacodonesis or a brunescent/hard cataract had higher odds
of developing intraoperative complications during cataract surgery, but could not differentiate
the odds for those with corneal pathology or ocular comorbidity.


Relative value of different The committee agreed there were two important pieces of information
outcomes which would inform any recommendations made. The first was
whether risk-stratification algorithms were able to accurately predict
individuals at higher risks of complications (and whether these
algorithms stratified the risk of all complications or whether they were
able to identify people at higher risk of specific complications).
Secondly, it would be important to have information on whether the
use of risk-stratification algorithms in practice leads to a reduction in
overall complication rates, as the use of such algorithms would only
be justified if it were to result in clinical benefit.
Trade-off between The committee noted that the evidence presented and risk factors
benefits and harms identified were largely in line with current clinical opinion and covered
the major risk factors, including those posed from patients taking
medication such as tamsulosin. The committee also noted that
evidence regarding conversion rates from phacoemulsification to
extracapsular cataracts extraction were likely to have changed over
time with much fewer extracapsular cataract extraction operations
taking place now.
The committee agreed the evidence presented showed both that risk-
stratification algorithms worked (that is, they were able to predict
people at higher risk of complications) and that the use of an
algorithm in an RCT demonstrated the potential to reduce
complication rates. Specifically, the use of a risk-stratification
algorithm, and the assignment of more complex cases to a more
experienced surgeon led to a significant reduction in complication
rates for trainee surgeons, without there being a significant increase
in rates for the more experienced surgeons. The committee also
agreed that since this evidence came from only 1 RCT using 1
particular risk stratification algorithm, that is was appropriate for this
recommendation to be made at only the ‘consider’ level.
94
The committee agreed there were a couple of unintentional
downsides that could potentially occur as a result of the widespread
adoption of risk-stratification. Firstly, while the assignment of more
complex cases to more experienced surgeons should reduce the
overall complication rate, it may result in more experienced surgeons
having worse adverse event rates, which can cause problems when
these rates are used to judge surgeon performance. It was noted that
surgeon-specific complication rates are risk-adjusted when results
are submitted and analysed, but this can only be done in cases
where patients have been preoperatively risk-stratified. Secondly, the
committee agreed that there is still a need to train the next generation
of cataract surgeons and it could hamper teaching opportunities if
they were not able to experience more complex surgeries.
As a result of this, the committee agreed that it was appropriate that
specific precautions were taken to maximise clinical outcomes in
people at a high risk of complications. The surgeon training needs
identified above meant that the committee agreed that it would not be
appropriate to say these cases should not be assigned to surgeon in
training, as this could lead to greater harms in the long-term from
future surgeons not being fully trained, but felt it was appropriate to
recommend that trainee surgeons should only undertake these more
complex cases under the close supervision of an experienced
surgeon.
The committee also agreed there was another important subgroup of
people, those with only 1 functional eye, where the consequences of
a complication could be very severe and therefore again it was
appropriate that trainee surgeons should only undertake these cases
under the close supervision of an experienced surgeon.
Consideration of health The committee agreed that the use of risk-stratification algorithms
benefits and resource was already widespread, and that the information needed did not
use represent anything that should not be considered as a part of the
normal preoperative process. Therefore, there was not expected to
be any substantial increase in resource use from these
recommendations. The committee agreed the only way in which a
significant increase in resource use might result was if the use of risk-
stratification led to a higher proportion of cases being assigned to
more experienced surgeons, but it was noted that the trial evidence
did not seem to suggest this would be a likely result.
Quality of evidence The committee agreed that, while the evidence on individual risk
factors was generally of low quality, the fact it supported existing
clinical opinion meant this was not a great cause of concern. It also
noted that a number of risk-stratification algorithms had been tested
in large groups of individuals with fairly consistent results, and this
provided additional support to the committee’s recommendations. It
was, however, noted that there was only a single study which
compared two risk-stratification algorithms against each other, and in
the absence of more such data it was not felt to be appropriate to
recommend the use of any specific algorithm, only that the one used
should have been previously validated.
Other considerations The committee agreed that some of the information coming out of this
review also had implications for the conversations that should be had
when an individual is deciding whether or not to have surgery.
The committee discussed the evidence which indicated that patients
with white, brunescent or hard cataracts were at an increased risk of
intraoperative complications. It agreed that surgeons like to have
greater illumination of the eyes features during surgery and, in
patients with a denser cataract, it can be harder to see what you are
doing, making the procedure more complex. It also noted that denser
cataracts are harder to break up, take longer during surgery and
those with denser cataracts tend to have worse visual acuity outcome
95
after surgery. The committee also noted that, due to the progressive
nature of most cataracts, a delay in the time of surgery may result in
the cataract having hardened and therefore the person being at a
higher risk of complications. The committee agreed that it was
appropriate that individuals considering surgery should be given this
information, as it may affect the risk–benefit balance of surgery for
people with good vision in the other eye.
The committee also agreed it was important that people be informed
of the results of their individual risk-stratification, as these may impact
the overall risk–benefit balance of surgery. It was, however, noted
that making sure these results are communicated clearly and
understood by the person was important, as otherwise they may
cause unnecessary concern. In particular, there was concern that
telling individuals they are at a higher risk of complications may
cause them concern, even when the absolute level of risk is still very
low. Therefore, the information provided to the individual should not
just talk about their relative risk of complications compared with other
people, but also the absolute level of risk, as this was felt to be easier
to understand and more informative for most people.
17. Consider using a validated risk stratification algorithm for people who have been
referred for cataract surgery, to identify people at increased risk of complications
during and after surgery.
18. Explain the results of the risk stratification to the person, and discuss how it may
affect their decisions.
19. To minimise the risk of complications during and after surgery, ensure that
surgeons in training are closely supervised when they perform cataract surgery
in:
 people who are at high risk of complications or
 people for whom the impact of complications would be especially severe
(for example, people with only 1 functional eye).
20. Explain to people who are at risk of developing a dense cataract that there is an
increased risk of complications if surgery is delayed and the cataract becomes
more dense.
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8 Intraocular lens selection
Polymethyl methacrylate (PMMA) lenses were the first type of intraocular lenses used after
cataract surgery. These have been followed by silicone lenses, and more recently acrylic
lenses, which can be either hydrophobic or hydrophilic. More modern lenses have tended to
be foldable, in contrast to the rigidity of earlier PMMA lenses. Different lens materials may
lead to different outcomes after surgery, including differences in rates of posterior capsule
opacification, and different optical aberrations that may occur after surgery. Intraocular
lenses may also have a rounded or square edge, which again may affect visual outcomes
and rates of posterior capsule opacification after surgery.
Aspheric lenses have a more complex surface shape than spheric lenses, as the shape does
not follow that of a sphere or cylinder. They are designed to reduce the level of spherical and
other optical aberrations after surgery, and are also hypothesised to improve levels of
contrast sensitivity after implantation, compared to spherical lenses.
All intraocular lenses in use today are designed to filter out ultraviolet light; these lenses are
colourless and absorb most ultraviolet radiation and a small amount of violet light. Blue-light
filtering lenses are designed to additionally block short-wavelength visible light – at the blue
end of the spectrum. It has been hypothesised that age-related macular degeneration may,
in part, be the result of cumulative retinal damage caused by phototoxicity from continued
exposure to short-wavelength visible light. If this hypothesis is correct, blue-filtering lenses
may play a role in reducing the incidence or progression of macular degeneration in people
after cataract surgery, but this needs to be balanced against the potential loss of contrast
sensitivity that the use of these lenses may cause.
Standard monofocal intraocular lenses, when implanted after cataract surgery have one
single point of focus, meaning that a person’s vision can only be optimised for either near or
distance vision, but not both. People will then often require spectacles in order to see at
whatever distance their lens has not been optimised for. Multifocal lenses are designed to
have multiple points of focus and therefore improve vision and reduce rates of spectacle
dependence, but there are concerns they may be associated with a range of optical
abnormalities, including glare and halos. An alternative technique to attempt to optimise both
near and distance vision is called monovision, where people have a monofocal lens
optimised for near vision implanted in one eye, and a monofocal lens optimised for distance
vision implanted in the other eye.
Toric intraocular lenses are designed to reduce postoperative astigmatism resulting from an
abnormal curvature of the cornea. Toric lenses have a different refractive power in the
horizontal and vertical plane, to counterbalance pre-existing visual distortions people may
have. As well as the use of toric lenses, certain surgical techniques, such as limbal relaxing
incisions and on-axis surgery, may also reduce levels of astigmatism by reshaping the
cornea during surgery.
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8.1 Lens design
 Are different lens designs (aspheric vs. spheric, plate vs. loop) effective in improving
postoperative vision (refractive outcomes, optical aberrations) in cataract surgery?
 Are different lens designs (square-edged vs. round-edge, plate vs. loop) and materials
(hydrophilic acrylic, hydrophobic acrylic, collagen, hydroxyethyl methacrylate-based vs.
silicone-based) effective in preventing posterior capsule opacification in cataract surgery?
8.1.2 Introduction
The aim of this review was to identify the most appropriate materials for and designs of
intraocular lenses, both for improving visual outcomes and preventing posterior capsule
opacification after cataract surgery.
For full details of the review protocol, see Appendix C. The main outcomes for this review
were visual acuity, visual function and quality of life after surgery, surgical complication rates,
patient satisfaction and resource use/costs.
Table 22: PICO inclusion criteria for lens material and design
Population Adults (18 years and over) undergoing phacoemulsification cataract surgery with
intraocular lens implantation
Interventions Different monofocal lenses:
 Aspheric vs. spheric
 Plate vs. loop vs. 3 piece
 Square-edged vs. round-edge
 Hydrophilic acrylic vs. hydrophobic acrylic vs. PMMA-based vs. silicone-based
Outcomes  Rates of posterior capsule opacification
 Visual acuity
 Visual function
 Patient reported dysphotopsia (count data)
 Night vision problems
 Contrast sensitivity
 Depth of focus
 Near vision
 Lens centration
 Quality of life
Randomised controlled trials (RCTs) and systematic reviews of RCTs were included if they
compared at least two different lenses which differed by a single one of the specified lens
design features. The only exception to this was papers looking at spheric versus aspheric
lenses and measuring outcomes (such as spherical aberration) which would not be expected
to be as significantly affected by other aspects of lens design. Papers were excluded if they:
 compared monofocal with multifocal lenses
 only compared different lenses which did not differ in any of the specified features
 only compared different lenses which differed in more than one of the specified features
 were narrative reviews, case studies/reports, case series, reliability studies, diagnostic
98

In total, 1,830 references were found for these review questions, and full-text versions of 206
citations that seemed potentially relevant to this topic were retrieved. A Cochrane review
containing 31 relevant RCTs was identified (other studies from the original review were
excluded as they did not meet the criteria specified in our protocol – primarily where lenses
differed in more than one of the features specified in this review), as were an additional 44
RCTs. The reference lists of 8 identified systematic reviews (Buehl et al. 2008, Cheng et al.
2007, Leung et al. 2014, Li et al. 2008, Li et al. 2013, Liu et al. 2013, Schuster et al. 2013,
Schuster et al. 2015) were also reviewed to identify any additional relevant studies. Of the 75
RCTs included in the final review:
 27 contained comparisons of different lens materials
 23 contained comparisons of aspheric versus spheric lenses
 18 contained comparison of 1-piece (loop or plate) versus 3-piece lenses
 15 contained comparisons of square-edged versus round-edged lenses
Since the studies identified used a number of different scales to measure levels of posterior
capsule opacification, all of the outcome measures were converted to a 0-100 scale before
analysis, with higher numbers corresponding to worse levels of posterior capsule
opacification.

The included studies are summarised in Table 23; full details are found in the evidence
tables (see Appendix E).
Table 23 Summary of included studies

Study & location Population Lens design comparison Outcomes
Findl 2010 32 relevant RCTs Lens material Visual acuity
Cochrane review Lens design PCO
YAG rate
Alio 2002 118 people with PMMA vs hydrophobic YAG rate
Spain chronic uveitis (inter- acrylic vs silicone
person comparison)
Baumeister 2005 53 people (fellow-eye Square-edge vs round- Lens decentration
Germany study) edge Lens tilt
Hydrophobic acrylic vs
silicone
Baumeister 2009 21 people (fellow-eye Aspheric vs spheric Aberrations
Germany study)
Caporossi 2007 100 people (inter- Aspheric vs spheric Visual acuity
Italy person comparison) Aberrations
Contrast
sensitivity
99
Chang 2013 80 people (inter- 1-piece vs 3-piece PCO
Sweden person comparison) YAG rate
Glistenings
Chang 2015 78 people (fellow-eye Hydrophobic acrylic vs Glistenings
Sweden study) hydrophilic acrylic
Chen 2006 20 people (fellow-eye Aspheric vs spheric Visual acuity
China study) Contrast
sensitivity
Crnej 2014 30 people (fellow-eye Aspheric vs spheric Visual acuity
Austria study) PCO
Contrast
sensitivity
Cui 2009 57 people (inter- Aspheric vs spheric Aberrations
China person comparison) Contrast
sensitivity
Denoyer 2007 20 people (inter- Aspheric vs spheric Visual acuity
France person comparison) Aberrations
Contrast
sensitivity
Espindola 2012 25 people (fellow-eye Aspheric vs spheric Visual acuity
Brazil study) Aberrations
Contrast
sensitivity
Findl 2015 50 people (fellow-eye 1-piece vs 3-piece Visual acuity
UK and Austria study) PCO
YAG rate
Hayashi 1997 160 people (inter- Hydrophobic acrylic vs Lens decentration
Japan person comparison) silicone Lens tilt
Hayashi 1998 100 people (fellow-eye 1-piece vs 3-piece Lens decentration
Japan study) Lens tilt
Hayashi 2001 100 people (fellow-eye Hydrophobic acrylic vs YAG rate
Japan study) hydrophilic acrylic Lens decentration
Lens tilt
Hayashi 2005 56 people (fellow-eye 1-piece vs 3-piece Lens decentration
Japan study) Lens tilt
Hennig 2014 1,200 people (inter- PMMA vs hydrophilic Visual acuity
Nepal person comparison) acrylic PCO
Hollick 1999 81 people (inter- PMMA vs hydrophilic YAG rate
UK person comparison) acrylic vs silicone
Jafarinasab 2010 34 people (inter- Aspheric vs spheric Visual acuity
Iran person comparison) Aberrations
Contrast
sensitivity
Kobayashi 2000 1,202 people (inter- PMMA vs hydrophobic Visual acuity
Japan person comparison) acrylic YAG rate
Kugelberg 2008 120 people (inter- Hydrophobic acrylic vs Visual acuity
Sweden person comparison) hydrophilic acrylic YAG rate
Luo 2010 260 people (inter- Aspheric vs spheric Visual acuity
sensitivity
100
Moorfields 2007 300 people (inter- Aspheric vs spheric Visual acuity
UK person comparison) Aberrations
Contrast
sensitivity
Morales 2011 40 people (fellow-eye Aspheric vs spheric Visual acuity
Mutlu 2005 88 people (inter- 1-piece vs 3-piece Lens decentration
Turkey person comparison) Lens tilt
Mylonas 2013 28 people (fellow-eye 1-piece vs 3-piece PCO
Austria study) YAG rate
Nanavaty 2009 47 people (fellow-eye Aspheric vs spheric Visual acuity
UK study) Aberrations
Depth of focus
Nanavaty 2012 47 people (fellow-eye Aspheric vs spheric Visual acuity
UK study) PCO
YAG rate
Papaliodis 2002 36 people with chronic PMMA vs hydrophobic YAG rate
USA uveitis (inter-person acrylic vs silicone
comparison)
Prinz 2011 40 people (fellow-eye Plate vs 3-piece Visual acuity
Austria study) PCO
YAG rate
Lens tilt
Prinz 2012 40 people (fellow-eye 1-piece vs 3-piece Visual acuity
Austria study) PCO
YAG rate
Rocha 2006 60 people (fellow-eye Aspheric vs spheric Visual acuity
Contrast
sensitivity
Sandoval 2008 27 people (inter- Aspheric vs spheric Visual function
USA person comparison) Contrast
sensitivity
Santhiago 2010 25 people (fellow-eye Aspheric vs spheric Visual acuity
Brazil study) Contrast
sensitivity
Shentu 2008 196 people (inter- Aspheric vs spheric Visual acuity
sensitivity
Takmaz 2009 60 people (inter- Aspheric vs spheric Aberrations
Turkey person comparison) Contrast
sensitivity
Trueb 2009 262 people (inter- Aspheric vs spheric Visual acuity
Switzerland person comparison) Contrast
sensitivity
Tzelikis 2007 25 people (fellow-eye Aspheric vs spheric Visual acuity
Contrast
sensitivity
Tzelikis 2008 25 people (fellow-eye Aspheric vs spheric Visual acuity
101
Contrast
sensitivity
van Gallan 2010 30 people (fellow-eye Aspheric vs spheric Visual acuity
Netherlands study) Aberrations
Vasavada 2011 68 people (fellow-eye Hydrophobic acrylic vs YAG rate
India study) hydrophilic acrylic
Vock 2009 22 people (fellow-eye Hydrophobic acrylic vs Visual acuity
Austria study) silicone YAG rate
Yamaguchi 2011 92 people (inter- Aspheric vs spheric Contrast
Japan person comparison) sensitivity
Zemaitiene 2011 89 people (inter- Hydrophobic acrylic vs Visual acuity
Lithuania person comparison) silicone PCO
1-piece vs 3-piece YAG rate
Zeng 2007 124 people (inter- Aspheric vs spheric Visual acuity
sensitivity

8.1.5.1 PMMA versus silicone

Low-quality evidence from up to 7 RCTs containing 450 eyes could not differentiate levels of
posterior capsule opacification or rates of Nd:YAG capsulotomy between people given
PMMA or silicone intraocular lenses.
8.1.5.2 PMMA versus hydrophilic acrylic

Moderate-quality evidence from 1 RCT containing 996 eyes could not differentiate levels of
uncorrected or corrected visual acuity between people given PMMA or hydrophilic acrylic
intraocular lenses.
Moderate-quality evidence from 1 RCT containing 53 eyes found lower levels of posterior
capsule opacification in people given PMMA compared with hydrophilic acrylic intraocular
lenses, but moderate-quality evidence from 1 RCT containing 996 eyes found clinically
meaningfully lower rates of Nd:YAG capsulotomy in people given hydrophilic acrylic versus
PMMA intraocular lenses.
8.1.5.3 PMMA versus hydrophobic acrylic

corrected visual acuity between people given PMMA or hydrophobic acrylic intraocular
lenses.
Low- to high-quality evidence from up to 3 RCTs containing 994 eyes found clinically
meaningfully lower rates of Nd:YAG capsulotomy in people given hydrophobic acrylic versus
PMMA intraocular lenses, but could not differentiate rates of Nd:YAG capsulotomy for the
subpopulation of people with pre-existing uveitis.
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8.1.5.4 Hydrophobic acrylic versus silicone
Low- to moderate-quality evidence from up to 4 RCTs containing 318 eyes could not
differentiate levels of corrected visual acuity, lens decentration or lens tilt between people
given hydrophobic acrylic or silicone intraocular lenses.
differentiate levels of posterior capsule opacification or rates of Nd:YAG capsulotomy
between people given hydrophobic acrylic or silicone intraocular lenses.
8.1.5.5 Hydrophobic acrylic versus hydrophilic acrylic

High-quality evidence from up to 2 RCTs containing 144 eyes found higher levels of
corrected visual acuity in people given hydrophobic acrylic versus hydrophilic acrylic
intraocular lenses.
Hhigh-quality evidence from 1 RCT containing 52 eyes found lower levels of posterior
capsule opacification in people given hydrophobic acrylic versus hydrophilic acrylic
intraocular lenses.
High-quality evidence from 6 RCTs containing 685 eyes found clinically meaningfully lower
rates of Nd:YAG capsulotomy in people given hydrophobic acrylic versus hydrophilic acrylic
intraocular lenses.
lens decentration or lens tilt between people given hydrophobic acrylic versus hydrophilic
acrylic intraocular lenses.
Low-quality evidence from 1 RCT containing 78 eyes found more glistenings in people given
hydrophobic acrylic versus hydrophilic acrylic intraocular lenses, but could not find any link
between glistenings and either visual acuity or contrast sensitivity.
8.1.5.6 Network meta-analyses (lens material)

Moderate-quality evidence from 2 network-meta analyses of up to 11 RCTs containing 1,258
eyes found that hydrophilic acrylic and PMMA lenses were associated with significantly
higher PCO scores than hydrophobic acrylic or silicone lenses, and hydrophilic acrylic lenses
were associated with significantly higher scores than PMMA lenses.
Moderate-quality evidence from a network-meta analysis of 21 RCTs containing 3,798 eyes
found that hydrophilic acrylic and PMMA lenses were associated with clinically meaningfully
higher rates of Nd:YAG capsulotomy than hydrophobic acrylic or silicone lenses.
8.1.5.7 Square-edge versus round-edge

Moderate-quality evidence from up to 5 RCTs containing 460 eyes could not differentiate
levels of corrected visual acuity, lens decentration or lens tilt between people given square-
edge versus round-edge intraocular lenses.
Moderate- to high-quality evidence from up to 11 RCTs containing 1,251 eyes found lower
levels of posterior capsule opacification and rates of Nd:YAG capsulotomy in people given
square-edge versus round-edge intraocular lenses.
8.1.5.8 Loop versus 3-piece

differentiate levels of uncorrected visual acuity, corrected visual acuity, lens decentration or
lens tilt between people given loop or 3-piece intraocular lenses.
103
Moderate-quality evidence from up to 13 RCTs containing 1,212 eyes could not differentiate
levels of posterior capsule opacification or rates of Nd:YAG capsulotomy between people
given loop or 3-piece intraocular lenses.
Low-quality evidence from 1 RCT containing 78 eyes found more glistenings in people given
loop versus 3-piece intraocular lenses, but could not find any link between glistenings and
either visual acuity or contrast sensitivity.
8.1.5.9 Plate versus 3-piece

corrected visual acuity or lens tilt between people given plate or 3-piece intraocular lenses.
Low- to moderate-quality evidence from 1 RCT containing 60 eyes could not differentiate
levels of posterior capsule opacification or rates of Nd:YAG capsulotomy between people
given plate or 3-piece intraocular lenses.
8.1.5.10 Aspheric versus spheric

Moderate- to high-quality evidence from up to 16 RCTs containing 1,675 eyes could not
identify and meaningful differences in levels of uncorrected or corrected visual acuity
between people given aspheric or spheric intraocular lenses.
differentiate levels of posterior capsule opacification or rates of Nd:YAG capsulotomy
between people given aspheric or spheric intraocular lenses.
Low- to moderate-quality evidence from up to 14 RCTs containing 932 eyes found lower
levels of spherical, higher-order and comatic aberrations in people given aspheric versus
spheric intraocular lenses.
Moderate- to high-quality evidence from up to 3 RCTs containing 309 eyes found lower
levels of depth of focus in people given aspheric versus spheric intraocular lenses, but could
not differentiate levels of visual-function (measured using the VFQ-25) or contrast sensitivity
(measured using the Pelli-Robson chart)
Low-quality evidence from up to 17 RCTs found higher levels of contrast sensitivity across all
spatial frequencies tested in people given aspheric versus spheric intraocular lenses, with
the difference being greater at mesopic lighting levels.

Please note: the recommendations around lens design and material have been removed to
allow for further consideration.
6. What is the most effective material for square-edge lenses for preventing posterior
capsule opacification and improving postoperative vision in cataract surgery?
Why is this important?

Although there is high-quality evidence for the short-term visual outcomes and adverse event
risks of different intraocular lens materials, lens design is advancing rapidly, and therefore
104
currently available research may not be fully representative of all currently available lens
technologies. Well conducted long-term randomised controlled trials reporting patient-
important outcomes and adverse events would help to inform future recommendations on
lens material choices for use in cataract surgery, in particular the trade-offs between visual
outcomes and adverse events with different lens materials.
7. What are the long-term outcomes of different choices of intraocular lens material
following cataract surgery?

Although there is high-quality evidence for the short-term visual outcomes and adverse event
risks of different intraocular lens materials, there is a lack of evidence for longer-term
outcomes. Lens design is advancing rapidly, and there are likely to be new designs
becoming available in the near future that have not yet been evaluated. Well conducted long-
term randomised controlled trials reporting patient-important outcomes and adverse events
would help to inform future recommendations on lens material choices for use in cataract
surgery, in particular the trade-offs between visual outcomes and adverse events with
different lens materials.
8. What are the long-term rates of and reasons for lens explantation after cataract
surgery?

The development of a register of lens explantations would help to explore if a particular lens
type needed to be explanted more than others, and allow the determination of when these
take place and the reasons behind them. Such evidence would enhance understanding of
possible issues pertinent to cataracts surgery, in particular whether there are certain lens
types associated with rare but significant problems, either adverse events or dissatisfaction
with visual outcomes, which require another surgical procedure to correct.
9. What is the effect of differences in contrast sensitivity and depth of focus on

overall visual function and quality of life?

This guideline identified differences in contrast sensitivity and depth of focus between
different lens designs, but there was not good evidence linking these intermediate outcomes
to either patient satisfaction or quality of life. Cross-sectional or cohort studies that looked at
the correlations between contrast sensitivity/depth of focus and quality of life would help to
better interpret the results from these clinical studies, and make it possible to judge whether
these differences, which are clinically measurable, are actually meaningful to the individuals
concerned.
105
8.2 Blue-light filtering vs ultraviolet-light filtering lenses
 Are tinted lenses effective in preventing the progression of age-related macular
degeneration compared with colourless lenses in cataract surgery?
8.2.2 Introduction
The aim of this review was to determine whether blue-light filtering lenses are effective in
preventing the progression of age related macular degeneration (AMD) compared with
colourless lenses. Colourless lenses (ultraviolet light blocking) are also referred to within the
included studies as ‘Neutral, Natural or Clear’. The term used is dependent on the author but
they are comparable. The review focused on identifying studies that fulfilled the conditions
specified in Table 24. For full details of the review protocol, see Appendix C. The main
outcomes for this review were age related macular degeneration, visual acuity, colour vision
and sleep problems.
Table 24 PICO inclusion criteria for the review question on blue-light filtering vs
ultraviolet-light filtering lenses
Interventions  Different monofocal/multifocal lenses
 Blue-light filtering vs. ultraviolet-light filtering
 Different colours
Outcomes  Incidence of age-related macular degeneration
 Rates of progression of age-related macular degeneration
 Visual acuity
 Colour vision
 Sleep problems
 Depression
 Quality of life

 were narrative reviews, case studies/reports, commentaries, editorials/letters or
opinion pieces

In total, 524 references were found from a database search for the review question, and full-
text versions of 44 citations that seemed potentially relevant to this topic were retrieved and
screened at full-text. A systematic review by Zhu was also identified, and was used as a
means to identify relevant studies, but all results are extracted from those primary studies,
rather than data being taken from the review. Studies included in the Zhu review were
excluded if they did not report any outcomes specified in this review.
106
In total, 13 randomised controlled trials (reported in 14 publications) were identified and
included within the reivew. One further paper was included after a re-run of the searches for
this review question (Brondsted et al., 2016).

The design of included studies is summarised in Table 25. Full details and results are found
in the evidence tables (see Appendix E).
Table 25 Summary of included studies – blue-light filtering vs ultraviolet-light filtering

lenses
Study &
location Population Methods
Brondsted 76 patients RCT determining the effect of cataract surgery on circadian
(2015) photoentrainment when receiving blue-blocking or neutral
USA IOLs
Brondsted 67 patients RCT determining the effect of blue-blocking and neutral
(2016) intraocular lenses on circadian photoentrainment and sleep
Denmark one year after cataract surgery (secondary publication of
Bronsted 2015).
Caporossi 50 patients RCT comparing the performance of 3 aspheric and 2
(2007) spherical IOLs. Citation found within Zhu (2012)
Italy Systematic Review
Caporossi 50 patients RCT comparing aspheric and spherical IOLs 2 years after
(2009) implantation on visual function (secondary publication of
Italy Caporossi 2007). Citation found within Zhu (2012)
Systematic Review
Espindle 257 patients RCT comparing quality of life improvements in patients
(2005) with blue light filtering IOLs compared with clear IOLs
USA
Kara-Junior 25 patients RCT comparing colour vision in patients with blue light
(2011) filtering IOLs compared with clear IOLs
Brazil
Leibovich 19 patients RCT comparing the visual outcomes in patients with blue
(2006) light filtering or natural IOLs. Citation found within Zhu
Australia (2012) Systematic Review
Marshall 297 patients RCT comparing visual function in patients with blue light
(2005) filtering IOLs or clear IOLs.
USA
Mester 47 patients RCT comparing the visual outcomes in patients with blue
(2008) light filtering with a yellow chromophore or clear IOLs.
Germany Citation found within Zhu (2012) Systematic Review
Neumaier- 80 patients RCT comparing visual performance with blue light filtering
Ammerer and ultraviolet light filtering intraocular lenses. Citation
(2010) found within Zhu (2012) Systematic Review
Austria
Pandita 80 patients RCT comparing visual function in patients with blue light
(2007) filtering IOLs compared with natural IOLs. Citation found
India within Zhu (2012) Systematic Review
Rocha 40 patients RCT comparing the visual performance of blue light
(2007) filtering and ultravioler filtering IOLs. Citation found within
Brazil Zhu (2012) Systematic Review
Schmidinger 31 patients RCT comparing the visual outcomes in patients with blue
(2008) light filtering with a yellow chromophore or clear IOLs.
Austria Citation found within Zhu (2012) Systematic Review
107
Study &
Vuori 37 patients RCT comparing colour vision between blue light and
(2006) ultraviolet light filtering IOLs. Citation found within Zhu
Finland (2012) Systematic Review
Wang 79 patients RCT comparing visual function in patients with blue light
(2010) filtering photochromic IOLs compared with yellow blue light
China filtering IOLs and clear IOLs. Citation found within Zhu
(2012) Systematic Review
Zhu 15 RCT studies Systematic Review comparing blue light-filtering IOLs and
(2012) UV light-filtering IOLs for cataract surgery.
China


Very low- to moderate-quality evidence from up to 7 RCTs containing up to 526 eyes could
not differentiate sleep efficiency, sleep quality, visual acuity, overall colour vision, macular
thickness or quality of life between people offered either an ultraviolet light-filtering or blue
light-filtering lens during cataract surgery, but did find people had worse colour vision under
mesopic light conditions if offered blue-light filtering lenses. These results were consistent if
studies from non-OECD countries were excluded.

Please note: the recommendations around lens design and material have been removed to
allow for further consideration.
10. What is the long-term effectiveness of blue light filtering IOLs in reducing the
incidence and/or progression of age-related macular degeneration?

There is a lack of evidence on the long term effectiveness of blue light filtering lenses with
regards to the incidence or progression of age-related macular degeneration. Since there is
currently a lack of robust evidence on either benefits or harms with blue-light filtering lenses,
well conducted long term randomised controlleds trials and longitudinal studies in this area,
which should measure macular degeneration incidence and progression as their primary
outcome measures, would help to add to the evidence base in this area of research and so
inform future recommendations on their use.
108
8.3 Multifocal vs monofocal intraocular lenses
 What is the optimal strategy to facilitate simultaneous distance and near vision following
cataract surgery?
8.3.2 Introduction
Reviews of multifocal lenses versus monofocal lenses, and multifocal lenses versus
monovision, were undertaken by the Cochrane Eyes and Vision Group, in collaboration with
the NICE Internal Clinical Guidelines Team. The NICE Internal Clinical Guidelines Team then
searched for additional evidence on monofocal lenses versus monovision, bifocal versus
trifocal lenses, and refractive versus diffractive multifocal lenses.
The aim of the review question was to determine the effects of multifocal compared with
monofocal intraocular lenses following cataract surgery from RCTs, and the comparative
effectiveness of different designs of multifocal lens. The review focused on identifying studies
that fulfilled the conditions specified in Table 26. For full details of the review protocol, see
Appendix C.
Table 26: PICO criteria – optimal strategies to facilitate simultaneous distance and
near vision
Adults (18 years and older) undergoing phacoemulsification cataract
Population surgery and intraocular lens (IOL) implantation in one or both eyes
Interventions 1. Any type of non-accommodative multifocal intraocular lenses (including toric
multifocal lenses)
Examples: AcrySof IQ ReSTOR SN6AD3, ReSTOR SN6AD1, ReSTOR SN60D3,
ReZoom NXG1, Gradiol (concept-gradient refractive index optics), Mplus X, MS
714 PB Diff, Sulcoflex 653F, TECNIS ZM900, ZMA00
2. Implantation of 1 or 2 monofocal intraocular lenses with the aim of optimising
near vision in 1 eye and distance vision in the other ('monovision')
3. Standard monofocal intraocular lenses with the same focal point in both eyes
plus spectacles /contact lenses (optical correction)
Examples: Akreos AO, ZA9003
Comparators  All 3 listed interventions vs. each other
 Different types of multifocal lenses vs. each other
Outcomes  Unaided near, intermediate and distance visual acuity
 Contrast sensitivity
 Complications: glare and other optical aberrations
 Visual function/Quality of life
 Best corrected visual acuity (BCVA): near, intermediate and distance
 Patient satisfaction
All RCTs involving either unilateral or bilateral implantation, comparing a multifocal IOL of
any type with a monofocal IOL as control were included. Trials comparing multifocal IOLs
with 'monovision', where 1 eye is optimised for distance vision and one eye optimised for
near vision were also considered. Finally, trials of bifocal versus trifocal and diffractive versus
refractive multifocal lenses were also included.
 only examined accommodating multifocal lenses
109
pieces
primary populations of people with different eye pathologies.

In the search undertaken by the Cochrane Eyes and Vision Group, 41 potentially relevant
citations were retrieved for full-text screening, with 20 studies finally identified as meeting the
inclusion criteria. For the full list of excluded studies, with reasons, see Appendix F.

Details of the included studies can be found in Table 27, with full information given in the
evidence tables (see Appendix E). Twenty RCTs were identified for inclusion in the Cochrane
review, (Cillino 2008; ElMaghraby 1992; Haaskjold 1998; Harman 2008; Javitt 2000; Ji 2013;
Jusufovic 2011; Kamlesh 2001; Labiris 2015; Leyland 2002; Nijkamp 2004; Palmer 2008;
Peng 2012; Percival 1993; Rasp 2012; Rossetti 1994; Sen 2004; Steinert 1992; Wilkins
2013; Zhao 2010). An additional study published after the searches for the Cochrane review
(Maxwell 2017) was added in to this analysis.
Table 27: Summary of included studies – multifocals vs monofocals and multifocals vs

monovision
Study & location Sample size Methods
Cillino (2008) 124 eyes Comparison of new-generation multifocal intraocular
Italy lenses with monofocal lenses.
El Maghraby (1992) 61 eyes Multifocal versus monofocal intraocular lenses. Visual and
Saudi Arabia refractive comparisons.
Haaskjold (1998) 221 eyes Comparison of a diffractive bifocal and a monofocal
Europe intraocular lens. Contrast sensitivity after implantation of
diffractive bifocal and monofocal intraocular lenses.
Harman (2008) 86 eyes Comparing the 1CU accommodative, multifocal, and
England monofocal intraocular lenses: a randomized trial.
Javitt (2000) 470 eyes Cataract extraction with multifocal intraocular lens
USA, Germany, implantation: clinical functional, and quality-of-life
Austria outcomes: multicentre clinical trial in Germany and Austria.
Cataract extraction with multifocal intraocular lens
implantation. A multinational clinical trial evaluating clinical,
functional, and quality-of-life outcomes.
Ji (2013) 64 eyes Visual performance of Acrysof ReSTOR compared with a
China monofocal intraocular lens following implantation in
cataract surgery.
Jusufovic (2011) 100 eyes Comparison of the binocular vision quality after
Bosnia and implantation of monofocal and multifocal intraocular
Herzegovina lenses.
Kamlesh (2001) 40 eyes Contrast sensitivity and depth of focus with aspheric
India multifocal versus conventional monofocal intraocular lens.
Labiris (2015) 150 eyes Mini-monovision versus multifocal intraocular lens
Greece implantation.
Leyland (2002) 120 eyes Prospective randomised double-masked trial of bilateral
England multifocal, bifocal or monofocal intraocular lenses.
Maxwell (2017) 638 eyes Comparison of new-generation multifocal intraocular lens
with a monofocal lens
110
Study & location Sample size Methods
Nijkamp (2004) 274 eyes Effectiveness of multifocal intraocular lenses to correct
Netherlands presbyopia after cataract surgery: a randomized controlled
trial.
Palmer (2008) 228 eyes Visual function with bilateral implantation of monofocal and
Spain multifocal intraocular lenses: a prospective, randomized,
controlled clinical trial.
Peng (2012) 202 eyes Optical performance after bilateral implantation of apodized
China aspheric diffractive multifocal intraocular lenses with +3.00-
D addition power.
Percival (1993) 50 eyes Prospectively randomized trial comparing the pseudo-
England accommodation of the AMO ARRAY multifocal lens and a
monofocal lens.
Rasp (2012) 292 eyes Bilateral reading performance of 4 multifocal intraocular
Austria lens models and a monofocal intraocular lens under bright
lighting conditions.
Rossetti (1994) 80 eyes Performance of diffractive multifocal intraocular lenses in
Italy extracapsular cataract surgery.
Sen (2004) 110 eyes Quality of vision after AMO Array multifocal intraocular lens
Finland implantation. Journal of Cataract and Refractive Surgery
Steinert (1992) 62 eyes A prospective, randomized, double-masked comparison of
USA a zonal-progressive multifocal intraocular lens and a
monofocal intraocular lens.
Wilkins (2013) 374 eyes Randomized trial of multifocal intraocular lenses versus
England monovision after bilateral cataract surgery.
Zhao (2010) 161 eyes Visual function after monocular implantation of apodized
China diffractive multifocal or single-piece monofocal intraocular
lens randomized prospective comparison.
The original Cochrane review also conducted subgroup analyses looking for differences
between unilateral and bilateral implantation of monofocal lenses, and differences between
refractive and diffractive optics. No significant heterogeneity was found between these
different groups, and therefore multifocal lenses are treated as a class in the analyses below.
The additional search undertaken by the NICE Internal Guidelines Team identified a further
177 potentially relevant references, of which 59 were ordered for full-text review. Of these, 56
were eventually excluded (see Appendix F for the full list of excluded studies, with reasons),
with 3 additional RCTs included in the review. Details of the included studies can be found in
Table 28, with full information given in the evidence tables (see Appendix E).
Table 28: Summary of included studies – bifocals vs trifocals and refractive vs

diffractive multifocals
Study &
Gunderson 22 people Intra-person RCT of bifocal versus trifocal lens
(2016) implantation
Norway
Junker 28 people Inter-person RCT of bilateral bifocal versus trifocal lens
(2015) implantation
Netherlands
Xu (2014) 621 people Systematic review containing 8 RCTs comparing refractive
China with diffractive multifocal lenses
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Network meta-analyses were conducted for all outcomes where sufficient relevant data were
available. Two types of analysis were undertaken:
 A class-level analysis, comparing monofocal, monovision and multifocal lenses.
 An analysis subdividing the different types of multifocal lens, and then comparing
monofocal, monovision, refractive multifocal and diffractive multifocal lenses.

4,306 references was retrieved, of which 0 were retained for this review question. Health
One study (Dolders et al., 2004) initially appeared relevant but was excluded after detailed
review. This Dutch study compared multifocal and standard monofocal IOLs in a prospective
analysis and the authors tracked costs and patient reported utilities over the course of the
trial. The study was primarily concerned with costs outside the NHS/PSS budget as an
endpoint. Moreover, the statistical analyses of utility values, and the differences between
values from different metrics obtained at different time points relative to surgery were poorly
described and the methods used could not be replicated nor, therefore, be critically
appraised. For all these reasons, the study was not judged to provide applicable and
worthwhile evidence.
8.3.5.1 Distance visual acuity

Very low- to low-quality evidence from 2 network meta-analyses containing up to 13 studies
(1,395 participants) could not differentiate uncorrected distance visual acuity between
monofocal, monovision and multifocal lenses at the class level, but found that refractive
multifocal lenses had better outcomes than diffractive multifocal lenses.
Moderate-quality evidence from 6 RCTs containing 848 participants showed better corrected
distance visual acuity in those given multifocal compared with monofocal lenses.
8.3.5.2 Intermediate visual acuity

Moderate-quality evidence from 2 RCTs containing 515 participants showed better
uncorrected and corrected intermediate visual acuity in those given multifocal compared with
monofocal lenses.
Moderate-quality evidence from 1 RCT containing 181 participants showed better
uncorrected intermediate visual acuity in those given monovision versus multifocal lenses.
8.3.5.3 Near visual acuity

Low-quality evidence from 2 network meta-analyses containing up to 7 studies (1,154
participants) found multifocal lenses, as a class, gave better uncorrected near visual acuity
than monofocal lenses, predominantly because of a benefit of diffractive multifocal lenses
over monofocal lenses.
Low-quality evidence from 7 RCTs containing 1,316 participants could not differentiate
corrected near visual acuity in people given multifocal compared with monofocal lenses.
112
8.3.5.4 Spectacle dependence
Low-quality evidence from 2 network meta-analyses containing up to 16 RCTs (1,786
participants) showed that people given monovision had higher spectacle dependence than
people given either monofocal or multifocal lenses at the class level, with monofocal lenses
having higher spectacle dependence than multifocal lenses. People given refractive
multifocal lenses had higher levels of spectacle dependence than people given diffractive
multifocal lenses.
Low-quality evidence from up to 6 RCTs containing 772 people showed that those given
multifocal lenses had lower levels of near spectacle dependence than people given
monofocal lenses, but could not differentiate levels of distance spectacle dependence.
Low-quality evidence from 1 RCT of 75 people showed that people given multifocal lenses
had lower levels of distance spectacle dependence than people given monovision, but could
not differentiate levels of near spectacle dependence.
8.3.5.5 Contrast sensitivity

Moderate-quality evidence from 2 network meta-analyses containing up to 6 studies (550
people) showed that monovision and monofocal lenses gave better contrast sensitivity than
diffractive multifocal lenses.
8.3.5.6 Visual function

Very low-quality evidence from up to 4 RCTs containing 480 people could not differentiate
levels of visual function (measured using the VF-7 or VF-14) between multifocal lenses and
either monovision or monofocal lenses.
8.3.5.7 Vision-related quality of life and patient satisfaction

Very-low to low-quality evidence from up to 6 RCTs containing 643 people could not
differentiate levels of vision-related quality of life or patient satisfaction between those given
multifocal or monofocal lenses.
8.3.5.8 Glare
Moderate-quality evidence from 2 network meta-analyses containing up to 11 RCTs (1,158
people) showed that multifocal lenses were associated with higher rates of glare than
monovision or monofocal lenses, with refractive multifocal lenses associated with higher
rates than diffractive multifocal lenses.
8.3.5.9 Halo
Moderate quality evidence from a network meta-analysis of 10 RCTs containing 1,089
people showed that multifocal lenses are associated with higher rates of halo than monofocal
lenses, with refractive multifocal lenses associated with higher rates than diffractive
multifocal lenses.
8.3.5.10 Dysphotopsia
Low-quality evidence from 1 RCT containing 86 participants could not differentiate rates of
dysphotopsia between people given multifocal or monofocal lenses.

113
Relative value of different The committee agreed that there were a range of relevant outcomes
outcomes for this review, including both corrected and uncorrected near,
intermediate and distance visual acuity, spectacle independence,
contrast sensitivity, glare and other optical aberrations. It agreed that
these trade-offs would be best assessed through measures that
synthesised both the benefits and harms of the lenses, which would
include visual function, quality of life and patient satisfaction.
Trade-off between The committee agreed that there was evidence that multifocal IOLs
benefits and harms showed a greater benefit in terms of uncorrected visual acuity and
spectacle independence than monofocal lenses, although it noted
that multifocal lenses were associated with higher rates of glare and
halos. It also agreed that the evidence showed that diffractive
multifocal lenses were of greater benefit than refractive lenses, and
had less adverse events. The committee stated that the higher
absolute rates of glare with more recent studies could be due to
modern multifocal lenses being more susceptible, or that the patients
in the studies were asked to report glare in different ways over time –
that is, any effects would have been spontaneously reported in early
studies but more carefully elicited as time progressed in the later
ones.
The committee stated that the very small advantage in best corrected
visual acuity for monofocal lenses could be explained by the lack of
compromise in optics with only one focal point.
The committee agreed that it did not find the uncorrected visual
acuity finding surprising and that no difference in visual function being
found between multifocal and monofocal lenses suggests that the
benefits and harms may cancel each other to some degree. It
discussed the trend in the evidence of patients reporting less
spectacle dependence with multifocal lenses, stating that this could
be due to how people feel about some loss of distance vision if they
do not need spectacles for near vision. Committee members also
raised concerns as to bias with regards to patient satisfaction for
spectacle dependence (especially distance) in how the questions
were phrased. Overall, the committee did not feel these was
evidence of compelling clinical benefits in favour of either multifocal
or monofocal lenses.
It was agreed the loss of intermediate visual acuity may be
particularly troublesome for younger patients. Group members
suggested that that older patients will have adapted to a gradual loss
of intermediate vision over time (varifocal spectacles can address
this, but the committee agreed that there was some variation in
practice for offering these).
The committee agreed that, in practice, monovision is optimised for
intermediate and distance vision rather than near and distance vision
as patients will not tolerate too big a difference between both eyes. It
highlighted that 1 of the studies of monovision aimed for slight
myopia in both eyes, and so it was unsurprising that people with
monovision in this study reported high levels of spectacle
dependence. Even when monovision aims for emmetropia in 1 eye,
people often require spectacles for driving in order to correct their
myopic eye.
The committee noted that it would like to see more research
undertaken in the area of monovision within different populations; in
particular, the degree of anisometropia should be studied in order to
identify an optimal difference.
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Consideration of health The committee noted that the benefits shown by multifocal lenses,
benefits and resource compared with monofocal lenses were in uncorrected visual acuity
use and spectacle independence. The committee discussed the often
expressed desire by people to be spectacle-free following their
surgery, but felt that the likely QALY gains of spectacle independence
would be extremely small. Consequently, the committee did not feel
that the known additional costs of multifocal lenses could be justified
by the benefits observed, and therefore felt it was appropriate to
make a “do not offer” recommendations for their routine use.
The committee reported that, in its experience, multifocal lenses are
many times the cost of monofocal lenses and thus their adoption
could have a substantial resource impact, although they were not
able to quantify the magnitude of that impact because multifocal
lenses in the UK are usually purchased according to locally
negotiated confidential price discounts. The committee was made
aware of the presence of a diffractive, square-edged multifocal lens in
the NHS purchasing catalogue at a price comparable to that of
monofocal lenses. It was agreed that this was likely to represent an
older lens type and one that would therefore not be used in clinical
practice. Group members were not familiar with this particular lens (or
its manufacturer) and, without having any direct experience, the
committee was not happy to assume that the lens is generally
available, nor that it would provide similar results to those used in the
RCTs under review. The committee agreed that it was not only the
individual cost of the lens that was the issue, but rather the cost of
the whole care pathway within the NHS, including costs incurred for
additional procedures in people not satisfied with outcomes after
multifocal lens implantation (for example, those who suffer from glare
or halos)
Quality of evidence The committee discussed the evidence presented and agreed that,
although there were gains in uncorrected visual acuity in multifocal
lenses, the increase in risk of glare and halos also has to be
considered. It agreed that overall the benefits demonstrated in the
RCTs were only seen in particular patient groups, as the trials
excluded potential participants such as professional drivers or people
with an unrealistic expectation of improved outcomes from any such
implantation. For these reasons, the committee concluded that, even
before cost is taken into account, it would not be appropriate to offer
multifocal lenses routinely.
The committee agreed that all the studies presented had a risk of
bias as they were not fully masked, and thus the evidence was
reduced in quality. The committee raised concerns that the tests used
in the studies were not sensitive enough to determine the quality of
life outcomes, and also that the newer generation of multifocals have
improved over time and a historical trend in outcome improvements
could be noted.
The committee noted very few trends in either benefit or harm within
the evidence presented for monovision, although it agreed that
monovision gave the poorest distance spectacle dependence
outcome. It stated that within current practice it was usual to aim for
monovision in patients who naturally have anisometropia, and agreed
it was appropriate to make a recommendation that people who have
preoperative anisometropia or who are already using monovision
before surgery and express a desire to remain that way after surgery,
should be offered postoperative monovision.
Other considerations The committee discussed whether it would be appropriate to make a
‘do not do’ recommendation with regard to multifocal lenses, when no
such recommendation was made under similar circumstances for
toric lenses (see section 8.4). It noted that, whereas it had seen
evidence of adverse outcomes with multifocal lenses, there were no
115
such concerns for toric lenses. The committee agreed that – although
current evidence does not support their use – it is not implausible that
toric lenses could provide benefit at a cost the NHS would consider
reasonable (this possibility motivated its research recommendation
on the subject). For these reasons, the committee agreed that it was
appropriate to make an explicit ‘do not do’ recommendation for
multifocal lenses, but should not explicitly recommend against toric
lenses.
22. Do not offer multifocal intraocular lenses for people having cataract surgery.
23. Offer monovision for use after cataract surgery to people who have either
anisometropia or monovision preoperatively and would like to remain with it.
11. What is the effectiveness of different approaches to monovision (the degree of

anisometropia) versus standard monofocal lenses?

The current evidence indicates that the approaches to monovision that have been tested in
clinical studies do not give good outcomes for either distance vision or spectacle
dependence, with current practice being to offer monovision in people who naturally have
anisometropia. However, there are other approaches to monovision that may provide better
outcomes, particularly in being able to simultaneously optimise for near and distance vision.
Well conducted research to determine the effectiveness of postoperative monovision against
the use of standard monofocal lenses would help to inform future recommendations for
cataract surgery.
116
8.4 Optimal strategy to address pre-existing astigmatism
 What is the optimal strategy to address pre-existing regular astigmatism in people
undergoing cataract surgery?
8.4.2 Introduction
The aim of this review was to determine the optimal strategy to address pre-existing
astigmatism in people undergoing cataract surgery. The review focused on identifying
studies that fulfilled the conditions specified in Table 29. For full details of the review
protocol, see Appendix C.
Table 29 PICO inclusion criteria for astigmatism

Population with intraocular lens implantation with pre-existing astigmatism
Interventions  Corneal (limbal) relaxing incisions
 On-axis surgery (incision is made on steepest axis to flatten it)
 Astigmatic keratotomy
 Opposite clear corneal incisions (OCCI)
 Toric intraocular lens
Outcomes  Visual acuity
 Level of astigmatism
 Quality of life
 Resource use and cost (including time taken)

pieces

In total, 688 references were found from a database search for the review question, and full-
screened at full-text. One systematic review (Kessel et al., 2016) reporting 8 RCTs was
identified, to which 4 randomised controlled trials identified in the search were added (Emesz
et al., 2015; Kaufmann et al., 2016; Leon et al., 2015 and Ouchi et al., 2010).

117
Table 30 Summary of included studies – astigmatism
Emesz (2015) 39 patients (78 eyes) RCT comparing low, moderate and high toric value
Austria lenses with a non toric lens in cataract patients with
astigmatism.
Gangwani (2014) 58 eyes RCT comparing multifocal toric lenses with multifocal
UK non-toric accompanied with peripheral corneal relaxing
incisions. Citation found within Kessel (2016)
systematic review
Hirnschall (2014) 30 patients (60 eyes) RCT comparing the astigmatism-reducing effect of a
UK toric intraocular lens and peripheral corneal relaxing
incisions. Citation found within Kessel (2016)
systematic review
Holland (2010) 517 patients RCT comparing toric and non-toric lenses, with no
USA limbal relaxing incisions allowed. Citation found within
Kessel (2016) systematic review
Kessel (2016) Systematic review of Systematic review comparing toric and non-toric IOLs
USA RCTs to correct astigmatism during cataract surgery.
Kaufmann (2005) 71 eyes RCT to compare limbal relaxing incisions with
placement of the corneal cataract incision on the
steepest keratometric axis to reduce pre-existing
astigmatism at the time of cataract surgery
Leon (2015) 102 eyes (102 RCT comparing toric and monofocal lenses with limbal
Italy patients) relaxing incisions to manage low corneal astigmatism
in cataract surgery.
Maedel (2014) 39 eyes RCT to compare the astigmatism-reducing effect of an
Austria aspheric toric IOL and an aspheric non-toric IOL with
an opposite clear corneal incision in cataract surgery.
Citation found within Kessel (2016) systematic review
Mendicute (2009) 40 eyes RCT to compare toric IOL implantation with paired
Spain opposite clear corneal incisions for astigmatism
correction in patients having cataract surgery. Citation
found within Kessel (2016) systematic review
Mingo-Botin 40 eyes RCT to compare toric and spherical IOL implantation
(2010) with peripheral corneal relaxing incisions to manage
Spain astigmatism during phacoemulsification. Citation found
within Kessel (2016) systematic review
Ouchi (2010) 189 eyes RCT to evaluate the outcomes of limbal relaxing
incisions combined with bimanual phacoemulsification
and insertion of an intraocular lens.
Visser (2014) 86 patients (172 RCT comparison of toric vs aspherical control lenses
Netherlands eyes) in cataract patients with astigmatism. Citation found
within Kessel (2016) systematic review
Waltz (2015) 197 patients (433 RCT to evaluate toric vs non-toric IOLs in patients with
USA eyes) corneal astigmatism undergoing cataract surgery.
Citation found within Kessel (2016) systematic review

4,306 references were retrieved, of which 1 was retained for this review question. Health
Pineda (2010) developed a decision-analytic model which examined the costs and outcomes
among patients 65 years and older with cataract and pre-existing astigmatism (1.5–
118
3.0 dioptres) who were allocated to either toric or conventional IOLs with and without
intraoperative refractive correction (IRC). Data were obtained from a literature review of
effectiveness studies, and a survey of ophthalmologists (n=60) conducted online in May
2008. For each treatment option, ophthalmologists indicated the percentage of patients who
would normally not need visual aids for distance vision following cataract treatment. They
also indicated the percentage of these patients whose uncorrected visual acuity would be
20/25 or better, worse than 20/25 to 20/40, and worse than 20/40 OU.
Surgeons also reported the percentage of patients who would require further intervention to
achieve optimal distance vision and the proportion of them with less than 1.0 D and 1.0 D or
more of residual refractive cylinder after cataract treatment. They also indicated the
percentage of these patients who would receive nonsurgical (spectacles or contact lenses)
and surgical (laser vision correction, incision corneal surgery, or conductive keratoplasty)
interventions for each refractive cylinder group.
The respondents reported rates of retreatment (second refractive surgery) to optimise vision,
use of different re-treatment options, and the mean time between cataract and follow-up
refractive surgery. In addition, the ophthalmologists indicated the percentage of their patients
receiving spectacles or contact lenses and undergoing refractive surgery among the 3 UCVA
groups mentioned previously.
Patient utilities were based on data from a prospective study using the time trade-off and
standard gamble methods among patients with various vitreoretinal diseases. Utility weights
were calculated by converting the UCVA levels into Snellen decimal values (a midpoint was
obtained for the level of 20/25 to 20/40 OU) and applying an equation derived by Brown et al.
2000 (Utility = 0.37 × UCVA + 0.514). Each additional year after surgery was weighted by
these utility values to derive quality-adjusted life years (QALYs), which were summed during
18 years and annually discounted by 3% to compute cumulative lifetime estimates.
Table 31 Economic results

Base-case Results
First Year Lifetime
Incrementa Incrementa ICER Incremental Incremental ICER

l Cost of l Cost per Cost of Cost per
Treatment Patient Treatment Patient With
With UCVA UCVA of
of 20/40 or 20/40 or
Better OU Better OU
Toric IOL
Patient costs $1,052 $12,074 $141,282 $-34 $-393 $-349
Total costs $1,080 $12,406 $145,165 $-5 $-61 $-54
Standard monofocal IOL with intraoperative LRI/PCRI
Patient Costs $947 $22,852 $299,650 $160 $3,866 $3,851
Total Costs $968 $23,346 $306,141 $181 $4,361 $4,344
Disaggregated and total QALYs are not reported in the text. The base-case results suggest
that incremental cost differences in treatment terms are small, and that over a lifetime
119
horizon the use of toric IOLs generates a small saving in terms of patient and provider borne
costs. A best-case and worst-case sensitivity analysis suggests that at both a lower cost of
the toric IOL and higher spectacle independence rate (best-case scenario), toric IOLs
remained a more expensive option in the first year compared with conventional IOLs without
IRC. However, modification of either or both of these measures resulted in greater
incremental lifetime savings compared with base-case measures. Conversely, at both a
higher toric IOL cost and a lower spectacle independence rate (worse-case scenarios), the
toric IOL became the more expensive option during the patient's lifetime. The toric IOL was
not a cost-saving option across the patient's lifetime if the frequency of changing spectacles
was reduced to once every 3 years. Similar patterns of sensitivity were evident in the
subgroup analysis.
8.4.5.1 Toric IOL versus non-toric IOL
8.4.5.1.1 Visual acuity (uncorrected distance)

High-quality evidence from 9 RCTs containing 773 eyes found that people who received a
toric intraocular lens had better uncorrected distance visual acuity than those who received a
non-toric intraocular lens (with or without limbal relaxing incisions).
8.4.5.1.2 Visual acuity (corrected distance)

Moderate-quality evidence from 2 RCTs containing 250 eyes could not differentiate corrected
distance visual acuity between people receiving a toric or a non-toric intraocular lens.
8.4.5.1.3 Residual astigmatism – refractive cylinder dioptres

High-quality evidence from 9 RCTs containing 781 eyes found that people who received a
toric intraocular lens had lower levels of postoperative astigmatism than those who received
a non-toric intraocular lens (with or without limbal relaxing incisions).
8.4.5.1.4 Spectacle independence for distance viewing

Moderate-quality evidence from 4 RCTs containing 659 eyes found that people who received
a toric lens had less spectacle dependence for distance viewing than those who received a
non toric lens (with or without limbal relaxing incisions).
8.4.5.2 Limbal relaxing incisions versus no limbal relaxing incisions
8.4.5.2.1 Visual acuity (uncorrected distance)

High-quality evidence from 1 RCT containing 189 eyes found that people who received
limbal relaxing incisions had better uncorrected distance visual acuity than those who
received no limbal relaxing incisions during cataract surgery.
8.4.5.2.2 Visual acuity (corrected distance)

Moderate-quality evidence from 1 RCT containing 189 eyes could not differentiate corrected
distance visual acuity between people receiving limbal relaxing incisions versus no limbal
relaxing incisions during cataract surgery.

High-quality evidence from 1 RCT containing 189 eyes found that people who received
limbal relaxation incisions had lower levels of postoperative astigmatism than those who
received no limbal relaxation incisions during cataract surgery.
120
8.4.5.3 Limbal relaxing incisions vs on-axis incisions

Low-quality evidence from 1 RCT containing 71 eyes could not detect a difference in levels
of postoperative astigmatism between people receiving limbal relaxing incisions versus on-
axis incisions during cataract surgery.

1 partly applicable study with serious limitations suggests that toric IOLs may reduce lifetime
patient borne costs by reducing the need for spectacles or contact lenses following cataract
removal.

Relative value of different The committee stated that improvements in quality of life, visual
outcomes outcomes, reduced residual astigmatism or a reduced need for
spectacles after cataract surgery would all be relevant outcomes. For
measures of visual outcomes or level of astigmatism, it was agreed
that the evidence would be stronger if it was able to demonstrate
what level of overall benefit in quality of life an individual would, on
average, receive from an improvement in these clinical measures.
Trade-off between The committee agreed that there was evidence to suggest a clinical
benefits and harms difference in improving uncorrected visual acuity, reducing residual
astigmatism and reduced use of spectacles between using toric and
non-toric lenses. However, there was no evidence to demonstrate
what impact these changes would have on the overall quality of life of
an individual, particularly when no differences were found in
corrected visual acuity. Similarly, a clinical benefit was demonstrated
for limbal relaxing incisions and, by extension, on-axis surgery (as no
difference could be found between limbal relaxing incisions and on-
axis surgery)
Consideration of health The committee reviewed one cost–utility analysis from the USA but
benefits and resource agreed that it was not possible to relate the costs used in that
use analysis to the NHS perspective. The committee agreed that, in
practice, the acquisition cost of toric lenses is unlikely to exceed that
of standard monofocal lenses by a significant margin. However, it had
significant concerns about the increased resource burden that would
be incurred by the NHS should toric lenses be recommended. This
could include the need for an additional preoperative appointment,
additional biometry to measure corneal topography (not available in
all centres) and additional minutes of surgical time (committee
estimated 5+ extra minutes). There would also be an additional cost
for surgical equipment (toric markers for example). The committee
also discussed the need for more follow-up appointments in patients
given toric lenses to check refractive correction, and the need to
account for the poor visual satisfaction in patients who may not be
able to get a toric lens in both eyes. Surgical members of the
committee also raised concerns that implanting toric lenses could
increase the likelihood of intraoperative complications because of the
additional complexity of the procedure, and this also had implications
for staff training. The committee emphasised that none of these
parameters were included in the cost-utility analysis presented.
The committee concluded that the relative benefit in UCVA from toric
lenses shown by the evidence (which was not matched by evidence
of relative BCVA gains) was not sufficiently robust evidence to justify
the trade-off in increased resource use. The committee discussed the
often expressed desire by people to be spectacle-free following their
surgery, but felt that the likely QALY gains of spectacle independence
121
would be extremely small, and many people would still require
spectacles for reading as is the case for people without astigmatism
undergoing cataract surgery. In the final analysis, the committee
reflected that, in the absence of clear advantage in quality of life over
standard monofocal lenses, toric lenses are unlikely to represent a
cost effective treatment option for patients with astigmatism
compared with standard monofocal lenses.
The committee agreed that further research was needed looking at
the cost effectiveness of toric lenses within an NHS context and in
the use of limbal relaxing incisions during cataract surgery.
The committee noted there were no such resource constraints for
either limbal relaxing incisions or on-axis surgery, and therefore felt it
reasonable to make a ‘consider’ recommendation for both these
aspects of surgical technique.
Quality of evidence The committee noted that, although the evidence presented was
moderate in quality, the studies will have been undertaken by
surgeons with a great deal of experience in using toric lenses. It also
commented on the high number of studies that were sponsored by
toric lens manufacturing companies. It agreed that, although the
exclusion criteria in the trials seemed extensive, they were
reasonable and unlikely to impact on the overall pattern of the
evidence.
Other considerations The committee discussed whether it would be appropriate to make a
‘do not do’ recommendation with regard to toric lenses (as it had for
multifocal lenses, see section 8.3). It noted that, whereas it had seen
evidence of adverse outcomes with multifocal lenses, there were no
such concerns for toric lenses. The committee agreed that – although
current evidence does not support their use – it is not implausible that
toric lenses could provide benefit at a cost the NHS would consider
reasonable (this possibility motivated its research recommendation
on the subject). For these reasons, the committee agreed that it
should not explicitly recommend against toric lenses, but should
confine itself to making a positive recommendation about alternative
strategies.
24. Consider on-axis surgery or limbal-relaxing incisions to reduce postoperative

astigmatism.
12. What is the cost effectiveness of toric lenses compared with on-axis or limbal-
relaxing incision surgery, or non-toric lenses with no further intervention, in an
NHS context, taking account of the whole care pathway cost implications from
pre- to postoperative phases, stratified by the preoperative level of astigmatism?

There is clear evidence that toric lenses are effective at reducing levels of postoperative
astigmatism, but evidence on their cost effectiveness is much less conclusive. Although a
cost–utility analysis of toric lenses was evidenced from the USA, it was not possible to relate
the costs to a UK NHS perspective. Acquisition costs of toric lenses are unlikely to exceed
those of standard monofocal lenses, but their use has possible associated costs, including
additional preoperative tests, biometry measurements, surgical time and equipment (toric
markers), postoperative assessments and further surgery, which could be significant. A
comparison with on-axis or limbal-relaxing incisions would be advantageous because there
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are currently no resource constraints for using these techniques. Further cost-effectiveness
research using UK NHS costings would be of benefit in helping to formulate future
recommendations about their use.
13. What is the effectiveness and cost effectiveness of limbal relaxing incisions (in
combination with any intraocular lens type) to reduce postoperative astigmatism?
A limited evidence base was identified on limbal relaxing incisions in combination with
monofocal intraocular lenses as a technique to reduce postoperative astigmatism, and the
committee made a consider recommendation based on this evidence. However, additional
studies, either adding to this evidence base or considering limbal relaxing incisions in
combination with other types of intraocular lens would help to strengthen the evidence base
in this area and guide future recommendations.
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9 Wrong lens implant errors
Although infrequent, one of the most prevalent confusions and potentially preventable errors
during cataract surgery remains the insertion of an incorrect or wrong intraocular lens (IOL)
implant. When unrecognised intraoperatively these IOL implantation errors result in
‘refractive surprise’, wherein an unexpected/unintended postoperative refractive outcome
occurs (Zamir et al., 2012).
Implantation of an incorrect IOL leading to unplanned refractive error is one of the most
frequent causes of litigation in ophthalmic care and is classified by the NHS as a ‘never
event’ (Kelly et al., 2012). Despite this, of the 442 NHS ‘never events’ reported for the 1 year
period between 1st April 2015 and 31st March 2016, 26 (5.9%) were due to wrong lens
implantation (NHS England Never Events report).
Unfortunately, these errors may occur at any stage from the decision to operate to the
insertion of the IOL, but they are almost universally due to a breakdown in the safety
protocols designed to prevent surgical confusion, rather than to a primary cognitive
misjudgement. Because these errors may be introduced at multiple different time points
throughout the cataract pathway, strict protocols, which encompass all elements of the
patient’s journey, will be necessary to abolish these preventable problems.
However, by careful introduction of, and rigid adherence to, suitable safety standards and
protocols, it should be possible for these system errors to be largely eliminated from current
ophthalmic practice.
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9.1 Wrong lens implant errors
 What are the procedural causes of wrong lens implant errors?
 What strategies should be adopted to reduce the risk of wrong lens implant errors?
9.1.2 Introduction
The aim of this review was to determine the procedural causes of wrong lens implant errors
and strategies that help to reduce the risk of these events from occurring.
The qualitative review focused on identifying studies that fulfilled the conditions specified in
Table 32. For full details of the review protocols, see Appendix C. The main outcomes for
these review questions were procedural causes of wrong lens implant errors and error rates
to assess the effectiveness of strategies to minimise the risk of occurrence of these events.
Although these were 2 separate review questions, all of the identified evidence overlapped
both topics.
Table 32: PICO inclusion criteria for the review questions on wrong lens implant errors
Factors/  Factors that result in wrong lens implant errors
Interventions  Strategies to minimise risk of wrong lens implant errors e.g. surgical checklists
Outcomes  Procedural causes of wrong lens implant errors
 Wrong lens implant error rates

 were not published in the English language

In total, 3,395 references were found for this review question and full-text versions of 35
citations that seemed potentially relevant to the topic were retrieved. These included a
mixture of registry audits, narrative reviews, editorials, letters/commentaries and case
reports. All citations were appraised for relevance against the inclusion criteria in the review
protocols and in terms of providing rich qualitative information (as defined by the CERQual
methodology detailed in Lewin et al., 2015) on the causes of wrong lens implant errors and
strategies to reduce the risk of such events. Papers were prioritised on the basis of richness
of content in terms of depth and volume, and relevance to the UK setting. Four key papers
were identified (Kelly and Jalil, 2011; Kelly et al., 2013; Schein et al., 2012; Zamir et al.,
2012). The remaining papers were appraised to identify any new additional information not
already included in these 4 key papers. An additional relevant paper was identified via an
editorial and included (Kelly and Astbury, 2006), and a further additional paper was identified
from the rerun searches conducted at the end of the guideline (Steeples et al., 2016).
The included studies contained quite different methodological approaches and data sources.
Kelly and Astbury (2006) designed a thematic analysis of narratives collected at a focus
group meeting of clinicians in the UK. Kelly and Jalil (2015) and Steeples (2016) reviewed all
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intraocular lens (IOL) related incidents reported in the England and Wales National Patient
Safety Agency (NPSA) National Reporting and Learning System database (NRLS) and
conducted a thematic qualitative analysis of the event types and causes. Kelly et al. (2013)
surveyed members of the Royal College of Ophthalmologists to ascertain the extent of
surgical checklist use and their design characteristics. In a US study of 7 IOL implant error
case studies, Schein et al. (2012) presented the narrative data collected during a root-cause
analysis (RCA) of wrong lens implant errors and possible strategies to reduce their
occurrence were derived from the RCA themes. Finally, Zamir (2012) qualitatively described
the implementation of a specific protocol to reduce wrong lens errors.
Details of the included studies are provided in Appendix E.
A thematic content analysis (Lewin et al., 2015) of the identified papers was undertaken to
determine the procedural causes of wrong lens implant errors and suggestions of strategies
or tested methods to minimise the risk of such events from occurring. The evidence was
assessed using the CERQual methodology (Appendix G).

9.1.5.1 Procedural causes of wrong lens implant errors

Evidence from 4 studies indicated that wrong lens implant errors may be attributed to
(moderate-confidence evidence base):
 Poor patient–provider communication (leading to mismatches between the preferences of
the patient and the target of the surgeon with regard to refractive outcome)
 Errors in preoperative biometry assessment (measurement, calculation and data entry
errors)
 Poor record/document management (misplacement of biometry results in wrong patient
records, confusion among multiple biometry results, transcription errors, illegible
handwriting and use of unclear signs/abbreviations)
 Poor pre-surgical planning/checking (out of stock or wrongly ordered IOLs e.g. negative or
positive dioptre, anterior or posterior chamber)
 Inadequate patient preparation/checks (lack of confirmation from records of correct eye,
no marking of the surgical eye, patients mistakenly indicate wrong eye when asked by
healthcare professionals)
 Poor theatre team communication (non- or partially updated surgical lists/whiteboards,
lack of correct patient identification and confirmation, assumption that other team
members are aware of issues)
 Poor or inconsistent handling of IOLs (unclear or mislabelled IOLs at manufacturer and
user levels, inconsistent placement of patient selected IOL in operating theatre, multiple
IOLs in operating theatre simultaneously)
 Poor management of intraoperative complications, which may require an alteration to the
surgical plan and a different lens, at which time an additional opportunity for incorrect lens
insertion arises
 Lack of adherence to standard operating procedures/checklists/protocols or unavailability
of such policy documents (time pressures, busy theatre list, new staff/staff turnover and
training)
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 Lack of systems/culture/environment to facilitate open reporting, learning from near
misses and critical incidents and implementation of solutions (multidisciplinary evaluation
of incidents to undertake root-cause analysis of patient safety incidents)
9.1.5.2 Strategies to reduce the risk of wrong lens implant errors

Evidence from 4 studies suggested the following strategies could minimise the risk of
occurrence of wrong lens implant errors (moderate-confidence evidence base):
 Comprehensive, documented patient–provider communication (including a documented
surgical plan, with refractive target and IOL type discussed with the patient)
 Confirmation of preoperative biometry assessment (use of original printouts or
automatically uploaded electronic systems, checking measurements and calculations with
multiple members of the surgical team, and the use of best practice guidelines in
undertaking calculations)
 Improved record/document management (including cross-checking 2 patient identification
variables – for example, full name, hospital number, address, date of birth)
 Improved theatre team communication (including confirmation of biometry from original
results rather than surgical lists/whiteboards)
 Pre-surgical checklists/standard operating procedures
 Use of surgical ‘time-out’ immediately before operation to confirm with the theatre team
that the correct patient and correct IOL implant are present, and the correct procedure is
to be undertaken in the correct eye



Relative value of different The main outcomes of interest were narrative descriptions of the
outcomes procedural causes of wrong lens implant errors, and strategies that
could be recommended to prevent their occurrence.
Trade-off between The qualitative review identified several commonalities in the

benefits and harms evidence with regard to the procedural causes of wrong lens implant
errors. These ranged from problems of communication between staff,
and between staff and patients, to technical considerations such as
data-input errors or calculation problems, to organisational/logistical
causes such as problems with lens stocks and surgical list
management. The committee noted that the emerging themes from
the evidence tallied with their own learning about such events, and
the clinical expert’s introduction to the topic given prior to the
evidence presentation.
The committee considered that all of the strategies emerging from the
thematic analysis were beneficial, with very little potential trade-off
with harm. The committee did note that the use of surgical lists had
value, but were keen to emphasise that generic checklists (such as
the WHO pre-surgical checklist) should be customised to fit the
context of cataract surgery, and cautioned that such checklists should
not become a box-ticking exercise but should be regarded as an
integral part of the surgical procedure. The committee recognised
that surgical checklists add to the time taken to perform the surgery,
and may therefore have some impact on throughput, but that this was
far outweighed by their overall benefit and that indirect evidence from
non-cataract surgeries demonstrates that surgical checklists reduce
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adverse outcomes. With fewer errors, and better outcomes,
checklists become a net benefit to throughput, and not a hindrance.
The committee was aware of the NPSA cataract surgery checklist,
but felt that it lacked some important items (no requirement for more
than 1 of the selected lens to be in stock in case of defects/problems
with the first one used; no matching of patient, notes and biometry
reports) which precluded them from recommending it outright.
Instead, the committee chose to highlight important items that should
be on a cataract-surgery-specific checklist, without making a specific
recommendation for a particular checklist.
There was inconsistency in the evidence about the timing of surgical
checklist administration, and the committee felt that this consideration
should take into account the type of anaesthesia used – noting that it
would be inappropriate to administer a checklist (which may contain
items requiring an abort of surgery) after the administration of general
anaesthesia.
The committee agreed it was important for the development of the
surgical plan to involve a discussion with the patient about the
refractive implications of lens selection and implantation (also
considered in the section of this guideline on patient information). The
patient preferences should be captured at the time of this discussion
and inserted into the patient notes. The committee placed emphasis
on the timing of the capture of this information, and were of the
opinion that errors and subsequent patient dissatisfaction with
outcome are more likely to occur if there is a delay between the
consultation with the patient and the recording of their stated
preferences.
The committee agreed that it was important to use 2 identifiers to
confirm a patient’s identity and match them to the correct notes and
biometry documentation. However, rare instances from committee
members’ own experience indicated that this may not be sufficient in
all cases, for example when two patients have very similar names
and share a date of birth. For this reason, the committee felt that the
patient’s address was a useful additional 3rd identifier, closer to being
truly ‘unique’, and one that was readily available whereas others, for
example hospital number would possibly not be known by the patient.
Transcription errors were a recurrent theme in the literature review,
and the committee felt that transcription should be avoided wherever
possible and original biometry printouts should become the standard
point of reference. The committee noted that in some instances there
was a need to transpose data into ultrasound biometry equipment
where A-Scan biometry was needed, but that errors could be
minimised by again ensuring that the source of input data was
checked, matched with information in the patient notes, and that
important numerical data were clearly highlighted and consistently
labelled. The committee felt it was important that biometry reports
should not be inserted loosely into patient notes but fixed securely, to
minimise the risk of loss or transposition.
The committee emphasised that patient notes must be available on
the day of surgery. If notes are unavailable, this would be cause to
direct-abort the planned procedure until the notes are found. In the
case of missing biometry only, it may be possible to re-measure on
the same day as the procedure and continue as planned.
benefits and resource it was not prioritised for de novo modelling work. The committee did
use not consider the recommendations made would have significant
resource implications.
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Quality of evidence The overall quality of evidence was graded as moderate. The
thematic analysis was based on relatively few studies, although
coherence between these studies was good throughout. Most
evidence was from NHS or US hospital settings, and had high
relevance and adequacy with the exception of two studies based on a
small UK focus group and a US case series of 7 events. Even though
these studies were limited in terms of sample size the committee felt
that the issues raised were relevant and congruent with the other
evidence.
Other considerations The committee emphasised in their discussions that a common

theme in the evidence was the systematic nature of errors leading to
wrong lens implant error. The name of the event implies that the error
occurs at the point of implantation, but in fact clinicians may be
operating in good faith that the lens is correct for the patient. The
error may have occurred much earlier, at the point of biometry report
transcription, or during the consultation with the patient about
refractive outcomes.
Strategies to limit the occurrence of IOL implant errors should
therefore be implemented at all stages of patient contact and before
and during the surgical procedure using a systematic approach. The
committee emphasised that an important distinction should be made
between circumstances where imperfect biometry calculation that is
not the result of any errors by an individual leads to an incorrect lens
implanted in good faith, which should not be classed as a ‘never
event’, and the circumstances in which procedural failure (for
example, incorrect transcription of data) results in an IOL implant
error, which would be classed as a ‘never event’.
The committee also highlighted the current ambiguity with regard to
mandatory reporting of root-cause analysis at the national level,
which should occur in order to facilitate a shared ’lessons learned’
approach at a wider scale than individual trusts. Whilst
acknowledging that this evidence review was primarily concerned
with ‘never events’ the committee drew attention to and sought to
encourage the use of the CORESS confidential incident report
database which has a remit to record and reduce near-misses, from
which learning may also be gained. The forthcoming National
Cataract Registry dataset will also include an opportunity to
document surgical complications including IOL implant errors. The
committee agreed that it was important that a root-cause analysis
always be undertaken after any never event, in order to ensure
procedures are put in place to prevent it from occurring again.
Before cataract surgery
25. Before the preoperative biometry assessment, ensure that the person’s correct
medical notes are used by confirming the person’s:
 name
 address and
 date of birth.
26. Immediately after the preoperative biometry assessment:

 check that the biometry results include the person’s name, address, date
of birth and hospital number
 either:
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 use electronic data transfer to upload the biometry results to an
electronic health record or
 securely fix the printed biometry results to the person’s medical notes
 do not transcribe the results by hand.
27. At the preoperative assessment:

 discuss the refractive implications of different intraocular lenses with the
person
 base the choice of intraocular lens on the person’s chosen refractive
outcome
 record the discussion and the person’s choices in their medical notes.
On the day of cataract surgery
28. The person’s medical notes, including biometry results, must be available in
theatre on the day of the cataract surgery.
29. Use a checklist based on the World Health Organization (WHO) surgical safety
checklist, modified to include the following cataract surgery checks, to ensure
that:
 the person’s identity has been confirmed and matches information in:
 the consent form
 the biometry results and
 the person’s medical notes
 the eye to be operated on has been checked and clearly marked
 there is only 1 intraocular lens in the theatre, that matches the person’s
selected lens type and prescription
 alternative intraocular lenses are in stock in case the selected lens
needs to be changed if there are complications during surgery
 at least 2 members of the team, including the surgeon, have previously
checked the appropriateness, accuracy and consistency of all:
 formulas
 calculations and
 intraocular lens constants.
30. Before giving the person anaesthetic, ensure that:

 there is only 1 intraocular lens in the theatre, that matches the person’s
selected lens type and prescription
 alternative intraocular lenses are in stock in case the selected lens
needs to be changed if there are complications during surgery.
31. Immediately before the operation, the surgeon should:

 confirm the person’s identity and ensure that the correct medical notes
are being used, especially if using electronic patient records
 refer to the printed biometry results, not to transcribed information in the
person’s medical notes
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 refer to the person’s medical notes to check which refractive outcome
they preferred
 verify that the correct intraocular lens has been selected and is available
in theatre.
Occurrence of wrong lens implant errors
32. If a wrong lens is implanted, refer to NHS England’s Never Events policy, and
together with the whole multidisciplinary team:
 undertake a root-cause analysis to determine the reasons for the
incident
 establish strategies and implementation tools to stop it from happening
again.
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10 Surgical timing and technique
10.1 Laser-assisted cataract surgery
Femtosecond lasers have been used to perform several stages of phacoemulsification
cataract surgery since 2009 (Nagy et al., 2009). Laser generated pulses of highly focused
infrared light (wavelength 1053nm) cut by creating localised cavitation bubbles within tissues,
a process termed photo-disruption. The ultrashort duration of each pulse (10-15
femtoseconds) minimises damage to adjacent tissue. During cataract surgery, such lasers
are used to create incisions, perform capsulorhexis, and fragment the lens. The procedure is
then completed using conventional phacoemulsification equipment and techniques.
Potential advantages of laser-assisted cataract surgery over conventional
phacoemulsification cataract surgery include:
 Reproducible incisions including, where necessary, additional incisions to reduce
postoperative astigmatism
 Accurately centred, circular capsulotomies of a specified size. This may allow better long-
term intraocular lens centration.
 Reduced corneal endothelial loss as a result of shorter phacoemulsification times and less
intraocular fluid flow during surgery (Donaldson et al., 2013)
These potential advantages need to be weighed against the costs of purchasing and
maintaining the laser (including employing a laser technician), the additional space required
for the laser equipment, and increased operating time (Donaldson et al., 2013).

 What is the effectiveness of laser-assisted phacoemulsification cataract surgery compared
with standard ultrasound phacoemulsification cataract surgery?
10.1.2 Introduction
This review was undertaken by the Cochrane Eyes and Vision Group, in collaboration with
the NICE Internal Clinical Guidelines Team.
The aim of this review was to compare the effectiveness of laser assisted
phacoemulsification cataract surgery with standard ultrasound phacoemulsification cataract
surgery and gather evidence on safety from randomised controlled clinical trials.
For full details of the review protocol, see Appendix C.
Table 33: PICO inclusion criteria for the review questions on laser-assisted surgery
Population and posterior chamber intraocular lens (IOL) implantation
Intervention Laser-assisted cataract surgery
Comparator Standard phacoemulsification cataract surgery
Outcomes  Intraoperative complications
 Postoperative complications
 Visual acuity
 Vision-related quality of life
 Refractive outcomes
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Randomised controlled trials (RCTs) were included if they compared laser-assisted
phacoemulsification cataract surgery with standard ultrasound phacoemulsification cataract
surgery. Papers were excluded if they:
 were guidelines, narrative reviews, case studies/reports, case series, reliability studies,
diagnostic accuracy studies, non-comparative studies
For the list of excluded studies with reasons, see Appendix F.

In total, 1,435 unique references were found for this review question, and full-text versions of
38 citations that seemed potentially relevant to this topic were retrieved. Sixteen studies were
identified which met the inclusion criteria, 11 were excluded and 11 were ongoing studies
where results have not yet been published.

Full details of the included studies are found in the evidence tables (see Appendix E).
Sixteen RCTs were identified for inclusion in the review, of which 5 were within-person
studies where 1 eye of each participant had manual phacoemulsification and the other eye
laser-assisted cataract surgery (Conrad-Hengerer 2013; Conrad-Hengerer 2014, Dick 2014,
Schargus 2015; Conrad-Hengerer 2015). Eleven studies were parallel group randomised
controlled trials (Nagy 2011, Filkorn 2012, Kránitz 2012, Takács 2012, Reddy 2013; Nagy
2014; Kovacs 2014; Mastropasqua 2014a, Mastropasqua 2014b, Hida 2014; Yu 2015).

were retrieved, of which 1 was retained for this review question.
Abell et al. (2014) conducted a cost–utility analysis of laser-assisted vs standard ultrasound
phacoemulsification using a decision tree model. The payer perspective was the private
secondary care provider with direct patient and Australian Medicare costs included. The
model considers a hypothetical cohort of patients undergoing cataract surgery on the better-
seeing eye. Utilities in the model were calculated according to a mathematical relationship
between visual acuity and HRQoL proposed based on studies by Brown et al. (1999 &
20020, Lansingh et al. (2009), and Saw et al. (2005) which is given as:
𝑦 = −0.04792𝑥 3 + 0.191𝑥 2 − 0.4233𝑥 + 0.9128

𝑦= 𝑢𝑡𝑖𝑙𝑖𝑡𝑦
𝑥= 𝑉𝐴 𝑖n 𝐿𝑜𝑔𝑀𝐴𝑅 𝑢𝑛𝑖𝑡𝑠
The authors used data on the effectiveness of phacoemulsification taken from the Swedish
National Cataract Registry, a multicentre prospective trial (Hahn et al. 2010) and a large
cohort study from a tertiary centre in Germany (Hoffman et al. 2011). In the absence of any
equivalent evidence on laser-assisted surgery, Abell et al. (2014) assumed that the benefit of
femtosecond surgery would be a 5% improvement in the number of eyes achieving ~6/12
133
visual acuity after surgery The increase in best corrected visual acuity (BCVA) after cataract
surgery in the laser group was assumed to reflect improved refraction owing to improved lens
positioning as a result of more regular capsulotomy incisions, as well as a decrease in the
intraoperative complication rate. Based on the simulated complication rates of standard and
laser-assisted surgery and assuming visual acuity improvement of 5% in uncomplicated
cases, laser-assisted surgery was associated with QALY gains of 0.06, but was also found to
have increased costs, with a resulting ICER of $AUS92,862 per QALY gained, which is
above conventional thresholds of cost effectiveness. Multivariable sensitivity analyses
revealed that laser-assisted surgery would need to significantly improve visual outcomes and
complications rates over standard surgery, along with a reduction in cost to patient, to
improve cost effectiveness. Modelling a best-case scenario of laser-assisted surgery with
excellent visual outcomes (100% achieving >6/12 vision), a significant 0% complication rate
and a significantly reduced total cost to the patient of $AUS300 resulted in an ICER of
$AUS20,000 per QALY. The evidence table for the study is included in Appendix E.
10.1.5.1 Intraoperative complications

Very low-quality evidence from 10 RCTs containing 1,076 participants could not differentiate
rates of anterior capsule tear or posterior capsule tear between people given laser-assisted
cataract surgery and those given standard ultrasound phacoemulsification.
10.1.5.2 Postoperative complications

Low-quality evidence from up to 9 RCTs containing 957 participants could not differentiate
rates of cystoid macular oedema or elevated intraocular pressure between people given
laser-assisted cataract surgery and those given standard ultrasound phacoemulsification.
10.1.5.3 Visual acuity

Low-quality evidence from 3 RCTs containing 338 participants could not detect a clinically
meaningful difference in postoperative levels of visual acuity (logMAR) between people given
laser-assisted cataract surgery and those given standard ultrasound phacoemulsification.
10.1.5.4 Duration of procedure

Low-quality evidence from 3 RCTs containing 274 participants could not differentiate total
procedure duration between people given laser-assisted cataract surgery and those given
standard ultrasound phacoemulsification.

One partly applicable study with potentially serious limitations suggests that laser-assisted
cataract surgery is not cost effective when compared with standard phacoemulsification
techniques.

Relative value of different The guideline committee stated that improvements in either visual
outcomes outcomes or complication rates with laser-assisted cataract surgery
would be relevant, as would differences in procedure duration. It
would also be important to consider the inclusion criteria of the
studies, as laser-assisted surgery may only be practical in certain
134
groups of patients (e.g. those with cataracts which the laser is
capable of breaking up).
The committee discussed whether it should consider measures of
endothelial cell loss as a relevant example of intraoperative or
postoperative complications. It noted that this outcome is only
indirectly relevant to patients – they are very unlikely to experience
worse or better quality of life as an immediate consequence of more
or less endothelial damage. However, if endothelial cell loss is a
reliable surrogate indicator of long-term sequelae, any differences
between approaches could arguably be deemed indirectly
meaningful. In particular, the committee noted that there may be an
association between endothelial cell loss and corneal
decompensation leading, in turn, to a need for corneal grafting.
However, the committee were not convinced that a clear surrogate
relationship was present, at levels of endothelial cell loss seen in
modern-day cataract surgery. Committee members agreed that, while
rates of corneal grafting in pseudophakic eyes had risen a little in the
early days of phacoemulsification surgery, more modern techniques
had rendered this an extremely rare outcome. Therefore, even if it
could be shown that an alternative approach results in reduced
endothelial cell loss, it is far from certain that this would translate into
meaningful benefits for the patient.
The committee also agreed that the patient-relevant long-term
sequelae that may be associated with increased endothelial damage
were, themselves, outcomes that should be captured in the review.
Therefore, the priority should be to assess whether there is any
meaningful difference in these outcomes, rather than to focus on an
uncertain surrogate predictor of them.
Trade-off between The committee agreed that there was no evidence to suggest a
benefits and harms clinical difference between using laser assisted and standard
phacoemulsification surgery. Whilst the trials in this area had quite
small sample sizes, they did not demonstrate any meaningful
improvements in visual acuity, visual function or complication rates.
The only statistically significant difference was a 1-1.5 letter
improvement in corrected visual acuity at 6 months, and this was
judged by the committee not to be a clinically meaningful difference,
particularly as it was not replicated at other time points, nor was a
difference identified in uncorrected visual acuity. The committee
therefore agreed it would be inappropriate for laser-assisted cataract
surgery to be regularly used.
However, the committee also agreed that, because of the relative
scarcity and low quality of the evidence base, and the fact there are
specific situations where laser-assisted surgery may have benefits
(for example, to improve outcomes for inexperienced surgeons),
there could still be value in additional trials comparing laser-assisted
surgery with ultrasound phacoemulsification in this situation. Whilst
the committee did not feel this need was sufficient to justify
recommending future trials (particularly in view of current trials known
to be ongoing such as the NIHR funded FACT study), it agreed that it
would be appropriate to recommend that the use of laser-assisted
surgery could be justified only within the context of clinical trials.
Consideration of health The committee agreed that the economic evidence presented was
benefits and resource neither directly relevant to the decision problem at hand nor
use particularly robust, with large amounts of the parameter inputs being
based solely on assumptions. Nevertheless, the committee agreed
that it still provided useful evidence to inform its decision, as it
demonstrated that the benefits it would be necessary for laser-
assisted surgery to achieve in order to be cost effective at a
population level were much larger than those shown by currently
published trials. However, the committee are aware of two large trials
135
with associated health economic evaluations that are due to publish
in the next 12 months; (the FACT trial in the UK and the FEMCAT
trial in France) which may offer new evidence. The committee also
considered that additional research could be undertaken to examine
whether femtosecond laser-assisted surgery enables greater surgical
throughput and therefore has health-economic benefits with regard to
increasing capacity which may offset the higher costs of the
procedure compared to standard phacoemulsification. For these
reasons, the committee felt an ‘only in research’ recommendation
was appropriate, and that it shoud be particularly specified that this
research collect resource use data, as this will be a key element in
deciding on the long-term place of laser assistance in cataract
surgery.
The committee also noted that there is not only a cost associated
with the initial purchase of the laser itself, but also an additional
incremental cost for each surgery undertaken, because of required
disposables. There are also problems with docking the laser on some
patients whose eye characteristics fall outside certain ranges.
Therefore, simply having a laser available would not mean that it
should be automatically used in all possible procedures.
Quality of evidence The committee noted that the evidence presented, although of low
quality, was largely in line with current clinical opinion and that,
although the exclusion criteria in the trials seemed extensive, they
were reasonable and unlikely to impact on the overall pattern of the
evidence.
Other considerations No other considerations were identified as part of this review
question.
33. Only use femtosecond laser-assisted cataract surgery as part of a randomised

controlled trial that includes collection of resource-use data, comparing
femtosecond laser-assisted cataract surgery with ultrasound phacoemulsification.
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10.2 Bilateral surgery
At present, the majority of patients presenting with bilateral cataracts undergo sequential
surgery with an intervening period between operations of weeks or months. This provides
opportunities to identify and treat any postoperative complications related to the first-eye
surgery and, if necessary, modify the choice of intraocular lens for the second eye according
to the refractive outcome of the first operation. However, the risk of complications for patients
without ocular comorbidities is small, and patients undergoing sequential surgery may
experience significant difficulty with anisometropia whilst waiting for the second-eye
operation. Furthermore, the interval between procedures delays the time at which patients
regain their full visual potential. Bilateral simultaneous (rapid sequential) cataract surgery
may, therefore, offer functional benefits to patients. Such surgery may also have cost
advantages in terms of theatre efficiency, and reduced numbers of hospital appointments for
the patient.
Some surgeons are now offering bilateral simultaneous cataract surgery to selected patients.
During such procedures, the patient usually stays on the operating table after successful
completion of the first eye surgery, and new drapes, instruments, irrigating lines and
solutions are used for the second eye. Selection criteria for bilateral simultaneous cataract
surgery typically include:
 No vision threatening ocular co-morbidities
 No evidence of lens instability
 Axial lengths within a range of 21 to 27 mm

 What is the effectiveness of bilateral simultaneous (rapid sequential) cataract surgery
compared with unilateral eye surgery?
 What is the appropriate timing of second eye surgery, taking into account issues such as
refractive power after first eye surgery?
10.2.2 Introduction
The aim of this review was to identify the correct timing for second eye cataract surgery, and
in particular:
 The effectiveness and safety of bilateral simultaneous (‘rapid sequential’) cataract surgery
compared with staged unilateral (‘bilateral sequential’) surgery.
 If bilateral sequential surgery is undertaken, the correct timing of second eye surgery
(which included never undertaking surgery as an option).
were visual acuity, visual function and quality of life after surgery, surgical complication rates,
patient satisfaction and resource use/costs.
Table 34: PICO inclusion criteria for the review questions on second eye surgery
Population Adults (18 years and over) with bilateral cataracts undergoing phacoemulsification
Interventions  Bilateral simultaneous cataract surgery
 Bilateral sequential cataract surgery, with different lengths of time between the
first and second operation
 Bilateral cataract surgery versus unilateral cataract surgery
 Visual function
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 Complication rates (including refractive surprise)
 Falls
either compared same-day bilateral cataract surgery with different-day bilateral cataract
surgery, or compared differing lengths of timing between different-day bilateral cataract
surgeries. Papers were excluded if they:

In total, 1,772 references were found for these review questions, and full-text versions of 29
citations that seemed potentially relevant to this topic were retrieved. Three unique RCTs
were included (Lundström et al., 2006; Sarikkola et al., 2011; Serrano-Aguillar et al., 2011)
focusing on bilateral simultaneous versus bilateral sequential cataract surgery for people with
bilateral cataracts; and 3 RCTs were included (Castells et al., 2006; Foss et al., 2006;
Laidlaw et al., 1998) looking at the additional value of doing versus not doing second-eye
cataract surgery. Six systematic reviews were also identified for this population (Frampton et
al., 2014; Gillespie et al., 2012; Ishikawa et al., 2013; Kessel et al., 2015; Lamoureux et al.,
2011; Malvankar-Mehta et al., 2015) but these did not provide any additional information that
was not available from the RCTs themselves. No RCTs were identified looking at different
timings of bilateral sequential cataract surgery.

tables (see Appendix E). All 6 identified primary studies were randomised controlled trials, 3
comparing same day bilateral cataract surgery with different day bilateral cataract surgery
and 3 comparing two eye cataract surgery with single eye cataract surgery for people with
bilateral cataracts.

Study & Comparator
location Population Intervention
Castells 296 people Surgery in both eyes (2-4 Surgery in first eye only
2006 Post first-eye surgery months apart)
Spain for bilateral cataracts
Foss 239 people Expedited second-eye Waiting list for second eye
2006 Post first-eye surgery surgery surgery
UK for bilateral cataracts
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Study & Comparator
location Population Intervention
Laidlaw 208 people Expedited second-eye Waiting list for second eye
1998 Post first-eye surgery surgery surgery
UK for bilateral cataracts
Lundström 96 people Immediate sequential Delayed sequential cataract
2006 Cataract with need for cataract surgery - both surgery – An interval of 2
Sweden surgery in both eyes. operations performed on months between the
the same day. surgeries.
Sarikkola 520 people Immediate sequential Delayed sequential cataract
2011 Visually significant cataract surgery – Both surgery – An interval of 4-6
Finland bilateral cataract. operations performed on weeks between the
the same day surgeries
Serrano- 845 people Immediate sequential Delayed sequential bilateral
Aguilar Uncorrected distance cataract surgery – Both cataract surgery – An
2012 visual acuity 20/40 or operations performed in the interval of 6 weeks between
Spain worse in each eye same surgical operating the surgeries.
because of cataract. room occupancy

were retrieved, of which 4 were included for these review questions. Health economic
evidence tables for these studies are provided in appendix J. An original health economic
model was also available to the committee for this review question, and is described in
section 6.1.4.2 of this Guideline and in Appendix J.
10.2.4.1 Bilateral simultaneous versus bilateral sequential

Malvankar-Mehta et al. (2013) developed a decision-tree model of immediate sequential
compared with delayed sequential bilateral cataract surgery (ISBCS vs DSBCS). Patients in
the DSBCS arm had immediate surgery on 1 eye and then the second eye within a 3-month
window if they elected to undergo the second surgery. HRQoL was estimated using the
patient preference values generated from visual acuity states in Brown et al. (2000). Surgery
was either classified as ‘successful’ or as a ‘failure’, with failure meaning that an
intraoperative or postoperative adverse event (endophthalmitis, CMO, or ‘other complication’)
occurred. Visual acuity outcomes for endophthalmitis were based on a 1991 study of
vitrectomy procedures (Doft, 1991) whereas all other success/failure rates and outcomes
were taken from a single Canadian hospital. The relative effectiveness of ISBCS and DSBCS
was based on expert opinion. In the base-case analysis, ISBCS dominated DSBCS (was
more effective and less costly). A one-way sensitivity analysis did not change this result.
Table 36 Base-case results from Malvankar-Mehta et al. (2013)

Absolute Incremental
Costs Effects Costs Effects ICER
Treatment ($) (QALYs) ($) (QALYs) ($/QALY)
ISBCS 1,334.08 0.96 - - Dominant
DSBCS 2,940.62 0.88 1,606.54 −0.08 Dominated
10.2.4.2 Second-eye surgery versus no second-eye surgery

Busbee et al. (2003) developed a decision-tree-based cost–utility analysis of second-eye
surgery based on data from the Patients Outcomes Research Team (PORT) study in the
USA, which included 722 participants (mean age 72) undergoing cataract extraction surgery.
139
The comparator was unilateral pseudophakia, and costs and QALY gains were considered
over a life expectancy time horizon. The model included costs for cataract surgery,
ambulatory and surgical procedures and retinal procedures. It also included drug expenditure
costs associated with cataract surgery for medical and postoperative management. The cost
of cataract surgery and management of endophthalmitis, intraocular lens dislocation, cystoid
macular oedema and lost lens fragments was assumed to occur close to the initiation of
cataract management whereas posterior capsule opacification (PCO) and retinal detachment
incurred costs at the mean time of treatment after surgery. No cost information was included
for unilateral pseudophakia, and the model assumed that the postoperative visual acuity in
the second eye was equal to that of the first-eye surgery. Second-eye cataract surgery
resulted in a gain of 0.92 quality-adjusted life-years (QALYs) over 12 years (discounted at
3% per annum). Second-eye cataract surgery resulted in a total discounted health-care cost
of US$2,509, giving an estimated cost–utility of second-eye cataract surgery of US$2,727
per QALY gained. No incremental analysis was conducted.
Sach et al. (2010) conducted a cost–utility analysis as part of a trial of second-eye cataract
surgery (Foss et al., 2006). The cohort was women over 70 years of age with a history of
successful cataract surgery and an operable cataract in the absence of other ocular
comorbidities. The comparison was patients on a watchful waiting list. HRQoL was measured
using the EQ-5D, and the payer perspective was NHS and PSS with carer costs included in
an additional scenario analysis. The mean total cost per patient for the lifetime analysis was
£12,171 and £10,887 in the operated and the control group, respectively. The incremental
cost effectiveness ratio (ICER) for surgery in the base case was £17,299 per QALY gained.
The authors discuss the limitations of the EQ-5D for detecting both the quality of life of
patients with a cataract prior to surgery and the gain in HRQoL incurred through surgery,
highlighting this as a possible reason for their comparatively high ICERs relative to other
studies.
Frampton et al. (2014) developed a cost–utility model based on a systematic review of the
clinical effectiveness and cost effectiveness of second-eye cataract surgery. They identified 3
randomised controlled trials (RCTs) of clinical effectiveness, 3 studies of cost effectiveness
and 10 studies of health-related quality of life (HRQoL) which met their inclusion criteria and,
where possible, were used to inform their economic analysis. Studies did not provide
evidence that second-eye surgery significantly affected HRQoL, apart from an improvement
in the mental health component of HRQoL as measured by the HUI (Health Utility Index -3)
in 1 RCT. The health economic analysis was conducted from the NHS and PSS perspective.
It simulated a cohort of patients undergoing either second-eye surgery or continued as
unilateral pseudophakia cases. In the surgery arm, people underwent successful surgery or
had an intraoperative or late complication (endophthalmitis, retinal detachment, PCO, cystoid
macular oedema (CMO), lost-lens fragments; with risks for PCO and retinal detachment
modelled time-dependently on a lifetime and 3-year time horizon respectively). Utility losses
and costs for adverse events were applied for 1 year, with costs and QALYs discounted at
3.5% per annum. Second-eye surgery generated 0.68 incremental QALYs with an ICER of
£1,964. Model results were most sensitive to changes in the utility gain associated with
second-eye surgery, but the procedure remained well below conventional limits at
£5,734/QALY even when a utility gain of as low as 0.02 was modelled. The model was
otherwise robust to changes in parameter values. The probability that second-eye surgery is
cost effective at QALY thresholds of £10,000 and £20,000 was 100%.
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Table 37 Base-case results from Frampton et al. (2014)
Absolute Incremental
Costs Effects Costs Effects ICER
Treatment (£) (QALYs) (£) (QALYs) (£/QALY)
No second-eye 411 5.29 - - -
surgery
Second eye 1,752 5.97 1,341 0.68 1,964
surgery
An original economic analysis, described in section 6.1.4.2 of this Guideline, suggestes that
for second-eye cases, immediate cataract surgery is shown to be cost effective compared
with no surgery in most scenarios, even if it confers no immediate HRQoL gain. This is
because, as with the first-eye surgery, immediate surgery avoids future QALY losses and
costs incurred by leaving the cataract(s) to progress until death. Compared with the first eye,
there are slightly more scenarios in which HRQoL gain is necessary to produce an ICER
lower than £20,000 / QALY; however, in common with the first eye, all these relate to people
aged 90. In most cases, these scenarios also feature a high risk of visual loss. A very similar
pattern is shown when comparing no surgery with delayed surgery with an acuity threshold of
6/12: most people are predicted to benefit from immediate surgery even if it confers no
HRQoL gain and, in those cases where a gain of HRQoL is necessary to justify the slightly
higher cost of immediate surgery, this benefit only has to be of 'very small' magnitude. All
these scenarios relate to 90-year-olds and most feature a high risk of visual loss.
Whilst it was not possible, because of structural constraints, to run any probabilistic
sensitivity analyses for the model, some deterministic sensitivity analyses were run. These
included simulating a more rapid deterioration of VA in people with cataract; including wider
NHS costs that would typically fall outside of the NICE reference case; and modelling an
alternative acuity threshold of 6/9 in the delayed surgery arm. The model behaved as
expected in these scenarios, with faster progression making immediate surgery more cost
effective in all cases, regardless of risk factors. Including wider costs, or changing the acuity
threshold to 6/6 increased the margin by which cataract surgery, in either eye, has to
improve HRQoL for 90 year old patients with higher risk profiles. A full description of the
sensitivity analyses is given in Appendix J.
10.2.5.1 Bilateral simultaneous versus bilateral sequential
10.2.5.1.1 Complication rates

Low- to moderate-quality evidence from 2 RCTs containing 2,613 eyes did not identify
meaningful differences in levels of intraoperative, postoperative or serious postoperative
complications between people undergoing bilateral simultaneous cataract removal and those
undergoing sequential surgery.

High-quality evidence from 1 RCT containing 807 participants found subjective visual
function (as measured by the VF-14) improved more in people who received immediate
sequential surgery than in those in whom second-eye surgery was delayed, before second-
eye surgery in the delayed group.
Moderate-quality evidence from 2 RCTs containing 1,298 participants could not differentiate
changes in visual function 1 month after second-eye surgery between people who received
immediate sequential surgery and those in whom second-eye surgery was delayed.
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Moderate-quality evidence from 1 RCT containing 751 participants could not differentiate
changes in visual function 1 year after surgery between people who received immediate
sequential surgery and those in whom second-eye surgery was delayed.
10.2.5.1.3 Pain during surgery

Moderate-quality evidence from 1 RCT containing 993 participants could not differentiate the
proportions of individuals experiencing pain during surgery between people who received
10.2.5.1.4 Patient satisfaction

High-quality evidence from 1 RCT containing 989 participants found there were no
meaningful differences in the proportions of people very satisfied with their surgery between
people who received immediate sequential surgery and those in whom second-eye surgery
was delayed.
levels of satisfaction with vision after second-eye surgery between people who received
10.2.5.1.5 Deviation from target refraction

High-quality evidence from 1 RCT containing 982 eyes found there were no meaningful
differences in the proportions of people with a deviation from target refraction <0.5 or <1.0
dioptres between people who received immediate sequential surgery and those in whom
second-eye surgery was delayed.

Very low-quality evidence from 3 RCTs containing 1,386 participants could not differentiate
changes in median visual acuity from preoperative to post-second-eye surgery between
people who received immediate sequential surgery and those in whom second-eye surgery
was delayed.
10.2.5.1.7 Health economics

One partially applicable CUA with serious limitations suggests that immediate sequential
cataract surgery dominates (is more effective and cheaper than) delayed sequential surgery,
although uncertainty around the estimate of cost effectiveness could not be reliably
established.
10.2.5.2 Second-eye surgery versus no second-eye surgery

High-quality evidence from 3 RCTs containing 685 participants found higher levels of best-
corrected visual acuity (logMAR) and binocular contrast sensitivity (measured using a Pelli–
Robson chart) in people offered second-eye surgery versus no surgery.
High-quality evidence from 1 RCT containing 274 participants found higher levels of
improvement in stereopsis (measured using the Titmus circles, Fly and TNO tests, reported
in log seconds of arc), self-reported trouble with vision (measured using a 4 item Likert scale)
and self-reported satisfaction with vision (measured using a 4 item Likert scale) for people
offered second-eye surgery versus no surgery.
High-quality evidence from 2 RCTs containing 503 participants found higher levels of visual
function (measured using the VF-14) in people offered second-eye surgery versus no
surgery.
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risk of falls or changes in quality of life (as measured by the EQ-5D) between people offered
second-eye surgery versus no surgery.
10.2.5.2.1 Health economics

One partially applicable cost–utility analysis from the USA with very serious limitations
suggests that second-eye cataract surgery is cost effective under the condition that the gains
in visual acuity and HRQoL are at least as large as those generated by the first-eye surgery.
One directly applicable study with minor limitations suggests that second-eye surgery is cost
effective compared with unilateral surgery in an NHS context. In a probabilistic sensitivity
analysis, the probability that second-eye surgery is cost effective at a willingness-to-pay
threshold of £20,000 per QALY was 100%.
One directly applicable CUA, with potentially serious limitations found that second-eye
surgery is cost effective when a lifetime time-horizon is considered, and wider costs to carers
are excluded from the analysis.
One directly applicable original health economic analysis with potentially serious limitations
suggests that for second eyes:
1) Cataract surgery is cost effective compared with no surgery in most scenarios, even if
it confers no immediate HRQoL gain.
2) Compared with delayed surgery, most people derive cost-effective benefit from
immediate surgery even if it confers no HRQoL gain and, in older, higher-risk cases
where a gain of HRQoL is necessary to justify the slightly higher cost of immediate
surgery, this benefit only has to be of 'very small' magnitude (see Appendix J).
The model results were somewhat sensitive to the inclusion of ‘unrelated’ costs after surgery
for first and second eyes, and the assumed rate at which visual acuity declines in
symptomatic eyes.

Relative value of different The committee noted that the relevant outcomes for this comparison
outcomes were the trade-off between short and long-term differences in visual
outcomes, compared with the risk of more serious complications with
simultaneous surgery. Committee members agreed that the best
available outcomes measures would be vision, health-related quality
of life and patient satisfaction, but that, in the absence of these
measures, visual acuity, visual function, contrast sensitivity and
stereopsis would together provide proxies for at least a substantial
proportion of the pre- to post-surgery changes.
Trade-off between The committee agreed that the evidence demonstrated a clear
benefits and harms clinical benefit from second-eye surgery, compared to no second-eye
surgery, across a range of domains including visual acuity, visual
function, contrast sensitivity and patient satisfaction. Therefore, the
key decision would be around the cost effectiveness of second-eye
surgery, as discussed in the section on health benefits and resource
use below.
The committee noted that the studies provided no evidence of
differences in long-term visual outcomes, or of rates of common intra-
or postoperative complications between same-day and different-day
bilateral surgery. The key trade-off was therefore identified as being
between short-term benefits with simultaneous surgery versus the
risk of more severe complications. Simultaneous surgery gave better
outcomes in the period before second-eye surgery in the sequential
143
group, with the duration of these additional benefits depending on the
time between sequential in the sequential group. Conversely,
simultaneous surgery had the potential for more severe adverse
events, as it is possible that loss of vision in both eyes could result
from a single error, whilst in the sequential group only 1 eye would be
damaged through a single mistake.
The committee noted that it is still unclear what the likelihood of
severe complications (damage to both eyes) is with simultaneous
surgery, and therefore people should be given specific information
about the potential for additional risks whenever same-day surgery is
being considered.
The committee agreed it was therefore appropriate that a ‘consider’
recommendation be made for bilateral simultaneous cataract surgery,
but did not feel it appropriate to make a stronger recommendation
than this, both because of the lack of robust data on rare adverse
events, and because of the relatively restrictive inclusion criteria in
the RCTs. They also agreed that, for people at a low risk of ocular
complications, there was no overwhelming clinical reason to prefer
one timing of second surgery to another, and therefore it was
important for people to be given information on the potential benefits
and harms of both approaches, in order for them to be able to make
an informed decision.
No evidence was found to inform any recommendations about the
appropriate length of time between procedures performed on different
days. Some participants in the control arms of the trials did have
intraocular lens adjustments after the first surgery in an attempt to
improve second surgery outcomes, and the committee noted that the
gap between surgeries needs to be large enough for the refraction to
have stabilised after surgery. However, in the absence of any
evidence, the committee did not feel it was appropriate to
recommend a specific length of time between first and second eye
surgeries.
Consideration of health The committee considered the modelling study by Malvankar-Mehta
benefits and resource et al. (2013) in the light of the clinical evidence presented at the
use meeting, and discussed in particular the contrasts between the
carefully selected populations included in the clinical studies and the
hypothetical cohort included in the model. The committee was
uncomfortable with the model’s lack of external validity; success rates
for surgery, adverse event rates, and the rate at which patients
elected to have second-eye surgery were all based on the clinical
experience of clinicians at a single centre. The committee noted that
it would have been possible, given the availability of published
evidence in this domain, to undertake a fuller sensitivity analysis of
these parameters using evidence external to the centre. The
committee considered that there may have been some pressure on
the centre to not use data other than expert opinion for surgical
outcomes, and that this was a potential source of bias in the analysis.
In common with the evidence presented for the questions on
indicators and thresholds for surgery (chapter 6), the committee felt
that the true costs of adverse events and their HRQoL implications
were underestimated by the model, and that the apparent difference
in absolute costs between delayed and immediate sequential surgery
was primarily driven by the need for two admissions in the delayed
surgery arm, and that this cost appeared overestimated.
The committee agreed that the small incremental utility gain noted by
Sach et al. (2010) and Frampton et al. (2014) was conservative, and
was likely driven by the lack of sensitivity of the EQ-5D to both the
pre-surgical morbidity of cataract, and the post-surgical gain in
HRQoL. Furthermore, these analyses assumed that the difference in
utility between second-eye surgery and no second-eye surgery was
144
constant until death, and as Sach et al (2010) note in their
conclusions, this is unrealistic as non-operated cataracts are likely to
incur a decrease in visual acuity over time, with related HRQoL
losses which could be prevented by offering surgery. The committee
felt that the one-year time horizon in Sach et al. was not appropriate,
as the benefits (and some potential harms) from surgery were likely
to be lifelong. Shorter timescales would also inflate the true lifetime
costs by excluding discounting. The committee broadly agreed with
the costs included in these studies, although it noted that the carer-
costs included in a sensitivity analysis in Sach et al. are not included
in the NICE reference case. The committee noted the increased non-
ocular NHS costs following cataract surgery (driven by greater uptake
of GP visits, A&E appointments, and nurse visits in the surgery
group), and expressed the view that these were somewhat surprising.
One possible explanation was that improving people’s visual
impairment empowers them to seek healthcare for other issues;
another is that simply being in the hospital environment increases the
likelihood of accessing other services. However, the committee
understood that such costs should usually be considered as
‘unrelated’ and therefore excluded from consideration in the NICE
reference case.
The committee noted that the systematic review of effectiveness
evidence in Frampton (2014) meant that the model was
parameterised with data that is now 10 years old, and that in that time
surgical outcomes have continued to improved and more second-eye
surgeries are being performed. Furthermore, the committee
discussed how the modelled cohort did not reflect the range of acuity
and morbidity seen in clinical practice, and noted that the cohort had
generally good preoperative acuity which would tend to make the
reported QALY gains more conservative.
The committee was presented with results from the original model
undertaken for this guideline, which concluded that second-eye
cataract surgery is likely to be cost effective in most cases even if it
confers no immediate HRQoL gain (see chapter 6). This is because
immediate surgery avoids future QALY losses and costs incurred by
leaving the cataract(s) to progress until death.
Compared with the first eye, the committee was mindful that there are
slightly more scenarios in which HRQoL gain is necessary to produce
an ICER lower than £20,000 / QALY; however, in common with the
first eye, all these relate to people aged 90. In most cases, these
scenarios also feature a high risk of visual loss, but even then only a
'very small' immediate HRQoL benefit is required to make surgery
cost effective. Therefore, the committee agreed that immediate
second-eye cataract surgery, without any requirement for acuity
thresholds, would invariably be the optimal strategy as it saves future
costs and QALY losses. The committee noted that the model results
were on the whole very similar for first-operated eyes, and that it was
common that in their own practice for first-eye patients to request
second-eye surgery because they found the first-eye surgery to be
beneficial. The original model was not designed to provide a dynamic
simulation of these potential concerns.The committee discussed the
likely resource and capacity impacts of recommending immediate
referral, particularly the increased demand for surgery and associated
pressures on capacity. The consensus of the group was that this
would likely be a short-term increase in demand as those people with
visual acuity below thresholds (in trusts where they currently apply)
would move to waiting lists, but that after that initial increase there
would be a return to a steady state.
This is supported by the Royal College of Ophthalmology NOD
studies which show that the modal acuity for first-eye patients is 6/6.
Therefore, the committee considered that using the same criteria as
145
recommended for first-eye surgery in Section 6 of the Guideline when
deciding to offer second-eye surgery was logical and justified by
these models.
Quality of evidence The committee agreed that the evidence presented was robust, both
in demonstrating the clear clinical benefits of second-eye surgery
versus no second-eye surgery, and in demonstrating that there were
no major differences in the long-term visual outcomes of same day or
different day surgery in the groups recruited, but agreed that there
were 2 major limitations in the evidence base.
Firstly, the sample sizes were too small to pick up potential
differences in rare but catastrophic complications, which are the main
reason for concern with simultaneous surgery. Secondly, the
populations in the trials were very carefully selected to only include
those people with low risk of intra- or postoperative complications,
and therefore no evidence was available on outcomes for people at
higher risk, such as those with ocular comorbidities. Therefore, the
committee decided it would only be appropriate to recommend
simultaneous surgery as an option in the population covered by the
trials, specifically those at low risk of intra- or postoperative
complications.
Other considerations The committee noted there were specific groups of people in which
general anaesthesia may be necessary for cataract surgery (for
example, people with cognitive impairment), and in whom general
anaesthesia may be associated which increase risks of complications
or distress. The committee agreed this represented an identifiable
group of people in whom bilateral simultaneous surgery may be a
relevant option, as it will mean the person only needs to undergo
general anaesthesia once rather than twice, and that this population
should be added to the ‘consider’ recommendation for bilateral
simultaneous surgery.
34. Offer second-eye cataract surgery using the same criteria as for the first-eye
surgery (see section 6 for referral for cataract surgery).
35. Consider bilateral simultaneous cataract surgery for

 people who are at low risk of ocular complications during and after
surgery or
 people who need to have general anaesthesia for cataract surgery but
for whom general anaesthesia carries an increased risk of complications
or distress.
36. Discuss the potential risks and benefits of bilateral simultaneous cataract surgery
with people, which should include:
 the potential immediate visual improvement in both eyes
 how it will not be possible to choose a different intraocular lens based on
the outcome in the first eye
 the risk of complications in both eyes during and after surgery that could
cause long-term visual impairment
 the likely need for additional support after the operation.
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11 Anaesthesia
Ophthalmic anaesthesia is a recognised sub-specialty of anaesthetic practice, providing care
for a wide range of patients, from neonates to the very elderly. Importantly, the quality of
anaesthesia can have a direct impact on the operating field, so close team-working with
surgical colleagues is essential.
Local anaesthesia for cataract surgery can be undertaken using a variety of methods
including topical (+/- intracameral) local anaesthesia, sub-Tenon’s anaesthesia (using a blunt
cannula), or one of the sharp needle techniques such as peribulbar or retrobulbar block.
Recent estimates of current use of these techniques for cataract surgery in the UK are 39%,
51%, 9% and 1% respectively (Lee et al., 2016). General anaesthesia is also an option, and
tends to be reserved for patients not suitable for local anaesthesia, or where surgery is
considered to be of unusually high risk.
When deciding which technique to use, a large number of factors need to be taken into
consideration. These include patient factors such as compliance, level of anxiety, pre-
existing medical conditions; surgical factors such as anticipated technical difficulty,
desirability for globe akinesia; and anaesthetic factors such as success rate versus the risks
involved from the technique itself (Lee et al., 2016; Eke et al., 1999; Eke et al., 2007).
Organisational issues may also be important such as cost and theatre efficiency, and the
availability of skilled ophthalmic anaesthetic cover.
Availability of monitored sedation may also be important for some patients. Undergoing
surgery on the eye can be extremely stressful for certain individuals and current UK sedation
rates for cataract surgery (4%, Lee et al., 2016) fall well below rates measured in other
OECD countries (60–88% Australia [Clarke et al., 2016], >77% in the USA [Betsy Lehman
Center, 2016]). Due to the unique patient case-mix, difficult intraoperative patient access and
the potentially disastrous consequences of unexpected patient movement, sedation should
only be undertaken by trained ophthalmic anaesthetists using carefully titrated anxiolytic
agents.
One aspect for future consideration is the likely increase in the number of patients needing
cataract extraction that have some degree of coincidental age-related dementia. This could
be as high as 5% of patients attending ophthalmic outpatients and these patients may well
require more input from dedicated ophthalmic anaesthetists to enable safe and effective
surgical intervention (Kumer et al., 2016). It is essential, therefore, that ophthalmic
anaesthesia remains an integral part of the package of ophthalmic care available to future
generations.
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11.1 Type and administration of anaesthesia
 What is the optimal type and administration of anaesthesia for cataract surgery?
11.1.2 Introduction
The aim of this review was to determine the optimal type and method of administration of
anaesthesia for phacoemulsification cataract surgery. The review focused on identifying
protocol, see Appendix C. The main outcomes for this review were intraoperative pain, pain
on administration of anaesthesia, surgical and anaesthetic related complication rates and
patient satisfaction.
Table 38: PICO criteria –optimal type and administration of anaesthesia

Population for non-trauma related cataracts and intraocular lens (IOL) implantation
Interventions Methods:
 Peribulbar/periocular block
 Retrobulbar block
 Sub-Tenon's anaesthesia
 Topical (drops) ± intracameral (diluted with saline)
Drugs:
 Lidocaine/xylocaine
 Bupivacaine
 Oxybuprocaine (also known as benoxinate)
Comparators  Different methods vs. each other
 Different drugs vs. each other
 Warming of drug vs. no warming of drug
Outcomes  Intraoperative pain
 Pain on administration of anaesthesia
 Surgical complication rates
 Anaesthetic-related complications

 were not randomised controlled trials

In total, 2,676 references were found from a database search for all the review questions
looking for randomised controlled trials on anaesthesia, and full-text versions of 90 citations
that seemed potentially relevant to this topic were retrieved and screened at full-text.
148
in the evidence tables (see Appendix E). Forty one studies were included in this review (4
systematic reviews and 37 additional RCTs not included in any of those reviews).To enable
all relevant data to be included as part of the meta-analyses, all continuous pain and patient
satisfaction measures were converted to a 0–100 scale before analysis.
Table 39: Summary of included studies – optimal type and administration of

anaesthesia
Study &
Jaichandran 100 patients RCT on the effect of lidocaine warming and alkalinisation
et al. (2010) on injection pain, motor and sensory nerve blockade.
India
Krause et al. 70 patients RCT to investigate the effect of warming local anaesthetic
(1997) solutions on pain of injection and on bulbar akinesia and
Germany analgesia of retrobulbar anaesthesia
Ursell et al. 40 patients RCT to investigate the effect of warming local anaesthetic
(1996) solutions on pain of injection for peribulbar anaesthesia
UK
Soliman et 60 patients RCT comparative clinical trial of topical anaesthetic agents
al. (2004) in cataract surgery.
Egypt
McLure et 91 patients RCT comparison of lidocaine 2% with levobupivacaine
al. (2005) 0.75% for sub-Tenon’s block
UK
Naeem et al. 200 patients RCT comparison of peribulbar vs topical anaesthesia for
(2007) phacoemulsification
India
Zhao et al. 1369 eyes (8 RCTs) Topical anaesthesia versus Regional anaesthesia for
(2012) cataract surgery: A Meta-analysis of Randomized
China Controlled Trials – systematic review
Guay et al. 617 patients (7 RCTs) Sub-Tenon’s anaesthesia versus topical anaesthesia for
(2015) cataract surgery – systematic review
Canada
Ezra et al. 1281 patients (8 Topical anaesthesia alone versus topical anaesthesia with
(2010) RCTs) intracameral lidocaine for phacoemulsification – systematic
UK review
Alhassan et 1438 patients (6 Peribulbar versus retrobulbar anaesthesia for cataract
al. (2015) RCTs) surgery – systematic review
Nigeria
Nielson et 66 patients Evaluation of local anaesthesia techniques for small
al. (1998) incision cataract surgery
Denmark
Ahmad et al. 80 patients RCT looking at satisfaction level with topical versus
(2012) peribulbar anaesthesia experienced by the same patient
Saudi for phacoemulsification.
Arabia
Sekundo et 100 patients RCT comparing Lidocaine and sub-Tenon anaesthesia –
al. (2004) included in Guay Systematic Review
Germany
149
Study &
Srinivasan 201 patients RCT comparing topical and sub-Tenon’s anaesthesia in
et al. (2004) routine cataract surgery– included in Guay Systematic
UK Review
Vielpeau et 50 patients RCT comparing topical and sub-Tenon’s anaesthesia for
al. (1999) cataract surgery– included in Guay Systematic Review
France
Boulton et 192 patients RCT of intracameral lidocaine during phacoemulsification
al. (2000) under topical anaesthesia– included in Ezra Systematic
Australia Review
Crandall et 136 patients RCT comparing patient comfort during cataract surgery
al. (1999) with topical versus topical anaesthesia with intracameral –
USA included in Ezra Systematic Review lidocaine
Gillow et al. 200 patients RCT to determine the efficiency of supplementary
(1999) intracameral lidocaine in routine phacoemulsification under
UK topical anaesthesia– included in Ezra Systematic Review
Roberts et 135 patients RCT comparing cataract surgery under topical anaesthesia
al. (2002) with and without intracameral lignocaine– included in Ezra
Australia Systematic Review
Tseng et al. 162 patients RCT evaluating patient discomfort during
(1998) phacoemulsification while under topical lidocaine alone or
China in combination with intracameral lidocaine– included in
Ezra Systematic Review
Carino et al. 60 patients RCT comparing topical tetracaine versus topical tatracaine
(1998) plus intracameral lidocaine for cataract surgery– included
Canada in Ezra Systematic Review
Gills et al. 303 patients RCT to determine whether intraoperative lidocaine
(1997) decreases pain during cataract surgery– included in Ezra
USA Systematic Review
Martin et al. 93 patients RCT comparing safety and efficiency of intracameral
(1998) injections of lidocaine to reduce intraocular sensation–
USA included in Ezra Systematic Review
Zafirakis et 200 patients RCT comparing topical and sub-Tenon’s anaesthesia
al. (2001) without sedation in cataract surgery– included in Guay
Greece Systematic Review
Mathew et 119 patients RCT comparing patient comfort during phacoemulsification
al. (2003) cataract surgery with sub-Tenon’s anaesthesia– included
UK in Guay Systematic Review
Chittenden 37 patients RCT comparing topical and sub-Tenon’s anaesthesia for
et al. (1997) small incision cataract surgery– included in Guay
UK Systematic Review
Athanikar et 142 patients RCT comparing Peribulbar and Retrobulbar anaesthesia –
al. (1991) included in Alhassan Systematic Review
India
Weiss et al. 79 patients RCT comparing retrobulbar and periocular anaesthesia for
(1989) cataract surgery– included in Alhassan Systematic Review
USA
Ali-Malkkila 300 patients RCT comparing regional anaesthesia for cataract surgery:
et al. (1992) comparison of 3 techniques– included in Alhassan
Finland Systematic Review
Ali-Malkkila 450 patients RCT comparing Retrobulbar and Peribulbar techniques for
et al. (1993) cataract surgery– included in Alhassan Systematic Review
150
Study &
Finland
Wong et al. 150 patients RCT comparing Peribulbar and Retrobulbar anaesthesia
(1993) for cataract surgery– included in Alhassan Systematic
Canada Review
Feibel et al. 317 patients RCT comparison of peribulbar and retrobulbar anaesthesia
(1993) – included in Alhassan Systematic Review
USA
Jacobi et al. 476 patients RCT comparing topical vs retrobulbar anaesthesia in
(2000) complicated cataract surgery– included in Zhao Systematic
Germany Review
Patel et al. 138 patients RCT comparison of topical and retrobulbar anaesthesia for
(1996) cataract surgery - included in Zhao Systematic Review
USA
Patel et al. 90 patients RCT evaluation of topical versus retrobulbar anaesthesia-
(1998) included in Zhao Systematic Review
USA
Ryu et al. 54 patients RCT comparison of retrobulbar block, sub-Tenon block
(2009) and topical anaesthesia during cataract surgery- included
South Korea in Zhao Systematic Review
Sauder et al. 140 patients RCT comparing topical versus peribulbar anaesthesia for
(2003) cataract surgery- included in Zhao Systematic Review
Germany
Uusitalo et 299 patients RCT evaluating converting to topical anaesthesia in
al. (1999) cataract surgery - included in Zhao Systematic Review
Finland
Virtanen et 100 patients RCT evaluating pain in scleral pocket incision cataract
al. (1998) surgery using topical and peribulbar anaesthesia - included
Finland in Zhao Systematic Review
Zehetmayer 72 patients RCT evaluating topical versus peribulbar anaesthesia in
et al. (1996) cataract surgery- included in Zhao Systematic Review
Austria
Gombos et 115 patients RCT comparing effectiveness of topical versus retrobulbar
al. (2007) anaesthesia for cataract surgery- included in Zhao
Hungary Systematic Review

11.1.5.1 Warming vs no warming

Low-quality evidence from 3 RCTs containing 210 participants found that people who
received anaesthetic warmed to 37oC reported lower injection pain scores than those who
received anaesthetic at room temperature during cataract surgery.
151
11.1.5.2 Network meta-analyses (pain)
11.1.5.2.1 Anaesthetic drug

Moderate-quality evidence from a network-meta analysis of 2 RCTs containing 181
participants found that oxybuprocaine and bupivacaine are associated with lower levels of
pain during application of anaesthesia than lidocaine and levobupivacaine.
participants found that lidocaine and levobupivacaine are associated with lower levels of pain
during surgery than oxybuprocaine and bupivacaine, and bupivacaine is associated with
lower levels of pain than oxybuprocaine.
11.1.5.2.2 Method of anaesthesia

participants found that retrobulbar anaesthesia is associated with higher levels of pain during
application of anaesthesia than peribulbar, sub-Tenon’s or topical anaesthesia.
Moderate-quality evidence from a network-meta analysis of 20 RCTs containing 3,172
participants found that sub-Tenon’s anaesthesia is associated with lower levels of pain
during surgery than topical or topical plus intracameral anaesthesia, and that both retrobulbar
and peribulbar anaesthesia are associated with lower levels of pain than topical anaesthesia
alone.
11.1.5.3 Anaesthetic drug (other outcomes)
11.1.5.3.1 Lidocaine vs bupivacaine

Low-quality evidence from 1 RCT containing 60 participants could not differentiate the
proportions of people willing to have the same anaesthetic again between people who
received either lidocaine or bupivacaine during cataract surgery.
11.1.5.3.2 Lidocaine vs oxybuprocaine

Moderate-quality evidence from 1 RCT containing 60 participants found that people who
received lidocaine were more likely to be prepared to have the same anaesthetic again than
those who received oxybuprocaine.
11.1.5.3.3 Bupivacaine vs oxybuprocaine

received bupivacaine were more likely to be prepared to have the same anaesthetic again
than those who received oxybuprocaine.
11.1.5.3.4 Lidocaine vs levobupivacaine

Low- to very low-quality evidence from 1 RCT containing 91 participants could not
differentiate the risks of a small subconjunctival haemorrhage or chemosis developing during
cataract surgery for people who received either lidocaine or levobupivacaine anaesthetic.
11.1.5.4 Method of anaesthesia (other outcomes)
11.1.5.4.1 Topical vs retrobulbar

proportion of people preferring topical or retrobulbar anaesthesia during cataract surgery.
152
received retrobulbar anaesthesia were less prepared to have the anaesthetic procedure
again compared with people who received topical anaesthesia during cataract surgery.
11.1.5.4.2 Topical vs sub-Tenon’s block

proportion of people preferring topical anaesthesia or a sub-Tenon’s block during cataract
surgery.
proportions of people prepared to repeat either topical anaesthesia or a sub-Tenon’s block
during cataract surgery.
Very low- to moderate-quality evidence from up to 3 RCTs containing 351 participants could
not differentiate the risks of postoperative iritis, iris prolapse, posterior capsule tear or
subconjunctival haemorrhage developing in people who received either a sub-Tenon’s block
or topical anaesthesia during cataract surgery, but did find a higher risk of chemosis in
people given a sub-Tenon’s block.
11.1.5.4.3 Topical vs topical with intracameral anaesthesia

Moderate-quality evidence from 5 RCTs containing 459 participants could not differentiate
the risk of an adverse surgical event during cataract surgery for people who received either
topical or topical with intracameral anaesthesia.
11.1.5.4.4 Peribulbar vs Retrobulbar

Low- to high-quality evidence from up to 7 RCTs containing 2,075 participants found that
people who received peribulbar anaesthesia were at greater risk of developing conjunctival
chemosis than those who received retrobulbar anaesthesia during cataract surgery, but
those who received retrobulbar anaesthesia were at higher risk of developing a lid
haematoma. The evidence could not differentiate rates of retrobulbar haemorrhage or ptosis.
11.1.5.4.5 Retrobulbar vs sub-Tenon’s block

proportion of people preferring a sub-Tenon’s block or retrobulbar anaesthesia during
cataract surgery.
received retrobulbar anaesthesia were less prepared to have the anaesthetic procedure
again compared with a sub-Tenon’s block during cataract surgery.
11.1.5.4.6 Topical vs retro/peribulbar

High-quality evidence from 1 systematic review of 4 RCTs containing 266 participants found
that people who received retro/peribulbar anaesthesia were less likely to be satisfied with the
anaesthetic procedure than those who received topical anaesthesia.
Very low- to moderate-quality evidence from 1 systematic review reporting a total of 1,359
participants could not differentiate the risks of a capsule rupture, zonular tear or iris prolapse
developing during cataract surgery in people who received either topical or retro/peribulbar
anaesthesia, but did find higher rates of chemosis, periorbital haematoma and
subconjunctival haemorrhage in people given retro/peribulbar anaesthesia.

153
Relative value of different The committee agreed that intraoperative pain, pain on administration
outcomes of anaesthesia, complication rates and patient satisfaction would all
be relevant outcomes. They also agreed that, for most people, pain
on administration was not as important a concern as pain during
surgery.
Trade-off between The committee agreed that surgeons are often reluctant to change
benefits and harms the method of anaesthesia they use, as each has an effect on how
the eye behaves for surgery, such as the lens sitting deeper in the
eye, which may impact on surgical technique. It discussed the risks
associated with the use of retrobulbar injections as, although they are
rare, severe, life-threatening complications can arise from its use
(e.g. brainstem anaesthesia or severe haemorrhage). It agreed that,
in the absence of any benefits noted from retrobulbar injections over
and above other methods of anaesthesia, its use could no longer be
justified.
The committee agreed with the evidence that peribulbar anaesthesia
was not meaningfully more efficient in terms of pain relief, and felt
that some of the serious complications seen in clinical practice,
including globe perforation, were not captured in the studies
presented, due to the relatively small sample sizes of the studies. It
did, however, note that the evidence showed periorbital haematoma
was more prevalent with peribulbar and retrobulbar injections
compared with topical anaesthesia, showing the increased potential
for vascular injury associated with deep injections (confirming the
group’s experience that more serious, albeit rarer, vascular injuries
can result for this approach).
The committee agreed that individual patient characteristics often
influence the preferred method of anaesthetic delivery, and
highlighted that it would be safer for those on anticoagulants to
receive a sub-Tenon’s block rather than a retrobulbar or peribulbar
injection, as it is less likely to cause severe retrobulbar haemorrhage.
Similarly, in patients with small pupils, greater pain may be
experienced due to the use of iris hooks and dilators, and thus sub-
Tenon’s anaesthesia may be of benefit. However, it noted that an
exception would be where the patient had undergone previous eye
surgery, in such cases a peribulbar injection may be necessary as it
may not possible to administer sub-Tenon’s anaesthesia.
The committee agreed that most patients given a topical anaesthetic
would achieve an appropriate level of anaesthesia without the
addition of an intracameral injection, assuming they had a well dilated
pupil, but added that some patients may benefit substantially in
reduced pain during surgery. It agreed that this would result in an
overall small average gain in giving the additional intracameral
injection.
The committee agreed that there was evidence to suggest a clinical
difference in analgesic effect from using a sub-Tenon’s block when
compared with the other methods of delivery, but noted that this is a
more invasive procedure when compared with topical anaesthesia.
The group also highlighted that some surgeons do not allow enough
time for the anaesthetic to reach maximal effect, thus believing it less
effective for akinesia. From this viewpoint the committee believed that
patients may choose topical ‘a priori’.
The committee agreed that, considering the evidence as a whole,
both topical and sub-Tenon’s anaesthesia represented reasonable
treatment options, with peribulbar only an acceptable choice if both
these other methods were contraindicated.
154
Consideration of health No economic evidence was identified for this review question and
benefits and resource economic modelling was not prioritised. The committee discussed the
use need for a specialist ophthalmic anaesthetist to give a retrobulbar or
peribulbar injection, and thus the additional costs associated,
whereas one was not needed in order to give sub-Tenon’s or topical
(with or without intracameral) anaesthesia. However, it was noted
that surgeons may have to consider giving a peribulbar injection
under specific circumstances such as for those who have undergone
previous surgery for retinal detachment. It was also highlighted that
there could also be an additional resource cost with sub-Tenon’s
block due to the use of syringes and needles when compared with
topical application, although the routine use of topical with
intracameral anaesthesia would imply additional costs along with the
theoretical risk of infection.
The committee noted that globe perforation – which is a known
complication of peribulbar anaesthesia – is the leading cause of
medicolegal claims arising from ophthalmic regional anaesthesia
(Szypula et al., 2010), and such claims are more likely than not to be
settled in favour of the claimant, with damages historically averaging
around £30,000 (Ali et al., 2011). It agreed that this was another
reason to avoid peribulbar anaesthesia wherever possible.
Quality of evidence The committee agreed that, on the whole, the evidence reflected the
treatment alternatives in practice. One exception was evidence
looking at oxybuprocaine versus lidocaine, which was drawn from a
single RCT from Egypt. The committee expressed the view that
outcomes from this trial did not mirror UK experience. It noted that
the mean verbally reported pain of people receiving oxybuprocaine
was around 7/10, and agreed that, if the majority of their patients
were reporting similar pain levels, committee members would have
noted this and it would be considered well outside acceptable limits. It
also commented on the comparison of lidocaine gel with eye drops; a
gel may be present longer on the eye and thus afford greater
anaesthetic effect, but the approach may also be associated with
higher rates of infection and is not commonly used in the UK. It was
noted that no evidence of proxymetacaine was presented, which is
very commonly used in the UK. The committee noted there was
some evidence of a pattern of drugs that resulted in higher pain on
application being associated with less pain during surgery, but
agreed that the problems with the evidence base meant it was not
possible to be confident in this finding.
Taking the inconsistencies and absences in the available evidence
into account, the committee concluded it was not appropriate to make
any recommendations on which drugs should be preferred for
anaesthesia.
The committee agreed that, although the exclusion criteria in the
trials seemed quite extensive on occasion, they were reasonable and
unlikely to impact on the overall pattern of the evidence. The
committee discussed the study dates for topical anaesthesia,
commenting that it believed this particular method of anaesthesia had
improved in efficacy since the early 2000s when many of the studies
presented were undertaken.
The committee agreed that there was evidence of benefit for the
warming of anaesthetic, but noted this evidence came from
peribulbar and retrobulbar anaesthesia. It did not believe it was
necessarily appropriate to extrapolate this to use in sub-Tenon’s and
topical methods of anaesthesia delivery, and as such were not
prepared to make recommendations on the evidence presented.
Other considerations The committee noted that both the Royal College of Anaesthetists
and the Royal College of Ophthalmologists have produced guidance
155
on ophthalmic anaesthesia, which provide more detailed
recommendations than are presented in this guideline.
37. Offer sub-Tenon’s or topical (with or without intracameral) anaesthesia for people
having cataract surgery.
38. If both sub-Tenon’s and topical (with or without intracameral) anaesthesia are
contraindicated, consider peribulbar anaesthesia.
39. Do not offer retrobulbar anaesthesia for people having cataract surgery.
156
11.2 Sedation as an adjunct to local anaesthesia
 What is the effectiveness of sedation as an adjunct to local anaesthesia during cataract
surgery?
11.2.2 Introduction
The aim of this review was to determine the effectiveness of sedation as an adjunct to local
anaesthesia during phacoemulsification cataract surgery. The review focused on identifying
protocol, see Appendix C. The main outcomes for this review were intraoperative pain, pain
on administration of the anaesthesia and patient satisfaction.
Table 40 PICO criteria – effectiveness of sedation as an adjunct to local anaesthesia

Interventions Sedation (midazolam, fentanyl, propofol)
Comparator No sedation
 Pain on administration of anaesthesia


that seemed potentially relevant to this topic were retrieved and screened at full-text. Two
randomised controlled trials were included (Inan et al., 2003 and Aydin et al., 2002).
157
Table 41 Summary of included studies – effectiveness of sedation as an adjunct to
local anaesthesia
Study &
Inan et al. 120 people RCT to determine the effects of systemic fentanyl in
(2003) preventing the pain related to the administration of
Turkey retrobulbar anaesthesia and cataract surgery.
Aydin et al. 68 people RCT to investigate the effects of sedation/analgesia with
(2002) fentanyl during phacoemulsification surgery under topical
Turkey anaesthesia.

11.2.5.1 Pain scores on application of the anaesthetic

Moderate-quality evidence from 1 RCT of 120 participants found that those who received
local anaesthetic and fentanyl reported lower pain scores on the application of anaesthetic
than those who received local anaesthetic alone.
11.2.5.2 Pain scores during surgery

Moderate-quality evidence from 1 RCT of 120 participants found that those who received
local anaesthetic and fentanyl reported lower pain scores during cataract surgery than those
who received local anaesthetic alone.
11.2.5.3 Patient satisfaction

High-quality evidence from 1 RCT of 68 participants found that those who received local
anaesthetic and fentanyl were more satisfied with the analgesia than those who received
local anaesthetic alone.


Relative value of different The committee agreed that intraoperative pain, pain on administration
outcomes of the anaesthesia and patient satisfaction would all be relevant
outcomes. It agreed that patient satisfaction would be at least
partially independent of reported pain due to the anxiolytic effect of
sedation.
Trade-off between The committee agreed that there was evidence to suggest that
benefits and harms fentanyl was successful in reducing reported pain on application of
anaesthetic and during surgery, and increasing patient satisfaction.
However no evidence was found on the use of midazolam or
propofol, both of which are also commonly used in the UK. The
committee agreed that, of all 3 of these options, fentanyl had the
158
largest analgesic and lowest anxiolytic effect, and therefore the
evidence did not entirely capture the effect of sedation alone.
The committee discussed whether it was possible to prospectively
identify patients who may require/benefit from sedation and it was
agreed that those with a large degree of anxiety would benefit most,
although the committee noted that intraoperative anxiety was
sometimes very difficult to determine or predict. The committee also
agreed that cases where the person was likely to find it difficult to
remain still (either due to physical problems or a longer operation
time) were likely to benefit from sedation.
benefits and resource and economic modelling was not prioritised. The committee
use discussed the implications of using sedation, noting that it is currently
given in 1.5% of all cataract operations in the UK. They agreed that if
sedation is given, then an anaesthetist has to be present throughout
the procedure, to monitor the patient. The committee agreed that this
would have cost implications, although it was noted that there would
be no additional postoperative cost implications as patients recovered
quickly from their sedation. It was agreed that such issues would
make the availability of sedation to all patients difficult. It noted that,
in some centres, a separate anaesthetist-supervised sedation list for
cataract surgery was scheduled to make best use of anaesthetist
time. The anaesthetic expert advising the committee related
experience that the presence of an anaesthetist for these more
complex cases can often result in more efficient throughput, more
than offsetting the additional costs inherent in the anaesthetist's time.
Quality of evidence The committee noted that the evidence presented was moderate to
high in quality but was limited due to it not addressing the effects of
all the sedative drugs in use within UK NHS practice. It also
commented that midazolam (alone or in combination with fentanyl) is
used in common practice, as is propofol, but no direct evidence was
presented from which to help guide the discussion on
recommendations.
The committee agreed that, since the evidence demonstrated benefit
in the general cataract population included in the trials, it was
therefore reasonable to assume the benefits would be at least as
large or greater in the subpopulations identified as likely to benefit
most from sedation.
Other considerations The committee noted that sometimes sedation may be used as an
alternative to general anaesthesia in people where this is deemed to
be inappropriate (for example, people with cognitive impairment
where there are concerns this may be exacerbated by the use of
general anaesthesia).
40. Consider sedation, administered by an experienced ophthalmic anaesthetist, as

an adjunct to anaesthesia for people if, for example:
 they have high levels of anxiety
 they have postural or musculoskeletal problems
 surgery is expected to take longer than usual.
159
11.3 Hyaluronidase as an adjunct to local anaesthesia
 What is the effectiveness of hyaluronidase as an adjunct to local anaesthesia during
cataract surgery?
11.3.2 Introduction
The aim of this review was to determine the effectiveness of hyaluronidase as an adjunct to
local anaesthesia during phacoemulsification cataract surgery. The review focused on
identifying studies that fulfilled the conditions specified in Table 42. For full details of the
review protocol, see Appendix C. The main outcomes for this review were intraoperative
pain, patient satisfaction, and volume of anaesthetic needed.
Table 42: PICO criteria – effectiveness of hyaluronidase as an adjunct to local

anaesthesia
Interventions Hyaluronidase/hyalase/hyaluronic acid
Comparator No hyaluronidase/hyalase/hyaluronic acid
 Volume of anaesthetic


that seemed potentially relevant to this topic were retrieved and screened at full-text. Four
RCTs were included (Rowley et al., 2000; Seghipour et al., 2012; Guise et al., 1999 and
Schulenburg et al., 2007)
The design of included studies is summarised in Table 43, with full details and results found
160
Table 43: Summary of included studies – effectiveness of hyaluronidase as an adjunct
to local anaesthesia
Study &
Rowley et al. 150 patients RCT to investigate the effect of hyaluronidase on the
(2000) quality of block achieved with sub-Tenon’s local
UK anaesthesia.
Seghipour et al. 42 patients RCT to investigate the effect of hyaluronidase use on
(2012) the quality of sub-Tenon’s anaesthesia for
Iran phacoemulsification
Guise et al. 120 patients RCT to investigate the effect of hyaluronidase on speed
(1999) of onset and block quality in sub-Tenon’s block
New Zealand
Schulenburg et 62 patients RCT to examine the addition of hyaluronidase on the
al. (2007) UK minimum local anaesthetic volume (MLAV) required for
a sub-Tenon’s block

11.3.5.1 Pain
Low-quality evidence from 1 RCT of 120 participants could not differentiate the proportions of
those who reported pain on injection of anaesthetic or pain during cataract surgery in those
who received anaesthesia with or without the addition of hyaluronidase.
Low-quality evidence from 1 RCT of 150 participants could not detect a difference in reported
post-injection pain scores or perioperative pain scores for those who received anaesthesia
with or without the addition of hyaluronidase.
11.3.5.2 Patient satisfaction

High-quality evidence from 1 RCT of 42 participants showed that those who received
anaesthesia with hyaluronidase were more likely to be satisfied with the anaesthesia.
11.3.5.3 Volume of anaesthetic

Low-quality evidence from 1 RCT of 62 participants showed that those who received
anaesthesia with hyaluronidase had a 2.4-fold reduction in median effective local anaesthetic
volume needed to achieve a sub-Tenon’s block.

161
Relative value of different The committee agreed that intraoperative pain, patient satisfaction
outcomes and volume of anaesthetic would all be relevant outcomes.
Trade-off between The committee agreed that there was evidence of improved patient
benefits and harms satisfaction with the addition of hyaluronidase to sub-Tenon’s
anaesthesia, and that it had no effect on reported injection pain. It
agreed that the evidence showed lower levels of anaesthetic were
necessary to achieve a sub-Tenon’s block when hyaluronidase was
added, but noted this did not represent the volume of anaesthetic
necessary for adequate pain control, but rather the volume necessary
to achieve eye akinesia (an outcome which some surgeons may
consider highly desirable, but one which others may not be
particularly concerned with).
The committee agreed that it was therefore reasonable to make a
‘consider’ recommendation for the use of hyaluronidase as an adjunct
to sub-Tenon’s anaesthesia, with a particular comment that its benefit
is likely to be greatest when attempting to achieve eye akinesia.
The committee also noted that 1 study showed that a high average
volume (6.4ml) of anaesthetic was needed in people randomised not
to receive hyaluronidase. The injection of this volume into the sub-
Tenon’s space could elevate the risk of vitreal compression.
benefits and resource and economic modelling was not prioritised. The committee
use discussed whether there were likely to be any resource implications
from recommending the use of hyaluronidase. It was noted that in the
experience of the committee members, and in light of the current low
cost of the drug itself (net price £7.60 per 1500-unit ampule, BNF
Online 2017), that any recommendation was unlikely to cause a
significant resource impact, especially given that the focus would be
restricted to those individuals where it is deemed important to
achieve eye akinesia.
low, but identified no significant negative consequences from the use
of hyaluronidase, with the anaesthetist member of the committee
informing members that hyaluronidase was used commonly in
practice.
Other considerations No other considerations were identified.
41. Consider hyaluronidase as an adjunct to sub-Tenon’s anaesthesia, particularly if

trying to stop the eye moving during surgery.
162
11.4 General anaesthesia
 In what circumstances should general anaesthesia be considered in phacoemulsification
cataract surgery?
11.4.2 Introduction
The aim of this review was to determine in what circumstances general anaesthesia should
be considered in phacoemulsification cataract surgery. The review focused on identifying
protocol, see Appendix C. The main outcomes for this review were indications for general
anaesthesia in phacoemulsification cataract surgery.
Table 44: PICO criteria – general anaesthesia

Interventions General anaesthesia
Comparator Forms of anaesthesia other than general anaesthesia
Outcomes Indications for general anaesthesia in phacoemulsification cataract surgery


In total, 1,059 references were found from a database search for the review question, and
full-text versions of 52 citations that seemed potentially relevant to this topic were retrieved.
No studies matched the review protocol for this question.
No relevant studies were identified in the update searches undertaken at the end of the
guideline development process.


No evidence was identified for this review question.

163
Relative value of different The committee agreed that indications for general anaesthesia in
outcomes cataract surgery would be a relevant outcome but were not surprised
that no relevant evidence was identified, as the population of relevant
people is not sufficiently large as to make studies easy to conduct.
Trade-off between The committee recognised the risk/benefits of general anaesthesia
benefits and harms (in particular, the risk of exacerbating cognitive decline) and agreed
that, although the use of general anaesthetic in cataract surgery was
of a shorter duration than the average across all surgical procedures,
the patients receiving it were much older than average for surgery
and so the risk of sequelae may well be close to the average. The
committee discussed and agreed that people whose mental capacity
limited their ability to undergo surgery, or those exhibiting extreme
anxiety, would often be given general anaesthetic for cataract
surgery. This was based on clinical experience due to the lack of
evidence in this area. Based on clinical experience, the committee
agreed that the surgeon would prefer patients to be adequately
sedated, but that the use of general anaesthetic would usually be
discussed in consultation with the patient and/or their
representative(s) before being undertaken. The committee agreed
that the points noted above represented current practice in the UK,
and therefore it was agreed that no specific recommendations were
necessary.
benefits and resource and economic modelling was not prioritised. The committee noted
use that, in the original health economic model performed to explore
indicators for referral for surgery, a sensitivity analysis in which the
overall cost of surgery was increased by £500 had shown little impact
on results – that is, immediate surgery remained the optimal choice in
a substantial majority of scenarios (see appendix J). The committee
agreed that this showed that, for people who need general
anaesthesia, the additional costs associated with it should not be
used as a reason to limit access to surgery.
It was agreed that there was little reason to believe the current rates
of general anaesthesia for cataract surgery were likely to change in
the near future, and therefore there were unlikely to be substantial
changes in resource use.
Quality of evidence No evidence was presented which the committee could comment on.
Other considerations The committee agreed it was important that the need for discussions
on general anaesthesia, where relevant, should be included in the
patient information section of the guideline.
No recommendations were made for this review question.
164
12 Preventing and managing complications
Modern phacoemulsification is one of the safest of all surgical procedures with a success
rate of 92% or higher. However, complications can potentially occur at any stage of the
patient journey. Whilst most are not serious, some complications may compromise visual
outcome and negatively impact on patient expectation.
Although it occurs very rarely (around 1 in 1,000 cases) infectious endophthalmitis is
considered one of the most serious complications of cataract surgery as, even when treated
promptly, it can result in complete loss of vision of the eye. The risk of endophthalmitis can
be reduced, but not totally eliminated, by a number of measures.
As it may be significantly associated with other unfavorable outcomes, the other complication
which has received much attention in large-scale audits is posterior capsular rupture (PCR).
For individual surgeons, having a PCR rate of approximately 2% or less is widely regarded
as an indicator of surgical competence , although the probability of PCR for a particular
cataract operation may be greatly increased by other factors including co-existing ocular
and/or systemic comorbidity. Examples of the former include small pupil size, very dense
cataract and poor zonular support.
Therefore, awareness of the likelihood of particular complications in an individual patient’s
eye, and appropriate risk stratification, is widely acknowledged as an important component of
careful preoperative assessment.
The purpose of this chapter is to address how potential complications in cataract surgery are
best prevented and, if complications do occur, how these should be managed to optimise the
most favourable visual outcome for the patient.
165
12.1 Interventions to prevent retinal detachment in people with
myopia
 What is the effectiveness of interventions (for example, prophylactic laser surgery) to
prevent retinal detachment in people with myopia undergoing cataract surgery?
12.1.2 Introduction
The aim of this review was to determine whether interventions designed to prevent retinal
detachment in people with myopia are effective. The review focused on identifying studies
Appendix C. The main outcome for this review was rates of retinal detachment.
Table 45: PICO criteria – preventing retinal detachment in people with myopia
Adults (18 years and over) with myopia undergoing phacoemulsification
Population cataract surgery with intraocular lens implantation
Interventions  Prophylactic interventions prior to cataract surgery (not at the time of surgery)
 Retinal LASER surgery
 Cryotherapy
Comparator  No prophylactic intervention
Outcomes  Rates of retinal detachment
 Time to event data


In total, 1,121 references were found from a database search for this review question, and

166


Relative value of different The committee agreed that rates of retinal detachment would be a
outcomes relevant outcome, but were not surprised that no relevant evidence
was identified, as it felt surgeons would be unlikely to undertake
research in this area.
Trade-off between The committee agreed that surgeons would continue to treat as per
benefits and harms current practice with possible referral to a vitreoretinal surgeon where
possible. The use of cryoprobes was discussed but it was stated that
they have inherent dangers such as retinal detachment. The
committee agree that, whilst it is possible that there are methods of
management that may be more or less effective in people with
cataracts than in those without, the lack of evidence made it
inappropriate to make specific recommendations.
use that, since its recommendation did not represent a difference from
current practice, it would have no resource implications.
Quality of evidence No evidence was presented on which the committee could comment.
Other considerations The committee considered whether the lack of evidence indicated
that a research recommendation was appropriate in this area.
However, it agreed this did not represent a high priority for research,
and that there were other areas of the guideline where it was more
important to prioritise research, and therefore no such
recommendation was made.
167
12.2 Intraoperative pupil size management
 What is the effectiveness of interventions to increase pupil size to improve visual
outcomes and reduce complications during phacoemulsification cataract surgery?
12.2.2 Introduction
The aim of this review was to determine the effectiveness of interventions to increase pupil
size to improve visual outcomes and reduce complications during phacoemulsification
cataract surgery. The review focussed on identifying studies that fulfilled the conditions
specified in Table 46. For full details of the review protocol, see Appendix C. The main
outcomes for this review were visual acuity.
Table 46 PICO criteria for interventions to increase pupil size

Population for with intraocular lens (IOL) implantation
Interventions Interventions to increase pupil size:
 Intracameral mydriatics (with or without anaesthesia)
 Viscomydriasis with a high-viscosity ophthalmic viscosurgical device (OVD) e.g.
sodium hyaluronate
 Manual separation: synechiolysis and/or pupillary membranectomy with spatula
and forceps
 Mechanical pupillary stretching using iris hooks
 Sphincter cutting
 Use of mechanical pupil dilation/expansion devices
Comparator  No additional procedure
 Each other
Outcomes  Complications (capsular rupture, haemorrhage)
 Postoperative complications (inflammation, distorted pupils)
 Visual acuity
 Visual function

pieces.
12.2.2.1 Deviations from protocol

When evidence on this question was discussed, the committee agreed that data on pupil size
would be a useful outcome as a marker for the effectiveness of interventions, even though
this was not specified in the original protocol. Only 1 included study presented data on pupil
size, and these results are included below. No further evidence on pupil size was found on a
re-run of the searches for this review question.
168
In total, 1,186 references were found from a database search for the review question. Full-
screened. Seven studies were included (5 randomised controlled trials and 2 case-controls;
Espindola et al. 2012; Lorente et al. 2012; Moschos et al. 2011; Papaconstantinou et al.
2014; Shigleton et al. 2001 and 2006; Wilczynski et al. 2013).

Espindola et al. (2012) 78 eyes RCT to compare the effects and outcomes of 2
Brazil viscosurgical devices during phacoemulsification
Lorente et al. (2012) 84 eyes RCT to evaluate the efficacy of IPH as prophylaxis
Spain against intraoperative floppy iris syndrome
Moschos et al. (2011) 77 eyes RCT to compare Viscoat and Visthesia during
Greece phacoemulsification cataract surgery
Papaconstantinou et al. 44 eyes RCT to evaluate Viscoat and Visthesia viscosurgical
(2014) devices in cataract surgery
Greece
Shingleton et al. (2001) 66 eyes Case-control study to compare (BCVA) and IOP in
USA eyes that had a foldable IOL implanted with the use of
an anterior chamber maintainer (ACM) in 1 eye and
Vitrax in the other
Shingleton et al. (2006) 240 eyes Case-control study to determine whether pupil
USA stretching during phacoemulsification affects
postoperative best corrected visual acuity compared
with results in patients without pupil stretch
Wilczynski et al. (2013) 40 eyes RCT to evaluate pupils dilated with Malyugin Ring in
Poland comparison with manual pupillary stretching hooks.

12.2.5.1 Best corrected visual acuity – DisCoVisc vs HPMC

Moderate-quality evidence from 1 RCT of 78 eyes could not detect a difference in best
corrected visual acuity, 6 months postoperatively, in people given DisCoVisc or HPMC during
cataract surgery.
169
12.2.5.2 Best corrected visual acuity – Viscoat vs VisThesia
Low-quality evidence from 2 RCTs containing 121 eyes could not detect a difference in best
corrected visual acuity postoperatively or at 28 days postoperatively in people given Viscoat
or VisThesia during cataract surgery.
12.2.5.3 Best corrected visual acuity – intracameral phenylephrine vs balanced salt solution
Low-quality evidence from 1 RCT of 84 eyes could not detect a difference in best corrected
visual acuity, 3 months postoperatively, in people given intracameral phenylephrine or
balanced salt solution during cataract surgery.
12.2.5.4 Mean best corrected visual acuity (decimal) – anterior chamber maintainer vs Vitrax
Very low-quality evidence from 1 case-control study of 66 eyes could not detect a difference
in mean best corrected visual acuity (decimal), 3-6 weeks postoperatively, in people given an
anterior chamber maintainer or Vitrax during cataract surgery.
12.2.5.5 Best corrected visual acuity – pupil stretching vs no stretching

Very low-quality evidence from 1 case-control study of 240 eyes could not detect a difference
in best corrected visual acuity, 1 year postoperatively, in people given pupil stretching
compared with those who were not given pupil stretching during cataract surgery.
12.2.5.6 Best corrected visual acuity – Malyugin Ring vs manual stretching

Moderate-quality evidence from 1 RCT of 40 eyes could not detect a difference in best
corrected visual acuity - decimal, 1 month postoperatively, in people given either a Malyugin
Ring or manual stretching of the pupil during cataract surgery.
12.2.5.7 Pupil size – intracameral phenylephrine vs balanced salt solution

Moderate-quality evidence from 1 RCT of 84 eyes found that people who were receiving
tamsulosin and given intracameral phenylephrine obtained an increased pupil size after
hydro-dissection compared with people given balanced saline solution during cataract
surgery.


Relative value of different The committee agreed that postoperative complications would be a
outcomes relevant outcome, but that visual acuity outcomes would be unlikely
to help answer this question as in non-randomised studies the aim of
these interventions is to ensure people do not achieve worse
outcomes than those with normal pupil sizes. Therefore, the
committee noted that it would not expect to see any benefits when
comparing these interventions in people with normal sized pupils.
They noted that additional data on pupil size measurements would be
of more interest and requested a deviation from the review question
protocol to enable this.
Trade-off between The committee discussed the evidence and raised concerns that the
benefits and harms outcomes measured in many trials did not directly answer important
clinical questions, as they were often tested in a very broad
population, which included people who would not be likely to receive
170
these interventions in clinical practice. From the range of evidence
presented, the committee agreed that 1 paper was of relevance to
show how phenylephrine increased pupil size in people taking
tamsulosin and at risk of floppy iris syndrome. From this evidence the
committee agreed that, although the benefit was seen in patients
receiving tamsulosin, the benefit would be generalisable to patients at
risk of floppy iris syndrome. Thus a consider recommendation could
be made regarding increasing the pupil size of patients at risk of
floppy iris syndrome.
The committee noted that it would be useful to see evidence on the
comparisons of drugs with devices but acknowledged that in most
cases the surgeon will try a pharmacological intervention initially and
only if this is not successful will revert to a mechanical one.
Consideration of health No health economic evidence was identified for this review question,
use that, although the manual devices used to stretch pupils cost £50-
£100, their use was justified when compared with the alternative of
failing to do the operation or causing intraoperative damage (e.g.
PCR) which costs much more to correct. They further stated that
such techniques are in common use and there is little alternative.
low. They noted that the outcomes reported in the trials often did not
help in addressing important clinical questions. The committee
requested that the evidence on pupil size be added to the evidence
base from the 1 paper in which it was reported.
question.
42. Consider intracameral phenylephrine to increase pupil size in people at risk of

floppy iris syndrome.
171
12.3 Interventions to reduce the impact of perioperative
posterior capsule rupture
 What is the effectiveness of interventions to reduce the impact of perioperative posterior
capsule rupture?
12.3.2 Introduction
The aim of this review was to determine the effectiveness of interventions to reduce the
impact of perioperative posterior capsule rupture. The review focused on identifying studies
Appendix C. The main outcome for this review was visual acuity.
Table 48 PICO inclusion criteria for interventions to reduce the impact of perioperative
posterior capsule rupture
intraocular lens implantation with a perioperative posterior capsule rupture.
Interventions  Anterior vitrectomy + triamcinolone
 Timing and type of lens insertion
 Early versus late lens removal when lens fallen into back of eye
 Anaesthesia
Comparator  Anterior vitrectomy
 Different timings and types
 Other timing
 Visual function
 Complications (inflammation and pressure)
 Quality of life

pieces.

the full-text version of 1 citation that seemed potentially relevant to this topic was retrieved.
172



Relative value of different The committee agreed that evidence on long-term visual outcomes or
outcomes rates of complications would be relevant for this review question.
Trade-off between No evidence was identified for this review question. However, the
benefits and harms committee agreed that it was appropriate to make a consensus
based recommendation that local areas should have a protocol in
place to deal with posterior capsule rupture. They agreed this was
necessary as inappropriate short-term management can lead to long
term complications, and there were established elements of good
quality care that all surgeons could reasonably be expected to follow.
The list of items such a protocol should include was decided by
informal committee consensus. It was agreed that in the absence of
evidence it would not be appropriate to specify details of what the
protocol should say, but felt it was appropriate to include a set of
minimum elements it should contain. The committee were aware of a
number of existing examples of such protocols (for example, one
developed by Moorfields Eye Hospital), which both demonstrated the
feasibility of developing such a protocol, and provided a template that
other centres could work from.
Consideration of health No economic evidence was identified for this review question, and
benefits and resource economic modelling was not prioritised. The committee agreed that
use inappropriate management of posterior capsule ruptures had the
potentially to lead to serious adverse events down the line, which
would be likely to cost considerably more than the cost of appropriate
management in the short-term. Therefore, the widespread adoption
of appropriate protocols would likely be cost saving.
Quality of evidence No evidence was identified for this review question.
Other considerations The committee identified the Royal College of Ophthalmologists as a
body that may be appropriate to develop consensus based guidelines
on managing posterior capsule ruptures, to serve as a template for
local protocols.
43. When dealing with posterior capsule rupture, follow a protocol that covers:
 removing vitreous from the wound and anterior chamber
 minimising traction on the retina
 removing lens fragments in the posterior chamber or vitreous cavity
 removing soft lens matter
173
 implications for any lens insertion.
174
12.4 Capsular tension rings
 What is the effectiveness of capsular tension rings applied during phacoemulsification
cataract surgery?
12.4.2 Introduction
The aim of this review was to determine the effectiveness of capsular tension rings applied
during phacoemulsification cataract surgery. The review focussed on identifying studies that
fulfilled the conditions specified in Table 49. For full details of the review protocol, see
Appendix C. The main outcomes for this review were postoperative refraction, visual acuity,
postoperative complications.
Table 49 PICO criteria for the effectiveness of capsular tension rings

Interventions Capsular tension rings
Comparator No capsular tension ring
Outcomes  Postoperative complications (decentration)
 Visual acuity
 Postoperative refraction

 were not randomised controlled trials.

screened. Seven randomised controlled trials were included (Alio et al. 2012; Bayraktar et al.
2001; Kocabora et al. (2007); Lee et al. 2002; Mastropasqua et al. 2013; Park et al. 2016 and
Rohart et al. 2009). Two of these studies (Bayraktar and Kocabura) contained a population of
people with pseudoexfoliation.
Table 50 Summary of included studies for the effectiveness of capsular tension rings
Alio et al. (2012) 90 eyes Rotationally asymmetric multifocal IOL implantation with
Spain and without capsular tension ring: refractive and visual
outcomes and intraocular optical performance
175
Bayraktar et al. (2001) 78 eyes Capsular tension ring implantation after capsulorhexis in
Turkey phacoemulsification of cataracts associated with
pseudoexfoliation syndrome. Intraoperative
complications and early postoperative findings.
Kocabora et al. (2007) 84 eyes The preventive effect of capsular tension ring in
Turkey phacoemulsification of senile cataracts with
pseudoexfoliation.
Lee et al. (2002) 40 eyes Effect of a capsular tension ring on intraocular lens
South Korea decentration and tilting after cataract surgery
Mastropasqua et al. 60 eyes Multifocal IOL implant with or without capsular tension
(2013) ring: study of wavefront error and visual performance
Italy
Park et al. (2016) 52 eyes Effect of co-implantation of a capsular tension ring on
South Korea clinical outcomes after cataract surgery with monofocal
Rohart et al. (2009) 40 eyes Influence of a capsular tension ring on ocular
France aberrations after cataract surgery: a comparative study

12.4.5.1 Full population

Low-quality evidence from 4 RCTs containing 356 eyes could not detect a clinically
meaningful difference in corrected or uncorrected distance or near visual acuity in people
given an intraocular lens fitted with or without a capsular tension ring during cataract surgery.
12.4.5.1.2 Cylindrical error

Moderate-quality evidence from 1 RCT containing 52 eyes could not detect a difference in
cylindrical error in people given an intraocular lens fitted with or without a capsular tension
ring during cataract surgery.
12.4.5.1.3 Corneal oedema

Low-quality evidence from 1 RCT containing 78 eyes could not differentiate the risk of
developing postoperative corneal oedema in people given an intraocular lens fitted with or
without a capsular tension ring.
12.4.5.1.4 Intraocular lens decentration

Moderate-quality evidence from 1 RCT containing 40 eyes found that people given an
intraocular lens fitted with a capsular tension ring had reduced decentration compared with
people given an intraocular lens fitted without a capsular tension ring 60 days after cataract
surgery.
176
Moderate-quality evidence from 1 RCT containing 60 eyes could not detect a difference in
decentration along the x-axis in people given an intraocular lens fitted with or without a
capsular tension ring 360 days after cataract surgery.
High-quality evidence from 1 RCT containing 60 eyes found that people given an intraocular
lens fitted with a capsular tension ring had increased decentration along the y-axis compared
with people given an intraocular lens fitted without a capsular tension ring 360 days after
cataract surgery.
12.4.5.2 People with pseudoexfoliation

Low-quality evidence from 2 RCTs containing 162 eyes found higher rates of IOLs being
successfully placed in the bag and lower rates of zonular dehiscence in people with
pseudoexfoliation fitted with a capsular tension ring after cataract surgery than those without.


Relative value of different The committee agreed that postoperative refraction, visual acuity and
outcomes postoperative complications would all be relevant outcomes. The
committee also agreed that it would be useful to report successful
IOL insertion and adverse event outcomes for people with
pseudoexfoliation, as this is a group where the committee believe
there is more likely to be a benefit from the use of capsular tension
rings.
Of the postoperative complication outcomes, the committee agreed
that corneal oedema was not as relevant as the others as this is
unlikely to be impacted by the use of CTR.
Trade-off between The committee discussed the evidence and raised concerns that
benefits and harms some surgeons may use capsular tension rings as an aid in their
surgical technique. They also noted that 1 study used multifocal
lenses whereas others used monofocal lenses. The committee
agreed that if the surgeon decentres a standard monofocal lens it
does not usually impact greatly on the patient’s vision but this is
much more critical when either multifocal or toric lenses are
implanted, due to the greater complexity of the lens. The committee
also agreed that the evidence did not show a benefit from using
capsular tension rings for general use and formulated a
recommendation advising not to use them for routine, uncomplicated
cataract surgery.
However, the committee noted there were benefits demonstrated in
the subpopulation of people with pseudoexfoliation (lower rates of
zonular dehiscence and a higher proportion of IOLs implanted
successfully). The committee therefore agreed to make a separate
recommendation for this sub-population to consider using capsular
tension rings during cataract surgery. The committee agreed it could
not make a stronger recommendation than this as the studies in this
population were short-term, and there was therefore no data
available on long-term outcomes.
use that the cost of capsular tension rings in the NHS supply chain
catalogue varies from around £40-80 per unit (with some outliers at
either end of the scale), but that this may not be the price paid in
practice as some areas will have confidential price discounts
177
arranged wirth manufacturers. The committee agreed that capsular
tension rings are relatively expensive and there would need to be
clear benefits to justify their use in routine procedures, and evidence
on adverse events in the subpopulation of people with
pseudoexfoliation is needed to address the potential cost-
effectiveness of using capsular tension rings in these cases.
However, the evidence suggest that lower rates of zonular
dehiscence and higher proportions of successful IOL implantation in
this subgroup are associated with capsular tension ring use, and the
committee therefore felt that a recommendation to consider their use
was appropriate for two reasons. 1) the clinical benefit in this
subgroup suggests that although a do not use recommendation was
appropriate generally, it did not want to rule out their use in cases of
pseudoexfoliation and 2) It would allow further, longer-term evidence
to be collated that would enable a thoroughgoing cost-effectiveness
analysis of CTRs to be undertaken.
reasonable. They were interested in the lower vitrectomy rates
reported in patients receiving a capsular tension ring. Vitrectomies
have costs and associated complication rates, such that a reduction
in vitrectomy rates implies a meaningful gain for patients. The
committee also agreed that 0.1mm or less decentration of the lens
postoperatively is unlikely to be meaningful.
The committee noted that as pseudoexfoliation occurs in around 15%
of patients, it would have been helpful to have seen evidence on lens
decentration in patients with the condition but accepted that there
were no studies reporting this outcome in the required population.
The committee formulated a research recommendation in order to
answer this, and assess the long-term effectiveness of capsular
tension rings in this group.
question.
44. Do not use capsular tension rings in routine, uncomplicated cataract surgery.
45. Consider using capsular tension rings for people with pseudoexfoliation.
14. What is the long-term effectiveness of capsular tension rings in people with
pseudoexfoliation undergoing cataract surgery?

Evidence indicates that there are benefits from using capsular tension rings in people with
pseudoexfoliation such as lower rates of zonular dehiscence and a higher proportion of IOLs
being implanted successfully but these were only measured a short time after surgery. Well
conducted randomised controlled trials in this population would help to show whether these
benefits continued in the long term and so inform future recommendations on their use.
178
12.5 Interventions to prevent endophthalmitis
 What is the effectiveness of prophylactic antiseptics and antibiotics to prevent
endophthalmitis after cataract surgery?
12.5.2 Introduction
The aim of this review was to evaluate the effectiveness of the following interventions to
prevent endophthalmitis after cataract surgery:
 prophylactic antiseptics (for example, topical iodine)
 prophylactic antibiotics
The review on antibiotics was undertaken by the Cochrane Eyes and Vision Group, in
collaboration with the NICE Internal Clinical Guidelines Team. For the purposes of this
guideline, papers from the Cochrane review were excluded if they were conducted in non-
OECD countries.
Table 51: PICO inclusion criteria for the effectiveness of prophylactic antiseptics and
antibiotics to prevent endophthalmitis
Population Adults (18 years and over) undergoing any cataract surgery
Comparisons  Antiseptics (povidone iodine, chlorhexidine, tisept, presept) vs. no antiseptics
 Preoperative antibiotics (in theatre, several days before surgery) vs. no
preoperative antibiotics
 Timing of intraoperative antibiotics (i.e. administered up to the end of the
operation e.g. with infusion in the middle of operation, at end of procedure)
 Route of administration of intraoperative antibiotics (topical, parenteral,
intravitreous, intracameral, subconjunctival, infusion during surgery) with or
without postoperative antibiotics vs. no intraoperative antibiotics or different
routes vs. each other
 Postoperative (early e.g. few days and longer term e.g. ≥1 week) topical and
systemic antibiotics vs. no postoperative antibiotics
 Different types of postoperative antibiotics vs. each other
 Duration and frequency of postoperative antibiotics
 Timing of antibiotics i.e. preoperative vs. intraoperative vs. postoperative vs.
combinations of timing of administration
Outcomes  Endophthalmitis rates: verified/confirmed/culture positive (preferred), suspected,
any
 Adverse effects of treatment
 Best corrected distance visual acuity
evaluated antiseptics, pre-, intra-, or postoperative antibiotic prophylaxis for acute
endophthalmitis after cataract surgery. Papers were excluded if they:
179

Two separate systematic searches were conducted (see Appendix D) – 1 for prophylactic
antiseptics and 1 for prophylactic antibiotics to prevent endophthalmitis after cataract
surgery.
Electronic literature searches for RCTs of cataract surgery that evaluated giving prophylactic
antiseptics to prevent endophthalmitis identified 356 potentially relevant references. After
removing duplicates the references were screened on their titles and abstracts and full
papers of 6 references were obtained and reviewed against the inclusion and exclusion
criteria in the review protocol (see Appendix C). However, none of these references met the
inclusion criteria for this review, for reasons such as not being a randomised-control trial or
not reporting an outcome of interest. No references on prophylactic antiseptics were
therefore included in this review.
As of 25 October 2012, electronic literature searches for RCTs of cataract surgery that
evaluated giving antibiotics shortly before, during, or immediately after surgery to prevent
endophthalmitis identified 491 potentially relevant titles and abstracts for this review (Gower
2013). After duplicate independent abstract review, 12 references were assessed at the full-
text level, of which 7 were excluded and 5 were included in the review. The 5 references
reported 2 studies. A review of references that cited the included studies and the reference
lists of included studies identified 1 additional record that was excluded after full-text
assessment.
An update search in April 2016 identified 123 new records. The Cochrane information
specialist removed 34 duplicate records and the remaining 89 reports were screened.
Overall, 84 references were excluded after reading the abstracts and full papers of 5
references were obtained for further assessment. However, none met the eligibility criteria for
this review and were therefore excluded.
In total 2 references on prophylactic antibiotics to prevent endophthalmitis after cataract
surgery were therefore included in this review.

Sobaci et al. (2003) was conducted in Turkey and compared antibiotics (vancomycin and
gentamicin) in balanced salt solution (BSS) irrigating infusion fluid with BSS-only irrigating
infusion fluid in 644 eyes of 640 participants. All were treated with ofloxacin and diclofenac
sodium 4 times on the day before surgery. Povidone iodine was used for antisepsis at the
time of surgery and a solution of ofloxacin, dexamethasone and indomethasine was given
postoperatively. Follow-up was for 6 weeks after the operation. Since the incidence of
endophthalmitis following cataract surgery is low (the study authors reported the rate of
postoperative endophthalmitis at their institution was 0.109%) and because only 644 eyes
were included in the study (with less than 1 eye expected to be affected), the study lacked
sufficient power to detect valid differences between treatments.
ESCRS 2007, conducted at multiple sites throughout Europe and Turkey, implemented a 2-
by-2 factorial design to evaluate intracameral cefuroxime injected at the end of surgery and
topical levofloxacin given immediately preoperatively (within 1 hour of surgery) and up to 15
minutes following surgery in 16,603 participants. In a factorial design studying 2 drugs or
180
procedures that are expected to act independently, treatment arms were allocated such that
both drugs can be evaluated alone and in combination.
In ESCRS 2007, the 2 interventions studied were intracameral cefuroxime and topical
levofloxacin. One group received only intracameral cefuroxime, 1 group received only topical
levofloxacin, 1 group received both intracameral cefuroxime and topical levofloxacin, and 1
group received neither intervention. Povidone iodine was used for antisepsis at the time of
surgery and topical levofloxacin was given to all participants starting the morning after
surgery. Follow-up was for 6 weeks after the operation.
tables (see Appendix E).
Table 52 Summary of included studies for the effectiveness of prophylactic antiseptics

and antibiotics to prevent endophthalmitis
Study &
location Population Comparison(s) Antibiotics or antiseptics Placebo
ESCRS 16,603 people Intracameral Intervention #1: intracameral Intervention #4:
2007 undergoing antibiotics vs. cefuroxime 0.9% (injected placebo drops (no
Austria, phacoemulsifi topical into the anterior chamber at sham injection was
Belgium, cation cataract antibiotics (pre- the end of surgery) given)
Germany surgery and Intervention #2: topical
, Italy, postoperative) levofloxacin 0.5% (instilled
Poland, vs. combined one drop one hour before
Portugal, intracameral surgery, one drop half an
Spain, and topical hour before surgery, and
Turkey antibiotics vs. three more drops at 5-minute
and the placebo intervals immediately after
UK surgery)
Intervention #3: combined
intracameral cefuroxime and
topical levofloxacin
Sobaci et 644 eyes of Intraoperative Intervention #1: balanced salt Intervention #2:
al. 2003 640 people antibiotics vs. solution (BSS) with antibiotics BSS-only irrigating
Turkey undergoing no antibiotics (20 mg/mL vancomycin and 8 infusion fluid
phacoemulsifi mg/mL gentamicin
cation cataract
surgery

12.5.5.1 Endophthalmitis rates
12.5.5.1.1 Culture-proven cases

Low- to moderate-quality evidence from 1 RCT containing 16,603 participants could not
detect a clinically meaningful difference in the risk of culture-proven postoperative
endophthalmitis at 6 weeks between topical levofloxacin alone and placebo drops, or
between eyes treated with intracameral cefuroxime alone and eyes treated with topical
181
levofloxacin alone, or combined intracameral cefuroxime and topical levofloxacin compared
with eyes treated with topical levofloxacin alone.
Very low-quality evidence from 1 RCT containing 640 participants found no meaningful
difference in the risk of culture-proven postoperative endophthalmitis at 6 weeks between
irrigation with balanced salt solution with vancomycin and gentamicin and balanced salt
solution alone.
12.5.5.1.2 Clinically diagnosed cases

High-quality evidence from 1 RCT containing 16,603 participants found that intracameral
cefuroxime injections, with or without topical levofloxacin, compared with no prophylaxis is
associated with a clinically meaningfully reduced risk of clinically diagnosed postoperative
endophthalmitis.
Moderate-quality evidence from 1 RCT containing 16,603 participants found that combined
intracameral cefuroxime and topical levofloxacin, compared with topical levofloxacin alone, is
associated with a clinically meaningfully reduced risk of clinically diagnosed postoperative
endophthalmitis.
12.5.5.2 Best corrected distance visual acuity (BCVA)

No evidence for BCVA was identified.
12.5.5.3 Adverse events

No evidence for adverse events was identified.


Relative value of different The committee agreed that both clinically diagnosed and culture-
outcomes proven endophthalmitis rates were useful outcomes, and that an
effect on either outcome would be meaningful.
Trade-off between The committee was not surprised that there were no RCT evidence
benefits and harms for antiseptics as they are used extensively as part of standard
surgical practice to prevent infection (in both cataract and other types
of surgery). It may therefore be unethical not to offer people
antiseptics or to randomise people to a pure placebo group in
research trials. The routine use of antiseptic prophylaxis was also
confirmed in the 2 RCTs of antibiotics, where antiseptics were used
as prophylaxis at the time of surgery. The committee agreed that,
although there is no evidence on the use of antiseptic prophylaxis, a
strong (‘use’) recommendation should still be made due to the
widespread practice. It also agreed that, since there was no evidence
to suggest antiseptic use should be any different in people with
cataract surgery, the use should be in line with standard general
surgical practice.
For the study by ESCRS, the committee discussed the evidence for
both clinically diagnosed and culture-proven endophthalmitis, where
significant findings were only seen in the clinically diagnosed
endophthalmitis with intracameral cefuroxime and in none of the
culture-proven cases. The committee discussed and agreed that
clinically diagnosed cases may not always be culture-positive.
Examples of possible reasons for this could be that the culture
182
techniques used are not sensitive enough or the sample taken is not
large enough to have captured an adequate amount of the bacteria to
grow on the culture plate. The committee was therefore not
concerned about the non-significant results for culture-proven
endophthalmitis.
The committee agreed that, as a significant reduction in clinically
diagnosed endophthalmitis with intracameral cefuroxime was evident
in the evidence and from the clinical experience of committee
members, intracameral injection is also more comfortable for the
patient, a strong (‘use’) recommendation should be made. However,
the committee stressed the importance of providing the correct
concentration of intracameral antibiotics to prevent toxicity. Accurate
dilution of the drug is therefore essential. The committee therefore
agreed that dilution of antibiotics should not take place in theatre,
where the risk of errors being made is considerably higher. The
antibiotic solution should either be commercially prepared
(reconstituted) or prepared in a designated pharmacy (which may be
within the hospital).
Consideration of health As antibiotics and antiseptics are commonly used there are not
benefits and resource expected to be any significant resource implications from the
use recommendations made, especially when compared with the
significant costs incurred in the treatment of endophthalmitis.
Quality of evidence The committee agreed that the ESCRS study was well-designed and
executed but for the Sobaci et al. (2003) study, the committee had
some concern that excluding people where the surgical technique
was modified may have excluded people at the highest risk of
infection. They also noted the small study sample size in the Sobaci
et al. study and agreed that the trial would need to be much larger in
order to provide any meaningful evidence.
The committee discussed the lack of evidence on postoperative
antibiotics, and that this may be due to the fact that they are provided
as part of standard good clinical practice in the UK (although there is
wide variation in practice around the world). In addition, the
committee recognised that patients are invariably receiving other
drops (e.g. steroids), which are likely provided in combination with
postoperative antibiotic drops and often in a single drop product. For
this reason, and in the absence of evidence, the committee agreed
that it would be inappropriate to make a recommendation for
postoperative antibiotics at this stage but instead it would useful to
make a recommendation for future research.
Other consideration The committee discussed the risk of antibiotic resistance but agreed
that the risk is low here because the doses are so low, and none of
the commonly used antibiotics are ones that are critical for use in
other situations. The committee was therefore not concerned about
any antibiotic resistance issues as a result of the recommendations
made.
46. Use preoperative antiseptics in line with standard surgical practice.
47. Use intracameral cefuroxime during cataract surgery to prevent endophthalmitis.
48. Use commercially prepared or pharmacy-prepared intracameral antibiotic

solutions to prevent dilution errors.
183
12.5.8 Research recommendation
15. What is the effectiveness of postoperative antibiotic drops to reduce rates of

endophthalmitis after cataract surgery?

There is a lack of evidence on postoperative antibiotics to reduce rates of endophthalmitis,
which may be because they are provided as part of standard good clinical practice in the UK.
In addition, it is recognised that patients are invariably receiving other drops (for example,
steroids), which are likely to be offered in combination with postoperative antibiotic drops,
and often in a single-drop product. Well-conducted randomised controlled trials of
postoperative antibiotics in people having cataract surgery would help add to the evidence
base and so inform future recommendations on their use.
184
12.6 Interventions to prevent cystoid macular oedema
 What is the effectiveness of prophylactic topical corticosteroids and/or NSAIDs to prevent
inflammation and cystoid macular oedema after phacoemulsification cataract surgery?
12.6.2 Introduction
This review was undertaken by the Cochrane Eyes and Vision Group, in collaboration with
the NICE Internal Clinical Guidelines Team. For the purposes of this guideline, papers from
the Cochrane review were excluded if they were conducted in non-OECD countries, did not
use phacoemulsification or compared oral corticosteroids and/or NSAIDs with no treatment
or another intervention within the same class.
The aim of this review was to evaluate the effectiveness of prophylactic topical
corticosteroids and/or non-steroidal anti-inflammatory drugs (NSAIDs) to prevent
inflammation and cystoid macular oedema following phacoemulsification cataract surgery.
Studies where no active intervention was given were not included, as these were deemed
not to be representative of current practice.
Table 53: PICO inclusion criteria for the effectiveness of prophylactic topical
corticosteroids and/or NSAIDs to prevent inflammation and cystoid macular
oedema
Comparisons  Combination of corticosteroid and NSAID drops vs. corticosteroid drops
 Combination of corticosteroid and NSAID drops vs NSAID drops
 Corticosteroid drops vs. NSAID drops
 Different dosing (frequency and duration) of postoperative treatment
Outcomes  Inflammation rates
 Cystoid macular oedema (clinically symptomatic, optical coherence tomography-
verified)
 Best corrected distance visual acuity
 Adverse effects of treatment e.g. raised intraocular pressure (steroid-induced
glaucoma), allergies (such as sensitivity to preservatives)
compared topical corticosteroids and/or NSAIDs with another relevant intervention. Papers
were excluded if they:
 compared oral corticosteroids and/or NSAIDs with no treatment or another intervention
within the same class
185
A systematic search was conducted (see Appendix D), which identified 928 references. After
removing duplicates the references were screened on their titles and abstracts and full
papers of 62 references were obtained and reviewed against the inclusion and exclusion
criteria in the review protocol (see Appendix C). From examining reference lists of the
retrieved studies, 2 additional references were identified as being potentially relevant.
Overall, 46 references were excluded as they did not meet the eligibility criteria, for reasons
such as not being a randomised-control design or not assessing an included intervention. A
detailed list of excluded studies and reasons for their exclusion is provided in Appendix F.
The remaining 18 studies were identified as being relevant and were therefore included in
this review.

tables (see Appendix E). All 18 identified primary studies were randomised controlled trials,
13 comparing NSAIDs plus steroids versus steroids alone, and 6 comparing NSAIDs versus
steroids (1 RCT had 3 treatment arms – NSAIDs plus steroids, NSAIDs and steroids).
Table 54 Summary of included studies for the effectiveness of prophylactic topical

corticosteroids and/or NSAIDs to prevent inflammation and cystoid macular
oedema
Study &
location Population Comparison(s) NSAIDS Steroid
Almeida 2008 98 people; 106 NSAIDS plus Ketorolac 0.5% Prednisolone
Canada eyes steroids versus acetate 1%
Average age steroids
(years): 72
Almeida 2012 193 people NSAIDS plus Ketorolac 0.5%, Prednisolone 1%
Canada Average age steroids versus Nepafenac
(years): 72 steroids 0.1%
Asano 2008 150 people; 150 NSAIDS versus Diclofenac Betamethasone
Japan eyes steroids 0.1% 0.1%
Average age
(years): 66
Cervantes 60 people; 60 eyes NSAIDS plus Nepafenac Dexamethasone
Coste 2009 Average age steroids versus 0.1% (combined with
Mexico (years): 72 steroids tobramycin)
Chatziralli 2011 145 people; 145 NSAIDS plus Ketorolac 0.5% Dexamethasone
Greece eyes steroids versus 0.1% (combined
Average age steroids with tobramycin
(years): 74 0.3%)
Donnenfeld 100 people NSAIDS plus Ketorolac 0.4% Prednisolone 1%
2006 Average age steroids versus
USA (years): 73 steroids
Endo 2010 75 people; 75 eyes NSAIDS versus Bromfenac Betamethasone
Japan Average age steroids (with fradiomycin
(years): 69 sulfate) followed
by
fluorometholone
186
Study &
location Population Comparison(s) NSAIDS Steroid
Jung 2015 91people; 91 eyes NSAIDS versus Bromfenac Prednisolone
South Korea Average age steroids 0.1% acetate 1%
(years): 67 Ketorolac 0.4%
Mathys 2010 84 people; 84 eyes NSAIDS plus Nepafenac Prednisolone 1%
USA Average age steroids versus 0.1%
(years): 72 steroids
Miyake 2007 62 people; 62 eyes NSAIDS versus Diclofenac 0.1% Fluorometholone
Japan Average age steroids 0.1%
(years): 66
Miyake 2011 60 people; 60 eyes NSAIDS versus Nepafenac Fluorometholone
Japan Average age steroids 0.1% 0.1%
(years): 65
Miyanaga 2009 72 people; 72 eyes NSAIDS plus Bromfenac Betamethasone
Japan Average age steroids versus 0.1% 0.1%
(years): 72 steroids/ NSAIDS
versus steroids
Moschos 2012 79 people; 79 eyes NSAIDS plus Diclofenac 0.1% Dexamethasone
Greece Average age steroids versus 0.1% (combined
(years): 77 steroids with
chloramphenicol
0.5%)
Wittpenn 2008 546 people; 546 NSAIDS plus Ketorolac 0.4% Prednisolone 1%
USA eyes steroids versus
(years): 70
Yavas 2007 189 people; 189 NSAIDS plus Indomethacin Prednisolone 1%
Turkey eyes steroids versus 0.1%
(years): 65
Zaczek 2014 160 people; 160 NSAIDS plus Nepafenac Dexamethasone
Sweden eyes steroids versus 0.1% 0.1%
(years): 69
Singh 2012 263 people NSAIDS plus Nepafenac Prednisolone
USA Average age steroids versus 0.1% acetate
(years): 66 steroids
All with diabetic
retinopathy
Pollack 2016 175 people NSAIDs plus Nepafenac Dexamethasone
Europe, India, Average age steroids versus 0.1% 0.1%
Israel New (years): 69 steroids
Zealand and All with diabetic
the USA retinopathy

187
12.6.5.1 Inflammation
Very low-quality evidence from 5 RCTs containing 346 participants found no meaningful
difference between NSAIDs and steroids in controlling postoperative inflammation (measured
as flare [photons/ms]) after cataract surgery.
Low quality-evidence from 1 RCT containing 47 participants indicates that, compared with
steroids alone, NSAIDs plus steroids are more effective in controlling postoperative
inflammation (measured as flare [photons/ms]) after cataract surgery.
difference between NSAIDs plus steroids and steroids alone in the risk of postoperative
inflammation (measured as number of events) after cataract surgery.
12.6.5.2 Cystoid macular oedema

Low-quality evidence from 4 RCTs containing 291 participants indicates that, compared with
steroids, NSAIDs are associated with a lower risk of cystoid macular oedema after cataract
surgery.
Low-quality evidence from 9 RCTs containing 1,388 participants indicates that, compared
with steroids alone, NSAIDs plus steroids are associated with a lower risk of cystoid macular
oedema after cataract surgery.
12.6.5.2.1 Population with diabetic retinopathy

Moderate-quality evidence from 2 RCTs containing 409 participants with diabetic retinopathy
indicates that, compared with steroids alone, NSAIDs plus steroids are associated with a
lower risk of cystoid macular oedema after cataract surgery.
12.6.5.3 Best corrected distance visual acuity (BCVA)

difference between NSAIDs and steroids on the improvement of BCVA [logMAR] after
cataract surgery.
difference between NSAIDs plus steroids and steroids alone on the improvement of BCVA
[logMAR] after cataract surgery.
12.6.5.3.1 Population with diabetic retinopathy

Low-quality evidence from 2 RCTs containing 405 participants with diabetic retinopathy
found a lower proportion of people treated with NSAIDs plus steroids lost at least 5 letters of
BCVA, compared with those treated with steroids alone.
Very low-quality evidence from 2 RCTs containing 404 participants with diabetic retinopathy
found no meaningful difference between NSAIDs plus steroids and steroids alone on the
improvement of mean BCVA [letters] after cataract surgery.
12.6.5.4 Poor vision due to cystoid macular oedema (CMO)

difference between NSAIDs plus steroids and steroids alone in the risk of poor vision due to
CMO after cataract surgery.
188
12.6.5.5 Adverse events
difference between NSAIDs and steroids in the risk of adverse events.
Very low-quality evidence from 10 RCT containing 1,467 participants found no meaningful
difference between NSAIDs plus steroids and steroids alone in the risk of adverse events.
12.6.5.6 Network meta-analyses

Low-quality evidence from a network meta-analysis of 5 RCTs containing 370 participants
found that NSAIDs plus steroids are more effective in controlling postoperative inflammation
after cataract surgery compared with steroids alone.
Low-quality evidence from a network meta-analysis of 12 RCTs containing 1,656 participants
found that, compared with steroids alone, NSAIDs plus steroids and NSAIDs alone both
lower the risk of cystoid macular oedema after cataract surgery.
Low-quality evidence from a network meta-analysis of 9 RCTs containing 979 participants
could not differentiate the improvements in BCVA after cataract surgery between people
receiving steroids, NSAIDs or NSAIDs plus steroids.


Relative value of different The committee considered that the measures of postoperative CMO
outcomes (measured by OCT), visual acuity and inflammation were all
important effectiveness outcomes. However, the committee noted
that, in the included studies, inflammation was measured using laser
flare photometry and because this is not used in current clinical
practice, it reduces its relative value in this review.
Trade-off between The committee noted that the evidence was only available in a low-
benefits and harms risk (routine) population and that majority of the studies had excluded
the higher-risk population, such as people at high risk of inflammation
or those with uveitis, who have a predisposition for CMO. The
committee discussed whether the evidence could be generalised and
applied to the high-risk population and it agreed that, based on
committee members’ clinical experience, they would expect to see
similar overall relative benefits in both groups (although absolute
effects would be greater, owing to higher underlying event rates),
despite the lack of evidence in the high-risk group.
The committee also discussed the use of topical steroids and
NSAIDs in current clinical practice and agreed that both groups of
drugs are routinely used in prophylaxis and treatment. In particular,
the committee highlighted that NSAIDs with or without steroids are
commonly administered to people with diabetes and for treatment of
symptomatic CMO, in which setting they have been shown to be
effective. However, the committee also acknowledged that some
clinicians may worry about prescribing NSAIDs due to side effects
such as stinging, burning, and conjunctival hyperaemia which could
potentially lead to poor compliance. These types of side effects were
also reported in some of the included studies.
Discussing the evidence, the committee agreed that, although
NSAIDs with or without steroids were shown to be better than
steroids alone in reducing the risk of CMO, in people with a low
189
preoperative risk of CMO, the effects shown would not be sufficient to
justify the routine use of combination NSAID and steroid therapy for
all people undergoing cataract surgery, particularly given the low
quality of much of the evidence base. Hence, based on the evidence-
base and the current clinical practice of providing either topical
steroids and/or NSAIDs as prophylaxis to people undergoing cataract
surgery, the committee agreed to make a recommendation to offer
topical steroids and/or NSAIDs for all people following cataract
surgery.
The committee discussed whether to make a specific
recommendation for the high-risk population. From the knowledge
and clinical experience of committee members, combination therapy
is commonly used in people who are at higher risk of CMO. The
majority of the studies intentionally excluded people who are at high
risk, and therefore the only relevant evidence came from populations
of people with diabetic retinopathy. The committee agreed that it was
reasonable to extrapolate this evidence to other populations at high
preoperative risk of CMO, such as people with other retinal disease
or uveitis, and therefore a ‘consider’ recommendation was made for
combination therapy in people at high risk of CMO.
No evidence was identified on the timing/duration of treatment, and
therefore the committee agreed it was not possible to make any
recommendations on this topic. The committee also discussed
whether to make a recommendation on dosages; however, due to no
evidence being available on what the correct/appropriate dosage
should be, it agreed not to make any recommendations.
Consideration of health The committee noted that, while the resource implications of offering
benefits and resource combination treatment over monotherapy were small in any individual
use case, a recommendation for routine dual therapy in every cataract
surgery would amount to a consequential increase in costs.
Therefore, the committee agreed this supported its recommendation
that combination therapy is not routinely necessary in people at low
risk of CMO. In high-risk populations, the extra resources used were
felt to be justified, as a significant reduction in rates of CMO would
have savings in terms of treatment which would comfortably offset
the costs of prophylaxis.
Quality of evidence The committee discussed that it may be difficult to generalise the
evidence to the most common settings in the UK because the
majority of the evidence was only available in populations at low
preoperative risk for CMO. Nevertheless, the committee agreed that it
would expect to see a similar overall relative response in both
groups.
The committee noted that the evidence presented consisted of
comparisons between active treatments, rather than comparisons to
no treatment or placebo. However, it agreed that it would be
considered unethical not to give some prophylactic treatment, and
therefore agreed this omission did not adversely affect the quality of
the evidence base.
Other considerations The committee noted that ongoing research is taking place in this
area (as identified from trial registries as part of the included
Cochrane review) and therefore agreed that, at this point, there is no
need for any research recommendation.
49. Consider topical steroids in combination with non-steroidal anti-inflammatory

drugs (NSAIDs):
190
 after cataract surgery for people at increased risk of cystoid macular
oedema, for example, people with diabetes or uveitis
 to manage cystoid macular oedema.
50. Offer topical steroids and/or NSAIDs after cataract surgery to prevent
inflammation and cystoid macular oedema.
191
12.7 Managing cystoid macular oedema
 What is the effectiveness of interventions used to manage cystoid macular oedema
following cataract surgery?
12.7.2 Introduction
The aim of this review was to determine the effectiveness of interventions used to manage
cystoid macular oedema (CMO) following cataract surgery. The review focussed on
identifying studies that fulfilled the conditions specified in Table 55. For full details of the
review protocol, see Appendix C. The main outcomes for this review were visual acuity and
time to resolution of macular oedema.
Table 55 PICO criteria for managing cystoid macular oedema

intraocular lens (IOL) implantation
Interventions  NSAIDs
 SAIDs
 Diamox
 Periocular and intraocular steroids
 Intraocular Anti-VEGF
 Vitrectomy
Comparator  No intervention
 Each other
 Further surgery (for non-vitrectomy interventions)
 Macular thickness
 Time to resolution
 Adverse events
 Quality of life

 were not randomised controlled trials.

screened. Three randomised controlled trials were included (Heier et al., 2000, Rho, 2003
and Singal et al., 2004).
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The initial protocol within the Heier et al. (2000) study had an additional treatment arm that
was placebo-only. The protocol was not approved in this form. The ethics board believed it
was unethical not to treat patients with acute CMO (despite the possibility of spontaneous
improvement) because they believed treatment with some form of anti-inflammatory was
considered to be standard care.
Table 56 Summary of included studies for managing cystoid macular oedema

Study &
Heier (2000) 28 patients RCT to evaluate the efficiency of ketorolac tromethamine,
USA prednisolone acetate and ketorolac and prednisolone
combination therapy in the treatment of acute cystoid
macular oedema occurring after cataract surgery.
Rho (2003) 34 patients RCT to compare diclofenac sodium solution and ketorolac
USA tromethamine solution in the treatment of cystoid macular
oedema after cataract surgery.
Singal (2004) 10 patients RCT to evaluate the use of NSAIDs and steroids in the
USA management of cystoid macular oedema.

12.7.5.1 Final visual acuity ≥ 20/40

proportion of people, who achieved visual acuity equivalent to, or greater than, 20/40,
between those who received prednisolone, ketorolac or a combination of ketorolac plus
prednisolone, after cataract surgery.
12.7.5.2 Elimination of cystoid macular oedema

proportion of people who had their cystoid macular oedema resolved, between those who
received ketorolac or diclofenac solution after cataract surgery.
Low-quality evidence from 1 RCT containing 34 participants could not detect a difference in
the average time taken, in weeks, for cystoid macular oedema to be resolved, for those
people who received ketorolac or diclofenac solution after cataract surgery.
12.7.5.3 Snellen equivalent visual acuity

Low-quality evidence from 1 RCT containing 26 participants could not detect a difference in
Snellen equivalent visual acuity, for those people who received ketorolac or ketorolac plus
prednisolone after cataract surgery.
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Relative value of different The committee agreed that visual acuity and time to resolution of
outcomes CMO would be relevant outcomes. They also noted that some cases
of measurable CMO would spontaneously resolve without the need
for further treatment, and this needed to be considered when
interpreting the results.
Trade-off between From their clinical experience, the committee agreed it was likely that
benefits and harms combination treatment with both steroids and NSAIDs would be more
effective than monotherapy with either alternative. The committee
noted that in the trials there was no significant improvement in visual
acuity with combination treatment, but the trials contained very small
numbers of individuals, with the point estimates in favour of
combination treatment. The limited evidence led to the committee to
agree that it would be reasonable to make a “consider”
recommendation for the use of combination therapy for the treatment
of CMO.
benefits and resource and economic modelling was not prioritised, However, the committee
use agreed that since only a small proportion of people will develop CMO
requiring treatment after cataract surgery, the overall resource
implications of this recommendation are likely to be minimal,
particularly as in many parts of the country the use of combination
treatment is already common practice.
Quality of evidence The committee agreed that the quality of the evidence was low,
highlighting the low number of patients within all the included studies,
meaning that it was very unlikely any significant effects would be
detected.
The committee noted that 1 study reported the average number of
people with a final visual acuity ≥ 20/40 as being statistically
significant but that the authors did not report their statistical analysis
clearly, making it difficult to use in helping to formulate
recommendations.
Other considerations The committee noted that evidence was only found for the use of
steroids and NSAIDs, and no evidence was found for the other
interventions specified in the protocol. They therefore agreed that
further research would be of benefit, leading to the formulation of a
research recommendation for the postoperative treatment of patients
with CMO.
The recommendations made for this review question are presented in section 12.6.7.
16. What is the most effective postoperative medical management for cystoid macular
oedema?

Although there is evidence for using steroids and non-steroidal anti-inflammatory drugs
(NSAIDs) in treating cystoid macular oedema, no evidence has been identified for
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interventions such as acetazolamide, steroid-based anti-inflammatory drugs or intraocular
anti-vascular endothelial growth factors (anti-VEGFs). Further randomised controlled trials
with increased numbers of participants would be of benefit to the evidence base, which
would help lead to the formulation of future recommendations for the postoperative treatment
cystoid macular oedema.
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12.8 Postoperative eye shields
 What is the effectiveness of postoperative eye shields to prevent complications after
cataract extraction?
12.8.2 Introduction
The aim of this review was to determine the effectiveness of postoperative eye shields to
prevent complications after cataract extraction. The review focussed on identifying studies
Appendix C.
Table 57 PICO inclusion criteria for the effectiveness of postoperative eye shields
Interventions  Postoperative eye shields
 Length of time with eye shield
Comparator  No postoperative eye shields
 Different lengths of time
Outcomes  Accidental trauma

pieces



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Relative value of different The committee agreed that outcomes relating to either levels of
outcomes accidental trauma or patient satisfaction would be relevant, but was
not surprised that no relevant evidence was identified.
The committee agreed that there was currently a variation in practice
between healthcare centres with some routinely giving patients
postoperative eye shields and others not. They also noted that when
eye shields are given, how long the patients wears them also
differed, ranging from 2 days to 6 weeks postoperatively.
Trade-off between The committee agreed that the use of eye shields came down to
benefits and harms individual preference and perception of protection postoperatively.
They also noted that the patients may also become influenced by the
experience of their partner or friends and family who have previously
undergone cataract surgery.
The committee agreed that for the majority of people after surgery,
there was unlikely to be a practical benefit from eye shields as
modern surgical techniques mean the eye is at no greater risk of
damage postoperatively than before surgery is undertaken. However,
it noted that some people receive psychological reassurance from
having an eye shield, and it may help them to return to their normal
routine more quickly, as they are less concerned about potentially
damaging their eye. As a result of these two opposing perspectives,
the committee did not feel able to make either a positive or negative
recommendation on the routine use of eye shields.
The committee agreed that it was important to make a specific
recommendation for people who showed the residual effects of
anaesthesia in the eye postoperatively, where there is potential for
damage to the eye through accidental trauma. Therefore the
committee agreed to recommend that postoperative eye protection
be routinely offered to this subgroup.
use that the cost of eye shields is very low (they are available for less
than 50p) and therefore the economic impact of any
recommendations made was likely to be minimal.
Quality of evidence No evidence was presented on which the committee could comment.
Other considerations The committee considered whether the lack of evidence indicated
that a research recommendation was appropriate in this area.
However, it agreed this did not represent a high priority for research
and therefore no such recommendation was made.
51. Offer eye protection for people whose eye shows residual effects of anaesthesia
at the time of discharge after cataract surgery.
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13 Postoperative assessment
Postoperative follow up for cataract surgery is traditionally recommended to detect possible
complications, assess the visual and refractive outcome whilst also considering whether
there is a need for surgery on the second eye.
Postoperative assessment may therefore take place outside the cataract operating unit
provided that the outcome is communicated back to the unit ensuring access for
management of complications is available. This is important to ensure a continuity of care for
the patient. Currently there is a variation in practice across the UK as to when and where this
takes place and this guideline will help to inform the questions of when this assessment
occurs and what aspects are included in the follow up examination to support consistency. In
order to prevent possible harms it is important that there is a clear route for postoperative
complications to be identified, reported and treated.
Postoperative complications can vary from mild, for example a slight swelling of the eye, to
severe, for example endophthalmitis, a rare bacterial infection in the eye, which can lead to
blindness. It is therefore important to understand the possible complications of cataract
surgery and their incidence in the UK population. This will allow both patients and clinicians
to have greater awareness of the risks associated with cataract surgery and as such make
better informed choices regarding surgery.
The purpose of this chapter is to consider both the setting and scope of postoperative
assessment along with identifying the postoperative complications of cataract surgery.
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13.1 Complications of surgery
 What are the early and late complications of cataract surgery?
13.1.2 Introduction
The aim of this review was to determine the early and late complications of cataract surgery.
were complications and loss of visual function.
Table 58 PICO inclusion criteria for complications of cataract surgery

Intervention Not relevant
Comparator Not relevant
Outcomes  All complications
 Loss of visual acuity
 Loss of visual function
The review aimed to identify prospective or retrospective cohort studies or case series
reporting rates of complications after cataract surgery. Papers were excluded if they:
pieces
 were not published in the English language

screened. Thirteen observational studies were included (6 retrospective cohort, 4
retrospective case series, 2 retrospective chart reviews and 1 retrospective longitudinal
study). One further retrospective cohort study was included after a rerun search for this
review question (Petousis, 2016).
in the evidence tables (see Appendix E). It was not possible to pool the results of individual
studies together, and therefore the results for each study are presented individually.
Table 59 Summary of included studies for complications of cataract surgery

Bjerrum et al. 202,226 Retrospective cohort to study the risk of pseudophakic
USA patients retinal detachment after first eye phacoemulsification
cataract surgery.
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Boberg-Ans et al. 6,352 Retrospective cohort looking at long-term incidence of
Denmark patients rhegmatogenous retinal detachment and survival in a
defined population undergoing standardized
phacoemulsification surgery
Chu et al. 81,984 eyes Retrospective case series looking at risk factors and
UK incidence of macular oedema after cataract surgery.
Clark et al. 46,258 Retrospective longitudinal study to determine the risk for
Australia patients retinal detachment after phacoemulsification.
Colleaux et al. 13 886 Retrospective chart review looking at effect of prophylactic
Canada cataract antibiotics and incision type on the incidence of
operations endophthalmitis after cataract surgery.
Creuzot-Garcher et al. 6 371 242 Retrospective cohort determining the incidence of acute
France eyes postoperative endophthalmitis after cataract surgery.
Day et al. (2015) 127,685 Retrospective cohort to describe the outcomes of cataract
UK patients surgery in the UK.
Day et al. (2016) 61 907 eyes Retrospective case series to investigate time to
UK pseudophakic retinal detachment (RD) after cataract
surgery.
Du et al. 2 261 779 Retrospective cohort to estimate the incidence of infectious
USA cataract endophthalmitis after corneal transplant or cataract
surgeries surgery.
Freeman et al. 490 690 Retrospective chart review to estimate annual incidence of
Canada cataract endophthalmitis after cataract surgery.
surgical
procedures
Ianchulev et al. 21,484 Retrospective case series to identify safety and
USA patients effectiveness outcomes of office-based cataract surgery.
Olsen et al. 7,856 Retrospective cohort to estimate the cumulative risk of
Denmark patients retinal detachment (RD) after routine cataract surgery by
phacoemulsification.
Petousis et al 18,065 Retrospective cohort to identify the risk factors for retinal
UK patients detachment following cataract surgery.
Venter et al. 4,683 Case series to report the effectiveness, patient satisfaction
UK patients and complication rate with a zonal refractive intraocular
lens in a high volume of patients

13.1.5.1 Retinal detachment

Moderate-quality evidence from 6 retrospective observational studies containing 328,313
participants found rates of retinal detachment post cataract surgery ranged from 0.21% to
0.30% in the UK, and rates from other OECD countries ranging from 0.23% to 0.93%.
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participants found rates of retinal detachment 90 days postoperatively ranging from 0.03% in
the UK to 0.14% in the US.
Moderate-quality evidence from 1 retrospective observational study of 4,683 participants
found a rate of retinal detachment during postoperative care after cataract surgery of 0.04%
in the UK.
13.1.5.2 Endophthalmitis
Moderate- to low-quality evidence from 2 retrospective observational studies of 3,983,525
eyes and 13,866 people respectively in OECD countries found rates of endophthalmitis post
cataract surgery ranging from 0.053% to 0.072%.
participants and 490,690 operations respectively found rates of endophthalmitis 90 days
postoperatively ranging from 0.03% in the UK to 0.08% in Canada.
Moderate-quality evidence from 1 retrospective observational study of 4683 participants
found a rate of endophthalmitis during postoperative care after cataract surgery of 0.1% in
the UK.
Low-quality evidence from 1 retrospective cohort study of 2,261,779 operations found rates
of endophthalmitis (0.063%) and fungal endophthalmitis (0.002%) 6 weeks postoperatively
after cataract surgery.
Low-quality evidence from 1 retrospective cohort study of 2,261,779 operations found rates
of endophthalmitis (0.09%) and fungal endophthalmitis (0.005%) 6 months post cataract
surgery.
13.1.5.3 Macular oedema

Moderate-quality evidence from 2 retrospective observational studies of 21,484 participants
and 81,984 eyes respectively found rates of macular oedema 90 days post cataract surgery
ranging from 0.03% in the US to 1.17% in the UK.
Moderate-quality evidence from 1 retrospective case series study of 4,683 participants found
rates of macular oedema during postoperative care after cataract surgery of 1.1% in the UK.
rates of macular oedema persisting 1 year post cataract surgery of 0.02% in the UK.
13.1.5.4 Corneal oedema

Moderate-quality evidence from 1 retrospective cohort study of 127,685 participants found
rates of corneal oedema post cataract surgery of 0.14% in the UK.
Moderate-quality evidence from 1 retrospective case series study of 21,484 participants
found rates of corneal oedema 3 months post cataract surgery of 0.51%.
rates of corneal oedema persisting 1 year post cataract surgery of 0.05% in the UK.
13.1.5.5 Hyphema
found rates of hyphema 30 days post cataract surgery of 0.02%.
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13.1.5.6 Iritis / Uveitis
found rates of iritis / uveitis 1 to 5 months post cataract surgery of 1.54%.
13.1.5.7 Raised intraocular pressure

rates of raised intraocular pressure requiring treatment persisting for 1 year post cataract
surgery of 0.01%.
13.1.5.8 Surgical re-intervention

rates of surgical re-intervention during postoperative care after cataract surgery of 0.5%.
found rates of surgical re-intervention within 3 months post cataract surgery of 0.61%.
found rates of surgical re-intervention within 6 months post cataract surgery of 0.70%.
13.1.5.9 Visual acuity loss

Moderate-quality evidence from 1 retrospective cohort study of 127,685 participants found
rates of visual acuity loss post cataract surgery of 1.55% in the UK.
13.1.5.10 Posterior capsule rupture and/or vitreous loss

Moderate-quality evidence from 2 retrospective observational studies of 127,685 and 21,484
participants respectively, found rates of posterior capsule rupture and / or vitreous loss
ranging from 1.95% in the UK to 0.95% in the US.
13.1.5.11 Intraoperative complications

Moderate-quality evidence from a retrospective cohort study of 127,685 participants found
the following incidence rates of intraoperative complications during cataract surgery in the
UK:
 Iris trauma / prolapse 0.50%
 Zonule dialysis 0.48%
 Corneal epithelial abrasion 0.28%
 Endothelial damage / Descemet’s tear 0.22%
 Nuclear / epinuclear fragment into vitreous 0.18%
 Lens exchange required / other IOL problems 0.12%
 Phaco burn / wound problems 0.08%
 Hyphaema 0.06%
 Choroidal / suprachoroidal haemorrhage 0.05%

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Relative value of different The committee agreed that all the reported complications presented
outcomes to them would all be relevant outcomes. They also noted that for
some complications (e.g. retinal detachment) that could also occur in
people who had not had cataract surgery, it was important to know
not only absolute rates but also relative risks compared with an age-
matched general population.
Trade-off between The committee agreed that there was lots of relevant evidence. They
benefits and harms noted that the reported reduction in retinal detachment rates over
time may reflect the increasing familiarity of surgeons with the
phacoemulsification procedure. They also highlighted that patients
with high myopia were at an increased risk of retinal detachment. The
committee discussed the French dataset evidence and agreed that it
is likely to include all cataract operations in France over the periods
of time reported, and therefore be a representative dataset of all
cataract operations. They also noted that the reduction in
endophthalmitis incidence rates in France over time may reflect the
increasing use of antibiotic prophylaxis, with a similar trend also
being observed in the UK. The committee noted that the use of
Nd:YAG capsulotomy was also associated with retinal detachments
and highlighted a possible causal pathway for later incidence of RD
being phacoemulsification procedure, development of cystoid
macular oedema, Nd:YAG procedure, leading to retinal detachment.
The committee highlighted important uncertainties remaining
regarding the risk of intraocular haemorrhage, with particular interest
in how anticoagulation treatment affects the risk of intraocular
haemorrhage and how uncontrolled hypertension affects the risk of
intraocular haemorrhage. They further agreed that haemorrhage and
endophthalmitis were the most critical complications in causing
blindness after cataract surgery, although it was noted that retinal
detachment can cause a permanent loss of sight.
Committee members noted that, when informing patients for consent
to surgery, they generally use the headline figures of 1–2/100 chance
of making sight worse or not better, 1/1,000 chance of requiring
additional surgery and a 1/10,000 chance of losing all sight.
benefits and resource but it was noted that much of the evidence presented on both
use absolute and relative risks of events would be of use in the
development of the economic model.
moderate and from a wide variety of sources. They also noted that
whilst the UK cataract dataset is still relatively new, if funding is
continued it should, in the future, be able to provide data on the long-
term risks of a wide variety of complications in the UK.
The committee noted that a number of the included studies were
retrospective cohorts, but agreed that as these studies tended to
include all cataract operations conducted in the area over the study
period, there were unlikely to be serious risk of bias concerns caused
by them being retrospective.
Other considerations Whilst the committee did not make any specific recommendations
based on the evidence presented in isolation, it noted it would form
an important part of the discussions around both patient information
and postoperative assessment, and the numbers would be used as
part of parameterisation of the risks of adverse events in the
economic model produced for this guideline.
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17. What is the risk of postoperative retinal detachment in people with high myopia?

Although it is thought that people with high myopia are at an increased risk of retinal
detachment following cataract surgery, there is currently a lack of evidence to support this.
This is turn makes it difficult to determine the importance of interventions to prevent retinal
detachment in people with high myopia. Well conducted prospective cohort studies would
help to build the evidence base in this area of research and so help to inform future
recommendations for this population having cataract surgery.
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13.2 Details of postoperative assessment
 What should the postoperative assessment include?
 Who and in what setting should carry out the postoperative assessment?
 What issues should be considered when organising postoperative care?
 What is the appropriate time to assess outcomes in the postoperative period?
 If the postoperative assessment and care are undertaken outside of the hospital, how
should outcomes between surgical units and these providers be effectively
communicated?
13.2.2 Introduction
The aim of this review was to determine the appropriate postoperative follow-up care for
people undergoing phacoemulsification cataract surgery.
For full details of the review protocols, see Appendix C.
Table 60: PICO inclusion criteria for postoperative assessment and care
Population Adults (18 years and over) undergoing phacoemulsification cataract surgery
with intraocular implantation
Information needs  Postoperative follow-up care
Outcomes  Content in postoperative assessment
 Investigations performed
 Further interventions – re referral rates
 Additional medications prescribed
 Delays in diagnosis and treatment
 Planned preoperatively at pre-assessment
 Stable visual outcome
Qualitative surveys or interviews were considered to be the most appropriate study designs
to derive information on postoperative follow-up care following phacoemulsification cataract
surgery. In a post-hoc deviation to the protocol, RCT evidence was also considered as no
relevant qualitative studies were identified. Papers were excluded if they:
 were narrative reviews, commentaries, editorials/letters, opinion pieces or case
studies/reports
 collected data using qualitative methods but analysed/presented the data using only
quantitative methods
primary population of people with different eye pathologies.

An overarching systematic search was conducted to inform the review questions on details of
postoperative assessment (see appendix D), which identified 2,407 references. The
references were screened on their titles and abstracts and full papers of 9 references were
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obtained and reviewed against the inclusion and exclusion criteria in the review protocols
(see Appendix C).
Overall, 5 studies were excluded as they did not meet the eligibility criteria, for reasons such
as not being a qualitative or randomised-controlled design. Of the remaining 4 studies that
did meet the eligibility criteria, 3 were RCTs and 1 was a systematic review and meta-
analysis. However, all 3 of the relevant RCTs were already included in the relevant
systematic review and meta-analysis identified from the search strategy. Therefore, in total,
only 1 systematic review and meta-analysis was included in this review.

A systematic review and meta-analysis (Kessel et al., 2015) examined whether first-day
postoperative examination after uneventful cataract surgery in low-risk patients can be
omitted without compromising patient safety. The review identified 3 RCTs that compared
patients seen either on the first postoperative day (n=2 studies) or 2 hours after surgery (n=1
study) with those reviewed at 2 weeks. In total, 886 participants were included in the 3
studies and the mean age ranged from 74 to 76 years. The 3 studies were conducted in
Greece, United Kingdom and Ireland, respectively. Full details of the included systematic
review and meta-analysis is found in the evidence tables (see Appendix E).

13.2.5.1 Postoperative complications

Very low-to low- quality evidence from 3 RCTs containing 886 participants found that
deferred-review is associated with a lower risk, compared with first postoperative day review
group, for encountering postoperative complications following cataract surgery but found no
meaningful difference between the groups in the risk of serious complications (defined as
endophthalmitis, wound leak, or iris prolapse).
13.2.5.2 Number of unscheduled visits

difference in the number of unscheduled visits between discharge and the 2-week
postoperative review between the deferred-review group and the first postoperative day
review group. Patient reassurance, eye drop toxicity, and corneal abrasion were reported to
be the main reasons for unscheduled visits.
13.2.5.3 Postoperative corrected distance visual acuity

Low-quality evidence from 3 RCTs containing 886 participants found no meaningful
difference in postoperative visual acuity (logMAR) between the deferred-review group and
the first postoperative day review group.
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Relative value of different The committee agreed that the outcomes noted in the protocol were
outcomes relevant but acknowledged that there was little evidence available to
comment on. In particular, the lack of qualitative data on patient
experiences of the postoperative pathway meant the committee
agreed that the recommendations made would need to be general,
and could not cover the full range of individual patient experiences
due to a lack of evidence.
Trade-off between Due to the lack of evidence to fully answer the questions the
benefits and harms committee discussed current practice for postoperative care of
patients. They agreed that current practice was not to check
postoperatively on day 1 following surgery and that generally both a
nurse led telephone helpline was utilised and patients told to ring in if
they have any issues. They agreed the RCT evidence identified
supported this approach as appropriate, and that no evidence had
been identified to justify the costs of routine in-person first-day review
in people after uncomplicated cataract surgery. The committee
therefore agreed a ‘do not’ recommendation was appropriate in this
context. However, the committee agreed that, to prevent possible
harms from this approach, it was crucial that there was a clear route
for postoperative complications to be reported/identified, and that
people should get prompt access to specialist ophthalmology
services when these complications did occur. It was agreed that this
should be the responsibility of service providers to ensure that such
policies/processes are in place at the local level.
The committee agreed that clinicians needed to see the patients at
some stage postoperatively but there was no evidence of when this
should take place. They highlighted the variation in practice with
some centres seeing patients 1 week postoperatively whilst others
waiting 2 to 4 weeks before discharging patients. In the absence of
evidence, the committee agreed it would not be appropriate to make
any specific recommendations around timescales for review.
The committee noted that as complications such as CMO generally
present 6-8 weeks postoperatively and PCO years after surgery that
these fall outside of any reasonable follow up timeframe. However it
was agreed that if they occurred the patient would be referred back
for treatment.
The committee agreed the need for a minimum dataset of information
which should be gathered at the postoperative visit and that this
should include 1. Outcome data, 2. Changes to routine treatment and
3. Second eye surgery listing if required. The committee again noted
that there was much variation in practice across the country, but
agreed that these represented a basic minimum standard that should
always be followed. The committee also noted that the measurement
of visual function and quality of life data would be useful, to help
assess the benefits of surgery, but agreed that the evidence
presented did not enable them to specify one tool as being more
appropriate than any other for this purpose.
Finally, the committee agreed there were 2 key points in the process
where information needed to be provided to the person undergoing
surgery. The first is the day of surgery itself, and should include what
to expect and who to contact if problems occur. The second point is
at the first postoperative visit, where people should be reminded of
the expected long term trajectory and who to contact if there are
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problems and given information about when and how to get
spectacles they may need.
Consideration of health No health economic evidence was identified for this review question,
benefits and resource and health economic modelling was not prioritised. The committee
use agreed that the recommendation to avoid first-day in-person review
for people with uncomplicated cataracts surgery would be cost-saving
in any areas where this is still undertaken, and that the other
recommendations made represented current good practice and
should therefore not involve a substantial resource impact.
low, mainly due to the lack of masking and a lack of precision in the
effect estimates, but that the findings did concur with current practice
in the UK.
Other considerations The committee also considered the evidence on patient information
needs identified in section 5.1 when discussing this review question.
They agreed that the recommendations made around patient
information needs were consistent with the themes identified from
that evidence.
52. Commissioners and service providers should ensure that the following are in
place:
 Processes that identify complications after surgery and ensure that there
is prompt access to specialist ophthalmology services.
 Processes to ensure that the UK Minimum Cataract Dataset for National
Audit is completed.
 Arrangements so that healthcare professionals discuss second-eye
cataract surgery with people who have a cataract in their non-operated
eye.
53. Consider collecting patient visual function and quality-of-life data for entry into an
electronic dataset.
54. Do not offer in-person, first-day review to people after uncomplicated cataract
surgery.
55. At the first appointment after cataract surgery, give people information about:
 eye drops
 what to do if their vision changes
 who to contact if they have concerns or queries
 when it is appropriate to get new spectacles and how to do so
 second-eye cataract surgery if there is a cataract in the non-operated
eye
 arrangements for managing ocular comorbidities.
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14 Glossary
Glossary of terms used in this guideline
Anisometropia Vision imbalance where the eyes naturally focus at different distances.
Bilateral simultaneous Surgery is undertaken to remove cataracts in both eyes during a single
cataract surgery operation or on the same day.
Brunescent cataract An advanced cataract that is brown in its appearance and has become
opaque.
Corneal refractive surgery Surgical remodelling of the cornea (the outer structure of the eye) to
improve how well the eye can focus on objects.
Corneal topography A non-invasive medical imaging technique for mapping the surface
curvature of the cornea (the outer structure of the eye).
Cystoid macular oedema Fluid and protein deposits collect on or under the macula of the eye (a
central area of the retina) and causes it to thicken and swell.
Eye akinesia A term for when the eye is incapable of moving (short term paralysis of
the muscles)
Floppy iris syndrome A surgical complication characterised by the iris flopping around in the
fluid of the eye making cataract extraction more difficult.
Glistenings A sparkling of light in the visual field.
Keratometry A process which is used to measure the curvature of the cornea,
particularly for assessing levels of astigmatism
Limbal-relaxing incisions Small cuts in the limbus (the border of the cornea and sclera – the
white of the eye), which allows the cornea to become more rounded
when it heals.
Mesopic light levels Low but not quite dark lighting conditions, for example the level of light
at night in an area with streetlights.
Monovision Wearing one contact lens with focuses that eye for distance vision,
and a second that focuses the other eye for near vision.
On-axis surgery A full thickness corneal incision (cut) which flattens the cornea to
reduce pre-existing astigmatism (blurred or distorted vision)
Phacoemulsification Cataract surgery in which the eye's internal lens is broken up using
ultrasound before being aspirated (removed by suction) from the eye.
Photopic light levels Well-lit lighting conditions.
Posterior capsule A thickening of the back (posterior) of the lens capsule which holds the
opacification artificial lens in place. This thickening of the capsule causes vision to
become cloudy.
Posterior capsule rupture A break or tear in the back of the lens capsule which holds the artificial
lens in place.
Pseudoexfoliation An aging–related disease which is characterized by the accumulation
of microscopic granular protein fibres, which can lead to a build-up of
pressure in the eye.
Refractive implications How well the eye can focus on objects after surgery and lens insertion.
Retinal detachment Where the retina separates from the back of the eye.
Snellen Chart An eyechart commonly used to measure a person’s visual acuity. It
consist of a series of letters of decreasing size viewed at a distance of
6 metres. Normally a Snellen Chart has one large letter at the top
down to a row of very small letters at the bottom. Although it is
beginning to be superseded by similar but more reproducible and
scientifically valid charts, it is still in common use in clinical practice
and is the chart most people will have been asked to read when
having their eyes and vision tested.
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Glossary of terms used in this guideline
Suprachorodial An accumulation of blood within the space between the sclera (white
haemorrhage part of the eye) and the choroid (layer in the eye which contains large
numbers of blood vessels).
Visual acuity The clarity and sharpness with which objects are seen, in particular
the ability to see fine details.
Zonular dehiscence Surgical complication where the wound ruptures along a surgical
incision in the eye.
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National Institute for Health and Care

NICE Guideline NG77

Commissioned by the National Institute for

© NICE 2017. All rights reserved. Subject to Notice of rights.

5.1.6 Evidence to recommendations ................................................................. 34

7.4.1 Review question....................................................................................... 85

8.3.8 Research recommendations .................................................................. 116

11.1.3 Evidence review ..................................................................................... 148

12.2.2 Introduction ............................................................................................ 168

12.7 Managing cystoid macular oedema ................................................................... 192

1 Guideline committee membership and ICG

Keith Allman (co-opted expert member)

Michael Glowala (co-opted expert member)

Kate Kotschy (Until July 2015)

Emily Lam (From July 2015)

Ruth O'Dea (co-opted expert member, from March 2016)

Mary Russell (co-opted expert member, from March 2016)

1.2 Internal Clinical Guidelines Team

Holly Irwin (Until February 2016)

Aimely Lee (From September 2016 to February 2017)

Hugh McGuire (Until December 2015)

Vonda Murray (From February 2016 to March 2016)

Adam O’Keefe (From June 2016)

Joshua Pink (From February 2016)

Stephen Robinson (From April 2016)

Jeremy Wight (From December 2015 to April 2016)

Interventions that must (or must not) be used

Interventions that should (or should not) be used – a

Interventions that could be used

3.1 Evidence synthesis and meta-analyses

3.2 Evidence of effectiveness of interventions

3.2.2 Methods for combining intervention evidence

3.2.3 Minimal clinically important differences (MIDs)

3.2.4 GRADE for pairwise meta-analyses of interventional evidence

Table 1: Rationale for downgrading evidence for intervention studies

3.3 Methods for combining direct and indirect evidence

3.3.2 Applying GRADE to network meta-analysis

3.3.2.1 Risk of bias

3.4 Association studies

3.4.1 Methods for combining association study evidence

3.4.2 Minimal clinically important differences (MIDs)

3.4.3 Modified GRADE for association studies

Table 2: Rationale for downgrading evidence for association studies

GRADE criteria Reasons for downgrading quality

3.5 Non-comparative studies

3.5.1 Modified GRADE for non-comparative evidence

Table 3: Rationale for downgrading evidence for non-comparative evidence

3.6 Qualitative evidence

3.6.2 CERQual for qualitative studies

Table 4: Rationale for downgrading evidence for qualitative questions

3.7 Mixed-quantitative and qualitative evidence

3.8 Health economics

Table 5 Applicability criteria

Table 6 Methodological criteria

3.9 External collaborations

 their position on the list

 securely fix the printed biometry results to the person’s medical

 refer to the printed biometry results, not to transcribed

 second-eye cataract surgery if there is a cataract in the non-

4.2 Research recommendations summary