A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-guided PRK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and the Star S4 IR™ Excimer Laser System
Phase: NA
Conditions: Stable Myopic Refractive Error, With or Without Astigmatism
Sponsor: Abbott Medical Optics

 
 
Study Protocol 
 
 
A PROSPECTIVE STUDY TO EVALUATE THE SAFETY AND 
EFFECTIVENESS OF WAVEFRONT-GUIDED PRK CORRECTION OF 
MYOPIC REFRACTIVE ERRORS WITH THE IDESIGN ADVANCED 
WAVESCAN STUDIOSYSTEM AND THE STAR S4 IR EXCIMER 
LASER SYSTEM 
 
 
NCT Number: NCT02675751 
 
Document date: 17 Nov 2015 
 
 
 
 
 
 

ABBOTT MEDICAL OPTICS INC.  
PROPRIETARY 
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    PR/STAR-115-MIPS 
 
PROPRIETARY 
The following contains proprietary information  
that is the property of Abbott Medical Optics Inc. 
 
A PROSPECTIVE STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF 
WAVEFRONT-GUIDED PRK CORRECTION OF MYOPIC REFRACTIVE ERRORS 
WITH THE IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM AND THE STAR S4 
IR EXCIMER LASER SYSTEM 
 
PROTOCOL NUMBER:  STAR-115-MIPS 
 
SPONSOR:  Abbott Medical Optics Inc. 
510 Cottonwood Drive 
Milpitas, CA 95035 
 
Investigator Agreement 
 
As an Investigator, I agree to: 
 Implement and conduct this study diligently and in strict compliance with this 
agreement; the protocol; Good Clinical Practices; 21CFR812, ISO 14155 and all 
other applicable FDA regulations; conditions of approval imposed by the 
reviewing Institutional Review Board (IRB) FDA or other regulatory authorities; 
and all other applicable laws and regulations. 
 Supervise all testing of the device where human subjects are involved. 
 Ensure that the requirements for obtaining informed consent are met. 
 Obtain authorization for use/disclosure of health information (e.g., HIPAA 
authorization or equivalent). 
 Maintain all information supplied by Abbott Medical Optics in confidence and, 
when this information is submitted to a local IRB or any other group, it will be 
submitted with a designation that the material is proprietary. 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
 
 
 
 
Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
Subinvestigator Printed Name 
Signature 
Date 
 
 
Acknowledged By: 
 
 
 
 
 
 
Signature of Sponsor’s Representative 
Date 
_________________________________________________________________ 
Printed Name and Title

ABBOTT MEDICAL OPTICS INC.  
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TABLE OF CONTENTS 
TITLE 
PAGE 
TABLE OF CONTENTS ................................................................................................... i 
Personnel and Facilities............................................................................................... iv 
Protocol Change History ............................................................................................... v 
1. 
Synopsis ............................................................................................................. 1 
2. 
Background/Introduction .................................................................................. 6 
3. 
Clinical Hypothesis ............................................................................................ 7 
4. 
Study Design ...................................................................................................... 7 
5. 
Acronyms ........................................................................................................... 8 
6. 
Study Objectives and Endpoints ...................................................................... 8 
6.1 
Primary Endpoints ............................................................................................. 9 
6.2 
Other Endpoints: ................................................................................................ 9 
6.3 
Definition of the Time Point of Refractive Stability ............................................ 10 
7. 
Study Products ................................................................................................ 10 
7.1 
iDesign Advanced WaveScan Studio System .................................................. 10 
7.2 
STAR S4 IR Excimer Laser System ................................................................. 11 
8. 
Study Population ............................................................................................. 11 
8.1 
Inclusion Criteria .............................................................................................. 12 
8.2 
Exclusion Criteria: ............................................................................................ 13 
9. 
Investigator Selection ...................................................................................... 14 
9.1 
Investigator Qualifications ................................................................................ 14 
9.2 
Investigator Obligations ................................................................................... 14 
9.3 
Investigator Approval ....................................................................................... 15 
10. 
Experimental Plan ............................................................................................ 16 
10.1 Overview ......................................................................................................... 16 
10.2 Visit Schedule .................................................................................................. 17 
10.3 Preoperative Procedures ................................................................................. 17 
10.4 Randomization and Masking ............................................................................ 19 
10.5 Operative Procedures ...................................................................................... 19 
10.6 Postoperative Procedures ............................................................................... 20 
10.7 Retreatment Procedures .................................................................................. 22 
10.8 Exit of Subjects ................................................................................................ 22 
10.9 Unscheduled Visits .......................................................................................... 23 
10.10 Protocol Deviations .......................................................................................... 24 
11. 
Adverse Events and Product Complaints ...................................................... 24 

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11.1 Adverse Event Definitions ................................................................................ 24 
11.2 Product Complaint/Device deficiency Definition ............................................... 26 
11.3 Adverse Event and Complaint Reporting Requirements .................................. 26 
11.4 Causal relationship .......................................................................................... 27 
11.5 Adverse Event Follow-up ................................................................................. 28 
12. 
Protocol Changes/Amendments ..................................................................... 28 
13. 
Ethics Review and Patient Welfare ................................................................. 28 
13.1 Institutional Review Board (IRB) ...................................................................... 28 
13.2 Informed Consent ............................................................................................ 29 
14. 
Documentation ................................................................................................. 29 
14.1 Source Documents .......................................................................................... 29 
14.2 Subject Confidentiality ..................................................................................... 30 
14.3 Case Report Form Completion ........................................................................ 30 
14.4 Study Summary ............................................................................................... 30 
15. 
Monitoring ........................................................................................................ 30 
15.1 Data Monitoring ............................................................................................... 30 
15.2 Administrative Monitoring ................................................................................ 31 
15.3 Safety Monitoring ............................................................................................. 32 
16. 
Publications ..................................................................................................... 32 
17. 
Risk Analysis ................................................................................................... 32 
18. 
Records Retention ........................................................................................... 33 
19. 
Termination of the Investigation ..................................................................... 34 
20. 
Statistical Methods .......................................................................................... 34 
20.1 Analysis Population ......................................................................................... 35 
20.2 Primary Study Endpoints ................................................................................. 35 
20.3 Additional Endpoints ........................................................................................ 37 
20.4 Visual Acuity conventions and General Statistics ............................................. 37 
20.5 Interim Reports ................................................................................................ 38 
20.6 Sample Size Calculations ................................................................................ 38 
Appendix A   Summary of Procedures Required at Each Visit ................................ 40 
Appendix B   Equipment List ...................................................................................... 41 
Appendix C Manual of Testing procedures ............................................................. 42 
Appendix D   Conversion Charts for Vector Vision charts ....................................... 45 
Appendix E    Maximum Plus Manifest Refraction Technique With 
Cylinder Refinement ............................................................................. 46 
Appendix F    Cycloplegic Refraction Technique ...................................................... 47 
Appendix G   Refraction Adjustments ....................................................................... 48 

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Appendix H   Instructions for Use of Vector Vision ETDRS Distance Visual Acuity 
Chart ...................................................................................................... 49 
Appendix I    Instructions for keratometry ................................................................ 51 
Appendix J   Slit-Lamp Exam grading scale .............................................................. 52 
Appendix K PRK Surgical Procedure ...................................................................... 53 
Appendix L   Adverse Event and Complaint Reporting Instructions ....................... 54 
Appendix M   Schirmer I TEAR test (with anesthetic) ............................................... 55 
Appendix N   Instructions for Monocular Contrast Sensitivity Testing Using the 
Vector Vision System ........................................................................... 56 
 
 
 

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PERSONNEL AND FACILITIES 
SPONSOR: 
Abbott Medical Optics Inc. 
 
510 Cottonwood Drive 
 
Milpitas, CA 95035 
 
SPONSOR PERSONNEL: 
 
 
Medical Monitor: 
 
 
 
Abbott Medical Optics Inc. 
510 Cottonwood Drive 
Milpitas, CA 95035 
 
 
 
Director, Clinical Research: 
 
 
 
 
 
 
Study Manager: 
 
 
 
 
 
 
 
Biostatisticians: 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
EMERGENCY TELEPHONE NUMBERS: 
 
Study Manager: 
 
 
 
 
 
 
 
 

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PROTOCOL CHANGE HISTORY 
Version 
Section(s) 
Page(s) 
Description of Change(s)  
Rationale for Change(s) 
1.0 
N/A 
N/A 
Original 
N/A 
2.0 
Personnel and Facilities 
iv 
Updated contact information  
Changes reflect a change in personnel and 
contact information 
 
1.0, 3.0, 6.1, 6.2, 8.0, 8.2, 
10.3, 10.5, 11.3, 19, 20.5, 
Appendices C, E, H, L 
1, 4, 9, 10, 
11, 34, 35, 
44, 46, 49, 
54 
Formatting, minor clarifications and typographical errors 
 
 
1.0, 4.0, 6.2, 8.0, 10.6, 20.6, 
Appendices A, B, C, G, N 
2, 4, 8, 9, 
18, 19, 20, 
22, 37, 39, 
40, 41, 42, 
48, 56 
Contrast sensitivity sub-study added to protocol 
Sub-study added based on FDA feedback 
 
1.0, 3.0 
1, 4, 7 
Rates of serious adverse events changed to specify 
only those that are device related 
Adverse event reporting SOP has been 
changed to clarify serious AE that are device 
related. 
 
1.0, 8.2 
4, 13 
Exclusion criteria #5 updated to also specifically 
exclude subjects with ocular hypertension (without 
glaucomatous changes) 
Clarification 
 
1.0, 6.2, 10.1, 10.3, 10.9, 
20.2, 20.3, Appendices A, C, 
H, I,  
16-21, 23, 
25, 27, 28, 
37, 40, 42, 
43, 51, 53, 
55 
Updates to evaluations, procedures, order of exams 
and statistical updates to the study design including: 
OSDI, NEI-RQL-42, Schirmer I Tear Test, satisfaction 
questionnaires, keratometry and video recording. 
Clarification of PRVSQ version name. 
Additional procedures added to the protocol 
to respond to FDA feedback and to improve 
the overall study design. 
 
2.0 
7 
Updated background to include that study G120151 
received PMA approval 
The section now reflects the current status of 
ongoing clinical studies. 
 
5.0, 6.1, 20.1, 20.2 
8, 9, 35 
NEI removed as a secondary endpoint. 
No longer seeking claims based on the NEI 
 
8.0 
12 
Specify that the protocol will enroll only those subjects 
eligible for military medical benefits. 
Added based on FDA feedback on study 
population 
 
1.0,8.2 
4, 13 
Added clarification to Exclusion criteria #5 that subjects 
will be excluded for severe dry eye syndrome or 
symptoms. 
Added based on updated iDesign labeling. 

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Version 
Section(s) 
Page(s) 
Description of Change(s)  
Rationale for Change(s) 
2.0 
cont’d. 
11.1 
25 
Removed the word “Serious” from the title of Study 
Specific Adverse Events to Clarify that events listed are 
not automatically considered serious adverse events. 
Updated criteria for determining adverse events of halo, 
glare and dry eye. 
Criteria were added based on FDA feedback 
and guidance documents. Serious removed 
as anticipated events are not automatically 
considered serious.  
 
11.1 
26 
Specified what determines “Foreign Body Sensation”, 
“Pain” and “Ghost/double images” to be recorded as 
study specific complications 
Clarification 
 
20.2 
36 
Added an alpha level to poolability analysis 
Clarification 
3.0 
20.1 
35 
Updated the significant number of missing data when 
ITT analyses are to be performed 
Corrected to match the statistical analysis 
plan 
 
6.2, 10.3, 10.6 and 20.3 
Appendices C, N 
9, 18, 22, 
37, 42, 56-
57 
Updated spatial frequencies for mesopic contrast 
sensitivity testing  
Updated based on FDA feedback on contrast 
sensitivity 

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1. 
SYNOPSIS 
PROTOCOL: 
A prospective study to evaluate the safety and 
effectiveness of wavefront-guided PRK correction of 
myopic refractive errors with the iDesign Advanced 
WaveScan Studio System and STAR S4 IR Excimer Laser 
System. 
Protocol Number:  STAR-115-MIPS 
 
STUDY TREATMENTS: 
Investigational Product: iDesign Advanced WaveScan 
Studio System (software version 1.3, international 
configuration) and STAR S4 IR Excimer Laser System 
(Abbott Medical Optics, CA) 
 
Control Product:  None 
 
STUDY OBJECTIVE: 
The purpose of this clinical study is to evaluate the safety 
and effectiveness of wavefront-guided Photorefractive 
Keratectomy, commonly referred to as PRK, performed 
with the iDesign Advanced WaveScan Studio System and 
STAR S4 IR Excimer Laser System (Abbott Medical 
Optics, CA) for the correction of myopic refractive errors 
with and without astigmatism.  
 
CLINICAL HYPOTHESIS: 
The results of this trial will demonstrate that wavefront-
guided PRK correction with the iDesign Advanced 
WaveScan Studio System and STAR S4 IR Excimer Laser 
System is safe and effective for the treatment of myopia 
with and without astigmatism by meeting the primary safety 
and effectiveness study endpoints including specific criteria 
for UCVA outcomes, predictability of MRSE, refractive 
stability, maintenance of BSCVA, induced refractive 
cylinder, corneal haze, and rates of serious, device-related 
adverse events. 
 
OVERALL STUDY DESIGN: 
Structure: 
Prospective, multicenter, bilaterally-treated, open-label, 
non-randomized clinical trial. 
 
Number of sites: 
Up to 7 sites in USA 
 
Duration: 
12 months 
 
Administration: 
Surgeons will perform wavefront-guided PRK for the 
treatment of myopic refractive errors based upon 
measurements obtained with the iDesign System using the 
STAR S4 IR laser. 
 

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Visit Schedule: 
There will be 9 scheduled study visits:  preoperative, 
operative, 1 day, 1 week, and 1, 3, 6, 9 and 12 months. 
 
STUDY POPULATION CHARACTERISTICS: 
 
Condition: 
Stable myopic refractive error, with or without astigmatism 
 
Number of Subjects: 
Up to 334 subjects will be enrolled to achieve a minimum 
of 334 treated eyes (in approximately 167 bilaterally 
treated subjects), resulting in at least 300 evaluable eyes 
at the point of refractive stability. Subjects will be treated 
bilaterally.   
 
Each site should treat a minimum of 20 eyes, and no site 
may treat more than 25% of eyes. 
 
A distance-corrected contrast sensitivity substudy will also 
be conducted with at least 65 eyes from a single site. 
 
Inclusion Criteria (all criteria apply to each study eye): 
1. Signed informed consent and HIPAA authorization  
2. At least 18 years of age at enrollment (date informed consent signed) 
3. The refractive error, based on the iDesign displayed refraction selected for treatment 
(“4.0 Rx calc” at 12.5 mm), must be myopia with or without astigmatism with sphere 
up to -8.00 D, and cylinder between 0.00 D and -4.00 D with a maximum spherical 
equivalent (SE) of -10.00 D. 
4. Anticipated residual stromal bed thickness of at least 250 microns as calculated by 
the iDesign system 
5. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better 
6. BSCVA  ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA)   
7. Less than or equal to 0.75 D difference between cycloplegic and manifest refraction 
sphere.  
8. A stable refractive error (based on a previous exam, medical records, lensometry, or 
prescription at least 12 months prior to the preoperative manifest refraction), as 
defined by a change of ≤1.00 D in MRSE. 
9. Any subject eye with a history of contact lens wear within the last 4 weeks must 
demonstrate refractive stability according to the following: 
o Rigid contact lenses (toric or spherical) must be removed for at least 4 weeks 
and soft contact lenses (toric or spherical) for at least 2 weeks prior to the first 
refraction used to establish stability.  
o Two consecutive manifest refractions and keratometry readings must be 
conducted at least 7 days apart. 
o Refractive stability is defined as a change of not more than 0.50 D in manifest 
refractive sphere and cylinder as well as keratometry meridian (either axis) 
between measurements. 

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o If the subject/eye meets the refractive stability criteria, contact lens wear is not 
permitted prior to surgery 
10. Agreement between manifest refraction (adjusted for optical infinity) and iDesign 
System refraction chosen for treatment, as follows: 
o Spherical Equivalent: Magnitude of the difference is less than 0.625 D. 
o Cylinder: Magnitude of the difference is less than or equal to 0.5 D.  
o Cylinder Axis Tolerance: If either the manifest cylinder entered into the iDesign 
System or the iDesign cylinder selected for treatment is less than 0.5 D, there is 
no requirement for axis tolerance. When both cylinders have a magnitude of at 
least 0.5 D, the axis tolerance as determined by the iDesign system is linearly 
reduced from 15 (0.5 D) to 7.5 (7.0 D) based on the average magnitude of both 
cylinders. Note: If the axis tolerance is not in the calculated range, the iDesign 
system will produce a warning and this exam may not be used for treatment 
planning.  
11. Willing and capable of complying with follow-up examinations for the duration of the 
study. 
 
Exclusion Criteria (all criteria apply to each eye):  
1. Women who are pregnant, breast-feeding, or intend to become pregnant, or not 
using an adequate method of birth control  [examples are any form of barrier 
contraception (such as condom or diaphragm with contraceptive cream/jelly), birth 
control pills, hormonal implant, IUD, abstinence or surgical sterilization (tubal ligation, 
hysterectomy or vasectomy)]. Note: Women who were pregnant or nursing may not 
be enrolled until 6 months after either delivery or have stopped nursing and there is 
documented refractive stability. 
2. Concurrent use of systemic (including inhaled) medications that may impair healing, 
including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months 
of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of 
treatment. 
NOTE:  The use of inhaled or systemic corticosteroids, whether chronic or 
acute, is deemed to adversely affect healing and subjects using such 
medications are specifically excluded from eligibility. 
3. History of any of the following medical conditions, or any other condition that could 
affect wound healing: collagen vascular disease, autoimmune disease, 
immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine 
disorders (including, but not limited to unstable thyroid disorders and diabetes), 
lupus, and rheumatoid arthritis. 
NOTE: The presence of diabetes (either type 1 or 2), regardless of disease 
duration, severity, or control, will specifically exclude subjects from 
eligibility.  
4. Subjects with a cardiac pacemaker, implanted defibrillator or other implanted 
electronic device. 
5. History of prior intraocular or corneal surgery (including cataract extraction), active 
ophthalmic disease or abnormality (including, but not limited to, symptomatic 

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blepharitis, recurrent corneal erosion, severe dry eye syndrome or symptoms, 
neovascularization > 1 mm from limbus), retinal detachment/repair, clinically 
significant lens opacity, clinical evidence of trauma, corneal opacity within the central 
9 mm and visible on topography, at risk for developing strabismus, or with evidence 
of glaucoma or propensity for narrow angle glaucoma. 
NOTE:  Subjects with ocular hypertension (without glaucomatous changes) or 
open angle glaucoma, regardless of medication regimen or control, or 
an IOP greater than 21 mmHg at screening, are specifically excluded 
from eligibility. 
6. Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography.  
7. Known sensitivity or inappropriate responsiveness to any of the medications used in 
this study. 
8. If either eye does not meet all inclusion criteria  
9. Desire to have monovision. 
10. Participation in any other clinical study, with the exception of the fellow eye in this 
study.  
EVALUATION CRITERIA: 
The purpose of this clinical study is to evaluate the safety and effectiveness of the 
iDesign Advanced WaveScan Studio System and STAR S4 IR Excimer Laser System 
(Abbott Medical Optics, CA).  The primary safety endpoints include the percentages of 
eyes with losses of BSCVA, induced astigmatism and serious adverse events. The 
primary efficacy endpoints include percent of eyes achieving refractive stability, percent 
of eyes with UCVA of 20/40 or better, and the predictability of MRSE outcomes. Other 
endpoints include contrast sensitivity, binocular UCVA, manifest cylinder, keratometry, 
iDesign measurements, intraocular pressure, anterior segment evaluation, non-directed 
ocular visual symptoms, patient reported outcomes (PRO) measures (OSDI, PRVSQ for 
PRK/LASIK, NEI-RQL-42, exploratory Satisfaction) and Schirmer I Tear Test (with 
anesthetic). 
DATA ANALYSIS: 
All endpoints will be evaluated at the refractive stability time point. The safety population 
will be the primary analysis population for all endpoints and includes all eyes that receive 
study treatment.  However, if there are greater than 10% of eyes with missing study 
exams at the stability time point, an intent-to-treat (ITT) population will be used as the 
primary analysis population for the primary effectiveness endpoints. 
STUDY VISITS AND PROCEDURES: 
The STAR S4 IR Excimer Laser System and the iDesign Advanced WaveScan Studio 
System will be used to perform wavefront-guided PRK treatments. Inclusion and 
exclusion qualifications will be assessed at the preoperative visit according to the 

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inclusion/exclusion criteria.  Both eyes of subjects are intended to be treated in the study 
on the same day. 
Key preoperative and postoperative data include iDesign measurements, visual acuities, 
manifest refraction, keratometry (iDesign and auto/manual), pachymetry, biomicroscopic 
slit-lamp findings, intraocular pressure, contrast sensitivity, iDesign measurements, 
Schirmer I Tear Test (with anesthetic), adverse events and complications, non-directed 
ocular visual symptoms and patient reported outcomes (PRO) assessments of visual 
functioning and directed ocular visual symptoms (using the NEI-RQL-42, OSDI and 
PRVSQ for PRK/LASIK instruments).  Ocular health and history are also assessed 
preoperatively.  A chart summary of procedures required at each study visit is provided 
in Appendix A. 
 
 

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2. 
BACKGROUND/INTRODUCTION 
Photorefractive Keratectomy, commonly referred to as PRK, is a procedure that uses 
excimer laser energy, after removal of the corneal epithelium, to create a superficial 
lamellar keratectomy in the corneal stroma that is of a shape designed to correct or 
ameliorate a refractive condition. PRK is a popular surgical treatment option for patients 
with thin corneas and the absence of any flap-related complications is a benefit as 
compared to LASIK. This benefit is particularly important to the US Armed Forces, where 
80% of the refractive surgeries performed are PRK.  
This will be the first study of wavefront-guided PRK using the iDesign System in 
conjunction with the STAR S4 IR Excimer laser for treatment of myopia with or without 
astigmatism. Currently no excimer lasers are approved for this indication in the US. 
The PRK technique was studied extensively in the 1990’s by VISX, Incorporated (now 
Abbott Medical Optics Inc., herein referred to as AMO) and was granted approval for 
non-wavefront guided PRK for the STAR Excimer Laser system to treat low to moderate 
myopia (PMA# P930016) in March, 1996.  
In 2003, VISX, Incorporated received FDA approval for its first indication of wavefront-
guided LASIK treatments using the STAR S4 IR Excimer Laser System with the 
WaveScan System aberrometer. Currently, the STAR S4 IR Excimer Laser System with 
the WaveScan System aberrometer is FDA approved in the United States and used 
internationally for wavefront-guided LASIK treatment of myopia, myopic astigmatism, 
mixed astigmatism, hyperopia, and hyperopic astigmatism.    
Following FDA approval of wavefront-guided LASIK treatment, wavefront-guided PRK 
was studied in an investigator-sponsored IDE #G030141. This prospective evaluation of 
the safety and effectiveness of the Star S4 IR laser and the WaveScan System was 
conducted by the US Navy (lead by investigator Capt. Steven Schallhorn, M.D.).  
Although VISX did not submit a PMA for the PRK indication, the study, which completed 
in 2007, showed good results.  Of the 597 eyes treated, (397 in the primary efficacy 
cohort), there were no eyes with losses of ≥2 lines of best spectacle corrected visual 
acuity (BSCVA), no eyes with BSCVA worse than 20/40 at any visit, no eyes with an 
increase in postoperative cylinder of ≥ 2.00 D, and there were no outstanding or 
unresolved adverse events or safety concerns at the time of study completion 
(12 months). 
In addition, there have been published reports of wavefront-guided PRK using the STAR 
and WaveScan System. Manche and Haw, 2011 conducted a prospective study of 
wavefront-guided PRK versus wavefront-guided LASIK using the STAR S4 IR Excimer 

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Laser system and WaveScan system and concluded that both wavefront guided PRK 
and LASIK are safe and effective at treating myopia1.  
Recently, AMO has developed a new aberrometry system, the iDesign Advanced 
WaveScan Studio System (referred to herein as the iDesign System). This aberrometer 
incorporates a higher density Hartmann-Shack sensor than the earlier AMO aberrometer 
(WaveScan System). The iDesign System creates treatment tables that are transferred 
to the STAR S4 IR Excimer Laser System for refractive treatments. 
The iDesign Advanced WaveScan Studio system is currently under investigation in two 
IDE clinical studies for different laser assisted in situ keratomileusis (LASIK) indications: 
mixed astigmatism (G120162) and hyperopia with or without astigmatism (G120164). A 
third study of myopia with or without astigmatism (G120151) has been completed and 
received FDA approval on May 6, 2015.  Prior to initiating the US iDesign studies, a 
treatment study in Canada using the iDesign system in conjunction with the STAR S4 IR 
Excimer laser was conducted for the same three LASIK indications.   
For myopia, the results of the Canadian study and the US IDE study showed that device 
performance was acceptable and exceeded effectiveness target values.  To improve 
outcomes, the results from the Canadian study were used to identify physician 
adjustments to optimize the treatment plans for the USA IDE clinical investigation.  The 
results of the US study showed that an additional adjustment would further improve 
outcomes. The updated adjustments based on outcomes of the US IDE study are now 
automated in iDesign software version 1.3.  
3. 
CLINICAL HYPOTHESIS 
The results of this trial will demonstrate that wavefront-guided PRK correction with the 
iDesign Advanced WaveScan Studio System and STAR S4 IR Excimer Laser System is 
safe and effective for the treatment of myopia with and without astigmatism by meeting 
the primary safety and effectiveness study endpoints including specific criteria for UCVA 
outcomes, predictability of MRSE, refractive stability, maintenance of BSCVA, induced 
refractive cylinder, corneal haze, and rates of serious, device related adverse events. 
4. 
STUDY DESIGN 
This study is a 12-month, prospective, multi-center, bilateral, open-label, non-
randomized clinical trial.  
                                               
1 Manche, E. and W. Haw. (2011). Wavefront-Guided Laser in Situ Keratomileusis (Lasik) versus Wavefront-
Guided Photorefractive Keratectomy (Prk): A Prospective Randomized Eye-to-Eye Comparison. Trans Am 
Ophthalmol Soc. 2011 Dec; 109: 201–220 

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Up to 334 subjects will be enrolled to achieve a minimum of 334 treated eyes (of 
approximately 167 bilaterally-treated subjects), resulting in at least 300 evaluable eyes 
at the point of refractive stability.  Twenty or more eyes are intended to be treated per 
dioptric bin across both sphere and cylinder treatment ranges. 
The study will be conducted at up to 7 sites in the USA. Each site should enroll a 
minimum of 20 eyes, and no site may treat more than 25% of eyes.  
A distance-corrected contrast sensitivity substudy will also be conducted with at least 
65 eyes from a single site. 
JUSTIFICATION OF STUDY DESIGN 
The study is being conducted for USA regulatory purposes to expand the STAR S4 IR 
Excimer Laser system indications to include wavefront-guided PRK for the treatment of 
myopia. The study design is based on the American National Standard for Ophthalmics 
for Laser Systems for Corneal Reshaping, ANSI Z80.11.2012. 
5. 
ACRONYMS 
The following acronyms are used throughout the document:   
 
UCVA:  Uncorrected visual acuity (distance) 
 
BSCVA: Best spectacle corrected visual acuity (distance) 
 
MR:  Manifest refraction 
 
MRSE:  Manifest refraction spherical equivalent 
 
MRS:  Manifest refractive sphere 
 
MRC:  Manifest refractive cylinder 
 
IDSE: iDesign spherical equivalent 
 
IDS: iDesign sphere 
 
IDC: iDesign cylinder 
 
PRK: Photorefractive Keratectomy 
 
LASIK: Laser assisted in situ keratomileusis 
 
D:  diopters 
6. 
STUDY OBJECTIVES AND ENDPOINTS 
The purpose of this clinical study is to evaluate the safety and effectiveness of PRK, 
performed with the iDesign Advanced WaveScan Studio™ System and STAR S4 IR 
Excimer Laser System (Abbott Medical Optics, CA) for the correction of myopic 
refractive errors with and without astigmatism.  

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6.1 
PRIMARY ENDPOINTS 
Effectiveness 
1. MONOCULAR UCVA 
o Success criteria:  ≥ 85% of eyes will achieve UCVA of 20/40 or better 
2. MRSE WITHIN 0.50 D OF TARGET 
o Success criteria:  ≥ 50% of eyes will have MRSE within 0.50 D of intended correction. 
3.  MRSE WITHIN 1.00 D OF TARGET 
o Success criteria:  ≥ 75% of eyes will have MRSE within 1.00 D of intended correction 
4. REFRACTIVE STABILITY 
o Success criteria:  ≥ 95% of eyes achieve refractive stability.  Note: Additional criteria 
for determining the time point for achievement of refractive stability are provided in 
Section 6.3.  
Safety 
1. MAINTENANCE OF BSCVA-LINES LOST 
o Success criteria:  <5% of eyes with a loss of >2 lines of BSCVA from preoperative 
o Success criteria: <1% of eyes with haze beyond 6 months with loss >2 lines of 
BSCVA  
2. MAINTENANCE OF BSCVA-PRESERVATION 20/40 
o Success criteria:  <1% of eyes with a BSCVA of 20/20 or better preoperatively will 
have BSCVA of worse than 20/40 postoperatively 
3. INDUCED MANIFEST REFRACTIVE ASTIGMATISM 
o Success criteria:  <5% of eyes will have induced manifest refractive astigmatism 
>2.00 D 
4. SERIOUS, DEVICE-RELATED ADVERSE EVENTS 
o 
Success criteria: <1% of eyes  with serious, device-related adverse events   
 
6.2 
OTHER ENDPOINTS:   
1. Monocular mesopic distance corrected contrast sensitivity with and without glare at 
spatial frequencies of 1.5, 3 , 6, and 12 cpd 
2. Monocular photopic distance corrected contrast sensitivity without glare at spatial 
frequencies 3, 6, 12 and 18 cpd 
3. Binocular UCVA 
4. Manifest cylinder analyses (vector and non-vector)  
5. iDesign aberrometry measurements (including higher order aberrations) 
6. Keratometry (iDesign and auto/manual) 
7. Intraocular pressure via applanation tonometry 

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8. Anterior segment evaluation (biomicroscopic slit-lamp exam) for determination of 
medical findings including re-epithelialization, corneal clarity, complications, etc. 
9. Visual symptoms via the patient reported outcomes (PRO) instrument  Patient 
Reported Visual Symptom Questionnaire (PRVSQ for PRK/LASIK)  
10. Ocular/visual symptoms (from non-directed responses obtained from the open-ended 
question “are you having any difficulties with your eyes or vision?”)  
11. National Eye Institute Refractive Error Quality of Life – 42 (NEI-RQL) questionnaire 
results for all 13 sub-scales: dependence on correction, satisfaction with correction, 
activity limitations, far vision, clarity of vision, expectations, near vision, diurnal 
fluctuations, glare, symptoms, worry, suboptimal correction, and appearance   
12. Ocular Surface Disease Index (OSDI) questionnaire 
13. Schirmer I Tear Test (with anesthetic) 
14. Exploratory satisfaction questionnaires non-validated questionnaires designed to 
collect patient satisfaction data prior to and following refractive corneal surgery 
 
6.3 
DEFINITION OF THE TIME POINT OF REFRACTIVE STABILITY  
The critical time point for analysis of safety and effectiveness is based on achievement 
of refractive stability.  The criteria for determination of the point of refractive stability are 
as follows (per ANSI Z80.11-2012): 
• 
At least 95% of the treated eyes have a change ≤1.00 D of MRSE and MRC between 
refractions performed at 1 month and 3 months after surgery or any two refractions 
performed at least 3 months apart 
• 
The mean rate of change in MRSE and MRC, as determined by a paired analysis, is 
≤0.5 D per year (0.04 D/month) over the same time period  
• 
The mean rate of change in MRSE and MRC decreases monotonically over time, with a 
projected asymptote of zero or a rate of change attributable to normal aging 
• 
The 95% confidence interval for the mean rate of change includes zero or a rate of 
change attributable to normal aging 
• 
Stability is confirmed at least 3 months after the stability time point by a statistically 
adequate subgroup. 
 
7. 
STUDY PRODUCTS 
7.1 
IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM  
The iDesign Advanced WaveScan Studio System (or iDesign System) incorporates 
iDesign Measurement System hardware and iDesign Treatment Planning Software.  The 
iDesign Measurement System measures lower order and higher-order wavefront 
aberrations of the human eye using a high density Hartmann-Shack wavefront sensor.  
In addition, the instrument measures keratometry, pupil diameter, and corneal 

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topography.  The Treatment Planning Software calculates treatment profiles from 
iDesign wavefront measurements using a Fourier based algorithm.  
In this study, all eyes will be targeted for emmetropia and “Surface PRK” treatments will 
be calculated using iDesign software version 1.3, in international configuration with no 
physician adjustments.  
The Principal Investigator is responsible for ensuring that the iDesign System is only 
used to treat subjects enrolled in this study. 
7.2 
STAR S4 IR EXCIMER LASER SYSTEM  
The STAR S4 IR Excimer Laser System is a Class III ophthalmic surgical laser designed 
to create a superficial lamellar keratectomy on exposed corneal tissue. Corneal tissue is 
removed by a process known as ablative photodecomposition. Ablative 
photodecomposition occurs when far-ultraviolet radiation reacts with organic molecules, 
resulting in the photochemical breakdown of the molecular bonds without a significant 
thermal effect. The source of the far-ultraviolet photons is a high efficiency, gas-
discharge excimer laser that electronically excites a combination of argon and fluorine, 
producing an ultraviolet wavelength of 193 nm. The STAR S4 IR Excimer Laser System 
combines submicron precision of tissue removal by an excimer laser with a sophisticated 
computer controlled delivery system.  
In the USA, the STAR S4 IR Excimer Laser System is approved for wavefront-guided 
LASIK, Conventional (manifest refraction based) LASIK, and Conventional PRK.  The 
system is also approved for phototherapeutic keratectomy (PTK).   In this study, the 
STAR S4 IR Excimer Laser will be used in conjunction with the iDesign treatment plans 
for wavefront-guided PRK. 
8. 
STUDY POPULATION 
All study subjects will be enrolled from the normal myopic patient population at up to 
7 sites in the U.S.A.  Up to 334 subjects will be enrolled to achieve a minimum of 334 
treated eyes (in approximately 167 bilaterally treated subjects), resulting in at least 
300 evaluable eyes at the point of refractive stability.  Each site should treat a minimum 
of 20 eyes, and no site may treat more than 25% of the enrollment total.   
This study will include only subjects who qualify for and intend to have bilateral PRK for 
the treatment of myopia with or without astigmatism and who meet all of the study 
inclusion and exclusion criteria in both eyes.  After signing the informed consent, 
subjects meeting all inclusion and exclusion criteria will be offered treatment in the study 
until either the dioptric bin allotment is full or the study/site limit is reached. Eligibility 
criteria may not be waived by the investigator.  Any questions regarding patient eligibility 

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are to be discussed with AMO prior to subject enrollment. Subjects must be eligible for 
military medical benefits.     
8.1 
INCLUSION CRITERIA  
Inclusion Criteria (all criteria apply to each study eye): 
 
1. Signed informed consent and HIPAA authorization  
2. At least 18 years of age at enrollment (date informed consent signed) 
3. The refractive error, based on the iDesign displayed refraction selected for treatment 
(“4.0 Rx calc” at 12.5 mm), must be myopia with or without astigmatism with sphere 
up to -8.00 D, and cylinder between 0.00 D and -4.00 D with a maximum spherical 
equivalent (SE) of -10.00 D 
4. Anticipated residual stromal bed thickness of at least 250 microns as calculated by 
the iDesign system 
5. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better 
6. BSCVA  ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA)   
7. Less than or equal to 0.75 D difference between cycloplegic and manifest refraction 
sphere.  
8. A stable refractive error (based on a previous exam, medical records, lensometry, or 
prescription at least 12 months prior to the preoperative manifest refraction), as 
defined by a change of ≤1.00 D in MRSE. 
9. Any subject eye with a history of contact lens wear within the last 4 weeks must 
demonstrate refractive stability according to the following: 
o Rigid contact lenses (toric or spherical) must be removed for at least 4 weeks 
and soft contact lenses (toric or spherical) for at least 2 week prior to the first 
refraction used to establish stability.  
o Two consecutive manifest refractions and keratometry readings must be 
conducted at least 7 days apart. 
o Refractive stability is defined as a change of not more than 0.50 D in manifest 
refractive sphere and cylinder as well as keratometry meridian (either axis) 
between measurements. 
o If the subject/eye meets the refractive stability criteria, contact lens wear is not 
permitted prior to surgery 
10. Agreement between manifest refraction (adjusted for optical infinity) and iDesign 
System refraction chosen for treatment, as follows: 
o Spherical Equivalent: Magnitude of the difference is less than 0.625 D. 
o Cylinder: Magnitude of the difference is less than or equal to 0.5 D.  
o Cylinder Axis Tolerance: If either the manifest cylinder entered into the iDesign 
System or the iDesign cylinder selected for treatment is less than 0.5 D, there is 
no requirement for axis tolerance. When both cylinders have a magnitude of at 
least 0.5 D, the axis tolerance as determined by the iDesign system is linearly 
reduced from 15 (0.5 D) to 7.5 (7.0 D) based on the average magnitude of both 

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cylinders. Note: If the axis tolerance is not in the calculated range, the iDesign 
system will produce a warning and this exam may not be used for treatment 
planning.  
11. Willing and capable of complying with follow-up examinations for the duration of the 
study. 
8.2 
EXCLUSION CRITERIA:  
Exclusion Criteria (all criteria apply to each study eye): 
1. Women who are pregnant, breast-feeding, or intend to become pregnant, or not 
using an adequate method of birth control [examples are any form of barrier 
contraception (such as condom or diaphragm with contraceptive cream/jelly), birth 
control pills, hormonal implant, IUD, abstinence or surgical sterilization (tubal ligation, 
hysterectomy or vasectomy)].  Note: Women who were pregnant or nursing may not 
be enrolled until 6 months after either delivery or have stopped nursing and there is 
documented refractive stability. 
2. Concurrent use of systemic (including inhaled) medications that may impair healing, 
including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months 
of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of 
treatment. 
NOTE:  The use of inhaled or systemic corticosteroids, whether chronic or 
acute, is deemed to adversely affect healing and subjects using such 
medications are specifically excluded from eligibility. 
3. History of any of the following medical conditions, or any other condition that could 
affect wound healing: collagen vascular disease, autoimmune disease, 
immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine 
disorders (including, but not limited to unstable thyroid disorders and diabetes), 
lupus, and rheumatoid arthritis. 
NOTE: The presence of diabetes (either type 1 or 2), regardless of disease 
duration, severity, or control, will specifically exclude subjects from 
eligibility.  
4. Subjects with a cardiac pacemaker, implanted defibrillator or other implanted 
electronic device. 
5. History of prior intraocular or corneal surgery (including cataract extraction), active 
ophthalmic disease or abnormality (including, but not limited to, symptomatic 
blepharitis, recurrent corneal erosion, severe dry eye syndrome or symptoms, 
neovascularization > 1 mm from limbus), retinal detachment/repair, clinically 
significant lens opacity, clinical evidence of trauma, corneal opacity within the central 
9 mm and visible on topography, at risk for developing strabismus, or with evidence 
of glaucoma or propensity for narrow angle glaucoma. 
NOTE:  Subjects with ocular hypertension (without glaucomatous changes) or 
open angle glaucoma, regardless of medication regimen or control, or 
an IOP greater than 21 mmHg at screening, are specifically excluded 
from eligibility. 
6. Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography.  

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7. Known sensitivity or inappropriate responsiveness to any of the medications used in 
this study. 
8. If either eye does not meet all inclusion criteria  
9. Desire to have monovision. 
10. Participation in any other clinical study, with the exception of the fellow eye in this 
study. 
   
9. 
INVESTIGATOR SELECTION 
9.1 
INVESTIGATOR QUALIFICATIONS 
AMO will select ophthalmic surgeons who have completed a residency in ophthalmology 
(or its documented equivalent), are licensed to practice medicine and perform refractive 
surgery at his/her investigative site.   
Investigators will be selected from surgeons who are experienced in refractive surgery 
with the STAR system for CustomVue treatments. All sites are required to have 
adequate staff support for reporting and subject follow-up, as well as the necessary 
instrumentation to conduct study testing.  Each site will have one designated principal 
investigator; some sites may have additional surgical sub-investigators.   
9.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 
 
Conduct the study in accordance with the relevant and current protocol.  Investigator 
will only make changes to a protocol after notifying and obtaining approval from 
AMO, the FDA or other governing agencies, and the Investigational Review Board 
(IRB) except when necessary to protect the safety, rights or welfare of subjects 
 
Personally conduct and supervise the study 
 
Maintain a list of appropriately qualified persons to whom the investigator has 
delegated significant trial-related duties 
 
Be responsible for protecting the rights, safety and welfare of subjects under the 
investigator’s care and be responsible for the control and documentation of the 
devices under investigation 
 
Inform patients that the device(s) are being used for investigational purposes and 
that requirements relating to obtaining informed consent and IRB approval are met 
according to 21CFR50, 21CFR56, 21CFR812 and all other applicable laws and 
regulations 
 
Maintain confidentiality as required by HIPAA or similar laws and regulations 
 
Shall not obtain written informed consent from any subject to participate or allow any 
subject to participate before obtaining FDA and IRB approval.  

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 
Document in each subject’s case history that informed consent was obtained prior to 
participation in the study as required by 21CFR812 
 
Report to AMO and the reviewing IRB any adverse experiences that occur during the 
course of the study in accordance with applicable laws and regulations 
 
Maintain adequate and accurate records in accordance with applicable laws and 
regulations and make available all study documents and subject medical records for 
inspection by either AMO, duly authorized regulatory agencies (e.g., FDA) and/or the 
IRB 
 
Submit progress reports on the investigation to AMO and the reviewing IRB at 
regular intervals, but no less often than yearly as required by 21CFR812.150  
 
Ensure the IRB that is responsible for initial and continuing review of the study 
complies with applicable laws and regulations 
 
Report all changes in research activity and all unanticipated problems involving risks 
to patients to the IRB and AMO 
 
Supervise and permit investigational device use and disposition in accordance with 
applicable regulations and protocol requirements.  Upon completion of enrollment or 
termination of the study or the investigator’s part of the study, or at AMO’s request, 
return to AMO any remaining supply of the investigational device 
 
Provide sufficient accurate financial information to AMO to allow AMO to submit 
complete and accurate certification or disclosure statements as required by 
21CFR54.  Promptly update this information if any relevant changes occur during the 
course of the investigation or for up to one year following completion of the study 
 
Comply with all other obligations of clinical investigators and requirements according 
to all applicable FDA regulations (e.g., 21CFR812), all other applicable laws and 
regulations, and all conditions of approval imposed by the reviewing IRB, the FDA 
and the regulatory agency of the country in which the study is being conducted 
 
Ensure that all associates, colleagues and employees assisting in the conduct of the 
study are adequately informed about the protocol, the investigational device, their 
study-related duties and functions and agree to fulfill their obligations in meeting the 
above commitments. 
Investigators shall provide adequate time and resources to conduct and report on the 
study. The Investigator, or delegate, shall notify AMO of any change in the conduct of 
the study including changes in study personnel assigned to the study project, location of 
the investigational device(s), or maintenance of study records, etc.  
9.3 
INVESTIGATOR APPROVAL  
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Study Files/Notebook.  Copies of IRB submissions and 
approvals should be forwarded to AMO.  Study sites will obtain IRB approvals and fulfill 
any other site-specific and/or region/service-specific regulatory requirements.  The 

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investigator is required to report to AMO within five working days any withdrawal of 
approval by the reviewing IRB for his/her participation in the investigation. 
Prior to the start of subject enrollment, the following documents must be signed and 
returned to AMO: 
 
Confidentiality Agreement 
 
Cooperative Research and Development Agreement (CRADA)  
 
Investigator Agreement/Protocol Signature page 
 
Clinical Investigator Brochure Signature page 
 
Financial Disclosure form 
 
Signed and dated copy of investigator’s current curriculum vitae 
 
Copy of the investigator’s current medical license 
 
IRB approval documents 
By signing the study documents, the investigator agrees to conduct this study according 
to the obligations above and all other applicable regulatory and legal requirements. 
10. 
EXPERIMENTAL PLAN 
10.1 
OVERVIEW 
This study will be conducted in accordance with U.S. Code of Federal Regulations, the 
Declaration of Helsinki, ISO 14155 and all other applicable laws and regulations.  The 
study will not begin until regulatory and IRB approvals have been obtained 
This study will be a 12-month, prospective, multicenter, open-label, bilateral, non-
comparative, non-randomized 1-year clinical investigation conducted at up to 7 sites.  Up 
to 334 subjects will be enrolled to achieve a minimum of 334 treated eyes (in 
approximately 167 bilaterally treated subjects), resulting in at least 300 evaluable eyes at 
the point of refractive stability.  After signing the informed consent, subjects meeting all 
inclusion and exclusion criteria for both eyes will be offered treatment in the study until 
either the dioptric bin allotments are full or the study/site limit is reached. Both eyes are 
intended to be treated on the same day.  The follow-up visit schedule will be the same 
for each operative eye, as described in Section 10.2, Visit Schedule.   
Although the study is not masked, to maintain consistency, study technicians conducting 
study-related vision testing (and qualified backups) should be designated by the 
investigator for all study-related vision testing. It is recommended that these technicians 
remain consistent throughout the study.    
Key data collection includes iDesign measurements, distance visual acuities, manifest 
refraction, keratometry (iDesign and auto/manual), pachymetry, biomicroscopic slit-lamp 
findings, intraocular pressure, contrast sensitivity, Schirmer I Tear Test (with anesthetic), 

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adverse events, non-directed ocular visual symptoms and PRO assessments of visual 
functioning and directed ocular visual symptoms (NEI-RQL-42, OSDI, and PRVSQ for 
PRK/LASIK) as well as the satisfaction questionnaires.  Ocular health and history are 
also assessed preoperatively.  A chart summary of procedures required at each study 
visit is provided in Appendix A. If needed, specific equipment necessary to perform the 
required procedures will be supplied for the duration of the study (Appendix B). 
10.2 
VISIT SCHEDULE 
All eyes will be examined preoperatively and postoperatively based on the following visit 
schedule outlined in Table 1. Unscheduled visits may be conducted as necessary at the 
discretion of the investigator for medically-indicated follow-up.  
 
Table 1:  Visit Schedule 
 
 
 
 
10.3 
PREOPERATIVE PROCEDURES 
All subjects enrolled in the study must sign the current IRB-approved informed consent 
document and meet the inclusion/exclusion criteria for both eyes.  The informed consent 
must be signed before any study-specific examinations are performed, and this must be 
documented in the source documents.  An Authorization for Use/Disclosure of Health 
Information Form (HIPAA authorization) or similar medical treatment privacy law 
documentation must also be signed.   
Following the informed consent process, completion of the preoperative study exam and 
determination that both eyes of the subject meet all of the required inclusion/exclusion 
criteria, the subject’s eyes may be treated in the study unless the dioptric bin(s) is(are) 
full or the study/site limit is reached. 
As the Informed Consent Form is signed prior to beginning study specific procedures, 
some subjects may not qualify after study-specific testing is performed.  Subjects will be 
considered screen-failures if they do not qualify, or if they qualify but decide not to 
proceed with surgery, do not undergo surgery because the dioptric bin(s) is(are) full, or 
site/study enrollment is complete. These subjects will be exited from the study.   
VISIT 
EXAM 
VISIT WINDOW 
1 
Preoperative Exam 
Within 120 days prior to surgery 
2 
Operative 
0-120 days after preoperative exam 
3 
1 day 
1-2 day postoperative 
4 
1 week 
5-8  days postoperative 
5 
1 month 
3-6 weeks postoperative 
6 
3 months 
10-14 weeks postoperative 
7 
6 months 
20-26 weeks postoperative 
8 
9 months 
35-43 weeks postoperative 
9 
12 months 
44-60 Weeks postoperative 
Note: 1 month = 4 weeks, 1 week = 7 days 

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The following preoperative procedures must be completed within 120 days prior to 
surgery (see also Appendix A).   General descriptions and requirements of the various 
tests are provided in the manual of testing procedures (Appendix C). Non-directed 
responses to the open-ended question “Are you having any difficulties with your eyes or 
vision?”, followed by all patient reported outcome questionnaires, followed by the 
iDesign measurement are to be administered first before any other study-specific ocular 
examinations. All non-contact procedures (e.g. topography and keratometry) will be 
performed before contact assessments (e.g. IOP and pachymetry). If required, 
cycloplegic refraction/fundus exam will be the final procedures performed at the study 
visits.  
The preoperative visit is unique in that some procedures (such as the pachymetry) may 
have been performed as part of a standard of care visit, prior to informed consent. If the 
subject returns for examination on a separate day the order above should be adhered to 
for the procedures being conducted on that day. 
PREOPERATIVE PROCEDURES  
 
Informed consent process and documentation 
 
Subject demographic information 
 
Ocular and systemic medical history 
 
Ocular and systemic concomitant medication history 
 
Non-directed ocular/visual symptoms (from non-directed responses obtained from 
the open-ended question “Are you having any difficulties with your eyes or vision?”).  
 
Binocular Subjective Questionnaires: OSDI, PRVSQ for PRK/LASIK, NEI-RQL-42 
and exploratory Satisfaction Questionnaire 
 
iDesign System Measurement (refraction, aberrometry, topography, keratometry, 
pupillometry) 
 
Keratometry (iDesign and auto/manual) 
 
Corneal topography (Humphrey/Zeiss Atlas or Pentacam) 
 
UCVA – photopic, monocular, distance (ETDRS) 
 
UCVA – photopic, binocular, distance (ETDRS) 
 
Manifest Refraction (ETDRS) 
 
BSCVA – photopic, monocular, distance (ETDRS) 
 
Monocular distance corrected contrast sensitivity substudy 
o Mesopic with and without glare at 1.5, 3, 6, and 12cpd 
o Photopic without glare at 3, 6, 12, and 18 cpd 
 
Refractive stability check for contact lens wearers 
 
Anterior segment examination (biomicroscopic slit-lam exam) 

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 
Schirmer I Tear Test (with anesthetic) 
 
Intraocular pressure (applanation tonometry) 
 
Pachymetry (ultrasound) 
 
Cycloplegic Refraction 
 
Dilated fundus examination 
 
Planned surgery date 
 
iDesign treatment planning and calculation 
 
Adverse events and complications 
 
Device deficiencies/complaints 
Note:  All eyes will be targeted for emmetropia and undergo a “Surface PRK” treatment; 
no physician adjustments will be used.  
10.4 
RANDOMIZATION AND MASKING 
This is a nonrandomized study without masking. 
10.5 
OPERATIVE PROCEDURES  
Following determination of the treatment profile using the iDesign system, wavefront-
guided PRK will be performed with Star S4 IR™ laser.  After anesthesia and placement 
of the lid speculum, an Amoils Epithelial Scrubber (Innova, Inc., Toronto, Ontario, 
Canada) will be used to remove the corneal epithelium.  Immediately after PRK 
treatment, apply mitomycin C 0.01% for 15 seconds immediately then rinse the ocular 
surface with balanced salt solution, instill topical medications, then place a bandage 
contact lens (BCL). The BCL should be worn until the 1-week study visit.  
Both eyes are intended to be treated on the same day. If a clinically significant 
complication or adverse event is observed during the treatment of the first eye, the fellow 
eye will not be treated until resolution of the event in the first eye.  
To ensure control of environmental conditions during treatments, including temperature 
and humidity, all laser suites shall be equipped with air conditioning and/or heating 
systems, humidifiers, and environmental monitoring devices. It is important to maintain a 
carefully controlled surgical environment. All treatments shall be performed in surgical 
environments where the humidity is between 35-45% and the temperature is between 
68-72° F. 
All eyes will undergo the PRK procedure using the STAR SR IR™ Excimer laser to 
perform ablation according to the iDesign treatment plan. It is recommended that Iris 
Registration (IR) be used for alignment of all treatments. Refer to Appendix K for a 
detailed summary of the surgical procedure. 

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10.6 
POSTOPERATIVE PROCEDURES  
Postoperatively, each treated eye will be examined according to the schedule in 
Appendix A, Visit Schedule.   
IMMEDIATE POSTOPERATIVE CARE  
Subjects may experience pain during the first week following treatment. The immediate 
postoperative pain control regimen is left to the Investigator’s discretion. All 
postoperative regimen components shall be recorded: 
 
Bandage contact lens 
 
Eye shield(s) during sleep (1 week) 
 
For all eyes, the postoperative medication regimen will consist of mitomycin C 0.01% 
for 15 seconds immediately after the ablation, ophthalmic antibiotic QID for 1 week, 
fluorometholone 0.1% for 8 weeks (QID initially and tapering 1 drop every 2 weeks 
starting at week 3) and analgesic as needed. Continued use beyond these 
guidelines is allowed if medically necessary.  
EARLY POSTOPERATIVE EXAMINATION PROCEDURES (1 DAY AND 1 WEEK) 
Postoperative examinations will be conducted at 1 day and 1 week after treatment. The 
following clinical information shall be assessed and recorded during each postoperative 
exam (see also Appendix A). General descriptions and requirements of tests are 
provided in Appendix C.  Following the assessment of non-directed optical/visual 
symptoms, iDesign measurements are to be performed before any other ocular 
examinations. All non-contact procedures (e.g. topography and keratometry) will be 
performed before contact assessments (e.g. IOP and pachymetry).  
 
Ocular and systemic medical history and concomitant medications 
 
Bandage contact lens should be removed before ocular exams (1-week only) 
 
Non-directed ocular/visual symptoms (from non-directed responses obtained from 
the open-ended question “Are you having any difficulties with your eyes or vision?”).  
 
iDesign System Measurement (refraction, aberrometry, topography, keratometry, 
pupillometry (1-week only) 
 
UCVA – photopic, monocular, distance (ETDRS) 
 
UCVA – photopic, binocular, distance (ETDRS) (1-week only) 
 
BSCVA – photopic, monocular, distance (ETDRS) (1-week only) 
 
PRVSQ for PRK/LASIK (1-week only) 
 
Anterior Segment Examination 
 
Adverse Events and Complications 
 
Device Deficiencies/Complaints 
 

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PERIODIC POSTOPERATIVE EXAMINATION PROCEDURES  
Periodic examinations will be conducted at 1, 3, 6, 9, and 12 months after treatment. In 
the event that extended follow-up is not needed, the follow-up period may be reduced.  
Note:  Subjects are not to wear contact lenses postoperatively until after completion of 
the study.  Wearing contact lenses may potentially cause wavefront or topography 
changes that may influence the visual acuity results.  During the study, if correction is 
required, spectacles should be prescribed.  
The following data shall be assessed and recorded during the periodic examinations, 
although not all are required at all periodic visits (see also Appendix A). General 
descriptions and requirements of the various tests are provided in Appendix C. Non-
directed responses to the open-ended question “Are you having any difficulties with your 
eyes or vision?”, followed by all patient reported outcome questionnaires, followed by the 
iDesign measurement, are to be administered first before any other ocular examinations. 
All non-contact procedures (e.g. topography and keratometry) will be performed before 
contact assessments (e.g. IOP and pachymetry). If required, cycloplegic 
refraction/fundus exam will be the final procedures performed at the study visits.  
 
Ocular and systemic medical history and concomitant medications  
 
Non- directed ocular/visual symptoms (from non-directed responses obtained from 
the open-ended question “Are you having any difficulties with your eyes or vision?”). 
 
Binocular Subjective Questionnaires: OSDI, PRVSQ for PRK/LASIK , NEI-RQL-42 
and exploratory Satisfaction Questionnaire (Note: For reliability validation purposes 
the PRVSQ will be completed by the subject at the visit and also at home 7 days 
after the 3-month visit and mailed back to the site.) 
 
iDesign System Measurement (refraction, aberrometry, topography, keratometry, 
pupillometry) 
 
Keratometry (iDesign and auto/manual) 
 
Corneal Topography (Humphrey/Zeiss Atlas or Pentacam) 
 
UCVA – photopic, monocular, distance (ETDRS) 
 
UCVA – photopic, binocular, distance (ETDRS) 
 
Manifest Refraction (ETDRS) 
 
BSCVA – photopic, monocular, distance (ETDRS) 
 
At 3 months or later, if there is a loss of 2 or more lines of BSCVA (≥ 10 letters) 
compared to the preoperative visit, a rigid contact lens over refraction should be 
performed to determine if the BSCVA loss is due to irregular astigmatism. If a 
rigid contact lens over refraction is not medically advisable, then a pin-hole acuity 
should be obtained 
 
Monocular distance corrected contrast sensitivity substudy 

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 
Mesopic with and without glare at 1.5, 3, 6, and 12 cpd 
 
Photopic without glare at 3, 6, 12, and 18 cpd 
 
Anterior Segment Examination 
 
Schirmer I Tear Test (with anesthetic) 
 
Intraocular pressure (applanation tonometry) 
 
Pachymetry (ultrasound) (1 and 12-months only) 
 
Cycloplegic Refraction (6 and 12-months only) 
 
Dilated Fundus Examination (6 and 12-months only) 
 
Adverse Events and Complications 
 
Device Deficiencies/Complaints 
10.7 
RETREATMENT PROCEDURES  
NON-REFRACTIVE RETREATMENTS 
Non-refractive retreatments or procedures without further laser treatment (e.g., treatment 
of complications, recurrent corneal erosions, etc.) may be performed as deemed 
necessary by the investigator. If possible notify the sponsor prior to performing any non-
refractive retreatments. 
REFRACTIVE RETREATMENTS 
Refractive retreatments are not allowed during the study. 
10.8 
EXIT OF SUBJECTS  
An Exit Case Report Form will be completed for all subjects, either when they complete 
the study or if they exit early.   
It is the responsibility of the investigator to provide follow-up data to AMO for each 
subject, and every attempt should be made to gather that complete follow-up data for 
subjects as missing data can have a negative effect on the study results. Patients who 
would be traveling, relocating or otherwise unavailable for postoperative follow-up visits 
should not be chosen for this clinical study. 
Subjects will be considered enrolled if they sign an informed consent form. A subject will 
be considered a screen failure if he/she does not meet the inclusion/exclusion criteria or 
if consent is withdrawn prior to treatment or the subject does not undergo surgery 
because the dioptric bin(s) is(are) full, or site/study enrollment is complete.  
Following treatment, subjects will be considered “lost-to-follow-up” from the study if 
irretrievably lost for unavoidable reasons such as: subject moved/unable to locate, 
subject uncooperative/refuses further study participation, subject ill/unable to travel.  In 
the event of subject relocation, efforts must be made by the investigator to secure follow-

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up information (i.e., slit-lamp findings and general visual acuity, etc.) from the subject’s 
new physician.  A subject will be considered discontinued from the study only if the 
subject dies.   
If a subject is exited early from the study, an Exit Case Report Form will be completed, 
indicating the reason for study exit.  In the event of a serious adverse event, the subject 
may be exited from the study; however, efforts must be made by the investigator to 
follow the subject until resolution of the event. 
If a subject terminates from the study before the 12-month visit then every attempt 
should be made to have a final visit with the subject and capture the procedures required 
at the 12-month visit as outlined in Appendix A.  Additionally, all study subjects are to 
be instructed to undergo regular eye examinations at least yearly and also to return to 
their doctor if any eye complications are experienced in the interim.   
10.9 
UNSCHEDULED VISITS  
During the study period, if a non-protocol-required visit is done for the purpose of 
medically-indicated follow-up for a study eye, data from this visit should be reported 
using the Unscheduled Visit CRF.  The need for unscheduled visits is at the 
investigator’s discretion.  Specific examinations to be performed at unscheduled visits 
are at the discretion of the investigator (based on the reason for the unscheduled visit), 
however, assessments that are recommended for every unscheduled visit are: UCVA, 
iDesign system measurement, manifest refraction, BSCVA, anterior segment exam, 
concomitant medication, adverse events, complications, device deficiencies and 
complaints as outlined in Appendix A.  In addition, if a subject is seen at an 
unscheduled visit due to an ocular visual symptom complaint, the PRVSQ for 
PRK/LASIK and OSDI, will be administered at that visit, as well as prior to any 
secondary surgical intervention (e.g. epithelial debridement) for an ocular visual 
symptom complaint.   
For unscheduled visits, the order of procedures (if performed) is to be similar to the 
scheduled study exams.  Non-directed responses to the open-ended question “Are you 
having any difficulties with your eyes or vision?”, followed by patient reported outcome 
questionnaires (if necessary),followed by the iDesign measurement (if performed) are to 
be administered first before any other study specific ocular examinations. All non-contact 
procedures (e.g. topography and keratometry) are to be performed before contact 
assessments (e.g. IOP and pachymetry).  Cycloplegic refraction/fundus exam (if 
performed) are to be the final procedures.  

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10.10 PROTOCOL DEVIATIONS  
Any departure from the protocol procedures represents a protocol deviation.  Protocol 
deviations may be subject-based (e.g., inclusion/exclusion criteria, informed consent 
deviation, etc.) or procedural-based (e.g., out-of-interval visits, non-compliance with 
testing procedures, etc.).  All protocol deviations will be documented using protocol 
deviation case report forms.  Any deviation made to protect the life or physical well-being 
of a subject in an emergency as well as any use of the investigational device without 
obtaining informed consent must be reported to AMO within 5 working days. Protocol 
deviations will be monitored by AMO, and if the non-compliance is persistent or 
egregious, AMO may take action, including but not limited to termination of the sites 
participation in the study.  Each Principal investigator is also responsible for informing 
the reviewing IRB of record of instances of protocol non-compliance in accordance with 
the IRB requirements. 
11. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS  
11.1 
ADVERSE EVENT DEFINITIONS 
Adverse Event (AE) 
An adverse event is defined (following ISO 14155) as any untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not related to the study device.   
Serious Adverse Event (SAE) 
An adverse event is considered serious (following ISO 14155) if it is an untoward 
occurrence which may or may not be related to use of the study device that 
 
is sight- or life-threatening,  
 
results in death,  
 
requires inpatient hospitalization or prolongation of hospitalization (a planned 
hospitalization for a pre-existing condition is not considered a serious adverse 
event), 
 
results in permanent impairment of a body structure or body function,  
 
necessitates medical or surgical intervention to prevent permanent impairment to a 
body structure or function, or 
 
results in fetal distress, fetal death or a congenital abnormality or birth defect 
Device-Related Adverse Event/Adverse Device Effect (ADE) 
A device-related adverse event is defined as any adverse event that is believed to be 
definitely, probably or possibly related to the study device (following the guidelines in 
Section 11.4, Causal Relationship).  A device related event is considered an adverse 
device effect (ADE; following ISO 14155) resulting from the use of the study device. 

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Study-Specific Anticipated Events 
ADVERSE EVENTS  
The following is a list including, but not limited to, ocular adverse events that are 
anticipated and must be reported to AMO for this study.  Any events that are unlikely but 
anticipated will be reported to the FDA.  
 
Corneal infiltrate or ulcer 
 
Any persistent corneal epithelial defect at 1 month or later 
 
Corneal edema at 1 month or later  
 
IOP with increase >10 mmHg above baseline on two consecutive examinations or an 
IOP greater than 30 mmHg on two consecutive examinations 
 
Haze beyond 6 months with loss of ≥2 lines (≥10 ETDRS letters) of BSCVA 
 
Decrease in BSCVA of ≥2 lines (≥10 ETRDS letters) not due to irregular astigmatism 
as shown by hard contact lens refraction (or pin hole acuity if hard contact lens 
refraction is not medically advisable) at 3 months or later 
 
Retinal detachment 
 
Retinal vascular accidents 
 
Ocular penetration 
 
At 3 months or later: 
 
Severe halos, based on subject response of both “Extremely bothered” to 
questions 1e and “Yes” to question 1f on the PRVSQ for PRK/LASIK  
 
Severe glare, based on subject response of both “Extremely bothered” to 
questions 2e and “Yes” to question 2f on the PRVSQ for PRK/LASIK  
 
Dry eye based on subject score of ≥ 33 on the OSDI in combination with a 
Schirmer score of ≤ 5 mm.   
 
Corneal melt 
 
Glaucoma or ocular hypertension 
 
Severe allergic reaction to study medication 
COMPLICATIONS  
The following events are considered refractive surgery complications (not an all-inclusive 
list): 
 
Corneal edema between 1 week and 1 month after the procedure  
 
Peripheral corneal epithelial defect at 1 month or later  
 
Recurrent corneal erosion at 1 month or later 
 
Foreign body sensation at 1 month or later per the non-directed assessment of 
ocular visual symptoms, “are you having any difficulties with your eyes/vision?” 
 
Pain at 1 month or later per the non-directed assessment of ocular visual symptoms, 
“are you having any difficulties with your eyes/vision?” 
 
Ghost/double images based on subject response to question 5 on the PRVSQ for 
PRK/LASIK 

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 
Transient light sensitivity syndrome  
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) 
Any UADE (USA 21CFR 812.3(s)) or USADE (ISO 14155) is defined as any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan (i.e., this protocol), 
application (including a supplementary plan or application), or risk assessment, or any 
other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects.   
11.2 
PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
A product complaint/device deficiency is defined (21 CFR 820.3(b) and ISO 14155) as 
any alleged deficiency related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a device. Product complaints can pertain to any 
marketed AMO device being used in the study as well as the investigational device.  The 
investigator is to assess whether the deficiency could have led to a serious adverse 
event without suitable action or intervention or under less fortunate circumstances.  
11.3 
ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
All adverse events and any complaint encountered using any AMO product, regardless 
of severity and whether or not attributed to the study device(s), are to be reported to 
AMO and recorded on the case report form corresponding to the visit during which 
awareness of the event occurred.  Adverse events are also to be reported to the 
reviewing IRB as per the IRB’s reporting requirements.  If required, adverse events will 
be reported to the appropriate regulatory agencies (e.g., FDA) according to all applicable 
laws and regulations.  Specific instructions on notification procedures to AMO are 
included in Appendix L, Adverse Event Reporting.   
Reporting of adverse events shall follow the USA Code of Federal Regulations 
(21CFR812) and ISO 14155. General guidelines are provided below: 
Adverse Event Reporting 
An adverse event that is not serious or device-related is to be reported to AMO in a 
timely manner.  Notification of non-serious and non-device related adverse events will 
occur by recording events on the CRF when noted.  Such adverse events are also to be 
reported to the reviewing IRB per their reporting requirements.  
Complaints/Device Deficiency Reporting  
A general product complaint or device deficiency is to be reported to AMO in a timely 
manner.  Notification of complaints/device deficiencies will occur by either recording 

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complaints on the CRF when the complaint occurred (e.g. operative form) or by a phone 
call to the Sponsor.  Any device deficiency that could have led to a serious adverse 
event without suitable action or intervention, or under less fortunate circumstances, must 
be reported to the sponsor immediately (no later than 48 hours after detection). Device 
deficiencies that could have led to a serious adverse event should also be reported to 
the investigator’s IRB per their reporting requirements. 
Serious and/or Device-Related Adverse Event Reporting 
Serious and/or device-related events (ADEs) are to be documented using the Detailed 
Adverse Event CRF.  In the event of a serious adverse event (SAE), which may or may 
not be related to use of the study device, AMO must be notified immediately (no later 
than 48 hours after detection).  Any SAE is to be reported by phone and by submitting 
the completed Detailed Adverse Event CRF.  The SAE should also be reported to the 
investigator’s IRB per their reporting requirements.  
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) Reporting 
If during the study, a serious adverse event occurs that may reasonably be regarded as 
study device-related and was not previously expected in nature, severity, or degree of 
incidence, the investigator is to report the UADE/USADE to AMO within 48 hours, and to 
the investigator’s IRB as soon as possible, but no later than 10 working days, after 
learning of the event as required by 21CFR812. 
11.4 
CAUSAL RELATIONSHIP  
The investigator should always be alert to adverse events that may be related to the 
study device or the use of the study device.  An attempt should be made in every case to 
determine if the event may be device-related.   
The following definitions are to be used as guidelines in determining the relationship 
between the event and the study device and/or procedure.   
Definitely related: 
There is a definite causal relationship between the adverse 
event and the device and/or the use of the study device. 
Probably related:   
There is a reasonable possibility of a causal relationship 
between the adverse event and the device and/or the use of the 
study device. 
Possibly related:   
The adverse event has not been determined to be related to the 
device or use of the device, but no other cause has been 
definitively identified and the device and/or the use of the study 
device cannot be ruled out as a possible cause. 
Unlikely to be related: The possibility of a potential causal relationship between 
adverse event and the device and/or the use of the study device 

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could exist, but the adverse event is most likely explained by 
causes other than the device and/or the use of the study device. 
Not related: 
There is no possibility of a causal relationship between the 
adverse event and the device and/or the use of the study device 
If an adverse event is believed to be definitely, probably or possibly related to the study 
device, the event will be considered device-related.   
11.5 
ADVERSE EVENT FOLLOW-UP 
For every adverse event, appropriate measures should be undertaken to treat and/or 
monitor the subject until resolution occurs.  Obtain and maintain in the subject's files all 
pertinent medical data relating to the event including the subject’s medical records and 
medical reports and/or judgments from colleagues or outside specialists who assisted in 
the treatment and follow-up of the subject. The investigator should keep AMO closely 
informed as to the outcome of serious and/or device-related adverse events, thereby 
allowing AMO to comply with the appropriate regulatory reporting requirements.  A 
Detailed Adverse Event Update CRF should be completed each time the subject returns 
to the investigator or other specialist(s) for follow-up of serious and/or device-related 
adverse event until resolution of the event.  Any subject who is exited from the study due 
to a serious and/or device-related adverse event will be followed until the outcome is 
determined. 
12. 
PROTOCOL CHANGES/AMENDMENTS  
If the investigator desires to modify any procedure and/or the design of the study, he or 
she must contact and obtain consent from AMO regarding the proposed changes prior to 
implementation.  Any modifications (including additional data collection beyond the 
protocol or outside the normal standard of care) require approval by the FDA and all 
other appropriate regulatory agencies, as well as approval of the governing IRBs prior to 
implementation.   
13. 
ETHICS REVIEW AND PATIENT WELFARE 
13.1 
INSTITUTIONAL REVIEW BOARD (IRB) 
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Notebook.  Copies of IRB submissions and approvals 
should be forwarded to AMO. 

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The investigator is responsible for notifying the IRB of reportable adverse events as well 
as any other circumstance in which additional procedures outside the protocol were 
conducted to eliminate apparent hazards to subjects. 
13.2 
INFORMED CONSENT 
The current version of the IRB-approved study informed consent must be signed by 
each study subject prior to any study-specific examinations being performed.  The 
IRB-approved informed consent is to be signed and dated by the subject as well as by 
the person who conducted the informed consent discussion.  The signed informed 
consent will be maintained by the investigator as a permanent part of the subject’s 
medical records.  A copy of the signed and dated form is to be provided to the subject.  
The investigator will provide AMO written acknowledgement on the preoperative case 
report form that a signed agreement of informed consent has been obtained and is in the 
investigator’s possession for each subject.  As required by 21CFR812 Part G, the site 
shall document in the source documents that informed consent was obtained prior to 
participation in the study for each subject enrolled. 
NOTE:  The informed consent process also includes obtaining the subject’s signature on 
an Authorization for Use/Disclosure of Health Information for Research Form.   
NOTE:  The sponsor will secure appropriate insurance for study subjects prior to study 
start. 
14. 
DOCUMENTATION 
14.1 
SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may include 
a subject’s medical records, hospital charts, clinic charts, the investigator’s subject study 
files, as well as results of any diagnostic tests or procedures such as topographies or 
laboratory tests with photographs or instrument printouts. 
Each site is expected to adhere to the clinic’s own standard documentation requirements 
for medical charts/clinic notes.  However, for the purposes of this clinical study, the 
medical charts/clinic notes must also include, at a minimum, the following data that will 
be considered source data and will be reviewed by AMO: 
 
Subject’s name  
 
Study identification number 
 
Subject’s contact information 
 
Study protocol number and the Sponsor name (AMO) 
 
A statement that informed consent was obtained prior to participation in the study 
(including the date)  

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 
Dates of all subject visits and surgeries throughout the duration of the study 
 
Concurrent medications 
 
Corrected and uncorrected distance visual acuity (NOTE: ETDRS visual acuity score 
cards are considered source documentation and are to be retained by the site in the 
subject chart) 
 
Manifest refraction 
 
Occurrence and status of any operative complications, postoperative medical 
findings and adverse events 
 
Occurrence and status of any subject complaints, e.g., ocular/visual symptoms 
 
The date the subject exited the study, and a notation as to whether the subject 
completed the study or reason for early exit. 
14.2 
SUBJECT CONFIDENTIALITY 
Subjects will be assigned a site/subject number to maintain subject confidentiality.  
Subject names may possibly be disclosed to AMO or regulatory agencies during 
inspection of medical records related to the study, but reasonable precautions will be 
taken to maintain confidentiality of personal information to the extent permitted by 
applicable laws and regulations. 
14.3 
CASE REPORT FORM COMPLETION 
This study will use an electronic data capture (EDC) system.  The investigator is 
responsible for ensuring that data are properly recorded on each subject’s case report 
forms and related documents.  Prior to database lock, the investigator will verify 
completeness and accuracy of data submitted to AMO.  
14.4 
STUDY SUMMARY 
A final investigator’s summary will be provided to AMO and the reviewing IRB within 
3 months after termination or the completion of the study or the investigator’s part of the 
investigation.  
15. 
MONITORING  
AMO will perform three types of monitoring to ensure compliance with regulations: data 
monitoring, administrative monitoring, and safety monitoring. 
15.1 
DATA MONITORING 
In order to ensure a well-controlled clinical trial, AMO will follow specific data monitoring 
procedures.  Following review of EDC data, requests for data clarification will be handled 
through the EDC data system.  To minimize data omissions and inconsistencies on 
clinical reports and to ensure that data are accurately transcribed to computer data files, 
AMO will follow internal data processing procedures that include automated and manual 

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quality control checks to identify any data discrepancies.  Any such items will be 
resolved and documented as needed on the case report forms at the investigative site 
and in the data management system at AMO. Ongoing data review for clinical data 
monitoring will be conducted and will include evaluation of outliers for visual acuity and 
refractions as well as review of adverse event listings.  
Prevention of Missing Data 
Methods used to safeguard against missing data that can have deleterious effects on the 
study integrity and reliability of its outcomes will include training study staff with 
centralized and on-site programs.  In addition, subjects will be encouraged at the time of 
informed consent to avoid missing study visits, as missing data may affect the study 
reliability and diminish the scientific value of their contribution to the study.  
15.2 
ADMINISTRATIVE MONITORING 
Administrative monitoring procedures will ensure that study devices (e.g., key cards), 
subjects, and forms can be traced and will allow monitoring of the study site progress 
and compliance.   
Device Accountability 
Use of the iDesign study device, the STAR-S4-IR laser and the STAR-S4-IR key cards 
used in this study will be tracked by the investigative site and AMO.  Key card 
accountability will be maintained at the investigative on a site log to track 
disposition/return to AMO.  During periodic investigative site monitoring visits AMO will 
review investigative site records and logs. 
Site Monitoring Plan 
Prior to performing any study treatments, the requirements of the study and reporting 
mechanisms will be explained to each investigator either personally at the investigative 
site or at a formal study investigator meeting.  When necessary, a pre-study site 
qualification visit may be performed to assess the adequacy of the site to perform the 
study for sites that have not previously worked with AMO or have undergone significant 
changes, or have not been visited in the past year.  A study initiation visit will be 
conducted for all sites prior to or at the time of the first treatment.  
Throughout the duration of the study, site visits to monitor compliance to this protocol will 
be made at each investigative site.  During a routine site monitoring visit, AMO will 
review informed consent documents and subject eligibility, and the data on study case 
report forms will be verified against subject charts and other source documents to 
ensure complete and accurate reporting.  The subject files will also be reviewed to 
assure that all adverse events and any issues encountered with AMO products have 
been reported in a timely fashion.   

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AMO will also review source documents to verify that all required items have been 
documented in the subject medical charts.  Refer to Section 14.1, Source Documents, 
for a list of items that are required for source documentation.  In addition to subject files, 
study logs will be checked and conformance to lighting levels for visual acuity tests will 
be verified.  Training on study-specific procedures may also be conducted during 
monitoring visits as necessary.   
Upon study completion, a final close-out site visit to each site will be made to monitor the 
last of the subject data records and finalize any outstanding study issues.  
A separate Study Monitoring Plan will be established prior to study start that will define 
the type and frequency of monitoring visits and frequency of record monitoring.  
15.3 
SAFETY MONITORING 
The medical monitor will review results throughout the clinical trial as necessary to 
ensure the continued safety of the device and to ensure that no subjects are exposed to 
unreasonable risk.  The medical monitor will be available to answer questions from 
investigators.  The medical monitor will review and assess any reports of serious and/or 
device-related adverse events as well as device deficiencies that could have led to a 
serious adverse event, and discuss these with the reporting investigator(s) as 
necessary.  The medical monitor, as well as any other qualified personnel designated by 
AMO, shall also review any interim progress reports, as applicable.   
16. 
PUBLICATIONS 
Refer to the Cooperative Research and Development Agreement (CRADA) for 
information regarding AMO publication policies. 
17. 
RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
The safety and effectiveness of an iDesign System guided PRK treatment with the STAR 
Excimer Laser System, as well as long-term effects of PRK surgery in general, have not 
been fully determined. Unexpected complications or side effects may occur. As with any 
surgery or investigational procedure, all potential risks cannot be identified.  
There may be complications and adverse events during or following the surgery which 
may be temporary or permanent.  These may include pain, infection, foreign body 
sensation, dryness, fluctuation or decreased vision, change in visual quality, glare, 
halos, double vision, photophobia, transient light sensitivity syndrome, haze, corneal 
scarring and other medical findings, over- or under-correction, irregular astigmatism, 
corneal transplant, or blindness. Additional medications or surgeries may be required to 
treat these complications/adverse events. 

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RISK MANAGEMENT 
Subjects will be closely monitored thought the trial duration.   The occurrence of adverse 
events and complaints will be assessed at each study visit and reported to AMO 
according to Section 11.0, Adverse Events and Product Complaints.  Additionally, AMO 
will monitor incoming data following the procedures outlined in Section 15.0, Monitoring.  
The Medical Monitor will ensure subjects are not exposed to additional risks by 
monitoring serious adverse events, device-related adverse events, and device-
deficiencies that could have led to serious adverse events (Section 15.3, Safety 
Monitoring).  
POTENTIAL BENEFITS 
PRK treatment using the iDesign system in conjunction with the STAR S4 IR Excimer 
laser is expected to provide improved uncorrected distance visual acuity and accurate 
and stable refractive outcomes.  Additionally, it is expected that the general clinical 
outcomes in this iDesign PRK study for the treatment of myopia with or without 
astigmatism will be similar to results obtained for the iDesign LASIK study for treatment 
of myopia with or without astigmatism, which has been submitted as a panel-track PMA 
supplement (P930016/S044).   
CONCLUSION 
The hazards/risks associated with Advanced CustomVue Treatment using the iDesign 
Advanced WaveScan Studio System in conjunction with the STAR S4 IR Excimer laser 
are acceptable and expected to be similar to those of LASIK treatment using the iDesign 
System and STAR S4 IR Excimer laser.  The potential clinical benefits of PRK treatment 
using the iDesign Advanced WaveScan Studio System in conjunction with the STAR S4 
IR Excimer laser outweigh the residual risks when the device is used as intended.  
18. 
RECORDS RETENTION 
All study-related correspondence, subject records, consent forms, Authorization for 
Use/Disclosure of Health Information Forms or similar medical treatment privacy law 
documentation, records of the distribution and use of all study products, and original 
case report forms should be maintained by the investigator.   
The investigator must maintain and have access to the following essential documents 
until notified by the Sponsor.   Note:  This may be for a minimum of 15 years after 
completion of the study unless country-specific requirements are longer.  AMO requires 
notification if the investigator wishes to relinquish ownership of the data so that mutually 
agreed-upon arrangements can be made for transfer of ownership to a suitably qualified, 
responsible person. 

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 
All case report forms 
 
All adverse event information (adverse event forms, follow-up letters, etc.) 
 
Investigational supply records/inventory 
 
IRB and regulatory approval documentation 
 
Study correspondence  
 
Study agreements 
 
Site visit documentation 
 
Protocol(s) and the reason for any deviations from the protocol 
 
Subject log(s) 
 
Clinical Investigator’s Brochure 
 
Completed subject informed consent forms and medical privacy forms (e.g., 
Authorization for Use/Disclosure of Health information or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment in 
the governing countries) 
 
Subject medical chart/clinic notes 
19. 
TERMINATION OF THE INVESTIGATION 
The clinical investigation will be suspended in the event of high levels of complications 
and/or adverse events that are unexpected in nature and/or severity and evaluated as to 
causality relative to the study device.  The clinical investigation may be suspended if the 
Medical Monitor or IRB, upon review and evaluation of the clinical data, finds 
unacceptable clinical performance or the level of single or total complications and/or 
adverse events unacceptable for continuation of the investigation. 
If causality is shown not to be related to the study device, the study may be resumed in 
accordance with the IRB and regulations of the FDA.  The study will be terminated if 
causality is shown to be related to the study device. 
Additionally, the investigator, or AMO, may stop a subject’s participation at any time.  
AMO may also stop the study at any time for reasons it determines appropriate. If 
refractive stability is established prior to the 12-month visit, the study may be terminated 
before all subjects reach the final 12 month visit.  However, no suspension of the study 
would be made to disadvantage the study subjects.  In the event of an early termination 
of the investigation, the sponsor will notify study sites, IRBs and appropriate regulatory 
bodies of the termination. Subjects will be followed as appropriate.  
20. 
STATISTICAL METHODS 
This section highlights the analyses for the primary and secondary study endpoints as 
well as the key safety endpoints.  All endpoints will be evaluated at the refractive stability 
time point. Visual acuities will be converted to logMAR. 

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20.1 
ANALYSIS POPULATION 
The safety population will be the primary analysis population for all endpoints and 
includes all eyes that receive study treatment.  However, if there are a significant 
number of missing values (>5% eyes with missing data at the time point of stability), an 
intent-to-treat (ITT) population will be used as the primary analysis population for the 
primary effectiveness endpoints.  In this case, missing data will be imputed.  
20.2 
PRIMARY STUDY ENDPOINTS 
All primary effectiveness and safety endpoints will be evaluated at the stability time-
point. 
PRIMARY EFFECTIVENESS ENDPOINTS 
MONCULAR UCVA 
The proportion of eyes achieving the target of 20/40 or better will be at least 85%. The 
frequency, proportion and 95% confidence intervals of eyes with each acuity line of 
UCVA will be summarized at each study exam.   
MRSE PREDICTABILITY (WITHIN 0.50 D AND 1.00 D OF TARGET) 
The proportion of eyes with MRSE within 0.50 D of intended correction will be at least 
50%.  In addition, the proportion of eyes with MRSE within 1.00 D of intended correction 
at the stability time-point will be at least 75%.  The frequency, proportion and 95% 
confidence intervals of eyes with achieved MRSE within 0.50 D and 1.00 D of intended 
will be summarized over time.     
REFRACTIVE STABILITY 
Refractive stability will be evaluated for two cohorts:  a “consecutive cohort” (eyes with 
data at two consecutive visits) and a “consistent cohort” (eyes with data at all periodic 
visits through the point of stability and the confirmatory time point).  At least 95% of eyes 
will have a change ≤1.00 D of MRSE and MRC between refractions performed at 
1 month and 3 months after surgery or any two refractions performed at least 3 months 
apart.   The frequency, proportion and 95% confidence intervals of eyes with MRSE and 
MRC changes ≤1.00 D, as well as ≤0.50 D, between visits will be presented. 
Additionally, the mean change (paired differences) in MRSE and MRC between visits will 
be calculated to evaluate the additional refractive stability criteria. The mean rate of 
change in MRSE and MRC is to be ≤0.50 D per year (≤0.04 D/month).  The mean rate of 
change in MRSE and MRC should decrease monotonically over time.  At the point of 
stability, the 95% confidence intervals of the mean rate of change in MRSE and MRC 
between visits should include zero.  Lastly, stability is to be confirmed at least 3 months 
after the stability time point by a statistically adequate subgroup using the same 
refractive stability criteria.  

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PRIMARY SAFETY ENDPOINTS 
MAINTENANCE OF BSCVA   
The proportion of eyes with a loss of >2 lines of BSCVA from preoperative will be <5%, 
the proportion of eyes with haze beyond 6 months with a loss > 2 lines of BSCVA will be 
<1%, and the proportion of eyes with BSCVA of 20/20 or better preoperatively and 
BSCVA 20/40 or worse postoperatively will be <1%.  The frequency, proportion and 
95% confidence intervals of eyes with BSCVA acuity line changes and eyes with each 
acuity line of BSCVA will be summarized at each study exam.  
INDUCED MANIFEST REFRACTIVE ASTIGMATISM 
The proportion of eyes with induced manifest refractive astigmatism of >2.00 D will be 
<5%.  The frequency, proportion and 95% confidence intervals of eyes with absolute 
changes in manifest refractive cylinder will be summarized at each periodic study visit. 
SERIOUS, DEVICE-RELATED ADVERSE EVENTS 
The proportion of eyes with serious, device-related adverse events will be <1% 
cumulatively.  The number and proportion of eyes with serious, device-related adverse 
events throughout the study will be summarized.  
Site Poolability 
Baseline demographic data (age, gender, race, and contact lens wear) and baseline 
iDesign refractions (IDS, IDC and IDSE) will be reported by site. To assess the 
poolability of the sites, a one-way ANOVA will be used for continuous variables and the 
Chi-square test or Fisher’s Exact tests will be used for categorical variables. An alpha 
level of 0.15 will be used to assess the site poolability. 
Outcome Stratification 
To evaluate the consistency of results, the primary effectiveness and safety points will 
be stratified by key factors at the stability point. These factors will include age group, 
gender, race, site, preoperative contact lens wear, preoperative iDesign spherical 
equivalent, preoperative iDesign sphere, preoperative iDesign cylinder, wavefront 
capture diameter, iris registration status, and clinically significant protocol deviations. 
For comparisons across categories, a Mantel-Haenszel chi-square test for ordinal data 
and a Cochran-Mantel-Haenszel test for non-ordinal data will be used to compare the 
observed percentages across categories. Additionally, the results for each category will 
be compared to the target criterion for each study endpoint using chi-square goodness-
of-fit test. All statistical tests and p-values will be reported as 2-sided and a significance 
level of 0.15 will be used to assess homogeneity of the primary safety and effectiveness 
endpoints for baseline and demographic variables. 

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Handling of Missing Data for Primary Effectiveness Endpoints 
Missing data for ITT analyses of the primary endpoints will be imputed using multiple 
imputation methods2 using the MI and MIANALYZE procedures in SAS.  Sensitivity 
analyses including worst-case analyses will also be performed for the primary 
effectiveness endpoints.  
20.3 
ADDITIONAL ENDPOINTS 
Results for mesopic contrast sensitivity with and without glare (1.5, 3, 6, and 12 cpd) and 
photopic contrast sensitivity without glare (3, 6, 12, and 18 cpd) will be reported using 
nonparametric analyses. The frequencies and proportions of eyes with each acuity line 
changes of binocular UCVA will be reported over time.  Mean MRSE, MRS and MRC 
outcomes, as well as the accuracy of MRS and MRC, will be presented over time.  MRC 
will be analyzed using both non-vector and vector methods.  Keratometric analyses will 
include mean average keratometry, stability of average keratometry, and keratometric 
cylinder analyses.  Mean iDesign aberrometry measurements (HOA) and changes in 
HOAs will be presented.  The mean change in Schirmer I Tear Test (with anesthetic) 
measurements will be evaluated. The change in intraocular pressure over time will also 
be evaluated.  The frequency and proportion of biomicroscopic slit-lamp findings, 
including corneal clarity, will be reported over time. The frequency and proportion of 
eyes with spontaneously reported ocular visual symptoms (non-directed) as well as 
analyses of the PRVSQ for PRK/LASIK PRO for subjective visual symptoms will be 
presented.  All 13 sub-scales of the NEI-RQL will be analyzed and reported over time. 
Additionally, mean scores for the OSDI PRO will be analyzed and reported over time. 
The frequency and proportion of patient satisfaction about the study procedure from the 
non-validated questionnaires designed to collect patient satisfaction data prior to and 
following refractive corneal surgery will be summarized. The numbers and proportions of 
eyes with complications and adverse events and retreatment procedures will be 
summarized.  
Results from the PRSVQ questionnaires completed following the 3-month study visit will 
be used for reliability validation purposes for the PRSVQ only and will not be analyzed in 
this study or used for AE reporting.  
20.4 
VISUAL ACUITY CONVENTIONS AND GENERAL STATISTICS 
Visual acuity data will be converted to LogMAR values prior to analysis and adjusted for 
the test distance used if it is not the standard distance for the chart.  Manifest and 
cycloplegic refractive data will be adjusted for optical infinity and converted to minus 
cylinder format for presentation and analyses.   
                                               
2 Little, R.J.A. and Rubin, D.B. (2002) Statistical Analysis with Missing Data. J. Wiley & Sons, New York 

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Descriptive statistics will typically include sample size (N), mean, standard deviation 
(SD), median, minimum (Min) and maximum (Max) as appropriate for continuous 
variables.  For continuous variables, statistical tests (e.g., t-test) assuming normality will 
generally be used.  For categorical data, the frequency and proportion will be reported 
and Fisher’s exact test or Chi-square test will generally be applied.   
20.5 
INTERIM REPORTS 
Interim Analyses 
Up to four interim analyses may be conducted to determine the point of refractive 
stability, when 90% of treated subjects have reached the 3, 6, 9 and 12 month visits, 
respectively. These analyses will only include refractive stability criteria evaluation. 
Interim analyses will not be disseminated to investigators/site personnel.  
20.6 
SAMPLE SIZE CALCULATIONS 
OVERALL STUDY SAMPLE SIZE 
Per ANSI Z80.11-2012, Annex E, the sample size calculation is to be based on the 
probability of observing an adverse event at a rate greater than or equal to the expected 
rate but less than or equal to an acceptable target. This study will be powered to detect 
the percentage of eyes losing 2 or more lines of BSCVA at 3 months. In the approved 
indication for the original STAR S4 IR System Myopia clinical study (PMA P930016-
S016, approved 05/23/03), the percentage of eyes losing 2 or more lines of BSCVA at 
3 months was 0.3% (1/318, 95% exact CI (0.00%, 1.7%)). The target rate will be chosen 
to assure that the proposed study will be able to detect at least the upper limit of the 
exact 95% confidence interval. 
The hypothesis is 
Ho: 
target
p
ptrt 
 
H1: 
target
trt
p
p

 
where  
trt
p
 =   Estimate of the percentage of eyes losing 2 or more lines of BSCVA at 
3 months using the STAR S4 IR and iDesign System 
target
p
=  Expected percentage of eyes losing 2 or more lines of BSCVA at 
3  months per previously approved PMA P930016-S016 
 
Using the binomial distribution with an alpha of 0.05, 80% power and a sample size of 
n=300 eyes, a rate of at least 1% can be detected.  Adding 15% for loss due to attrition 
yields a sample size of 340 eyes. Adding 10% for loss due to attrition yields a sample 
size of 334 eyes (167 subjects) to be treated in order to achieve 300 evaluable eyes at 

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the point of refractive stability. Adding an additional 50% to account for screen failures 
allows approximately 334 subjects to be enrolled. 
CONTRAST SENSITIVITY SUBSTUDY SAMPLE SIZE  
The sample size calculation for the sub-study is based on ANSI guidance (ANSI Z80.11) 
using non-inferiority approach. With a sample size is 65, a paired t-test with a 0.05 one-
sided significance level will have over 90% power to detect the paired difference in mean 
contrast sensitivity is no less than 0.15 below zero when the expected mean difference 
is 0, assuming the non-inferiority margin equals 0.15 and the the standard deviation of 
the differences is 0.40.

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APPENDIX A   SUMMARY OF PROCEDURES REQUIRED AT EACH VISIT 
 
Preop  
Op 
1 Day 
1 Wk  
1 Mo 
3 Mo 
6 Mo 
9 Mo 
12 Mo/ET 
Unsched.3 
Examination 
Note: 1 month = 4 weeks, 1 week = 7 days 
Days 
-120 to 01 
Day 
0 
Days 
 1-2 
Days 
5-8 
Weeks 
3-6 
Weeks 
10-14 
Weeks 
20-26 
Weeks 
35-43  
Weeks  
44-60  
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
Ocular and systemic medical history and concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Inclusion/Exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
Ocular/Visual Symptoms (Non-directed)8 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PRVSQ, OSDI, NEI-RQL-42 and Satisfaction7 PRO Questionnaires 
X 
 
 
X9 
X 
X9 
X 
X 
X 
X3 
iDesign System Measurement of refraction, aberrometry, topography, 
keratometry, pupillometry  
X 
 
 
 
X 
X 
X 
X 
X 
X (after 1 week) 
Keratometry (iDesign and auto or manual) 
X 
 
 
 
X 
X 
X 
X 
X 
X 
Corneal topography (Humphrey/ Zeiss Atlas or Pentacam) 
X 
 
 
 
X 
X 
X 
X 
X 
X 
UCVA-photopic, monocular, distance (ETDRS) 
X 
 
X 
X6 
X 
X 
X 
X 
X 
X (after 1 week) 
UCVA-photopic, binocular, distance (ETDRS) 
X 
 
 
X6 
X 
X 
X 
X 
X 
 
Manifest Refraction (ETDRS)  
X 
 
 
 
X 
X 
X 
X 
X 
X 
BSCVA- photopic, monocular, distance (ETDRS) 
X 
 
 
 
X 
X2 
X2 
X2 
X2 
X2 
Contrast sensitivity substudy (monocular distance corrected) 
X 
 
 
 
 
X 
X 
X 
X 
X 
Refractive stability assessment for contact lens wearers 
X 
 
 
 
 
 
 
 
 
 
Anterior segment exam (biomicroscopic slit-lamp exam) 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
Schirmer I Tear Test (with anesthetic) 
X 
 
 
 
X 
X 
X 
X 
X 
X 
Intraocular pressure (applanation tonometry) 
X 
 
 
 
X 
X 
X 
X 
X 
X 
Pachymetry (ultrasound) 
X 
 
 
 
X 
 
 
 
X 
X 
Cycloplegic refraction 
X 
 
 
 
 
 
X 
 
X 
X 
Bilateral PRK Surgery 
 
X 
 
 
 
 
 
 
 
 
Dilated fundus exam 
X 
 
 
 
 
 
X 
 
X 
X 
Complications5 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse events (Ocular2/Non-Ocular) 
X4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Device deficiencies/complaints 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
1 All screening assessments should be performed prior to surgery. The screening period is the 120 days before surgery, up to and including the day of surgery.  
2 At 3 months or later, if there is a loss of 2 or more lines of BSCVA (≥ 10 letters) compared to the preoperative visit, a rigid contact lens over refraction (or pin hole acuity if rigid 
contact lens over refraction is medically inadvisable) should be performed to estimate the best poss ble corrected visual acuity. 
3 At the investigator’s discretion for unscheduled visits based on the reason for the unscheduled visit. Subject seen at an unscheduled visit due to an ocular visual symptom 
complaint should complete the PRVSQ, OSDI, and NEI-RQL. 
4 Adverse event collection begins after informed consent. 
5 As determined by slit lamp findings and patient reported outcomes questionnaires. 
6 Examinations should be performed after removal of the bandage contact lens (if re-epithelized). 
7 Two exploratory Satisfaction PROs will be administered (Pre-Op and then all other time points).  
8 Non-directed responses are obtained from asking the open-ended question “Are you having any difficulties with your eyes or vision?” 
9 For instrument validation purposes the PRVSQ will be the only PRO conducted at week 1. At M3 the PRVSQ will be given a second time at 3M + 7 days for reliability validation. 
Note: Non-directed responses to the open-ended question “Are you having any difficulties with your eyes or vision?”, followed by all patient reported outcome questionnaires,  
followed next by the iDesign measurement are to be obtained first in that order before any other ocular examinations. All non-contact procedures (e.g. topography and 
keratometry) are to be performed before contact assessments (e.g. IOP and pachymetry). Cycloplegic refraction/fundus exam are to be the final procedures.   

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APPENDIX B   EQUIPMENT LIST 
The following equipment may be supplied to an investigative site for the duration of the 
study provided that the site does not already have such equipment available for use.  
This equipment loan will be documented in the Cooperative Research and Development 
Agreement (CRADA) CRADA, which indicates that the equipment is to be returned to 
Abbott Medical Optics at the completion of the study. 
 
iDesign Advanced WaveScan Studio System 
 
One Vector Vision CSV-1000 ETDRS visual acuity light box, stand  
 
Three Vector Vision ETDRS 4.0 meter distance charts (100% contrast)  
 
Vector Vision Contrast Sensitivity charts 
 
Light Meter 
 
Tape measure (meters) 
 
Trial lenses 
 
 
 

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APPENDIX C 
MANUAL OF TESTING PROCEDURES  
Anterior Segment Examination shall be performed via biomicroscopic slit-lamp exam 
for determination of anterior segment medical findings including but not limited to the 
adnexa, conjunctiva, sclera, cornea, and iris. The cornea should be examined in detail 
and corneal clarity should be graded based on the scale in Appendix J.  Any 
abnormalities such as corneal infiltrates or opacities, and degree of re-epithelialization 
should be recorded.  
BSCVA (Best Spectacle Corrected Visual Acuity) shall be measured using the Vector 
Vision 100% contrast ETDRS charts with the Vector Vision self-calibration, backlit light 
box at a test distance of 4 meters and calibrated to a photopic luminance of 85 cd/m2 
(80-110 cd/m2).  The ambient room lighting shall be set from dim to dark illumination. 
BSCVA testing is to be performed with the ETDRS 4.0-meter manifest refraction in 
place; no refractive adjustment is necessary for BSCVA measurement. Detailed 
instructions for performing BSCVA testing are provided in Appendix E. A conversion 
chart for distance visual acuity testing between the number of correctly-read ETDRS and 
Snellen/Decimal acuity is provided in Appendix D.   
Contrast Sensitivity shall be measured with the Vector Vision CSV 1000 at 8 feet 
under mesopic lighting conditions with and without glare and under photopic conditions 
without glare at spatial frequencies of 1.5, 3, 6, 12 and 18 cpd.  See Reference 
Appendix N for full instructions. 
Corneal Topography shall be measured with the iDesign System and a Scheimpflug 
(Pentacam) or Placido (Humphrey/ Zeiss Atlas) disk-based system.  Images will be 
retained by the Investigator.  
Cycloplegic Refraction shall be performed at least 30 minutes following installation of 
1-2 drops of cyclopentolate 1% or tropicamide 1% to determine the subject’s refraction 
without accommodation.   
Dilated Fundus Examination shall be performed following installation of mydriatic 
agents approximately 30 minutes prior to determine the status of the ocular media, retina 
and lens.   
iDesign Advanced WaveScan Studio System measures the refractive error and 
wavefront aberrations of the human eye using a Hartmann-Shack wavefront sensor. 
Preoperatively, a minimum of three measurements shall be taken to allow the iDesign 
system to select the exam for use in the generation of the treatment profile; a minimum 
wavefront diameter of 4.0 mm for preoperative measurements is required.  
Postoperatively, at least one measurement is required at designated study exams. Every 

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effort shall be made to obtain measurements with the largest wavefront diameter 
possible at each visit. 
Schirmer I Tear Test (with anesthetic) is to be performed before applanation 
tonometry, ultrasonic pachymetry and other procedure that may irritate the cornea. See 
Appendix M for instructions on how to perform the Shirmer I Tear Test. 
Intraocular pressure is to be measured using applanation tonometry and is to be 
performed after manifest refraction, vision tests, keratometry, topography, aberrometry, 
and biomicroscopy. 
Keratometry (not simulated K) shall be conducted using the iDesign System and an 
auto or manual keratometer.  The same keratometry method is to be used at each 
required visit, e.g., if auto keratometry was recorded at the preoperative exam, all 
postoperative keratometry readings should be auto K’s.  Do not use “sim K” from a 
corneal topography unit other than the iDesign system.  
Lighting levels and lane calibration will be assessed by a representative of the 
Sponsor to ensure the lane length and lighting conditions are consistent across sites. 
The site or Sponsor designee will verify ambient room lighting is dim to dark illuminance 
with photopic chart background luminance level of 85 cd/m2 (80-110 cd/m2) with a light 
meter at least annually during the active enrollment and follow-up period. Verification of 
the chart luminance level will be done. 
Manifest Refraction is to be performed using the phoropter or trial frames and the 
100% ETDRS charts and the self-calibrating, backlit box at a distance of 4.0 meters and 
calibrated to a photopic luminance of 85 cd/m2 (80-110 cd/m2).  The ambient room 
lighting shall be set from dim to dark illuminance. Manifest refraction is to be performed 
using the Maximum Plus refraction method as detailed in Appendix E.  Because 4.0 
meters is not optical infinity, refraction adjustments are necessary for some vision tests 
to ensure proper vision testing taking into account test distance and the ETDRS 
refraction distance (4 m).  Appendix G lists the refraction adjustments required for the 
various different vision tests using the ETDRS 4.0-meter refraction. 
Ocular Surface Disease Index (OSDI) is a 12-question patient reported outcomes 
(PRO) instrument designed to measure severity of dry eye symptoms. 
Patient Reported Visual Symptom Questionnaire (PRVSQ) (2015 version for 
PRK/LASIK) is a self-administered, questionnaire designed to measure patient reported 
occurrence and level of bother related to ocular visual symptoms. Severity of patient 
reported ocular visual symptoms area also assessed under different situations including 
with and without correction and under mesopic conditions. 

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National Eye Institute Refractive Error Quality of Life Instrument – 42 (NEI-RQL-42) 
(2001 version) is a self-administered assessment tool designed specifically for those 
who through correction of refractive error have normal visual acuity, but may still be 
experiencing problems in vision-related functioning and well-being. The NEI-RQL 
questionnaire is to be administered before any other visual assessment or exam both 
preoperatively and at designated postoperative study exams.  
Pachymetry to measure the central corneal thickness shall be performed with an 
ultrasonic pachymeter preoperatively and postoperatively as described in Appendix A. 
Photopic Luminance is defined as 85 cd/m2 (acceptable range of 80-110 cd/m2).  
Mesopic Pupil Size shall be measured using the iDesign System. 
Refractive Stability (preoperative) is defined as a change of ≤1.00 D in MRSE (based 
on a previous exam, medical records, lensometry or prescription) at least 12 months 
prior to the preoperative manifest refraction.  
Refractive Stability Check for Contact Lens Wearers is based on a change of not 
more than 0.50 D in manifest refractive sphere and cylinder as well as keratometric 
meridian (either axis) between 2 separate measurements at least 7 days apart with 
readings following cessation of contact lens wear of 4 weeks for rigid contact lenses 
(toric or spherical) and 2 weeks for soft contact lenses (toric or spherical). 
iDesign Treatment Planning is required prior to the operative exam.  All eyes will be 
targeted for emmetropia and undergo a “Surface PRK” treatment.  The iDesign System 
will be used to create a treatment shape for each eye that qualifies for the study.  The 
iDesign software used in this study is Version 1.3, in international configuration, with no 
physician adjustments.   
UCVA (Uncorrected Visual Acuity) shall be measured using the Vector Vision 100% 
contrast ETDRS charts with the Vector Vision self-calibration, backlit light box at a test 
distance of 4 meters and calibrated to a photopic luminance (80-100 cd/m2)  The 
ambient room lighting shall be set from dim to dark illuminance. UCVA testing is to be 
performed through a +0.25 D trial lens refractive adjustment to compensate for optical 
infinity.  Detailed instructions for performing UCVA testing are provided in Appendix H. 
A conversion chart for distance visual acuity testing between the number of correctly-
read ETDRS and Snellen acuity is provided in Appendix D.   

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APPENDIX D   CONVERSION CHARTS FOR VECTOR VISION CHARTS 
Conversion Reference Chart for Vector Vision Distance Chart at 4.0 Meters 
 
Standard 
Snellen 
 
20/___ 
(Decimal) 
Number of 
Letters 
Read At 
4 Meters  
(13 Feet) 
 (ETDRS) 
 
Standard 
Snellen 
 
20/___ 
(Decimal) 
Number of 
Letters 
Read At 
4 Meters  
(13 Feet) 
 (ETDRS) 
10 
55 
 
87 
8 
10 
54 
 
91 
7 
11 
53 
 
96 
6 
12 
52 
 
100 (Decimal 0.2) 
5 
12 
51 
 
105 
4 
13 
50 
 
110 
3 
13 
49 
 
115 
2 
14 
48 
 
121 
1 
14 
47 
 
126 
0 
15 
46 
 
 
 
16 
45 
 
 
 
17 
44 
 
 
 
17 
43 
 
 
 
18  
42 
 
 
 
19 
41 
 
 
 
20 (Decimal 1.0) 
40 
 
 
 
21 
39 
 
 
 
22 (Decimal 0.9) 
38 
 
 
 
23 
37 
 
 
 
24 
36 
 
 
 
25 (Decimal 0.8) 
35 
 
 
 
26 
34 
 
 
 
28 
33 
 
 
 
29 (Decimal 0.7) 
32 
 
 
 
30 
31 
 
 
 
32 
30 
 
 
 
33 (Decimal 0.6) 
29 
 
 
 
35 
28 
 
 
 
36 
27 
 
 
 
38 
26 
 
 
 
40 (Decimal 0.5) 
25 
 
 
 
42 
24 
 
 
 
44 
23 
 
 
 
46 
22 
 
 
 
48 
21 
 
 
 
50 (Decimal 0.4) 
20 
 
 
 
53 
19 
 
 
 
55 
18 
 
 
 
58 
17 
 
 
 
60 
16 
 
 
 
63 
15 
 
 
 
66 (Decimal 0.3) 
14 
 
 
 
69 
13 
 
 
 
73 
12 
 
 
 
76 
11 
 
 
 
80 
10 
 
 
 
83 
9 
 
 
 

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APPENDIX E    MAXIMUM PLUS MANIFEST REFRACTION TECHNIQUE 
WITH CYLINDER REFINEMENT  
Manifest refraction testing will be performed using a self-illuminating light box calibrated 
to a photopic luminance of 85 cd/m2 (80-100 cd/m2) and 100% contrast ETDRS charts 
designed for 4.0 meters. The ambient room lighting shall be set to dim to dark 
illuminance.  NOTE: Objective refraction by iDesign measurement must be used as 
a starting point for the Manifest Refraction.  Always ensure that the endpoint of 
refraction is maximum plus (or minimum minus) power that yields maximum visual 
acuity. 
1) Occlude the fellow eye. 
2) Place the iDesign system (4 mm Rx Calc) sphere (adjusted to 4 meters) and  
cylinder power and axis from the iDesign exam (vertex distance at 12.5mm) selected 
for treatment in the phoropter or trial frame 
3) SPHERE: Starting with the objective refraction, refine the sphere to yield best visual 
acuity. 
4) CYLINDER AXIS: Refine cylinder with a cross-cylinder and the objective cylinder 
refraction as the starting point.  Refine axis first and power second, since the correct 
axis can be found with an incorrect power, but the correct power cannot be found 
with an incorrect axis.  
a. Direct the subject’s attention to 1 line above (larger letters) the best visual acuity.  
With the trial cylinder (axis and power) in the phoropter, introduce cross-cylinder 
for axis refinement.  When asking the subject which cross-cylinder axis position 
is better, “one or two?”, remind the subject to look at different letters on the line 
and report preference based on the overall clarity of the letters.  
b. Refine the axis based on the subject’s responses, using small steps (less than 
five degrees), until the subject reports no difference in the two choices. 
5) CYLINDER POWER: Set the cross cylinder to refine cylinder power and present 
choices to the subject, remind the subject to look at different letters on the line and 
report preference based on overall clarity of the letters.  Reduce or increase trial 
cylinder power accordingly.  
a. Maintain the spherical equivalent throughout cylinder power refinement by 
adjusting the sphere once for every two clicks of cylinder power change. 
6) SPHERE CHECK: Introduce fogging lens (typically +0.75D sphere) and reduce in 
0.25D steps until visual acuity shows no improvement.  

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APPENDIX F    CYCLOPLEGIC REFRACTION TECHNIQUE  
The baseline refraction and the amount of accommodation that the subject habitually 
employs can only be determined by refracting with and without cycloplegia. The chief 
benefit of cycloplegia, therefore, is that it reduces accommodation so that the examiner 
can make an accurate measurement of the refraction in the un-accommodative state. By 
comparing this result with a manifest refraction, the true refractive state of the eye and 
the accommodative tone can be established.  
There are two pieces of information that are available from the cycloplegic examination 
that cannot be deduced from the manifest refraction alone: 
 
the magnitude of the refractive error free from the influence of accommodation 
and, 
 
the extent to which the accommodative tone influences the refractive state. 
The following cycloplegic refraction technique is to be used throughout the study:   
1. Instill 1-2 drops of cycloplegic agent (cyclopentolate 1% or tropicamide 1%) and wait 
at least 30 minutes to allow for a full cycloplegic effect. 
2. Start with the Manifest Refraction (maximum plus; refined from the objective iDesign 
measurement). 
3. Refine the sphere magnitude so the least minus yields the most letters. It is required 
that you do not refine the cylinder axis or the cylinder power. 
 
 
 

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APPENDIX G   REFRACTION ADJUSTMENTS 
Postoperative study manifest refractions are to be performed using the 100% ETDRS 
charts at a distance of 4.0 meters.  Because 4.0 meters is not optical infinity, refraction 
adjustments are necessary to ensure proper vision testing taking into account test 
distance and refraction distance.  The adjustment required (in diopters) is 1/test distance 
(in meters).  To adjust a 4.0-meter manifest refraction to optical infinity, -0.25 D is to be 
added to the sphere of the refraction to obtain a true distance (infinity) correction.  When 
testing uncorrected visual acuity at 4.0-meters a +0.25 D sphere is required.  In the case 
where the manifest refraction distance (4.0 meters) and the vision test distance 
(4.0 meters) are the same, no adjustment is necessary.  The following table lists the 
refraction adjustments required for the various vision tests in this study: 
 
Refraction Adjustments for Vision Testing 
 
Vision Test 
Test 
Distance 
Correction/Adjustment 
Uncorrected distance visual acuity (UCDVA) 
4.0 m 
+0.25 D adjustment only 
Best corrected distance visual acuity (BCDVA) 
4.0 m 
No adjustment; ETDRS Rx only 
Best corrected contrast sensitivity 
8.0 ft  
(2.5 m) 
+0.12 D added to ETDRS sphere Rx 
 
 
 

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APPENDIX H   INSTRUCTIONS FOR USE OF VECTOR VISION ETDRS 
DISTANCE VISUAL ACUITY CHART 
Distance visual acuity testing will be performed using the Vector Vision CSV-1000 
retroilluminated light box and 100% contrast ETDRS (Early Treatment Diabetic 
Retinopathy Study) distance charts at a test distance of 4.0 meters (13 feet).  All 
subjects will be tested both uncorrected monocularly and binocularly, it is recommended 
that monocular testing be completed before binocular testing. 
The CSV-1000 light box is self-illuminated and self-calibrates to a light level of 85 cd/m2 
(a range of 80-110 cd/m2 is acceptable). Room lighting is to be set lower than the 
illumination from the light box, per the manufacturer’s instructions.  Ambient illuminance 
should be from dim to dark to maximize pupil size.  No surface (including reflective 
surfaces) within the subject’s field of vision should exceed the chart background in 
luminance. 
The light box must be placed 4.0 meters from the subject for testing distance visual 
acuities.  Reverse charts are available for rooms that require “folding” via a mirror to 
reach a distance of 4.0 meters.  Whether standard or “folded,” if the room set-up does 
not allow the chart to be placed precisely at 4.0 meters, record the actual test distance 
used (e.g., 3.9 meters), and visual acuity measurements will be mathematically adjusted 
by AMO for the actual test distance used. 
Refraction adjustments should be used as necessary for the 4.0 meters visual 
acuity test distance.  As manifest refractions are to be performed using the ETDRS 
chart at 4.0 meters, no adjustment is required to the refraction when testing BCDVA at 4 
meters.  However, as 4 meters is not optical infinity, an adjustment of +0.25 D sphere is 
required to test UCDVA at 4 meters (1/test distance in meters = adjustment in diopters). 
To test subjects monocularly, occlude the fellow eye in the phoropter or with an occluder 
(if trial lenses are used).  To measure visual acuity, subjects should be instructed to start 
with the smallest line where they can read all of the letters. If they miss any letters, go up 
a line until they are able to read all the letters on a line, then continue to read each 
subsequently smaller line. The subject should be encouraged to read as many letters 
possible, even if they have to guess. Testing may be stopped when it is evident that no 
further readings can be made.  Record the total number of letters read correctly on the 
chart.  Score sheets similar to the example below will be provided for the study.  To 
score the visual acuity, draw a line through each letter missed (or circle letters read 
correctly) and then tally the total number of letters correctly read.  Scoring sheets must 
be used and retained as source documentation.  A conversion chart is provided on 
the scoring sheet for reference between the number of correctly-read ETDRS letters and 
Snellen equivalents. (Appendix D).  

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TO AVOID MEMORIZATION:  charts will be changed between visual acuity tests. 
 
Example of ETDRS Score Chart 
ETDRS 
Chart #1 
Line 
 
 
 
 
 
RUNNING 
TOTAL 
NUMBER 
READ 
1 
N 
C 
K 
Z 
O 
5 
 
2 
R 
H 
S 
D 
K 
10 
 
3 
D 
O 
V 
H 
R 
15 
 
4 
C 
Z 
R 
H 
S 
20 
 
5 
O 
N 
H 
R 
C 
25 
 
6 
D 
K 
S 
N 
V 
30 
 
7 
Z 
S 
O 
K 
N 
35 
 
8 
C 
K 
D 
N 
R 
40 
 
9 
S 
R 
Z 
K 
D 
45 
41 
10 
H 
Z 
O 
V 
C 
50 
 
11 
N 
V 
D 
O 
K 
55 
 
 
 
 

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APPENDIX I    
INSTRUCTIONS FOR KERATOMETRY  
Every effort should be made to obtain keratometry readings from the iDesign system at 
every visit in addition to auto and/or manual keratometry. Keratometry must be 
performed prior to dilation and any contact with the cornea (e.g., tonometry or 
pachymetry) as follows: 
1. Measure keratometry using the iDesign System and also perform an auto or manual 
keratometry reading. If possible use the same method at each required visit, e.g., if 
auto keratometry was recorded at the preoperative exam, all keratometry readings 
postoperatively should be auto K’s in addition to those from the iDesign system. 
2. Do not use “sim K”s from a corneal topography unit.  
3. Always record the flat meridian (smaller number, e.g., 42.25) as K1. Record the 
steeper meridian (larger number, e.g., 43.00) as K2 along with the corresponding 
axis (e.g., 42.25 / 43.00 x 165).  
4. Record spherical corneas by placing the corneal curvature values in both K1 and K2 
and marking axes 180 attached to K2 (e.g., 44.00 / 44.00 x 180). Spherical Ks will 
not be accepted with axes other than 180 (do not use 0). 
 
 

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APPENDIX J   SLIT-LAMP EXAM GRADING SCALE 
A.  Corneal Clarity 
Below is the grading scale to be used for corneal clarity: 
Grade 
Description 
0.0 
Clear 
0.5 
Faint/trace haze 
1.0 
Mild haze, not affecting refraction 
2.0 
Moderate haze, refraction possible 
3.0 
Dense haze/ prevents refraction, AC visible 
4.0 
Dense haze/AC not visible 
 
 
 
 
 
 

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APPENDIX K 
PRK SURGICAL PROCEDURE 
The following steps represent a typical PRK surgical procedure and should be used as a 
standard model.  Both eyes will be treated on the same day provided that treatment of 
the first eye is without an adverse event or clinically significant surgical complication.  
1. Standard preoperative preparation and intraoperative medications will be used.  
2. Activate the recording device (e.g., DVD recorder) and begin video acquisition of the 
subjects procedure. 
3. After anesthesia and placement the lid speculum, an Amoils Epithelial Scrubber 
(Innova, Inc., Toronto, Ontario, Canada) with a 9.0 mm brush will be used to remove 
the corneal epithelium prior to laser treatment. 
4. Ensure magnification on the operating microscope is 1.6X. Ensure the subject’s pupil 
is centered in the reticle as the subject is fixating on the fixation LED. Focus on the 
anterior stromal surface. 
5. Remind patient to fixate on flashing LED, activate ActiveTrak and Iris Registration on 
the STAR S4 IR Excimer Laser System.  
6. Confirm proper placement of the outer iris boundary (OIB). 
7. After ensuring that the reticle is centered over the subject’s pupil and the subject is 
viewing the fixation light, fully depress the foot pedal to perform the laser treatment. If 
necessary, stop the laser and dry the cornea if there is fluid accumulation. 
8. Apply mitomycin C 0.01% for 15 seconds immediately after the ablation.   
9. Rinse the stromal surface with 30 cc of balanced salt solution.  
10. Instill ophthalmic antibiotic QID for 1 week, fluorometholone 0.1% for 8 weeks (QID 
initially and tapering 1 drop every 2 weeks starting at week 3) and analgesic as 
needed. Continued use beyond these guidelines is allowed if medically necessary.  
11. A bandage contact lens will be placed on the operated eye.  
12. Note the treatment time, whether the eye tracker lost track of the eye at any time 
during the procedure. Record environmental conditions (temperature and humidity.) 
13. Print the STAR S4 IR Operative Report. 
14. Note any adverse events or complications that occurred during treatment. Report 
any adverse events to the Sponsor. 
15. Patients will receive antiemetics, pain medication, and lubrication at the discretion of 
the investigator. 
 

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APPENDIX L   ADVERSE EVENT AND COMPLAINT REPORTING 
INSTRUCTIONS 
All adverse events and complaints related to using AMO products must be reported to 
AMO.   
ALL ADVERSE EVENTS AND COMPLAINTS: 
For events that are not considered serious or related to the study device: 
1. Record the event and/or complaint on the case report form that corresponds to 
the visit during which awareness of the event occurred.  Additionally, a complaint 
may be reported via a telephone call to AMO. 
2. Ensure the data are submitted to AMO electronically within a timely manner.  
SERIOUS ADVERSE EVENTS OR DEVICE DEFICIENCIES THAT MAY HAVE LED TO 
A SERIOUS EVENT 
In the event of a serious event (i.e., life- or sight-threatening incident) whether or not 
related to the device, or a device deficiency that may have led to a serious event, the 
investigator shall: 
1. Notify AMO immediately (no more than 48 hours after learning of the event) as 
follows:  
a. Contact the following AMO personnel by phone: 
  
 
 
b. Complete a Detailed Adverse Event Form and submit electronically to AMO 
 
NON-SERIOUS, DEVICE-RELATED EVENTS: 
For events that are not considered serious but are believed related to the study device 
(ADEs): 
1. Complete a Detailed Adverse Event Form 
2. Ensure the data are submitted to AMO electronically within a timely manner.  
 
 
 
 

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APPENDIX M   SCHIRMER I TEAR TEST (WITH ANESTHETIC)  
Prepare the strips while they are still in the package by folding the rounded end at the 
indentation, approximately 5 mm from the tip. Open the plastic package and remove the 
strip for the right eye, holding the strip by the square-cornered end. Instill topical 
anesthetic solution into both eyes, wait for a few minutes for the drops to dissipate, and 
then insert the strips. Ask the patient to look up, gently retract the lower lid, and insert 
the strip into the inferior cul-de sac, placing the fold at the lid margin. Position the strip so 
that it is at the lateral third of the eyelid with the longer end hanging downward over the 
lower eyelid. As the strip is inserted, avoid touching any part of the eye. After inserting 
the remaining strip into left eye, the patient may gently close the eyes. Alternatively the 
patient may blink as desired but should avoid forceful lid closure. Dim the lights in the 
room to enhance patient comfort. 
Leave the strips in place for 5 minutes or until the strips are completely wet, whichever 
occurs first. Ask the patient to look up, remove the strips from the inferior cul-de-sac, and 
measure the length of each strip that has been wetted by the tears, beginning the 
measurement at the notch. A measuring guide is found on the Schirmer strip package. A 
template of the strip next to the guide allows for accurate measurement of the amount of 
strip wetting. Alternatively, a millimeter rule may be used to measure the length of the 
strip wetted by the tears. 
Interpretation 
A normal eye will wet between 10 and 30 mm of the strip and a severe dry eye will be 
wet less or equal to ≤ 5 mm in 5 minutes when the Schirmer I is performed. 
Note: 
Schirmer tear tests are performed before applanation tonometry or any other procedure 
that may irritate the cornea. If the topical ophthalmic anesthetic is not allowed to 
dissipate before inserting the strips, the amount of tears in the eye may be 
overestimated. 
 

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APPENDIX N   INSTRUCTIONS FOR MONOCULAR CONTRAST SENSITIVITY 
TESTING USING THE VECTOR VISION SYSTEM 
Monocular contrast sensitivity on the subject’s first eye with the best distance correction 
in place (with refraction adjustment of +0.12 D added to the ETDRS refraction) will be 
measured using the Vector Vision self-illuminated light box and the Vector Vision 
Contrast Sensitivity charts, which contain a series of sine-wave gratings.  The 
CSV-1000E chart tests four different spatial frequencies: A = 3 cycles/degree (cpd), 
B = 6 cpd, C = 12 cpd, and D = 18 cpd; whereas the CSV-1000-1.5CPD chart tests only 
one spatial frequency: E = 1.5 cpd. The test distance is 8 feet (2.5 meters).   
Contrast sensitivity will be tested under mesopic conditions with and without glare (1.5, 
3, 6 and 12 cycles per degree) and photopic conditions without glare (3, 6, 12 and 
18 cycles per degree).   
A trial reading with the subject should be done prior to recording the testing data to 
ensure subject understanding of the test procedure. 
Monocular contrast sensitivity testing will be measured with the subject’s best distance 
correction (with a refraction adjustment of +0.12 D added to the sphere of the ETDRS 
refraction) in front of the eye being tested with the other eye occluded.   
To measure monocular contrast sensitivity using the CSV-1000E chart, subjects are to 
identify which circle in each vertically-aligned circle set (1-8) contains the sine-wave 
pattern.  The reference pattern for each spatial frequency is provided under the spatial 
frequency designation (A, B, etc.) on the chart.  A similar pattern appears in either the 
top or bottom of each paired circle set, getting fainter and harder to see with each 
subsequent circle set.  Subjects should be instructed to identify whether the top circle, 
bottom circle, or neither circle in each circle set contains the pattern.  The subject should 
be prompted until no difference can be determined between the two circles in each set.  
Any incorrect response(s) prior to no difference being detected should be retested. For 
example, if a subject detects no difference at number 7, but responded incorrectly at 
number 4, the subject should be retested starting at number 3.  After retesting, the 
number corresponding to the last correct response in a paired circle set is the score for 
that spatial frequency.  If the subject is unable to see the reference pattern under the 
letter, then the score for that spatial frequency is zero.  If the subject is able to see the 
reference pattern under the letter, but cannot identify any pattern in circle sets 1-8, then 
the score for that spatial frequency is the spatial frequency designation (A, B, etc.).  
Note that the circle sets on the Vector Vision CSV-1000-1.5CPD chart are oriented side-
by-side instead of being vertically aligned, so subjects should be instructed to identify 
whether the right circle, left circle or neither circle contains the pattern for this chart.  

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NOTE: Spatial frequency testing is to be performed twice under each lighting 
condition.  Score sheets must be retained as source documentation.  
Mesopic testing without glare should be performed first, followed by mesopic testing with 
glare and lastly photopic testing without glare. 
MESOPIC TESTING:  Ensure room lighting is set to the proper level; typically all room 
lights are off or dimly lit with the exam-room door closed.  In addition, the subject must 
view the test through the neutral density filter lenses, which will reduce the amount of 
illumination in the room to approximately 2.5 cd/m².  After a recommended 10-minute 
adaptation period, mesopic testing may be performed.  First use the CSV-1000-1.5CPD 
chart to test the spatial frequency of 1.5 cycles per degree.  Then use the CSV-1000E 
chart to test the spatial frequencies of 3, 6 and 12 cycles per degree.  (Testing at 18 cpd 
is not required for mesopic testing). Repeat mesopic testing without glare, and then 
perform and repeat mesopic testing with glare.   
PHOTOPIC TESTING:  Following mesopic testing, photopic testing without glare is to be 
performed and repeated.  Room lighting should be set as low as possible with the 
majority of illumination from the light box.  The illumination from the box is automatically 
calibrated at 85 cd/m2, but should be confirmed with the light meter (a range of 80-110 
cd/m2 is acceptable).  Continue to use only the CSV-1000E chart test face to test the 
spatial frequencies of 3, 6, 12 and 18 cycles per degree.