Safety and Efficacy of Ahmed Glaucoma Valve Implantation in Refractory Glaucomas in Northern Indian Eyes
Safety and Efficacy of Ahmed Glaucoma Valve Implantation in Refractory Glaucomas in Northern Indian Eyes
Safety and Efficacy of Ahmed Glaucoma Valve Implantation in Refractory Glaucomas in Northern Indian Eyes
Original Article
⇑
Suneeta Dubey a, , Vijeta Sharma a,1, Anugya Agrawal a, Lokesh Chauhan a, Gordon Douglas b
Abstract
Purpose: To evaluate the safety and efficacy of Ahmed glaucoma valve (AGV) implantation in refractory glaucoma in Northern
Indian eyes.
Background: The success rate of trabeculectomy remains low in cases of refractory glaucoma even with the use of antifibrotics.
Glaucoma drainage devices have proven to be more efficacious in reducing intraocular pressure (IOP) in these glaucomas.
Methods: Retrospective records of 55 consecutive patients who underwent AGV implantation at Dr. Shroff’s Charity Eye Hospital,
New Delhi, India from January 2003 to December 2012 were reviewed. Pre-operative data included age, gender, eye laterality,
specific diagnosis, number of anti-glaucoma medications, number of prior incisional surgeries, visual acuity and IOP on medical
treatment. Postoperative data included visual acuity and IOP on day one, 1 week, 1 month, 3 months, 6 months, 1 year and yearly
thereafter, number of anti-glaucoma medications, any complication or additional surgical intervention required. Success was
defined as IOP >5 and <22 mmHg with or without treatment.
Results: Mean IOP decreased from 39.71 ± 8.99 pre-operatively to 17.52 ± 5.72 mmHg at last follow-up (p < 0.001) and number of
medications reduced from 3.27 ± 0.84 to 1.25 ± 0.88 (p < 0.001). Visual acuity remained within one Snellen line or improved at last
follow-up in 47 cases (85.4%). The cumulative probability of success was 85.45% at 1 year and 79.63% at 3 years. The incidence
of post-operative complications was 25.45%.
Conclusion: AGV implantation has proven to be safe and is effective in controlling IOP in refractory glaucoma in Northern Indian
eyes.
2014 Production and hosting by Elsevier B.V. on behalf of Saudi Ophthalmological Society, King Saud University.
http://dx.doi.org/10.1016/j.sjopt.2014.06.007
Received 21 November 2013; received in revised form 14 June 2014; accepted 17 June 2014; available online 25 June 2014.
a Dr. Shroff’s Charity Eye Hospital, 5027, Kedarnath Road, Daryaganj, New Delhi 110002, India
b
University of Calgary, 2500 University Dr NW, Calgary, AB T2N 1N4, Canada
⇑ Corresponding author. Address: 814, Technology Apartment, IP Extension, Patparganj, Delhi 110092, India. Tel.: +91 9818224290.
e-mail addresses: [email protected] (S. Dubey), [email protected] (V. Sharma), [email protected] (A. Agrawal),
[email protected] (L. Chauhan), [email protected] (G. Douglas).
URL: http://www.sceh.net (S. Dubey).
1
Tel.: +91 7838878710.
In 1969, Molteno introduced the first drainage implant with a Alcon, Fort Worth, TX, USA). The tube was shortened to the
long silicone tube attached to a thin acrylic plate. 13,14 desired length with its sharp bevel facing anteriorly to allow 2–
All currently available GDDs are based on the concept of the 3 mm of tube in anterior chamber. An anterior cham-ber (AC)
Molteno implant with various modifications such as introduc- paracentesis wound was created at the peripheral cornea and
tion of a valve mechanism or variations in surface area of the sodium hyaluronate 1% (Healon , Abbott Medi-cal Optics) was
end plate. injected to prevent collapse of the AC after sclerostomy was
The Ahmed glaucoma valve (AGV) (New World Medical made. To prevent tube movement, a radial groove was made
Inc., Rancho Cucamonga, CA, USA) is a shunt device with a in the sclera at the proposed site & the edges of the groove
built-in Venturi valve which opens at a specific level of IOP, were retracted using mild cautery. The tube of the implant
thus reducing the chances of hypotony in the early post-oper- entered the AC parallel to the iris plane through the
ative period.15 The valve may act as a potential site for sclerostomy made with a 23 gauge syringe nee-dle. For ease
obstruction by inflammatory debris, especially in Asian eyes of entry, the needle was bent in a Z-shaped manner. In
that are known to have more severe reactions. 16 The purpose pseudophakic patients with post-penetrating ker-atoplasty
of the present study is to evaluate the safety and efficacy of (post-PK) glaucoma and peripheral anterior synech-iae, the
AGV implants in refractory glaucomas in a Northern Indian tube was placed in the ciliary sulcus. Concurrent anterior or
population. pars plana vitrectomy was performed in aphakic patients and
in patients in whom pars plana insertion of tube was planned.
The tube was fixed to the sclera with 9–0 black nylon (Ethicon,
Materials and methods
Ethilon) suture. The anterior part of the tube was covered with
a donor scleral patch graft, which was then fixed to the sclera
This is a retrospective cohort study of 55 patients with
with 9–0 black nylon sutures. The conjunc-tiva was closed with
refractory glaucoma, who underwent AGV implantation at Dr.
8–0 polyglactin suture (Vicryl ; Ethicon, Inc., Somerville, NJ,
Shroff’s Charity Eye Hospital, New Delhi, India from Jan-uary
USA). The sodium hyaluronate in the AC was removed as
2003 to December 2012.
much as possible through the paracente-sis site. No adjunctive
Patients of all ages and both genders with refractory glau-
antimetabolite was used in any of the cases. Patients with
coma unresponsive to conventional medical and surgical
neovascular glaucoma were treated with panretinal
therapy or significant conjunctival scarring or inflammation
photocoagulation and/or intravitreal bevacizumab (Avastin ,
precluding trabeculectomy were included. Patients were
Genentech, South San Francisco, CA, USA) before the AGV
excluded if they had irregular or inadequate (<3 months) fol-
was implanted.
low up. Two patients were excluded because of irregular fol-
Postoperatively, all patients received intensive steroid,
low-up from a pool of 57 patients. The Institutional review
antibiotic and cycloplegic drops daily. The antibiotic drops
board approval was obtained for this research. Further, writ-
were stopped at 2 weeks postoperatively, and steroid drops
ten informed consent also was obtained from each participant.
were tapered gradually over 4–8 weeks.
All the parameters studied for the postoperative evalua-tion
were documented on each follow-up wherever possible and
Data collection decisions to start antiglaucoma medications or to per-form
other surgeries were taken accordingly.
Pre-operative data were collected from patients’ records
including age at the time of surgery, gender, eye laterality,
specific glaucoma diagnosis, number of anti-glaucoma med- Success criteria
ications used pre-operatively, number of prior incisional sur-
geries, visual acuity and pre-operative IOP on medical Success was defined as IOP >5 and <22 mmHg with or
treatment. Postoperative data included visual acuity and IOP without anti-glaucoma treatment. Failure was defined as IOP
on day one, 1 month, 3 months, 6 months, 1 year and yearly <5 or >22 mmHg using every available glaucoma medi-cation
thereafter, number of anti-glaucoma medications used post- that the patient could topically or systemically toler-ate17
operatively, any significant intra-operative or post-oper-ative (maximal medical therapy or MMT), need for additional
complications and any additional surgical intervention if glaucoma surgery or loss of light perception. Results of the
required. most recent examination were used to record the final IOP for
classification as a success or failure. Preoper-ative IOP was
Surgical technique recorded on the most recent visit prior to sur-gery. IOP was
measured with a Goldmann applanation tonometer, a
handheld applanation tonometer (Kowa , Kowa Optimet Inc.,
The surgical procedure consisted of AGV implantation
Torrance, CA, or Perkins , Clement Clarke, Columbus, OH) or
(models S2, S3, FP7, FP8) using a standardized surgical tech-
a Tono-pen (Mentor O & O, Nor-well, MA).
nique by a single experienced surgeon (SD). Surgery was
done after obtaining informed written consent under peribul-
bar or general anesthesia. After applying a superior rectus
bridle suture or corneal traction suture, a fornix-based con- Statistics
junctival flap and tenon’s capsule were dissected to allow
insertion of the plate of the implant into sub-tenon’s space 8 Statistical analysis was done using the SPSS software
mm behind the corneal limbus. Before insertion of the plate, (Chicago, Illinois). The Kolmogorov–Smirnov test was used to
the valve of the implant was primed with balanced salt solution test for normality of numeric variables. For comparisons of two
(BSS , Alcon, Fort Worth, TX, USA). The plate was fixed to the normally distributed numerical variables, we used paired
sclera with 9–0 black nylon sutures (Ethicon , Student’s t tests to determine any significant changes
Safety and efficacy of Ahmed glaucoma valve implantation in refractory glaucomas 105
in various quantitative parameters preoperatively and post- tively. The cumulative probability of success was 85.45% at 1
operatively. The cumulative success probability was deter- year and 79.63% at 3 years (Figs. 3 and 4).
mined using the Kaplan–Meier survival analysis based on the Of the six eyes that had failed based on IOP criteria, there
aforementioned criteria. P values less than 0.05 were con- was one each in neovascular, congenital, post-VR surgery and
sidered statistically significant. malignant group while two in the post-PK category. How-ever,
subgroups were small and asymmetrical precluding sta-tistical
Results comparisons. The eyes that had failed underwent a mean of
1.83 ± 0.40 prior incisional surgeries as compared to 1.55 ±
The baseline characteristics of the study sample are sum- 0.67 in successful eyes. However, the difference was not
marized in Table 1. The mean age was 41.16 ± 19.41 years statistically significant (p = 0.30).
(range 9–77 years). Forty-one patients (74.54%) were male The mean IOP in eyes that had AGV implantation as the
and 14 (25.46%) were female. The mean follow-up period was primary procedure and prior failed filtering surgery was 16.59 ±
619 ± 384 days (range 90 days to 3 years). Before 6.12 and 18.82 ± 4.97 mmHg respectively. The dif-ference
implantation, eyes had been treated with an average of 1.58 ± although clinically significant, was not statistically sig-nificant
0.65 ocular procedures (Table 1). Of the three eyes with (p = 0.15).
neovascular glaucoma, two had proliferative diabetic Among the failed eyes, two eyes suffered loss of light per-
retinopathy and one had central retinal vein occlusion. Three ception; one developed retinal detachment, whereas three
patients presented with congenital glaucoma with associated required additional glaucoma surgery. However, the loss of
aniridia and cataractous lens in one. Twenty-three patients had light perception in both the patients was determined to be not
undergone previous filtering surgery and 32 patients had AGV directly related to AGV implantation.
implantation as a primary procedure. The tube was positioned The case of malignant glaucoma had a past history of com-
in AC in 39 eyes, pars plana in 2, and ciliary sulcus in 14 eyes. bined phacotrabeculectomy. Following AGV implantation, the
patient developed a shallow AC requiring IOL explanta-tion
Of the 55 patients, 49 (89.09%) were considered success- and re-vitrectomy. However, during insertion of infusion
ful at the most recent follow-up as per the defined criteria cannula, the surgery was complicated with suprachoroidal
(Table 2). The mean pre-operative IOP was 39.71 ± 8.99 hemorrhage and retinal detachment.
mmHg and 74.54% patients were on three or more anti- The patient with neovascular glaucoma was primarily a
glaucoma drugs. Post-operatively, the mean IOP and number case of central retinal vein occlusion. Tube implantation was
of medications used, at different time points are described in performed after failure of conventional filtering procedure.
Figs. 1 and 2, respectively. After the initial postoperative Later, this patient developed progressive proliferative vitreo-
reduction in medications, the mean number of medications retinopathy with loss of IOP control and light perception.
gradually increased over a period of time. However, at any One patient with congenital glaucoma with aniridia and
point of time it was less than the preopera-tive requirement. subluxated lens with a history of lens aspiration with vitrec-
tomy underwent trabeculotomy and trabeculectomy as a pri-
Of the 49 successful eyes, 95% required one or more anti- mary surgery. AGV implantation was performed in view of
glaucoma medications and 5% were not treated postopera- uncontrolled IOP after failed filtering surgery in this patient.
The patient subsequently required trans-scleral photoabla-tion
for the control of IOP.
Table 1. Characteristics of patient population studied (n = 55). A hypertensive phase (HP) was defined as a rise in IOP to
Age in years (mean ± SD) 41.37 ± 22.88 >21 mm of Hg within 3 months of AGV implantation, after
reduction of IOP to <22 mmHg during the first postoperative
Gender
Male (%) 41 (74.54) week and not caused by tube obstruction, tube retraction, or
Female (%) 14 (25.46) malfunctioning of the valve.18 Resolution of the HP was
Specific glaucoma diagnosis defined as an IOP <22 mmHg along with (1) a reduction of the
Post-penetrating keratoplasty glaucoma 19 (34.55%) IOP by 3 mmHg or more with the same number of med-
Glaucoma post VR surgery 8 (14.55%) ications or less or (2) reduction of at least one medication with
Traumatic glaucoma 6 (10.91%)
a change of IOP <3 mmHg. This phase was observed between
Neovascular glaucoma 3 (5.45%)
Uveitic glaucoma 3 (5.45%) 1 and 3 months in 15/55 (27.27%) patients in our study (Fig.
Aphakic glaucoma 3 (5.45%) 1). The peak mean IOP at 3 months postopera-tively was
ACIOL with secondary glaucoma 3 (5.45%) significantly higher than that at 6 months (P = 0.008). There
Congenital glaucoma 3 (5.45%) was resolution of HP in 12 (80.0%) patients in our series. No
Advanced POAG 3 5.45%)
patient considered as successful, required systemic
Advanced CACG 2 (3.64%)
Microphthalmos 1 (1.82%) antiglaucoma medication after the HP was over. Moreover,
Malignant glaucoma 1 (1.82%) none of our patients required secondary surgical intervention
Frequency of type of previous glaucoma surgery to control the HP.
Trabeculectomy ± Mitomycin C 18 (32.7%) Visual acuity remained stable (within one Snellen line of
Trabeculotomy 3 (5.45%) preoperative levels in cases wherever quantitative visual acu-
Combined cataract and trabeculectomy 2 (3.64%) ity measurement was possible) or improved at last follow-up in
Lens status 47 cases (85.4%). Of the 8 patients, who had worse visual
Phakic 20 (36.36%) acuity compared with the preoperative level, two actually lost
Pseudophakic 24 (43.64%)
Aphakic 11 (20%)
light perception, one developed retinal detachment, two had
cataract progression, and one suffered graft failure whereas
106 S. Dubey et al.
Table 3. Post-operative complications. most of the post-PK patients were pseudophakic with periph-
Complication No. of Surgical eral anterior synechiae, thereby prompting us to place the tube
patients intervention in the ciliary sulcus. This reduces the likelihood of tube-corneal
Post-operative 6 2 touch.
hypotony ± choroidal effusion Obstruction of the tube is a known complication following
Graft failurea 1 1 GDD surgery and occurred in 2 patients.32 One of the patients,
Tube obstruction 2 2
Tube erosion 1 1 who developed obstruction of the tube due to a vit-reous tag,
Tube corneal toucha 2 was post-trauma and phakic with suspected infe-rior zonular
Phthisis bulbi 1 dialysis. However, there was no vitreous in the AC at the time
Retinal detachmentb 1 of implantation. On the fourth postoperative day, the vitreous
Suprachoroidal hemorrhageb 1 tag advanced from the suspected zonular dialysis and blocked
Conjunctival erosion 1
Motility disorder 0 the tube. It was removed successfully by anterior vitrectomy.
Bleb related infections 0 The other patient who developed blockade of the tube had
Wound leak 0 undergone PK with ECCE/IOL 6 months prior to implantation
Loss of light perceptiona 2 and had no visible cortex at the time of surgery. Cortical
Malignant Glaucomaa 1 1 material did appear post-opera-
a
More than one complication may have occurred in an eye. tively, which required removal to relieve the obstruction. Tube
b
Complication was unrelated to surgery.
erosion has been well reported in the literature.33,34
A standard of care to prevent tube erosion is with the use of a
between 67% and 94% depending on the criteria used to patch graft. Common materials used include pericardium,
define success and lengths of follow-up.18,21 Our study sclera, fascia lata, and cornea.35 Tube erosion occurred in one
reported the success rate of AGV implantation to be 89.1% patient in our series, requiring repositioning with rein-
which is comparable to the published data.27 forcement. The lower incidence could be explained by the use
In our study, AGV implant reduced the pre-operative mean of a scleral patch graft providing tectonic strength and
IOP of 39.71 ± 8.99 mmHg to 17.52 ± 5.72 (p < 0.001) and protection against tube erosion.
dependency on anti-glaucoma medications from 3.27 ± 0.84 Implant endplate size and its biomaterial have been con-
pre-operatively to 1.25 ± 0.88 (p < 0.001) at final follow up visit sidered to play a role in the final effect of GDDs on IOP con-
which is comparable to other studies.2,3 (Table 2). trol. Ishida et al. showed probabilities of success of 94.2% at
The cumulative probability of success was 85.45% at 1 year 12 months and 82.4% at 24 months for the silicone plate
and 79.63% at 3 years which is comparable to various group, and 83.2% at 12 months and 56. 7% at 24 months, for
published case series. A North Indian study reported a suc- the polypropylene plate group.29 In their series, Tenon’s cysts
cess rate of 86.91% at 12 months and 83.76% at 24 months. 2 that required needling or surgical excision were observed in
Huang et al.27 reported a success rate of 88% and Lima et al. 3 4.5% with silicon AGV implantation in compari-son to 18.2%
reported it to be 70.5%. with polypropylene device. The polypropylene material may be
A HP is a frequent finding after placement of AGV.28 In a the reason for the high risk of failure due to encapsulation in
report by Ayyala and associates, this ‘hypertensive phase’ these cases.
(HP) occurred in 82% of the cases (70 of 85 patients). 28 Nouri- We did not encounter any case of encapsulation in our
Mahdavi et al. reported the incidence of a HP to be 56.4% in study. This could possibly be explained due to less frequent
their series.18 Resolution of the HP occurred in 19 of 68 eyes use of polypropylene implants (20%) as compared to silicone
(28%) in their study with available data. Panda et al. reported a AGV (80%).
HP in 80% of eyes between 1 and 3 months that was resolved Although formal motility testing was not performed, we did
with anti-glaucoma medications.20 The inci-dence of a not encounter clinically-relevant motility disorders in any of our
hypertensive phase with the silicone implant has been patients. The reason might be the placement of
reportedly lower than with the polypropylene implant 36.4% the implant in the superotemporal quadrant in most of our
versus 48.5%, respectively.29 The HP (27.27%) in our study patients.36,37
might have been minimized because of more frequent use of The major limitation of our study is its retrospective design.
silicone implants and postoperative antiglaucoma medications Secondly, we had more patients in groups with post-PK
in these eyes. glaucoma and glaucoma post-VR surgery as com-pared to
In the present study, the incidence of post-operative com- other groups, so we could not compare the success rate of
plications was 25.45%. Transient hypotony in the post-opera- AGV implantation and risk factors for failure in various groups.
tive period is a common finding, more so with the non-valved
implants. Valved implants open at a specific IOP level, thus These series of patients are unique in that the patients were
having a lower chance of post-operative hypotony. The inci- operated by a single surgeon, with a consistent technique.
dence of hypotony (10.90%) in our study compares favorably They were followed without significant secondary interven-
with other studies.30 In our study, a total of 6 patients devel- tions such as needling or 5-fluorouracil injection. The results in
oped post-operative hypotony, of which 4 had spontaneous terms of the IOP control, visual acuity and the complication
resolution. However, none of them had wound leaks as a rate in the series were satisfactory. The majority of the postop-
cause. erative complications related to implant were resolved either
One of the patients with post-PK glaucoma developed graft spontaneously or with simple surgical procedures.
failure due to tube-corneal touch. The incidence of In conclusion, Ahmed glaucoma valve implantation has a
tube-corneal touch was much lower in our patients as com- good success rate in terms of IOP control and dependency
pared to other studies.2,31 The reason for this might be that over antiglaucoma medications and has low incidence of
108 S. Dubey et al.
complications. So, this surgery can be considered as a rela- 18. Nouri-Mahdavi Kouros, Caprioli Joseph. Evaluation of the hypertensive
tively safe and effective treatment modality for refractory phase after insertion of the Ahmed glaucoma valve.
Am J Ophthalmol 2003;136:1001–8.
glaucomas in Northern Indian Eyes. 19. Dubey S, Prasanth B, Acharya MC, Narula R. Conjunctival erosion
after glaucoma drainage device surgery: a feasible option. Indian J
Ophthalmol 2013;61:355–6.
Conflict of interest 20. Panda A, Prakash VJ, Dada T, Gupta AK, Khokhar S, Vanathi M.
Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: a
The authors declared that there is no conflict of interest. critically evaluated prospective clinical study. Indian J Ophthalmol
2011;59:185–9.
21. Minckler DS, Heuer DK, Hasty B, Baerveldt G, Cutting RC, Barlow WE.
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