BAUSCH & LOMB

TECHNOLAS@217AEXCIMER LASER
SYSTEM

LASER ASSISTED IN-SITU KERATOMILEUSIS

(LASIK)
PROFESSIONAL USE INFORMATION
FOR THE REDUCTION OR ELIMINATION OF LOW-TO-
MODERATE NATURALLY OCCURRING HYPEROPIA UP
TO +4.00 DIOPTERS MRSE, WITH SPHERE BETWEEN
+l.OO TO +4.00 DIOPTERS WITH OR WITHOUT
REFRACTIVE ASTIGMATISM UP TO +2.00 DIOPTERS AT
THE SPECTACLE PLANE

RESTRICTED DEVICE: U.S. Federal Law restricts this device to sale, distribution, and use by or on the
order of a physician o r other licensed practitioner. U.S. Federal Law restricts this device to practitioners who
have been trained in its calibration and operation and who have experience in the surgical management and
treatment of refractive errors.

This document provides information concerning the intended clinical use of the Bausch & Lomb
TECHNOLAS 217A Excimer Laser System. For complete information concerning system components, safety
instructions, installation, maintenance, and troubleshooting, refer to the Bausch & Lomb TECHNOLAS
217A Excimer Laser System User Guide.

Carefully read all instructions prior to use. Observe all contraindications, warnings, and precautions noted
in these instructions. Failure to do so may result in patient and/or user complications.

Bausch & Lomb, Incorporated

180 E.Via Verde Drive
San Dimas, CA 91773

Refractive Hotline:
(800) 496-7457

Bausch & Lomb and Technolas are trademarks of Bausch & Lomb Incorporated and/or its affiliates.
Other productshrands are trademarks of their respective owners.

1
 TABLE OF CONTENTS

PAGE

SECTION 1 .General Warnings.................................................................................. 6

Restricted Device .......................................................................................................... 6
Ventilation & Air-Borne Contaminants ..................................................................... 6
. . .
Electromagnetic Compatibility .................................................................................... 6
Gas Handling ................................................................................................................... 6
Skin and Eye Exposure .................................................................................................... 6

SECTION 2 .Device Description ................................................................................. 7

Features and Components ofthe Excimer Laser System................................................. 7

SECTION 3 .Indications. Contraindications. Warnings. Precautions and Adverse

Events ............................................................................................................................. 8
3.1. Indications for Use ................................................................................................... 8
3.2. Contraindications..................................................................................................... 8
3.3. Warnings .................................................................................................................. 9
3.4. Precautions ............................................................................................................... 9
3.5. Adverse Events and Complications ......................................................................... 10

SECTION 4 .Clinical Results ...................................................................................... 14

4.1. Study Objectives ...................................................................................................... 14
4.2. Data Analysis and Results........................................................................................ 14
4.2.1. Demographics and Baseline Parameters and Accountability................................ 14
4.2.2. Safety and Effectiveness Results .......................................................................... 15
4.2.3. Safety and Effectiveness Results at the Point of Stability .................................... 16
4.2.4. Stability of the Manifest Refraction...................................................................... 23
4.2.5. Cylinder ConectionNector Analysis.................................................................... 23
4.2.6. Patient Symptoms and Subjective Evaluations..................................................... 27

2
 TABLE OF CONTENTS
(Cont ’d.)

SECTION 5 .Surgical Planning and Procedures ...................................................... 35

5.1. Introduction.............................................................................................................. 35
5.2. Patient Selection....................................................................................................... 35
5.3. Procedure .................................................................................................................. 37
5.4. Peri-Operative Procedures ....................................................................................... 37
5.4.1. Anesthesia ............................................................................................................. 37
5.5. Intra-Operative Procedures ...................................................................................... 37
5.5.1. Creating the Lamellar Flap with the Microkeratome............................................ 37
5.5.2. Performing the Laser Ablation .............................................................................. 37
\.

5.6. Post-operative Procedures........................................................................................ 38

5.6.1. Patching and Medications ..................................................................................... 36
5.6.2. Analgesia................................................................................................................ 38
5.6.3. Handling Complications ....................................................................................... 38
5.7. Post-Procedure ......................................................................................................... 38

SECTION 6 .Bausch & Lomb Excimer Laser Surgical Procedure Step-By-

Step Procedure ............................................................................................................... 39
Prior to Surgery................................................................................................................ 39
. . ................................................................................................................ 39
Patient Training
Microkeratome Surgery ................................................................................................... 39
Laser Surgery ................................................................................................................... 39
Post.Operative .................................................................................................................. 40

SECTION 7 .Emergency Off ...................................................................................... 41

3
 LIST OF TABLES

Table 1 : Key Safety, Adverse Events, and Complications, All Treated Eyes................11
Table 2: Increased Patient Symptoms from Preoperative at 3,6,9 and >12 Months
All Treated Eyes............................................................................................... 13
Table 3: Demographics, All Treated Eyes ..................................................................... 14
Table 4: Preoperative Refraction Parameters, Stratified By Sphere
And Cylinder Components, All Treated Eyes ..................................... 15
Table 5: Accountability, All Treated Eyes ....................................................... 15
Table 6: Summary of Key Effectiveness Variables, All Treated Eyes .............. 16
Table 7: Summary Of Key Safety Variables, At 6 Months (Stable Point)
Stratified By Preoperative MRSE, All Treated Eyes .......................... 17
Table 8: Summary Of Key Safety Variables, At 6 Months (Stable Point)
Stratified By Preoperative MRSE Eyes Treated for Spherical
Hyperopia Only ............................................................................... 18
Table 9: Summary Of Key Safety Variables, At 6 Months (Stable Point)
Stratified By Preoperative MRSE Eyes Treated for Astigmatic
Hyperopia ...................................................................................... 19
Table 10: Accuracy of Manifest Spherical Equivalent at 6 Months -
Attempted vs Achieved, Stratified by Preoperative MRSE
All Treated Eyes ............................................................................. 20
Table 1 1: Accuracy of Manifest Spherical Equivalent -
Attempted vs Achieved, All Treated Eyes ........................................ 21
Table 12: Summary Of Key Effectiveness Variables At 6 Months
Stratified By Preoperative MRCYL*, Eyes Treated For
Spherical Hyperopia Only ................................................................ 22
Table 13: Summary Of Key Effectiveness Variables at 6 Months
Stratified By Preoperative MRCYL*, Eyes Treated For
Astigmatic Hyperopia.. .................................................................... 22
Table 14: Stability Of Manifest Refraction Spherical Equivalent (MRSE)
6-Month Consistent Cohort ............................................................. 23
Table 15: Increase in Astigmatic Vector Magnitude (SIRC-IRC) at the
Point of Stability (6 Months) Stratified By Attempted Spherical
Correction ...................................................................................... 24
Table 16: Cylinder Correction Effectiveness at the Point of Stability
(6 Months) Stratified by Preoperative Cylinder - Astigmatic
Hyperopia Eyes with Complete Preoperative and Postoperative
Refraction ...................................................................................... 25
Table 17: Report Of The Residual Astigmatic Error At 6 Months Stratified
By Preoperative Diopter of Absolute Cylinder Eyes Treated for
Astigmatic Hyperopia ..................................................................... 26
Table 18: Patient Symptoms Changes from Preop & 6 Month,
All Treated Eyes ............................................................................ 27
Table 19: Patient Symptoms Changes from Preoperative to 1 Month,
All Treated Eyes ............................................................................ 28
Table 20: Patient Symptoms Changes from Preoperative to 6 Month,
All Treated Eyes ............................................................................ 29

4
Table 21: Patient Symptoms Changes from Preoperative to 212 Months,
All Treated Eyes ............................................................................ 30
Table 22: Impact of Treatment Accuracy On Patient Symptom Changes
from Preoperative to 6 Months ....................................................... 31
Table 23: Impact of Treatment Type (Astigmatic vs. Spherical) On
Patient Symptom Changes from Preoperative to 6 Months ...............32
Table 24: Self-Evaluation Overall Quality of Vision, Choose Again,
& Satisfaction, All Treated Eyes ..................................................... 33
Table 25: Self-Evaluation at 3 and 6 Months Overall Quality of Vision,
Choose Again, & Satisfaction, All Treated Eyes ............................. 34
Table 26: Wearing Spectacles and Contact Lenses for Distance Vision ........... 35

5
SECTION 1

GENERAL WARNINGS

Restricted Device: Federal (U.S.) law restricts these devices to sale by or on the order of, a
physician.

Carefully read all instructions prior to use. Observe all contraindications, warnings, and
precautions.

Ventilation & Air-borne Contaminants

The treatment room must be adequately ventilated to provide air circulation. However, air
contamination can cause attenuation of the ultraviolet laser radiation in the optical path, reducing
the available power at the treatment site. It is recommended that a three stage 99.8% HEPA
filtration system be used. Steps must be taken to keep the ambient air free of vapors from
solvents or cleaning fluids, including floor wax and the adhesives used in new floor and wall
coverings. Dust generating work and smoking are prohibited in the laser room.. Use of air
sterilization devices must be avoided. Disinfecting of the patient must not be carried out with
volatile, organic hydrocarbons (alcohol). Storage of explosive or flammable substances in the
treatment room is prohibited. Please refer to the Bausch & Lomb TECHNOLASB 217A Excimer
Laser System User Guide, Section 4, Site Requirements and Installation.

Electromagnetic Compatibility
Radio interference or electromagnetic radiation can influence the function of the laser and/or
other devices in the vicinity. The operator must remove possible interference sources. Persons
wearing pacemakers should not be present in the treatment room when the laser is in operation.
The use of mobile phones in the direct vicinity of the Bausch & Lomb TECHNOLAS 2 17A
Excimer laser is not allowed as a negative influence cannot be ruled out. Please refer to the
Bausch & Lomb TECHNOLAS 217A Excimer Laser System User Guide, Section 2, Safety
Considerations.

Gas Handling
The high-pressure gas cylinders should only be handled by service technicians professionally
trained by Bausch & Lomb TECHNOLAS. Please refer to the Bausch & Lomb TECHNOLAS
2 17A Excimer Laser System User Guide, Section 2, Safety Considerations.

Skin and Eye Exposure

The Bausch & Lomb TECHNOLAS 217A Excimer Laser System contains a Class IV laser with
an output at 193nm which is potentially hazardous to the skin and the surface layers of the
cornea. For this reason, specific controls are required which prevent accidental exposure of laser
energy to the eye and skin from both direct and reflected laser beams. In addition, precautions
must be taken in the surgical area to prevent the hazards of fire and electrical injury. Please refer
to the Bausch & Lomb TECHNOLAS 2 17A Excimer Laser System User Guide, Section 2,
Safety Considerations.

6
SECTION 2
DEVICE DESCRIPTION

The TECHNOLAS 2 17A Excimer Laser System for hyperopic astigmatism uses an optical zone that is
selectable between 5.0 mm and 6.0 mm and a blend zone of 1.90mm for spherical hyperopia and
1.75mm for hyperopic astigmatism. The laser is locked out for refractive corrections greater 4.00D
sphere and greater than 2.00D cylinder. The software used in the clinical trial was 2.9994A. The final
commercial release version for hyperopic astigmatism, incorporating the changes made during PMA
review, is 3.14A.

A. Laser System
The specifications for the Bausch & Lomb TECHNOLAS 2 17A Excimer Laser System are provided
below.

Laser Type: Argon Fluoride

Laser Wavelength: 193 nanometers
Laser Pulse Duration: 18 nanoseconds
Laser Head Repetition Rate: 50 Hz
Effective Corneal Repetition Rate: 12.5 Hz
Fluence (at the eye): 120 mJ/cm2
Range of Ablation Diameter: 2.0 to 2.05 mm

Features and Components of the Excimer Laser System:

Laser Unit The laser unit consists of the laser head (discharge system), which contains the
optical resonator and a discharge chamber, which is filled with a premix of
argon, fluorine, and a buffer of other noble gases.

Control Unit The control unit contains the personal computer that uses a software algorithm
to calculate the number and location of laser pulses required to achieve the
desired correction.

Tower Unit The tower unit provides the stable holding construction for the optical system
of the Bausch & Lomb TECHNOLAS 2 17A Excimer Laser. The tower unit
contains the optical elements that condition the laser beam to the appropriate
characteristics. The tower also contains the visualization optics (the operating
microscope) and the positioning and fixation optics for properly locating and
monitoring the progress of the ablation. There is a distance of 21 cm (“working
distance”) between the focusing point on the cornea and the laser arm.

Operating Elements The operating elements of the Bausch & Lomb TECHNOLAS 2 17A Excimer
Laser System consist of two joysticks for movement of the patient bed in all
axes and other operating elements and external connectors.

Bed Unit and Chair The bed unit allows for accurate positioning of the patient during the surgical
procedure while the operating chair allows the surgeon to adjust hisher
position at the operating microscope.

7
B. Microkeratome:

The microkeratome is an instrument that creates a hinged corneal flap (lamellar flap) prior to the laser
ablation procedure. The microkeratome is commercially available and cleared for marketing via
premarket notification. The device used in this study consists of a sterilizatiodstorage tray which
includes the microkeratome head, a IeWright eye adapter, suction ring, suction handle, and blade
insertion tool. The microkeratome motor, tonometer, cleaning brush, disposable blades, black suction
ball, power/suction supply unit with vacuum and motor footswitch and power cords are provided as
separate components and accessory stand and equipment suitcase which complete the system.

SECTION 3

INDICATIONS, CONTRAINDICATIONS,WARNINGS,
PRECAUTIONS AND ADVERSE EVENTS
,
3.1. INDICATIONS FOR USE
The Bausch & Lomb TECHNOLAS 2 17A Excimer Laser System is indicated for use in laser assisted
in-situ keratomileusis (LASIK) treatments for:

0 The reduction or elimination of low-to-moderate naturally occurring hyperopia up to +4.00

diopters (D) MRSE, with sphere between +1 .OO to +4.00 D with or without refractive astigmatism
up to +2.00 D at the spectacle plane.

0 In patients with documented evidence of a change in manifest refraction of less than or equal to
0.50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the
pre-operative examination.

In patients who are 21 years of age or older.

3.2. CONTRAINDICATIONS
LASIK surgery is contraindicated in:

0 Patients with collagen vascular, autoimmune, or immunodeficiency diseases;

Pregnant or nursing women;

Patients with signs of keratoconus;

Patients who are taking one or both of the following medications: isotretinoin (Accutane), or
amiodarone hydrochloride (Cordarone).

8
3.3. WARNINGS
0 The decision to perform LASIK surgery in patients with systemic disease likely to affect wound
healing, such as connective tissue disease, diabetes, severe atopic disease or an
immunocompromised status should be approached cautiously. The safety and effectiveness of the
Bausch & Lomb TECHNOLAS 2 17A Excimer Laser System has not been established in patients
with these conditions.

0 LASIK is not recommended in patients with a known history of Herpes simpIex or Herpes zoster.

0 LASIK is not recommended for patients whose preoperative corneal thickness would leave less
than 250 microns of remaining stromal bed following the laser treatment.

0 Poorer uncorrected distance visual acuity outcomes may be anticipated with correction of higher
refractive errors.

3.4. PRECAUTIONS

The safety and effectiveness of the Bausch & Lomb TECHNOLAS 2 17A Excimer Laser System have
NOT been established:

0 In patients with ocular disease, corneal abnormality, and previous corneal surgery or trauma to the
intended ablation zone

0 In patients with corneal neovascularization within 1.O mm of the ablation zone

In patients under 21 years of age

In patients taking hormone replacement therapy or antihistamines who may have delayed re-
epithelialization of the cornea following surgery

In patients who are taking sumatripin (Imitrex) for migraine headaches

0 In patients with a history of glaucoma

In patients with a history of keloid formation

For treatment of hyperopic astigmatism greater than +4.00 D of sphere or >+2.00 D of cylinder

Over the long term (i.e. more than 12 months after surgery)

0 For retreatment of hyperopic astigmatism

9
LASIK flap diameter that is minimally larger (0.5 mm) than the optical zone size may result in
decreased success rate

The effects of LASIK on visual performance under poor lighting conditions have not been determined.
It is possible, following LASIK treatment, that patients will find it more difficult than usual to see in
conditions such as very dim light, rain, snow, fog, or glare from bright lights at night. Visual
performance possibly could be worsened by large pupil sizes.

Pupil size should be evaluated under mesopic conditions, and patients with large mesopic pupils
should be advised of the potential for negative effects on optical visual symptoms after surgery such as
glare, halos, and difficulty with night driving.

The optical zone should be (a) at least as large as the scotopic pupil and (b) small enough to leave at
least 250 microns of residual stromal thickness. Prospective patients who can not satisfy both of these
criteria should be disqualified for treatment.

Preoperative evaluation for dry eye should be performed. Patients should be advised of potential for
worsening of symptoms associated with dry eye syndrome post-LASIK surgery.

LASIK is not recommended in patients with latent hyperopia to the degree that the patient cannot
accept the full cycloplegic refraction and the cycloplegic refraction differs from the manifest refraction
by 0.75 D or more.

Treatment of hyperopic astigmatism using a minus cylinder ablation profile will remove more tissue
than the same corneal refractive modification using a plus cylinder profile.

3.5. ADVERSE EVENTS AND COMPLICATIONS

Table 1 presents all the cumulative key safety, adverse events, and complications for all treated eyes
reported in the study. The most commonly reported complication was debris in the interface, reported
at least once for 15.1% of eyes. Debris continued to be reported for 9 eyes (3.1%) at the 6 month visit.

10
 Key Safety, Adverse Events, & Complications 3 Months 6 Months 212 Months Cumulative*
nm (Yo) nm (Yo) nm (Yo) nm (Yo)
r..sare!Y..Evenf. ........................................... ........................................ "..........................................
Loss of 2 2 lines BSCVAt 16/341 (4.7%) I 81290 (2.8%) 8/172 (4.7%) 18/358 (5.0%)
Loss of > 2 lines BSCVAt 0/172 (0.0%) 3/358 (0.8%)
BSCVA worse than 20/40t 0/177 (0.0%) 1/358 (0.3%)
BSCVA worse than 20/25 if 20/20 or better 4/168 (2.4%) 7/333 (2.1%)
preoperative1y t
Haze 2 trace with loss of BSCVA > 2 linest 0/177 (0.0%) 0/358 (0.0%)
tncreased manifest refractive astigmatism > 2.0 DS Oh30 (0.0%) 3/21 1 (1.4%)
Refractive astigmatism treatment error > 2.0 DO 0/44 (0.0%) 2/147 (1.4%)
.........................................
~
All Adverse Event -..... ............ C
Reports !e!.tha!..A!?..ve. I.rirnY..P!?.!!!!P!?.ri ve Visits
........................................ ....
"

Angioplasty 0/343 (0.0%) 0/290 (0.0%) 2/178 (1.1%) 2/358 (0.6%)

Anterior membrane dystrophy 4/343 (1.2%) 3/290 (1 .O%) 1/178 (0.6%) 4/358 (1.1%)
Corneal edema (flap) at > 1 month 0/343 (0.0%) 0/290 (0.0%) ID78 (0.6%) 2/358 (0.6%)
Debris in interface 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 1/358 (0.3%)
Decrease in BSCVA of > 2 lines not due to irregular 0/343 (0.0%) 2/290 (0.7%) 0/178 (0.0%) 3/358 (0.8%)
astigmatism
Edema 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 1/358 (0.3%)
Epithelial ingrowth 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 3/358 (0.8%)
Folds in flap 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0Yo) 3/358 (0.8%)
Heart attack 0/343 (0.0%) 01290 (0.0%) 01178 (0.0%) 2/358 (0.6%)
Lamellar keratitis 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 6/358 (1.7%)
Mini-stroke 0/343 (0.0%) 0/290 (0.0%) 2/178 (1.1%) 2/358 (0.6%)
Procedure aborted 01343 (0.0%) 0/290 (0.0%) 01178 (0.0Yo) 1/358 (0.3%)
Secondary surgical intervention other than excimer 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 7/358 (2.0%)

......................................................................................................................... ................. ........... ................. ra!.!ve.v!%s ........ ......................................

Allergies 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 1/358 (0.3%)
Bells palsy 01343 (0.0%) 0/290 (0.0%) 1/178 (0.6%) 1/358 (0.3%)
Blepharitis 2/343 (0.6%) 4/290 (1.4%) 3/178 (1.7%) 7/358 (2.0%)
Bluny vision 0/343 (0.0%) 0/290 (0.0Yo) 0/178 (0.0%) 1/358 (0.3%)
Bowmans wrinkle 0/343 (0.0%) 1/290 (0.3%) 1/178 (0.6%) 1/358 (0.3%)
Chalazion 01343 (0.0%) 0/290 (0.0%) 01178 (0.0%) 1/358 (0.3%)
Conjunctival injection 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 1/358 (0.3%)
Conjunctivitis 2/343 (0.6%) 4/290 (1.4%) 4/178 (2.2%) 8/358 (2.2%)
Corneal abrasion 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 3/358 (0.8%)
Corneal edema atlbefore 1 month 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 241358 (6.7%)
Debris in interface I 18/343 i5.2%) 9/290 (3.1%) 8/178 (4.5%) 54/358 (15.1%;
N = # of eyes returned for the corresponding visit and with non-missing measurements.
* For cumulative Key Safety Events, the time frame is defined as at 6 months or later.
t For cumulative Key Safety Events, if an eye did not have visits t 6 months or did have visits 2 6 months but missing
BSCVA, the last non-missing BSCVA was camed forward.
$ For eyes treated for spherical myopia only.
$ For eyes treated for astigmatic hyperopia.

11
 Table 1 (Continued)
Key Safety, Adverse Events, And Complications
All Treated Eyes
Key Safety, Adverse Events, & Complications 3 Months 6 Months 212 Months Cumulative*
n/N (Yo) n/N (Yo) n/N (Yo) n/N (Yo)
A!!.C!!mP!.!.F.a!!. !..?!..A.!?.Y.X.!!!!!?l .at.!ve.v!!!!s
......... .......................................
Double vision 0/343 (0.0%) 1/290 (0.3%) 01178 (0.0%) 3/358 (0.8%)
Edema 01343 (0.0%) o m 0 io.o%j 0/178 (0.0%) 31358 (0.8%)
Epiretinal membrane 0/343 (0.0%) 0/290 (0.0'Yo) 1/178 (0.6%) 1/358 (0.3%)
Epithelial defect 1/343 (0.3%) 01290 (0.0'Yo) 0/178 (0.0%) 8/358 (2.2%)
Epithelial ingrowth 3/343 (0.9%) 21290 (0.7%) 1/178 (0.6%) 51358 (1.4%)
Epithelium in the interface 0/343 (0.0%) 01290 (0.0'Yo) 0/178 (0.0%) 11358 (0.3%)
Epithelium in the interface with loss I 2 lines of 1/343 (0.3%) 4/290 (1.4%) 0/178 (0.0'Yo) 51358 (1.4%)
BSCVA
Erosion 01343 (O.Oo/) 01290 (0.0'Yo) 0/178 (0.0Yo) 11358 (0.3%)
Folds in flap 2/343 (0.6%) 0/290 (0.0%) 2/178 (l.lYo) 3/358 (0.8%)
Ghost images 01343 (0.09'0) 01290 (0.0%) 0/178 (0.0'Xo) 21358 (0.6%)
Guttata 0/343 (0.0%) 1/290 (0.3%) 0/178 (0.0Yo) 51358 (1.4%)
Interface disruption 1/343 (0.3%) 0/290 (0.0%) 0/178 (0.0Yo) 11358 (0.3%)
Itching 0/343 (0.0%) 2/290 (0.7%) 01178 (0.0Yo) 2/358 (0.6%)
Keratitis 0/343 (0.0%) 1/290 (0.3%) 0/178 (0.0%) 11358 (0.3%)
Meibomitis 0/343 (0.0%) 2/290 (0.7%) 0/178 (0.0Yo) 21358 (0.6%)
Opacity, crystalline lens 0/343 (0.0%) 5/290 (1.7%) 5/178 (2.8%) 10/358 (2.8%)
Pain > 7 days 0/343 (0.0%) 1/290 (0.3%) Oil78 (0.0Yo) 11358 (0.3%)
Papillae 2/343 (0.6%) 0/290 (0.0Yo) 01178 (0.0Yo) 4/358 (1.1%)
Partial flap 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 11358 (0.3%)
Peripheral corneal epithelial defect (on the flap) 0/343 (0.0%) 1/290 (0.3%) 0/178 (0.0%) 8/358 (2.2%)
Posterior vitreous detachment 1/343 (0.3%) 01290 (0.0%) 0/178 (0.0%) 1/358 (0.3%)
Pterygium 0/343 (0.0'Yo) 0/290 (0.0Yo) 0/178 (0.0%) 11358 (0.3%)
Puncta1 stenosis 0/343 (0.0'Xo) 0/290 (0.0%) 0/178 (0.0%) 2/358 (0.6%)
Redness 0/343 (0.0%) 01290 (0.0%) 0/178 (0.0%) 1/358 (0.3%)
Sebaceous cyst 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 1/358 (0.3%)
Subconjunctival hemorrhage 01343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 2/358 (0.6%)
Subepithelial opacity 0/343 (0.0%) 11290 (0.3%) 01178 (0.0%) 1/358 (0.3%)
Trichiasis 0/343 (0.0%) U290 (0.3%) 0/178 (0.0%) 2/358 (0.6%)
Vitreal traction 0/343 (0.0%) 0/290 (0.0%) 0/178 (0.0%) 2/358 (0.6%)
Vitreous detachment 0/343 (0.0%) 01290 (0.0%) Oh78 (0.0%) 1/358 (0.3%)
N = # of eyes returned for the corresponding visit and :h non-missing measurements.

t For cumulative Key Safety Events, if an eye did not have visits 2 6 months or did have visits 2 6 months but missing
BSCVA, its last non-missing BSCVA was carried forward.
$ For eyes treated for spherical myopia only.
9 For eyes treated for astigmatic hyperopia.

At each scheduled postoperative visit, patients were asked to complete a questionnaire that allowed
them to report any findings they had regarding their vision or ocular comfort following the surgery.
The percentage of subjects that rated each condition as worse than before surgery are provided in
Table 2.

12
gI ';

i
SECTION 4
CLINICAL RESULTS

4.1. STUDY OBJECTIVES

A prospective, non-randomized, multicenter clinical study of 358 eyes was conducted to evaluate the
safety and effectiveness of the Bausch & Lomb TECHNOLAS 2 17A Excimer Laser System.
4.2. DATA ANALYSIS AND RESULTS

4.2.1. DEMOGRAPHICS AND BASELINE PARAMETERS AND ACCOUNTABILITY

Demographic characteristics of the study population are presented in Table 3. The baseline refraction
parameters for the study population are presented in Table 4. Accountability for all treated eyes across
the study visit schedule is presented in Table 5.
Table 3
Demographics
All Treated Eyes
Demographics Treated for Spherical Treated for Astigmatic All Treated Eyes
Hypero ia Only Hyperopia
Number Percentage Number I Percentage Number I Percentage
NUMBER OF EYES & 2 I I Eyes of 128 Enrolled 147 Eyes of 96 Enrolled 358 Eyes of 194 Enrolled
SUBJECTS Subjects Subjects Subjects
GENDER
Male I04 49.3% 74 50.3% 178 49.7%
Female 107 50.7% 73 49.7% 180 50.3%
RACE
White 208 98.6% 142 96.6% 350 97.8%
Black 1 0.5% 3 2.0% 4 1.1%
Other 2 0.9% 2 1.4% 4 1.1%
SURGICAL EYE
Right IO0 47.4% 79 53.7% 179 50.0%
LeR 111 52.6% 68 46.3% 179 50.0%
AGE (in years)
Mean 52.8 ( 7.5) 53.6 ( 9.5) 53.1 (8.4)
Minimum, Maximum 23.4,68.9 23.9, 69.0 23.4,69.0

14
 Table 4
Preoperative Refraction Parameters
Stratified by Sphere and Cylinder Components
All Treated Eyes
Manifest Manifest Cylinder Total
Sphere Mean (SD): 0.50 (0.46), Range: 0.00 to 2.00
Mean (SD): 1.92 (0.79) 0.25-0.99 D I .OO-1.74 D 1.75-2.00 D
Range: 0.50 to 4.00 nA YO nlN % nA YO nlN YO
0.00-0.50 D 2/358 (0.6) 11358 (0.3) 01358 (0.0) 3/358 (0.8)
0.51-1.00 D 40/358 (11.2) 8/358 (2.2) 11358 (0.3) 49/358 (13.7)
1.01-1.50D 85/358 (23.7) 21/358 (5.9) 3/358 (0.8) 109/358 (30.4)
1.51-2.00 D 56/358 (15.6) 9/358 (2.5) 4/358 (1.1) 69/358 (19.3)
2.01-2.50 D 53/358 (14.8) 8/358 (2.2) 0/358 (0.0) 61/358 (17.0)
2.51-3.00 D 281358 (7.8) 3/358 (0.8) 2/358 (0.6) 331358 (9.2)
3.01-3.50 D 21/358 (5.9) 1/358 (0.3) 1/358 (0.3) 23/358 (6.4)
3.51-4.00 D 9/33? (2.5) 1/358 (0.3) 1/358 (0.3) 11/358 (3.1)
Total 294/358 (82.1) 52/358 (14.5) 121358 (3.4) 358/358 (100.0)

Status 1 Month 3 Months 6 Months 9 Months 2 12 Months

Available for Analysis nrN (%) 3331358 (93.0%) 343/358 (95.8%) 2901358 (81.0%) 222/358 (62.0%) 178/358 (49.7%)

Discontinued* n/N (%) 1/358 (0.3%) 1/358 (0.3%) 1/358 (0.3%) 13/358 (3.6%) 19/358 (5.3%)

Active nM (%) 0/358 (0.0%) 01358 (0.0?40) 48/358 (13.4%) 50/358 (14.0%) 152/358 (42.5%)
(Not yet eligible for the interval)

Lost to Follow-upt nm (“Yo) 0/358 (0.0%) 01358 (0.0%) 0/358 (0.0%) 6/358 (1.7%) 6/358 (1.7%)

Missed Visit$ nm (“xl) 24/358 (6.7%) 14/358 (3.9%) 191358 (5.3%) 67/358 (18.7%) 3/358 (0.8%)

% Accountability = Available for Analysis 333/357 (93.3%) 3431357 (96.1%) 290/309 (93.9%) 2221295 (75.3%) 178/187 (95.2%)
+ (Enrolled - Discontinued -Not yet
eligible)
N =Total eyes enrolled.
* Discontinued = Exited due to Technolas laser retreatment (0 eye) or non-Technolas laser retreatment (18 eyes) or aborted procedure (I
eye) or death (0 eye).
t Loss to follow-up: Eyes not examined at the 24-month visit, and not considered active or discontinued.
$ Missed visit: Eyes not examined at the scheduled visit, but were then seen at a subsequent visit.

4.2.2 SAFETY AND EFFECTIVENESS RESULTS

Table 6 presents the summary of the key safety and effectiveness variables for the treated eyes at all
available postoperative visits.

15
 Table 6
Summary of Key Safety and Effectiveness Variables
All Treated Eyes
Key Safety 81Effectiveness Variables 3 Months 6 Months 9 Months 2 12 Months
nm ( Y o ) n/N (%) nm (Yo) n/N (%)
Effectiveness Variables
UCVA 20/20 or bettee 1591265 (60.0%) 143/233 (61.4%) 1001168 (59.5%) 83/141 (58.9%)
UCVA 20/40 or hettert 2551265 (96.2%) 2211233 (94.8%) 161/168 (95.8%) 134/141 (95.0%)
MRSES, Attempted vs. Achieved, f 0150 D 2221343 (64.7%) 174/290 (60.0%) 142/222 (64.0%) 109/177 (61.6%)
MRSEf, Attempted vs. Achieved, f I .00 D 314/343 (91.5%) 2511290 (86.6%) 1911222 (86.0%) 1511177 (85.3%)
MRSEf, Attempted vs. Achieved, f 2.00 D 3401343 (99.1%) 287/290 (99.0%) 220/222 (99. I%) 175/177 (98.9%)
MRSEf, h m Emmetropia, f 0.50 Dt 1931265 (72.8%) 155/233 (66.5%) 120/168 (71.4%) 95/141 (67.4%)
MRSEf, from Emmetropia, f 1.00 D t 2461265 (92.8%) 209/233 (89.7%) 1471168 (87.5%) 120/141 (85.1%)
MRSEf, from Emmetropia, f 2.00 D t 2631265 (99.2%) 232/233 (99.6%) 1671168 (99.4%) 140/141 (99.3%)
Safety Variables
Loss o f t 2 lines BSCVA 161341 (4.7%) 81290 (2.8%) 91220 (4.1%) 8/172 (4.7%)
Loss of > 2 lines BSCVA 54341 (1.5%) 2/290 (0.7%) 11220 (0.5%) 0/172 (0.0%)
BSCVA worse than 20140 21341 (0.6%) 01290 (0.0%) 11221 (0.5%) 01177 (0.0%)
BSCVA worse than 2 0 0 5 if 20120 or better 8/319 (2.5%) 31268 ( I . 1%) 31204 (1.5%) 41168 (2.4%)
preoperatively
H A L trace with loss of BSCVA > 2 lines 0/341 (0.0%) 0/290 (0.0%) 01221 (0.0%) 01177 (0.0%)
Increased manifest refractive astigmatism> 2.0 VI96 ( I .O%) 11178 (0.6%) 2/119 (1.7%) 01130 (0.0%)
Refractive astigmatism treatment error > 2.0 D§ 11147 (0.7%) 2/112(1.8%) 0/103 (0.0%) 0/44 (0.0%)

The 95%confidence interval was adjusted for the correlation hehveen eyes.
t For all eyes minus those treated for monovision.
$ MRSE = Manifest Spherical Equivalent = Manifest Sphere + 0.5 x Manifest Cylinder.
1 For eyes treated for spherical hyperopia only.
5 For eyes treated for astigmatic hyperopia.
One eye (170-7015-80) received a treatment (+0.75/+0.75 x 180) outside the approved range for sphere

4.2.3. SAFETY AND EFFECTIVENESS RESULTS AT THE POINT OF STABILITY

Tables 7 through 9 present the results for key safety and effectiveness for all treated eyes, eyes treated
for spherical hyperopia only, and eyes treated for astigmatic hyperopia at the point of refractive
stability (6 months) stratified by the preoperative hyperopia.

The accuracy of the refractive outcomes and the rate of 20/20 UCVA or better are seen to decrease
with increasing preoperative MRSE. This is due in part to the increased rate of undercorrections with
increasing baseline MRSE as seen in Table 10. Accuracy within 0.50D of intended refractive outcome
fell below the target rate of 50% for treatment of MRSE greater than +3.00D. Table 1 1 shows that
undercorrections of greater than 1 .OOD occurred at a rate of 12.4% and 13.0% at month 6 and month
12 respectively and. that the average undercorrections were 0.3 1D and 0.37D at these visits.

The accuracy of the refractive outcomes and the rate of 20/20 or better UCVA decreased with
increasing preoperative manifest refractive cylinder as shown in Tables 12 and 13. The impact of
preoperative cylinder on UCVA is especially noticeable in the group of eyes with 0.50 to 0.75 D
cylinder that received spherical treatments.

Most reports of Key Safety findings at 6 months occurred in eyes treated for spherical hyperopia only
and only 2 occurred in eyes treated for hyperopic astigmatism. Six out of the 8 eyes with 2 2 lines of
BSCVA loss at 6 months had returned to within 1 line of the preoperative BSCVA at the last available
visit. The 2 eyes with a sustained 2-line loss had BSCVA of 20/20 and 20/25.

16
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4.2.4. STABILITY OF THE MANIFEST REFRACTION
Table 14 presents the results for the stability of the manifest refraction spherical equivalent for
the consistent cohort (all treated eyes examined at 1 , 3 , and 6 months). The results indicate that
at least 95% of eyes were within 1.OO D of the previous visit’s spherical equivalent refraction
value during the 1 to 3 months interval. The mean of the paired-differences of MRSE reached
I 10.121 D in the 3 to 6 months interval. Thus, stability was demonstrated by 6 months
postoperative.

Table 14
Stability of Manifest Refraction Spherical Equivalent (MRSE)
6-Month Consistent Cohort
Change in Refraction Between 1 and 3 Between 3 and 6 Between 6 and 9 Between 9 and 212
Months Months Months Months
Change of MRSE by I 1 .OO D
n/N (%) 2581267 (96.6%) 2621269 (97.4%) 2051210 (97.6%) 1 I111 12 (99.1%)
95% CI for % (94.5%, 98.8%) (95.3%,99.5%) (95.2%,99.9%) (96.1%, 99.9%)
Change of MRSE (Paired-Differences)in
Diopters
Mean 0.127 0.08 1 -0.0I5 0.041
SD 0.483 0.408 0.388 0.352
95% CI for Mean (0.065,0.189) (0.032,0.130) (-0.074,0.044) (-0.031,0.113)

4.2.5. CYLINDER CORRECTIONNECTOR ANALYSIS

Table 15 summarizes the increase in astigmatic vector magnitude, or induced astigmatism for
spherical treatments stratified by the attempted level of treatment. This table shows that
spherical only treatment in eyes with low cylinder (<ID) at baseline appears to induce more
astigmatism (which increases with the amount of attempted spherical correction). The treatment
created astigmatism in most farsighted patients who had no astigmatism before. The amount of
induced astigmatism tended to be larger in patients who were more farsighted before surgery.
Table 12 shows the impact of the amount of preoperative cylinder on the key efficacy outcomes.
These tables demonstrate that astigmatic treatment appears to result in better effectiveness
outcomes.

23
 Table 15
Increase in Astigmatic Vector Magnitude (SIRC-IRC) at the Point of Stability (6 months)
Stratified by Attempted Spherical Correction
Statistics Attempted Spherical Correction
0.51 to 1.01 to 1.51 to 2.01 to 2.51 to 3.01 to 3.51 to
1.00D- 1.50D 2.00D 3.50D 3.00 D 4.50 D 4.00 D
N 8 35 34 36 31 17 17
MEAN 0.34 0.47 0.48 0.5 1 0.57 0.62 0.7 1
MEDIAN 0.26 0.50 0.46 0.50 0.41 0.50 0.57
STD 0.13 0.30 0.36 0.36 0.49 0.56 0.48
MIN 0.23 0.00 0.00 0.00 0.00 0.00 0.00
MAX 0.50 I .25 1 .so 1.69 1.85 2.25 1.83

Table 16 presents percent reduction of absolute cylinder and achieved vs. intended vector
magnitude ratio (SIRCDRC) at the point of stability, stratified by diopter of preoperative
cylinder. The vector magnitude ratio (SIRCLRC) was 1.33 at 6 months, which was the point of
refractive stability. Overcorrection of astigmatism was most pronounced when treating less than
1.OOD cylinder as shown by the mean SIRCARC ratio of 1.49 in this group. Table 17 shows that
the large axis shifts (greater than 30") that result from overcorrections were most often associated
with less than 1.OOD of residual astigmatism. Overcorrections of this nature contributed to the
low mean percent reduction (7387.5%) of absolute cylinder reported in Table 16.

There was a strong tendency for overcorrection of cylinder, with a significant number of eyes
with large axis shifts and residual astigmatism. The overcorrection of astigmatism averaged
0.22D and affected UCVA 20/20 outcome. Spherical corrections induced greater amounts of
astigmatism than present at baseline. Astigmatism treatments tended to be too strong, leaving
most patients with some astigmatism at a very different axis than before the treatment. Of eyes
with axis shifts greater than 30°, 16% had at least 1 diopter of astigmatism 6 months after surgery
and 3 % had at least 2 diopters. Such overcorrections of astigmatism can cause visual distortions
that are disturbing to the patient. Of all eyes treated for astigmatism, 18% had more astigmatism
6 months after surgery than they had before surgery.

24
 Preoperative Percent Reduction of Absolute Cylinder (Not Vector)* Achieved vs Intended Vector Magnitude Ratio (SlRC/IRC)t
Cylinder N Mean(SD) - Median (Range) N Mean (SD) Median (Range)
0.25to 0.99 D 60 7.50 (87.46) 16.67 (-300.0to 100.00) 60 1.49(0.83) 1.20(0.12to 4.07)
1.00to 1.74 D 41 5 I .26(40.14) 50.00 (-100.0to 100.00) 41 1.19(0.47) 1.05 (0.31 to 2.99)
1.75 to 2.00D 11 59.58(39.92) 71.43 (-12.50to 100.00) 11 I .06(0.40) 0.99(0.58to 2.05)
Total 112 28.63 (72.91) 45.00 (-300.0to 100.00) I12 1.33 (0.70) 1.04(0.12to 4.07)

25
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4.2.6. PATIENT SYMPTOMS AND SUBJECTIVE EVALUATIONS

The rate of symptoms reported as none, mild, and moderate to severe preoperatively and at the
point of stability (6 months) are reported in Table 18.

Table 18
Patient Symptoms at Preop & 6 Months
All Treated Eyes
Patient Symptoms None
Yo I N) % (dN) % (dN)
Preon. 6 Months Preop. 6 Months Preop. 6 Monlhs
Light sensitivity 47.7% (1671350) 442% (12 11274) 29.1%(102/350) 36.1%(99/274) 23.1% (811350) 19.7% (541274)
Headaches 68.6% (240/350) 84.7% (232/274) 19.7% (691350) 12.4% (341274) 11.7% (411350) 2.9% (81274)
Pain 89.4% (3 131350) 92.0% (2521274) 8.3% (291350) 6.9% (l9/274) 2.3% (81350) l.l%(31274)
Redness 75.4% (2641350) 7 I .9% ( 1971274) 18.6% (65/350) 20.4% (561274) 6.0% (211350) 7.7% (211274)
Dryness 60.6% (212/350) 34.3% (941274) 29.4% (1031350) 43.8% (1201274) 10.0% (351350) 21.9% (601274)
Tearing 76.3% (2671350) 88.3% (2421274) 16.3% (571350) 9.1% (251274) 7.4% (26/350) 2.6% (71274)
Burning
.
Gritty feeling
77. I % (2701350)
77.4% (2711350)
77.0% (21 11274)
67.9% ( I86/274)
19.4% (681350)
19.7% (691350)
20.8% (571274)
25.5% (701274)
3.4% (121350)
2.9% (101350)
2.2% (61274)
6.6%(18/274)
Glare 59.1% (2071350) 49.6% ( I 36l274) 28.9% (IOl/350) 37.6% (1031274) 12.0% (421350) 12.8% (35/274)
Halos 82.0% (2871350) 73.7% (2021274) 11.1% (391350) 16.4% (451274) 6.9% (241350) 9.9% (27/274)
Blurred vision 57.1% (2001350) 43.8% (1201274) 21.4% (75/350) 37.6% (103/274) 21.4% (751350) 18.6% (5 l/274)
Double vision 91.7% (3211350) 82.5% (2261274) 5.1% (181350) 12.0% (331274) 3.1%(11/350) 5.5%(151274)
Ghost images 92.3% (3231350) 78.8% (216/274) 4.9% (171350) 16.8% (461274) 2.9% (101350) 4.4% ( I 21274)
Fluctuations of vision 70.0% (2451350) 38.3% (105074) 24.3% (851350) 47. I% (1291274) 5.7% (201350) 14.6% (401274)
Variation of vision in 58.3% (2041350) 57.7% (158/274) 30.0% (1051350) 32.5% (891274) 11.7% (411350) 9.9% (271274)
bright light
Variation of vision in 78.9% (2761350) 63.5% ( I 741274) 16.0% (561350) 29.2% (801274) 5.1% (181350) 7.3%(20/274)
normal light
Variation of vision in 5 I .4% ( 1801350) 35.8% (98/274) 30.3% (1061350) 36.5% (1001274) 18.3% (641350) 27.7% (761274)
dim lieht
I

Night driving vision 43.4% (152/350) 59.5%- (163/274\

\ - I
38.0% (1331350) 29.6% (811274) 18.6% (651350) 10.9% (301274)
N = Number of Sel
At 6 months, the symptoms graded as moderate or worse that were reported at an incidence level of more than 1% higher than the
baseline incidence level were redness, dryness, gritty feeling, halos, double vision, ghost images, fluctuations of vision, variation of
vision in normal light, and variation of vision in dim light.
IS ‘other’ symptoms were reported preoperative and 8 ‘other’ symptoms were reported at 6 Months

Changes in patient symptoms from preoperative to 1 month, 6 months and 212 months are
presented in Tables 19 through 2 1.

27
 Table 19
Patient m t o m changesfromPreoperativeto 1 Month
Au Treated Eyes
-
Significantly Significantly
Patient I
P M a Ben6 Nochange WorSe WorSe

- %(n) % (n) % (n) %(n) % (n)

Light SLmitivity 304 4.6 % ( 14) 16.1 % ( 49) 43.1 % ( 131) 27.0 % ( 82) 9.2 Yo ( 28)
Headachg 305 4.3 % ( 13) 18.0 % ( 55) 66.9 % (204) 8.5 % ( 26) 2.3 % ( 7)
Pain 303 1.0 % (3) 5.6 % ( 17)83.2 % ( 252) 9.9 Yo ( 30) 0.3 % ( 1)
Rehss 304 23% (7) 10.9 % ( 33)64.1 % ( 195) 18.8 % ( 57) 3.9 % ( 12)
m 304 0.7 % ( 2) 6.6 % ( 20) 38.5 % ( 117) 39.1 % ( 119: 15.1 % ( 46)
EicesiveTearing 305 3.6% ( 11) 15.1 % ( 46) 76.4 % (233) 4.6 % ( 14) 0.3 % ( 1)
Ehming 303 1.3 % (4) 122 % ( 37) 71.0 % (215) 13.2 % ( 40) 2.3 % ( 7)
Csitty Feling 304 0.7 % ( 2) 8.2 % ( 25) 67.4 % ( 205) 22.7 % ( 69) 1.0 % ( 3)
Glare. 304 3.3 Yo ( 10) 11.2 % ( 34) 50.0 % ( 152) 25.7 % ( 78) 9.9 Yo ( 30)
Halos 304 2.6 Yo ( 8) 7.2 % ( 22) 58.6 % ( 178) 21.4 % ( 65) 10.2 % ( 31)
Bluny Vision 301 10.3 % ( 31) 11.0 Yo ( 33) 36.9 % ( 111) 26.2 % ( 79) 15.6 % ( 47)
IxxlbleVision -. 303 1.7 % ( 5) 4.3 % ( 13) 75.6 Yo ( 229) 12.2 % ( 37) 6.3 % ( 19)
303 1.3 % (4) 2 3 % ( 7 ) 74.9 % ( 227) 15.8 % ( 48) 5.6 % ( 17)
Fluctuation of Vision 304 0.3 % ( 1) 4.3 % ( 13) 39.8 % ( 121) 36.5 % ( 111 19.1 Yo ( 58)
variatim of Vision in Bright Light 303 3.3 % ( IO) 14.2 % ( 43) 49.5 % ( 150) 24.1 % ( 73) 8.9 % ( 27)
variatim of Vision in N a n d Light 301 1.7 % ( 5) 7.0 % ( 21) 62.1 % ( 187) 21.6 % ( 65) 7.6 % ( 23)
variatim of Visial in Dim Light 304 6.9 % ( 21) 11.2 % ( 34) 421 % ( 128) 27.0 % ( 82) 12.8 % ( 39)
Dillidties with Night I x i ~ n g 297
- 9.4 % ( 28) 21.5 % ( 64) 44.8 % ( 133) 13.5 % ( 40) 10.8 % ( 32)

* Mnrtw of CRFs receidwith mmssingmhmat both thelxeopaativevisit and the

indicated follow-up visit.

28
 Table 20
Patient Symptom Changes from Preoperative to 6 Month
All Treated Eyes

I
Patient Symptom N*
Significantly
Better
% (n)
Better
% (n)
No Change
% In)
Worse
% (n)
Significantly
Worse
% (n)
Light Sensitivity 264 8.0 % ( 21) 21.2 % ( 56) 45.1 % ( 119) 18.6 Yo ( 49) 7.2 % ( 19)
Headaches 265 . 7.9 % ( 21) 21.1 % ( 56) 66.0 % ( 175) 4.2 % ( 11) 0.8 % ( 2)
Pain 263 1.5 % ( 4) 7.6 % ( 20) 85.2 % ( 224) 4.9 % ( 13) 0.8 % ( 2)
Redness 264 3.4 % ( 9) 10.2 % ( 27) 70.5 % ( 186) 11.4 % ( 30) 4.5 Yo ( 12)
Dryness 266 2.3 % ( 6) 7.5 % ( 20) 46.2 % ( 123) 32.7 % ( 87) 11.3 % ( 30)
Excessive Tearing 266 3.8 % ( 10) 14.3 % ( 38) 76.3 % ( 203) 4.5 % ( 12) 1.1 % ( 3)
Burning 264 1.9 % ( 5) 12.5 % ( 33) 72.0 % ( 190) 12.1 % ( 32) 1.5 % ( 4)
Gritty Feeling 265 1.5 % ( 4) 9.8 % ( 26) 67.9 % ( 180) 15.5 % ( 41) 5.3 % ( 14)
Glare 265 5.3 % ( 14) 18.9 % ( 50) 47.2 % ( 125) 24.2 % ( 64) 4.5 % ( 12)
Halos 265 4.9 % ( 13) 10.6 % ( 28) 63.4 % ( 168) 13.6 % ( 36) 7.5 % ( 20)
Blurry Vision 263 10.3 % ( 27) 16.3 % ( 43) 43.0 % ( 113) 20.2 % ( 53) 10.3 % ( 27)
Double Vision 264 2.3 % ( 6) 4.9 % ( 13) 78.0 % ( 206) 9.8 % ( 26) 4.9 % ( 13)
Ghost Images 265 1.9 % ( 5) 4.5 % ( 12) 75.5 % ( 200) 14.0 % ( 37) 4.2 % ( 11)
Fluctuation of Vision 265 1.9 % ( 5) 7.5 % ( 20) 48.3 % ( 128) 32.5 % ( 86) 9.8 % ( 26)
Variations of Vision in Bright Light 264 6.4 % ( 17) 19.7 % ( 52) 50.4 % ( 133) 17.4 % ( 46) 6.1 % ( 16)
Variations of Vision in Normal Light 265 1.5 % ( 4) 10.6 % ( 28) 61.5 % ( 163) 20.8 % ( 55) 5.7 % ( 15)
Variations of Vision in Dim Light 265 6.0 % ( 16) 14.3 % ( 38) 43.0 % ( 114) 22.3 % ( 59) 14.3 % ( 38)
Difficulties with Night Driving 265 14.3 Yo ( 38) 24.5 % ( 65) 42.6 % ( 113) 12.1 % ( 32) 6.4 % ( 17)

* Number of CRFs received with non-missing values at both the preoperative visit and the
indicated follow-up visit.

29
 Table 21
Patient Symptom Changes from Preoperative to 2 12 Months
All Treated Eyes

i
I
Patient Symptom
Significantly
Better Better No Change Worse
Significantly
Worse
% (n) % (n) % (n) % (n) % (n)
Light Sensitivity 19.8 Yo ( 33) 21.6 % ( 36) 13.1 Yo ( 72) 12.0 % ( 20) 3.6 Yo ( 6)
Headaches 19.2 Yo ( 32) 20.4 % ( 34) 55.1 Ya ( 92) 4.2 Yo ( 7) 1.2 % ( 2)
Pain 11.4% ( 19) 7.2 Yo ( 12) 78.9 Yo ( 131) 0.6 % ( I) 1.8 Yo ( 3)
Redness I66 13.9 Yo ( 23) 16.3 Yo ( 27) 50.6 % 84) 17.5 Yo ( 29) 1.8 Yo ( 3)
Dryness I66 19.3 Yo ( 32) 21.1 Yo ( 35) 51.2 % 85) 7.2 Yo ( 12) 1.2 % ( 2)
Excessive Tearing 167 15.0 % ( 25) 13.2 % ( 22) 66.5 % 111) 4.8 Yo ( 8) 0.6 Yo ( 1)
Burning 166 13.3 % ( 22) 1 1 . 4 % ( 19) 63.3 % 105) 10.8 % ( 18) 1.2 % ( 2)
Gritty Feeling 167 12.0 % ( 20) 8.4 % ( 14) 65.3 % 109) 12.0 % ( 20) 2.4 Yo ( 4:
Glare 167 16.8 % 28) 18.6 Yo ( 31) 44.9 % 75) 18.6 % ( 31) 1.2 Yo ( 2:
Halos 167 13.2 % 22) 10.8
% ( 18) 62.3 Yo ( 104) 10.8 % ( 18) 3.0 % ( 5:
Bluny Vision 166 20.5 % 34) 16.9
Yo ( 28) 36.1 % ( 60) 20.5 Yo ( 34) 6.0 % ( 10
Double Vision 166 12.7 % 21) 6.6% ( 11) 67.5 Yo ( 112: 11.4 % ( 19) 1.8 % ( 3:
Ghost Images 167 12.0 % 20) 4.2Yo ( 7) 72.5 Yo ( 121: 10.8 % ( 18) 0.6 Yo ( I ‘
Fluctuation of Vision 167 11.4 % 19) 7.2Yo ( 12) 44.9 % ( 75) 29.9 % ( 50) 6.6 % ( I 1
Variations of Vision in Bright Light 167 15.0 % ( 25) 22.2
Yo ( 37) 44.3 % ( 74) 13.2 % ( 22) 5.4 % ( 9:
Variations of Vision in Normal Light 167 13.8 Yo ( 23) 7.8
Yo ( 13) 54.5 Yo ( 91) 19.2 % ( 32) 4.8 7’0 ( 8
Variations of Vision in Dim Light 167 20.4 % ( 34) 10.8 % ( 18) 37.1 Yo ( 62) 20.4 % ( 34) 11.4 % ( 1s
Difficulties with Night Driving 167 19.8 % 33) 25.1 % ( 42) 37.7 Yo ( 63) 16.2 % ( 27) 1.2 % ( 2

* Number of CRFs received with non-missing values at both the preoperative visit and the
indicated follow-up visit.

An analysis of the impact of treatment accuracy on symptoms showed that the rate of “worse”
and “significantly worse” symptoms increased as the magnitude of the treatment inaccuracy
increased as seen in Table 22. The effect reached statistical significance (pC0.05) for headaches
and for variation of vision in bright and dim light. As reported in Section 4.2.3, there is an
increased rate of treatment outcome inaccuracies as the attempted treatment increases.

It was reported in Section 4.2.5, Table 15, that induced astigmatism was associated with
spherical treatments. Table 12 in Section 4.2.3 shows that the efficacy of spherical treatments
was reduced relative to astigmatic treatments for eyes with low amounts of astigmatism. The
symptom data for the spherical versus astigmatic treatments, shown in Table 23, do not follow
these same trends.

30
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Presented in Table 24 are the results for the patient subjective assessments of their overall quality
of vision after the surgery, whether or not they would choose to have the surgery again if given
the choice, and their overall satisfaction with the surgery. Table 25 separates these results for the
spherical and astigmatic treatments at the 3 and 6 month visits.

Table 26 gives details about 14 eyes of 9 patients that reported using spectacles or contact lenses
for distance vision tasks at the 6-month visit. Three of the patients received a monovision
correction and therefore the use of spectacles for certain distance tasks is not unexpected. Seven
out of these nine patients indicated that they would have the surgery again if they had the
opportunity to make the decision over.
Table 24
Self-Evaluation
Overall Quality of Vision, Choose Again, & Satisfaction
All Treated Eyes
Self-Evaha tion Response 3Months I 6Months I 9Months I 2 12 Months
Questions
I I I
~~~ ~

Overall Quality of No Improvement 1.2% (4/331) 1.1% (3/269) 0.5% (11208) 0.6% (1/165)
Vision after Slight Improvement 4.8% (101208) 4.2% (7/165)
Excimer Laser Moderate Improvement 7.2% (15/208) 11.5% (19/165)
Marked Improvement 30.8% (64/208) 24.8% (41/165)
Extreme lmorovement 56.7% (1 18/208) 58.8% (97/165)
Not rmorted* 1 0
Totalt 209 165
Choose Excimer No 0.0% (0/205) 0.0% (0/161)
Laser Again? Unsure (7.3%) (15/205) 7.5% (12/161)
Yes 92.7% (1 90/205) 92.5% (149/161)
Not rmorted* 4 4
Totalt 337 214 209 165
How Satisfied with Very Satisfied 72.7% (152/209) 71.5%(118/165)
the Excimer Laser Moderately Satisfied 22.0% (46/209) 22.4% (37/165)
Results? Neutral 1.4% (3/209) 4.2% (7/165)
Dissatisfied 3.8% (8/209) 1.8% (3/165)
Very Dissatisfied 0.0% (0/209) 0.0% (0/165)
Not reported* 8 I 9 0 0
Totalt

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t Number of CRFs received at each visit.
241333 (7.2%) at the 1 Months visit, 61343 (1.7%) at the 3 Months visit, 16/290 (5.5%) at the 6 Months visit, 131222 (5.90/) at
the 9 Months visit, and 13/178 (7.3%) at the 12 Months visit were not reported with the Self-Evahation CRFs.

33
 Table 25
Self-Evaluation at 3 and 6 Months
Overall Quality of Vision, Choose Again, & Satisfaction
All Treated Eyes
Self-Evaluation Questions Response Overall Spherical Astigmatic
Hyperopia Hyperopia
YO(n/N) Y’ (dN) % (n/N)

........................................................................................... 6.,Months
............ .......................................................................................
~.
of Vision I N 0 Improvement 1.1%( 0.6%(1/157) 1 1.8%(2/112)
after Excimer Laser Slight Improvement 4.5% (121269) 3.2% (5/157) 6.3% (7/112)
Moderate Improvement 10.0% (27/269) 10.2% (16/157) 9.8% (1 1/112)
Marked Improvement 34.2% (92/269) 33.1% (52/157) 35.7% (40/112)
Extreme Improvement 50.2% (135/269) 52.9% (83/157) 46.4% (52/112)
Not reDorted* 5 5 0
Total? 274 162 112
Choose Excimer Again? No 1.9% (5/263) 0.6% (1/154) 3.7% (4/109)
Unsure 8.7% (23/263) 7.8% (12/154) 10.1% (1 1/109)
Yes 89.4% (235/263) 91.6% (141/154) 86.2% (94/109)
Not reported* 11 8 3
Totalt 274 162 112
How Satisfied with the Very Satisfied 71.7%(190/265) 76.8% (1191155) 64.5% (711110)
Excimer Laser Results? Moderately Satisfied 20.8% (55/265) 18.7% (29/155) 23.6% (26/110)
Neutral 4.9% (13/265) 3.2% (5/155) 7.3% (8/110)
Dissatisfied 2.3% (6/265) 1.3% (2/155) 3.6% (4/110)
Very Dissatisfied 0.4% (11265) 0.0% (0/155) 0.9% (1/110)
Not reported* 9 7 2
Total? 274 162 112

34