Clinical Investigation of the WaveLight® EX500 Excimer Laser for Hyperopic LASIK
Phase: NA
Conditions: Hyperopia, Hyperopic Astigmatism
Sponsor: Alcon Research

 
 
 
 
 
Clinical Investigation of the WaveLight® EX500 Excimer 
Laser for Hyperopic LASIK 
 
 
STUDY ID:  
RFD530‐P001 
 
 
PROTOCOL 
 
 
NCT04805593 

Document ID: 
V-CLN-0000451 
Status: Approved, Version: 2.0 
Approved Date: 26 Mar 2021 
Page 1 of 67 
 
Alcon – Business Use Only 
 
Device Protocol for RFD530-P001 
Title: Clinical Investigation of the WaveLight® EX500 Excimer Laser for 
Hyperopic LASIK 
 
Protocol Number: 
RFD530-P001 
Development Stage of 
Project: 
Product Support 
Sponsor Name and 
Address: 
Alcon Research, LLC and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
Test Product: 
WaveLight® EX500 excimer laser system 
 
 
 
Property of Alcon 
Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of Alcon 

Document ID: 
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Status: Approved, Version: 2.0 
Approved Date: 26 Mar 2021 
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Investigator Agreement: 
• I have read the clinical study described herein, recognize its confidentiality, and agree 
to conduct the described trial in compliance with Good Clinical Practice (GCP), the 
ethical principles contained within the Declaration of Helsinki, this protocol, all 
applicable regulatory authority regulations, and conditions of approval imposed by the 
reviewing IRB or regulatory authority. 
• I will supervise all testing of the device involving human subjects and ensure that the 
requirements relating to obtaining informed consent and IRB review and approval are 
met in accordance with applicable local and governmental regulations. 
• I have read and understand the appropriate use of the investigational product(s) as 
described in the protocol, current Investigator’s Brochure, product information, or other 
sources provided by the Sponsor. 
• I understand the potential risks and side effects of the investigational product(s). 
• I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection. 
• I agree to comply with all other requirements regarding the obligations of clinical 
Investigators and all other pertinent requirements of the Sponsor and government 
agencies. 
• I agree to ensure that all associates, colleagues, and employees assisting in the conduct 
of the study are informed of their obligations in meeting the above commitments. 
Have you ever been disqualified as an Investigator by any Regulatory Authority? 
 No        Yes 
Have you ever been involved in a study or other research that was terminated? 
 No        Yes 
If yes, please explain here: 
 
 
Principal Investigator: 
 
Signature 
 
 
 
 
 
Date 
Name and professional 
position: 
 
Address: 
 
 
 

Document ID: 
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Approved Date: 26 Mar 2021 
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Table of Contents 
Device Protocol for RFD530-P001 ............................................................................................ 1 
Table of Contents ....................................................................................................................... 3 
List of Tables .............................................................................................................................. 6 
List of Figures ............................................................................................................................ 6 
1 
GLOSSARY OF TERMS .................................................................................................... 7 
2 
LIST OF ACRONYMS AND ABBREVIATIONS ........................................................... 12 
3 
PROTOCOL SUMMARY ................................................................................................. 14 
4 
PROTOCOL AMENDMENTS ......................................................................................... 21 
5 
INTRODUCTION ............................................................................................................. 25 
5.1 
Rationale and Background ................................................................................ 25 
5.2 
Purpose of the Study .......................................................................................... 25 
5.3 
Risks and Benefits ............................................................................................. 26 
6 
STUDY OBJECTIVES...................................................................................................... 26 
6.1 
Primary Objective(s) ......................................................................................... 26 
6.2 
Secondary Objective(s) ..................................................................................... 28 
6.4 
Primary Safety Objective(s) .............................................................................. 28 
6.5 
Refractive Stability ............................................................................................ 29 
7 
INVESTIGATIONAL PLAN ............................................................................................ 30 
7.1 
Study Design ..................................................................................................... 30 
7.2 
Rationale for Study Design ............................................................................... 30 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations ........................................................................................ 31 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 31 
7.4 
Data Monitoring Committee.............................................................................. 31 
8 
STUDY POPULATION .................................................................................................... 31 
8.1 
Inclusion Criteria ............................................................................................... 32 
8.2 
Exclusion Criteria .............................................................................................. 33 
8.3 
Rescreening of Subjects .................................................................................... 34 

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9 
TREATMENTS ADMINISTERED................................................................................... 35 
9.1 
Investigational Product(s) .................................................................................. 35 
9.2 
Other Medical Device or Medication Specified for Use During the Study ...... 36 
9.3 
Treatment Assignment / Randomization ........................................................... 37 
9.4 
Treatment Masking ............................................................................................ 37 
9.5 
Accountability Procedures ................................................................................. 37 
9.6 
Changes to concomitant medications, treatments/ procedures .......................... 38 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 39 
10.1 Informed Consent and Screening ...................................................................... 40 
10.2 Description of Study Procedures and Assessments ........................................... 40 
10.2.1 
Aberrometry ...................................................................................... 41 
10.2.2 
Adverse Event Collection: Safety Assessment .................................. 41 
10.2.3 
Best Corrected Distance Visual Acuity: Efficacy and Safety 
Assessment ........................................................................................ 41 
10.2.4 
Concomitant Medications .................................................................. 41 
10.2.5 
Cycloplegic Refraction ...................................................................... 42 
10.2.6 
Demographics .................................................................................... 42 
10.2.7 
Device Deficiencies: Safety Assessment ........................................... 42 
10.2.8 
Dilated Fundus Examination: Safety Assessment ............................. 42 
10.2.9 
Intraocular Pressure: Safety Assessment ........................................... 42 
10.2.10 Keratometry ....................................................................................... 43 
10.2.11 LASIK Surgery .................................................................................. 43 
10.2.12 Manifest / Subjective Refraction: Efficacy and Safety Assessment .. 43 
10.2.13 Medical History ................................................................................. 43 
10.2.14 Mesopic Pupil Size ............................................................................ 44 
 
 
10.2.17 Slit Lamp Examination: Safety Assessment ...................................... 44 
10.2.18 Topography ........................................................................................ 44 
10.2.19 Uncorrected Distance Visual Acuity: Effectiveness and Safety 
Assessment ........................................................................................ 45 
10.2.20 Urine Pregnancy Test ......................................................................... 45 
10.3 Unscheduled Visits ............................................................................................ 45 
10.4 Discontinued Subjects ....................................................................................... 46 
10.4.1 
Screen Failures .................................................................................. 46 

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10.4.2 
Incomplete Treatments ...................................................................... 46 
10.4.3 
Discontinuations ................................................................................ 46 
10.5 Clinical Study Termination ................................................................................ 47 
10.5.1 
Follow-Up of Subjects After Study Participation Has Ended ........... 47 
10.6 Contingency Measures ...................................................................................... 47 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 48 
11.1 General Information .......................................................................................... 48 
11.2 Monitoring for Adverse Events ......................................................................... 52 
11.3 Procedures for Recording and Reporting .......................................................... 52 
11.4 Return Product Analysis .................................................................................... 54 
11.5 Unmasking of the Study Treatment ................................................................... 55 
11.6 Follow-Up of Subjects with Adverse Events ..................................................... 55 
11.7 Pregnancy in the Clinical Study ........................................................................ 55 
12 ANALYSIS PLAN ............................................................................................................ 55 
12.1 Subject Evaluability........................................................................................... 56 
12.2 Analysis Sets ..................................................................................................... 56 
12.2.1 
Safety Analysis Set ............................................................................ 56 
12.2.2 
Full Analysis Set ................................................................................ 56 
12.3 Demographic and Baseline Characteristics ....................................................... 56 
12.4 Refractive Stability ............................................................................................ 56 
12.5 Effectiveness Analyses ...................................................................................... 58 
12.5.1 
Analysis of Primary Effectiveness Endpoint(s)................................. 58 
12.5.1.1 
Statistical Hypotheses ........................................................ 58 
12.5.1.2 
Analysis Methods .............................................................. 58 
 
 
12.6 Handling of Missing Data ................................................................................. 60 
12.7 Safety Analyses ................................................................................................. 60 
12.7.1 
Analysis of Primary Safety Endpoint(s) ............................................ 60 
12.7.1.1 
Statistical Hypotheses ........................................................ 60 
12.7.1.2 
Analysis Methods .............................................................. 60 
 
 
 
 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 62 

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13.1 Subject Confidentiality ...................................................................................... 62 
13.2 Completion of Source Documents and Case Report Forms .............................. 62 
13.3 Data Review and Clarifications ......................................................................... 63 
13.4 Sponsor and Monitoring Responsibilities ......................................................... 63 
13.5 Regulatory Documentation and Records Retention .......................................... 64 
13.6 Quality Assurance and Quality Control ............................................................. 64 
14 ETHICS ............................................................................................................................. 65 
15 REFERENCES .................................................................................................................. 66 
15.1 References Applicable for All Clinical Studies ................................................. 66 
15.1.1 
US References Applicable for Clinical Studies ................................. 66 
15.2 References For This Clinical Study ................................................................... 67 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 12 
Table 3–1 
Schedule of Study Procedures and Assessments ............................................. 19 
Table 6–1 
Primary Objective(s) ........................................................................................ 26 
 
 
 
 
Table 6–4 
Primary Safety Objective(s) ............................................................................. 28 
 
 
Table 9–1 
Test Product – WaveLight EX500 Excimer Laser System .............................. 35 
Table 9–2 
Procedural Complications ................................................................................ 39 
 
List of Figures 
Figure 11–1 
Categorization of All Adverse Events .............................................................. 49 
 
 
 

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1 
GLOSSARY OF TERMS 
Names of test product(s) 
Throughout this document, test product(s) will be 
referred to as the WaveLight EX500 excimer laser 
system or EX500. 
Name of Control Product(s) 
N/A 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational 
medical device (investigational product) or control 
product. Note: This definition includes adverse events 
resulting from insufficient or inadequate instructions for 
use, deployment, implantation, installation, or 
operation; any malfunction; and use error or 
intentional misuse of the investigational medical device 
(investigational product) or control product. 
Adverse Event (AE) 
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 investigational medical 
device (investigational product). Note: This definition 
includes events related to the investigational medical 
device, comparator, or the procedures involved. For 
users or other persons, this definition is restricted to 
events related to the use of investigational medical 
devices (investigational product) or control product. 
Requirements for reporting Adverse Events in the study 
can be found in Section 11. 
Anticipated Serious Adverse 
Device Effect (ASADE) 
An effect which by its nature, incidence, severity or 
outcome has been identified in the risk assessment. 
Device Deficiency 
Inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, usability, safety, 
or performance. Note: This definition includes 
malfunctions, use errors, and inadequacy in the 

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information supplied by the manufacturer including 
labelling. 
This definition includes device deficiencies related to 
the investigational medical device or the comparator. 
Requirements for reporting Device Deficiencies in the 
study can be found in Section 11. 
Enrolled Subject 
Any subject who signs an informed consent form for 
participation in the study. 
Interventional Clinical Trial 
A research trial that prospectively assigns, whether 
randomly or not, human participants or groups of 
humans to one or more health-related interventions to 
evaluate the effects on health outcomes, and/or a 
research trial in which diagnostic or monitoring 
procedures beyond standard of care are conducted and 
generate outcomes for use in analysis of data.  
Investigational Product 
Is defined as a preventative (vaccine), a therapeutic 
(drug or biologic), device, diagnostic, or palliative used 
as a test or control product in a clinical trial, including a 
product with a marketing authorization when used or 
assembled (formulated or packaged) in a way different 
from the authorized form, or when used for an 
unauthorized indication, or when used to gain further 
information about the authorized form. 
Malfunction 
Failure of an investigational medical device to perform 
in accordance with its intended purpose when used in 
accordance with the instructions for use or clinical 
investigation plan (CIP), or Investigator’s brochure 
(IB). 
Non-serious Adverse Event 
Adverse event that does not meet the criteria for a 
serious adverse event. 

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Postmarketing/Postauthorization 
study 
Any study conducted within the conditions laid down in 
product labelling and other conditions laid down for the 
marketing of the product or under normal conditions of 
use. A postmarketing study falls either within the 
definitions of an interventional or a non- interventional 
study and may also fall within the definition of a 
postapproval study. 
Product Complaints 
Any oral, electronic, or written communication that 
alleges deficiencies related to the identity (labeling), 
quality, durability, reliability, safety, effectiveness, or 
performance of a marketed product, including failure of 
the product, labeling or packaging to meet 
specifications, whether or not the product is related to or 
caused the alleged deficiency. A complaint may allege 
that an adverse event or medical device malfunction has 
occurred. 
Serious Adverse Device Effect 
(SADE) 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Serious Adverse Event (SAE) 
Adverse event that led to any of the following: 
• Death. 
• A serious deterioration in the health of the subject, 
users or other persons as defined by one or more of 
the following:  
a. a life-threatening illness or injury. 
Note: Life-threatening means that the 
individual was at immediate risk of death 
from the event as it occurred, ie, it does 
not include an event which hypothetically 
might have caused death had it occurred 
in a more severe form. 

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b. any potentially sight-threatening event or 
permanent impairment to a body structure 
or a body function including chronic 
diseases. 
c. in-patient hospitalization or prolonged 
hospitalization. 
Note: Planned hospitalization for a pre-
existing condition, without serious 
deterioration in health, is not considered 
a serious adverse event. In general, 
hospitalization signifies that the 
individual remained at the hospital or 
emergency ward for observation and/or 
treatment (usually involving an overnight 
stay) that would not have been 
appropriate in the physician's office or an 
out-patient setting. Complications that 
occur during hospitalization are adverse 
events. If a complication prolongs 
hospitalization or fulfills any other 
serious criteria, the event is serious. 
When in doubt as to whether 
“hospitalization” occurred, the event 
should be considered serious. 
d. a medical or surgical intervention to 
prevent a) or b). 
e. any indirect harm as a consequence of 
incorrect diagnostic test results when used 
within manufacturer’s instructions for 
use. 
• Fetal distress, fetal death, congenital abnormality or 
birth defect including physical or mental 
impairment. 
Note: Planned hospitalization for a pre-existing 
condition, or a procedure required by the CIP, without 

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serious deterioration in health, is not considered a 
serious adverse event. 
Refer to Section 11 for additional SAEs. 
Serious Health Threat 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious 
deterioration in the health in subjects, users or other 
persons, and that requires prompt remedial action for 
other subjects, users or other persons. 
Note: This would include events that are of significant 
and unexpected nature such that they become alarming 
as a potential serious health hazard or possibility of 
multiple deaths occurring at short intervals. 
Unanticipated Serious Adverse 
Device Effect (USADE) 
Serious adverse device effect which by its nature, 
incidence, severity or outcome has not been identified in 
the risk assessment. 
Use Error 
Act or omission of an act that results in a different 
medical device response than intended by manufacturer 
or expected by user.  
Note: 
a) Use error includes the inability of the user to 
complete a task. 
b) Use errors can result from a mismatch between 
the characteristics of the user, user interface, 
task or use environment. 
c) Users might be aware or unaware that a use 
error has occurred. 
d) An unexpected physiological response of the 
patient is not by itself considered a use error. 
e) A malfunction of a medical device that causes an 
unexpected result is not considered a use error.” 
 
 
 

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2 
LIST OF ACRONYMS AND ABBREVIATIONS 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol 
Abbreviation 
Definition 
ADE 
Adverse device effect 
AE 
Adverse event 
ANSI 
American National Standards Institute 
ASADE 
Anticipated serious adverse device effect 
BCDVA 
Best corrected distance visual acuity 
°C 
Degrees Celsius 
 
 
 
 
CFR 
Code of Federal Regulations 
CIP 
Clinical investigation plan 
CRF 
Case report form 
D 
Diopter 
eCRF  
Electronic case report form 
EDC 
Electronic data capture 
ETDRS 
Early Treatment of Diabetic Retinopathy Study 
EX500 
WaveLight EX500 excimer laser system 
°F 
Degrees Fahrenheit 
FAS 
Full analysis set 
FDA 
US Food and Drug Administration 
FS200 
WaveLight FS200 femtosecond laser unit 
GCP 
Good Clinical Practice 
GmbH 
Gesellschaft mit beschränkter Haftung - company with limited liability 
hPa 
hectopascal 
IB 
Investigator’s brochure 
ICF 
Informed consent form 
ICH 
International Conference for Harmonization of Technical 
Requirements for Pharmaceuticals for Human Use 
IEC 
Independent ethics committee 
IDE 
Investigational Device Exemptions 
IOP 
Intraocular pressure 
IP 
Investigational product 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
LASIK 
Laser-assisted in situ keratomileusis   
LED 
Light emitting diode 
m 
Meter 
max 
Maximum 
min 
Minimum 

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Abbreviation 
Definition 
mmHg 
Millimeter of mercury 
MOP 
Manual of procedures 
MRSE 
Manifest refraction spherical equivalent 
N 
Number 
N/A 
Not applicable 
PMDA 
Pharmaceuticals and Medical Devices Agency 
 
 
RMSh 
Root mean square height 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SAF 
Safety analysis set 
SD 
Standard deviation 
SOP 
Standard operating procedure 
UCDVA 
Uncorrected distance visual acuity 
US 
United States 
USADE 
Unanticipated serious adverse device effect 
USV 
Unscheduled visit 
VA 
Visual acuity 
WFO 
Wavefront Optimized 
 
 

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3 
PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Interventional 
Investigational 
products 
Test Product: WaveLight EX500 excimer laser system 
Purpose and 
rationale 
Refractive surgery by excimer laser system is recognized as an 
effective treatment for myopia and hyperopia with or without 
astigmatism. Japan’s guideline for refractive surgery allows 
correction for hyperopia with and without astigmatism. However, 
the WaveLight EX500 excimer laser system has not been 
approved for hyperopic treatment in Japan. 
The purpose of this study is to collect efficacy and safety data on 
the WaveLight EX500 excimer laser system for the correction of 
hyperopia up to +3.0 D of sphere with and without astigmatic 
refractive errors up to +3.0 D at the spectacle plane, with a 
maximum manifest refraction spherical equivalent (MRSE) of 
+3.0 D to apply for registration in Japan. 
Objective(s) 
To collect efficacy and safety data on the WaveLight EX500 
excimer laser system for the correction of hyperopia with and 
without astigmatism by laser in situ keratomileusis (LASIK) 
treatment. 
Endpoint(s)  
Primary Effectiveness  
Endpoint 
Target 
Percentage of eyes with MRSE within ±0.50 D at 
refractive stability* 
>50% 
Percentage of eyes with MRSE within ±1.00 D at 
refractive stability* 
>75% 
*The definition of refractive stability refers to ANSI Z80.11-2012 (R2017) F.3. 

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Primary Safety 
• Percentage of eyes experiencing ocular adverse events 
Assessment(s)  
Effectiveness 
• Manifest refraction 
Safety 
• Patient reported outcome 
• Best corrected photopic distance visual acuity (BCDVA) 
• Manifest refraction 
• Intraocular pressure (IOP) 
• Slit lamp examination 
• Dilated fundus examination 
 
 
Study Design 
This is a prospective, single-arm, multi-center, interventional study 
with planned bilateral treatment. 
Qualified subjects will receive bilateral LASIK treatment and be 
followed for 1 year. Subjects will be asked to attend a total of 
9 visits (screening, surgery, day 1, 1 week, 1 month, 3 month, 
6 month, 9 month, and 1 year). Total expected duration of subject 
participation is approximately 1 year. 
Subject population 
Subjects 18 years of age or older who desire to have LASIK will 
be consented and screened for meeting the inclusion and exclusion 
criteria. 
Planned number of subjects enrolled/consented: approximately 
70 eyes (35 subjects) 
Planned number of treated/randomized subjects: approximately 
60 eyes (30 subjects) 

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Planned number of completed subjects: approximately 50 eyes 
(25 subjects) 
Key inclusion 
criteria 
(See Section 8.1 for a 
complete list of 
inclusion criteria) 
Subjects must meet all inclusion criteria as listed in Section 8.1. 
Key Inclusion Criteria include: 
• Hyperopia up to +3.0 D of sphere with and without 
astigmatic refractive error up to +3.0 D at the spectacle 
plane, with a maximum MRSE of +3.0 D 
• Intended to treat bilaterally 
• Best corrected photopic distance visual acuity of 20/20 or 
better 
• Uncorrected photopic distance visual acuity of 20/40 or 
worse 
• Stable refraction (within ±0.50 D), as determined by MRSE 
for a minimum of 12 months prior to surgery 
Key exclusion 
criteria 
(See Section 8.2 for a 
complete list of 
exclusion criteria) 
Subjects must not meet exclusion criteria as listed in Section 8.2. 
Key Exclusion Criteria include: 
• History or evidence of active or inactive corneal disease or 
retinal vascular disease, keratoconus, glaucoma (or suspect), 
or cataract 
• Previous intraocular or corneal surgery 
• Intent to have monovision treatment 
• Increased risk for developing strabismus post-treatment 
Data analysis and 
sample size 
justification 
The safety analysis set (SAF) will include all eyes for which 
refractive surgery is attempted with test device (regardless of 
success or failure). Full Analysis Set (FAS) will include all eyes 
with successful refractive surgery having at least 1 postoperative 
visits. The primary analysis set for effectiveness analysis will be 
the FAS. 
 
 
 

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 Subject evaluability will be 
determined prior to locking database. No interim analysis is 
planned. 
In order to evaluate efficacy of the WaveLight EX500 excimer 
laser system for the correction of hyperopia with and without 
astigmatism, the following primary effectiveness analyses will be 
conducted. 
Test 1: 
Percentage of eyes with MRSE within ±0.50 D at 
refractive stability is greater than the target level of 
50% 
Test 2: 
Percentage of eyes with MRSE within ±1.00 D at 
refractive stability is greater than the target level of 
75%. 
For the statistical test of primary effectiveness variables, the exact 
test of a binomial proportion will be used, and the p-values will be 
provided for Test 1 and Test 2. 
 
 
 Type 1 error at each test is set as 
one-sided 2.5%. 
Refractive surgery will be bilaterally performed for all subjects. 
Both eyes from each subject will be used for analysis.  

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Each safety variable will be summarized descriptively. Incidence 
of adverse events will be calculated. 
Key words 
• LASIK 
• Hyperopia 
• Astigmatism 
Associated materials 
• WaveLight EX500 Laser System 
• WaveCard 

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Table 3–1 
Schedule of Study Procedures and Assessments 
 
Screening1 
Surgery 
Postoperative 
Other 
 
Visit 0 
Visit 00/ 
Visit 
00A2 
Visit 1/ 
Visit 
1A 
Visit 2/ 
Visit 2A 
Visit 3/ 
Visit 3A 
Visit 4/ 
Visit 4A 
Visit 5/ 
Visit 5A 
Visit 6/ 
Visit 6A 
Visit 7 
Visit 7A 
Early 
Exit 
USV3 
Procedure/ Assessment 
Day -45 
to -1 
Day 0 
Day 1 
Day 5 
to 9 
Day 21 
to 35 
Day 70 
to 98 
Day 147 
to 182 
Day 245 
to 301 
Day 330 
to 420 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
X 
X4 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
Medical History5 
X 
 
 
 
 
 
 
 
 
 
 
Concomitant Medications6 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Urine Pregnancy Test7 
X 
 
 
 
 
 
 
 
 
 
 
Cycloplegic Refraction 
X 
 
 
 
 
 
X 
 
X 
X 
 
Mesopic Pupil Size 
X 
 
 
 
 
 
 
 
 
 
 
Aberrometry 
X 
 
 
 
 
 
 
 
 
 
 
Keratometry 
X 
 
 
 
 
 
 
 
 
 
 
Topography8 
X 
 
 
 
 
 
 
 
 
 
 
UCDVA 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Manifest/Subjective 
Refraction 
X9 
 
 
X 
X 
X 
X 
X 
X 
X 
 
BCDVA 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
 
IOP 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Slit Lamp Examination 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Dilated Fundus 
Examination 
X 
 
 
 
 
 
X 
 
X 
X 
X 
LASIK surgery 
 
X 
 
 
 
 
 
 
 
 
 
Adverse Events11 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Device Deficiencies 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

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1. Screening should cover evaluation of both eyes with intent for bilateral treatment on the same surgery day. 
2. ‘A” denotes visit for 2nd eye treated. Although visits are listed for 1st and 2nd eye treatment, the expectation is to perform surgery and follow-up visits on the 
same day for both eyes. 
3. Unscheduled visit – additional clinical assessments may be performed per the Investigator’s discretion. 
4. Confirm inclusion/exclusion criteria as needed. 
5. Refer to Protocol Section 10.2.13, electronic case report form (eCRF) Guidelines, and Manual of Procedures (MOP) for collection and documentation 
requirements. 
6. Refer to Protocol Sections 9.6 and 10.2.4, eCRF Guidelines, and MOP for collection and documentation requirements. 
7. Required only for women of child-bearing age, not postmenopausal or surgically sterile women. Data is collected in source only. 
8. Allow Investigator to use best judgement for post-op care. 
9. Subjective Refraction to assess for inclusion stability at Screening (Visit 0) should be performed on the site’s chart; subjective refraction for VA testing will 
be refraction on Sponsor provided electronic chart. 
 
 
11. Refer to Protocol Sections 10.2.2 and 11, eCRF Guidelines, and MOP for collection and documentation requirements. 

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4 
PROTOCOL AMENDMENTS 
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the Study Sponsor and must be 
approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions.  
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC. 

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5 
INTRODUCTION 
5.1 
Rationale and Background 
Refractive surgery using the Wavelight EX500 excimer laser system is recognized as a safe 
and effective treatment for hyperopia with or without astigmatism (El-Naggar 2017, 
Motwani 2017, Durrie 2010). The Wavelight EX500 excimer laser is approved by the FDA 
for treatment of hyperopic subjects. Although, Japan’s guideline for refractive surgery allows 
correction for hyperopia with and without astigmatism. The WaveLight EX500 excimer laser 
system has not been approved for hyperopic treatment in Japan. The purpose of this study is 
to collect safety and efficacy data to apply for registration in Japan. 
5.2 
Purpose of the Study 
The purpose of this study is to collect efficacy and safety data on the WaveLight EX500 
excimer laser system for the correction of hyperopia up to +3.0 D of sphere with and without 
astigmatic refractive errors up to +3.0 D at the spectacle plane, with a maximum MRSE of 
+3.0 D, to apply for registration in Japan. 
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards. 
There are no immediate plans to submit the results of this postmarket study for publication; 
however, the results may be offered for publication if they are of scientific interest, or if the 
results relate to a product that is subsequently approved or cleared for marketing.  

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5.3 
Risks and Benefits 
As with any refractive surgical procedure, there are potentials risks with the use of the 
WaveLight EX500 excimer laser system. However, there are no additional warnings or 
precautions associated with these outside of the risks identified for other LASIK procedures. 
There may also be unknown risks to the use of WaveLight EX500 excimer laser system. Any 
risk to subjects in this clinical study will be minimized by compliance with the eligibility 
criteria and study procedures, clinical oversight and monitoring. 
More information on summary of the literature, description of the investigational device, 
guidance for the Investigator, as well as known and potential risks and benefits can be found 
in the Procedure Manual and User Manual for WaveLight EX500 excimer laser system and 
the user manual. 
6 
STUDY OBJECTIVES 
6.1 
Primary Objective(s) 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
To evaluate the correction accuracy 
of WaveLight EX500 excimer laser 
system treatment 
• Percentage of eyes with MRSE within ±0.50 D 
at refractive stability (Target > 50%) 
• Percentage of eyes with MRSE within ±1.00 D 
at refractive stability (Target > 75%) 
 

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6.2 
Secondary Objective(s) 
Not Applicable. 
6.4 
Primary Safety Objective(s)  
Table 6–4 
Primary Safety Objective(s) 
Objective(s) 
Endpoint(s) 
To confirm the safety of the 
WaveLight EX500 excimer laser 
system 
Percentage of eyes experiencing ocular adverse 
events  
 

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6.5 
Refractive Stability 
Stability analyses will be performed on eyes that have every follow-up exam from 1 month 
up to the stability time point 
, as well as on the eyes that have 
2 consecutive exams, but not necessarily every follow-up exam. The definitions of refractive 
stability are described in Section 12.4. 

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7 
INVESTIGATIONAL PLAN 
7.1 
Study Design 
This is a prospective, single-arm, multi-center, interventional study with planned bilateral 
LASIK treatment with the WaveLight EX500 excimer laser system for subjects requiring 
refractive correction of hyperopia with or without astigmatism. All treated eyes will be 
targeted for emmetropia. The postoperative state of each treated eye will be compared to the 
preoperative state of the same eye.  
Subjects will be evaluated initially for suitability as candidates for bilateral LASIK. Potential 
subjects willing to participate will be consented and screened. Approximately 30 qualified 
subjects (up to 60 eyes) will receive bilateral LASIK and be followed for 1 year. Total 
duration of subject participation is approximately 1 year and includes 9 study visits consisting 
of Screening, Surgery, 1 day, 1 week, 1 month, 3 month, 6 months, 9 months, and 12 months. 
Approximately 4 US study sites will participate in this clinical study. It is estimated that 
enrollment and follow-up of all subjects will take approximately 17 months. Additional 
information on the study population can be found in Section 8. 
Assessments will be obtained at baseline and at appropriate times after LASIK to evaluate the 
safety and effectiveness of the treatment. 
 
 Clinical assessments to be obtained at study 
visits are outlined in Table 3–1 and defined in Section 10.  
The main analyses for effectiveness will be conducted at refractive stability for the FAS 
(Refractive Stability is defined in Section 12.4). Subjects are followed for at least 12 months 
(Day 330 to Day 420) for safety and supportive effectiveness assessments. All data analyses 
will be conducted at study completion. 
7.2 
Rationale for Study Design  
The prospective, single-group study design, objectives, planned visits and assessments, and 
planned analysis at refractive stability are based on recommendations by ANSI Z80.11-2012 
(R2017), the FDA Checklist of Information Usually Submitted in an IDE (1996), and ISO 
14155:2011.  
The study population includes subjects with hyperopia, with or without astigmatism, based 
on this being a prevalent refractive error for LASIK treatments today and the intended 
population for hyperopic LASIK. 

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Bilateral treatments of subjects will be implemented in this study based on past clinical study 
results that provide safety, effectiveness, and stability data (El-Naggar 2017, Motwani 2017, 
Durrie 2010). 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations 
No interim analysis is planned. No changes to study design, after the initiation of the study, 
are planned. 
7.3 
Rationale for Duration of Treatment/Follow-Up 
One year follow-up (Day 330 to 420) of subjects will be implemented in this study based on 
past clinical study results using EX500 for hyperopic LASIK (El-Naggar 2017) and follow-
up recommended by ANSI Z80.11-2012 (R2017). 
7.4 
Data Monitoring Committee 
Not applicable. 
8 
STUDY POPULATION 
The study population consists of male and female subjects (18 years of age or older) who 
have hyperopia up to +3.0 D of sphere with or without astigmatic refractive errors up to 
+3.0 D at the spectacle plane, with a maximum MRSE of +3.0 D and desire to have LASIK. 
It is aimed to enroll (consent) approximately 35 subjects in approximately 4 sites in the 
United States, with a target of up to 30 subjects treated. Site-specific targets may vary based 
upon individual site capabilities. Estimated time needed to recruit subjects for the study is 
approximately 5 months. Because a 10% screening failure rate and up to 10% lost to follow-
up rate is expected, approximately 30 subjects are expected to be treated in order to allow for 
treatment and follow-up of at least 25 subjects. 

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8.1 
Inclusion Criteria 
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study. 
Subjects eligible for inclusion in this study must fulfill all of the following criteria: 
1. 
Subject must be able to understand and sign an IRB/IEC approved Informed 
Consent form. 
2. 
Willing and able to attend all scheduled study visits as required per protocol. 
3. 
Minimum 18 years of age. 
4. 
Hyperopia up to +3.0 D of sphere with and without astigmatic refractive error up to 
+3.0 D at the spectacle plane, with a maximum MRSE of +3.0 D. 
5. 
Intended to treat bilaterally. 
6. 
Intended to target emmetropia. 
7. 
Best corrected photopic distance visual acuity of 20/20 or better. 
8. 
Uncorrected photopic distance visual acuity of 20/40 or worse. 
9. 
Less than 0.75 D spherical equivalent difference between cycloplegic and manifest 
refraction. 
10. 
Stable refraction (within ±0.50 D), as determined by MRSE for a minimum of 
12 months prior to surgery, verified by consecutive refractions and/or medical 
records or prescription history. 
11. 
Demonstrate a stable refraction (within ±0.50 D) for contact lens wearers: within 
±0.50 D MRSE on two consecutive exam dates under the following conditions: 
a. Lenses are not worn for at least 2 weeks (rigid or toric contact lenses) or 
3 days (soft contact lenses) prior to the first refraction used to establish 
stability and through the day of surgery. 
b. The two subjective refractions are performed at least 7 days apart. 

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8.2 
Exclusion Criteria 
Subjects fulfilling any of the following criteria are not eligible for participation in this study. 
1. 
Women of childbearing potential, defined as all women who are physiologically 
capable of becoming pregnant and who are not postmenopausal for at least 1 year or 
are less than 6 weeks since sterilization, are excluded from participation if any of the 
following apply: 
a. they are currently pregnant, 
b. have a positive urine pregnancy test result at Screening, 
c. intend to become pregnant during the study period, 
d. are breast-feeding. 
Note: Subjects who become pregnant during the study will not be discontinued; 
however, data will be excluded from the effectiveness analyses because pregnancy 
can alter refraction and visual acuity results. 
2. 
Acute or chronic disease or illness that would increase the operative risk or 
confound the outcomes of the study (eg, dry eyes, immuno-compromised, 
connective tissue disease, clinically significant atopic disease, diabetes). 
3. 
Current use of systemic medications that may confound the outcome of the study or 
increase the risk to the subject, including, but not limited to steroids, antimetabolites, 
isotretinoin, amiodarone hydrochloride. 
4. 
Ocular condition that may predispose the subject to future complications, for 
example: 
• history or evidence of active or inactive of corneal disease (eg, herpes simplex 
keratitis, herpes zoster keratitis, recurrent erosion syndrome, corneal 
dystrophy) 
• evidence of retinal vascular disease  
• glaucoma or glaucoma suspect by exam findings and/or family history 
• keratoconus or keratoconus suspect 

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• cataract (including, but not limited to nuclear cataract, lens opacity or lens 
abnormalities such as lens subluxation) 
5. 
Previous intraocular or corneal surgery that might confound the outcome of the 
study or increase the risk to the subject. 
6. 
Intended to have monovision treatment. 
7. 
An increased risk for developing strabismus post-treatment. 
8. 
A known sensitivity to medications used in the study. 
9. 
Other condition or assessment that causes subject to not be an acceptable candidate 
for treatment or study participation as clinically assessed and documented by the 
investigator. 
10. 
Participation in other ocular clinical trials during the course of the study. 
8.3 
Rescreening of Subjects 
Rescreening of subjects is allowed for the conditions listed below:  
Rescheduling of surgery: If a subject reschedules surgery or surgery is rescheduled due to 
other reasons, and this rescheduling results in preoperative/screening assessments (Visit 0) 
falling outside of the -45 to -1 day window, assessments should be repeated and 
inclusion/exclusion criteria re-verified to ensure the subject still qualifies to proceed with 
study surgery. 
Criteria not met: Rescreening of subjects who did not meet inclusion/exclusion criteria is 
allowed one time per subject. Rescreening is allowed only if criteria previously not met could 
reasonably have changed since the prior screening. Criteria that could change and rescreening 
would be allowed include: Inclusion 3, 8, or if changes in refractive stability or receipt of 
additional past records can show stability for criteria 9-11, and Exclusion Criteria 1, 3, or 6. 
Repeat assessments only for criteria not met as long as the assessments are within the 45-day 
screening window. If the repeat assessments fall outside the 45-day screening window, all 
screening procedures must be repeated and inclusion/exclusion criteria re-verified. 

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9 
TREATMENTS ADMINISTERED 
9.1 
Investigational Product(s) 
Test Product(s): 
WaveLight EX500 excimer laser system 
Control Product(s) (If applicable): Not applicable 
Table 9–1 
Test Product – WaveLight EX500 Excimer Laser System 
Test Product 
WaveLight EX500 excimer laser system 
Manufacturer 
WaveLight GmbH 
Am Wolfsmantel 5  
91058 Erlangen, Germany 
Indication for use 
and intended 
purpose in the 
current study  
The WaveLight EX500 excimer laser system is an FDA approved 
stationary scanning-spot excimer laser system used in refractive 
surgery for the treatment of myopia, myopic astigmatism, 
hyperopia, hyperopic astigmatism, and mixed astigmatism, 
including customized refractive surgery based on data delivered by 
WaveLight’s diagnostic devices. 
Product description 
and parameters 
available for this 
study 
For treatments, at least the following components of the system 
have to be operated: 
• Laser Console - containing operating elements, laser head, 
optical transmission system, energy, and system controls; 
o Eyetracker, scanner motors, gas supply, plume evacuator, 
headup display, video system, N2 generator focusing and 
fixation lights, system software and ablation profiles with 
scanning spot patterns, operating microscope with 
illumination, LED slit illumination system, and test systems 
• Patient Bed - with moving motors and bed control 
• System Notebook (WaveNet Planning System) – containing 
software for programming treatment parameters 
Formulation 
N/A 
Usage 
In this study, the Wavefront Optimized (WFO) Ablation profile of 
the WaveLight EX500 excimer laser system will be used for 

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bilateral LASIK treatment of hyperopia with and without 
astigmatism. 
Prior to usage for the laser portion of the treatment, a corneal flap 
must be created. For this study, the WaveLight FS200 femtosecond 
laser unit (FS200) will be utilized to create the flap. 
The WaveLight EX500 excimer laser system is intended for use 
solely by the physicians trained in the use of this laser system and 
its accessories. During its operation, the WaveLight EX500 excimer 
laser system does not come into contact with the eye, and treatment 
usually lasts 1.3 seconds per diopter. 
Operating 
Conditions 
Temperature: + 64°F (+ 18°C) to + 86°F (+ 30°C) above dew point 
Humidity: 20% to 70% at + 77°F (+ 25°C), not condensing 
Air pressure (recommended): 800 hPa to 1060 hPa (Barometric) 
Supply 
Each selected investigational site must have an FS200 and an 
EX500. 
 
The Investigator will be responsible for ensuring that the products are used in accordance 
with their respective indications and procedural guidance provided in the appropriate User 
and Procedure Manuals. 
 
 
 
 
 
More information on the test product can be found in the WaveLight EX500 User Manual. 
9.2 
Other Medical Device or Medication Specified for Use During the 
Study 
During the clinical study, additional medical devices and/or medications that are required in 
conjunction with the treatment include the following: 
• FS200: The FDA approved FS200 will be used for creation of the corneal flap 
according to MOP and associated user manuals, and is to be performed by a qualified 
ophthalmic surgeon. 

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• Patient Interface: The disposable patient interface designed for use with the FS200 
will be used according to the approved user guide. 
• WaveCard: A study-specific WaveCard will be used for clinical study treatment. This 
WaveCard is serial-number-specific for a particular laser and has a defined number of 
treatments. This WaveCard will be provided to the site and labeled with the protocol 
number. 
• Medications given for WaveLight EX500 excimer laser system LASIK will be per the 
Investigator’s standard of care for LASIK. 
9.3 
Treatment Assignment / Randomization 
After signing the ICF, a subject must be entered into the EDC system and will be assigned a 
subject number upon entry. This subject number will be used to identify the subject through 
the clinical study. Subjects who qualify based on inclusion and exclusion criteria should be 
treated as schedules allow surgery to be performed. This is a single-group study, as 
recommended by ANSI Z80.11 2012(R2017), and all subjects will be planned for bilateral 
LASIK with a target of emmetropia; therefore, no randomization will be used. 
9.4 
Treatment Masking 
The clinical study design is a single-arm treatment and therefore all members associated with 
the study (at the site and the Study Sponsor) are unmasked to the assigned treatment. 
9.5 Accountability Procedures 
Upon receipt of Investigational Products (IP), the Investigator or delegate must conduct an 
inventory of the WaveCard by serial number, complete study-specific confirmation of receipt 
procedures as described in the MOP, and retain any required documentation in the 
Investigator’s clinical study records. Throughout the study, the Investigator or delegate must 
maintain records of IP use for each subject (eg, WaveCard use documentation). This record 
must be made available to the study monitor for the purposes of verifying the accounting of 
IP use. Any discrepancies and/or deficiencies between the observed disposition and the 
written account must be recorded along with an explanation. All IPs sent to the Investigator 
must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized 
manner. 

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• Return to the Study Sponsor investigational product associated with a device 
deficiency. Refer to Section 11 of this protocol for additional information on the 
reporting of device deficiencies and to the MOP for information on return of study 
products associated with these events. 
The Investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instructions provided in the MOP. 
9.6 
Changes to concomitant medications, treatments/ procedures 
After the subject is enrolled into the study, the Investigator must instruct the subject to notify 
the study site about: 
• Any new medications  
• Alterations in dose or dose schedules for current medications,  
• Any medical procedure or hospitalization that occurred or is planned 
• Any non-drug therapies (including physical therapy and blood transfusions).  
The Investigator must document this information in the subject’s case history source 
documents. 
Preoperative and postoperative medications should be given as per site standard of care, 
documented in the subject’s chart, confirmed as used by subject, and be listed as required in 
the EDC for each subject.  
Surgical procedural steps that may impact treatment and related precautions, actions to be 
taken, or recommendations that result in discontinuation of study treatment are listed in 
Table 9–2. The table includes, but is not limited to, the most common or likely complications. 

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Table 9–2 
Procedural Complications 
Treatment/Procedure 
Complication 
Precaution(s) and 
Action(s) to be taken 
Subject Status 
Flap Creation incomplete or 
irregular 
If flap creation is 
unsuccessful or irregular, 
THEN the flap should not 
be lifted and/or subject 
should not be treated 
Subject should be followed 
as per Section 10.4.2. 
Partial or incomplete 
LASIK ablation 
IF LASIK ablation is not 
successfully completed, 
retreatment is not allowed. 
Subject should be followed 
as per Section 10.4.2. 
 
10 STUDY PROCEDURES AND ASSESSMENTS 
Study specific assessments will be obtained, including baseline prior to WaveLight EX500 
excimer laser system LASIK and postoperatively at the study visits outlined below (where 
“A” denotes the visit for the 2nd eye treated): 
• Screening - Visit 0 [-45 to -1 day prior to treatment] 
• Visit 00 / Visit 00A [Day 0 – surgery] 
• Visit 1 / Visit 1A [Day 1] 
• Visit 2 / Visit 2A [Day 5 to 9] 
• Visit 3 / Visit 3A [Day 21 to 35] 
• Visit 4 / Visit 4A [Day 70 to 98] 
• Visit 5 / Visit 5A [Day 147 to 182] 
• Visit 6 / Visit 6A [Day 245 to 301] 
• Visit 7 / Visit 7A [Day 330 to 420] 
In addition to the scheduled visits listed above, the following visits may apply as needed: 
• Early Exit [completed when a treated subject reports they wish to discontinue study 
participation, if subject is willing] 
• Unscheduled Visit [completed when a treated subject reports for additional follow-up] 
Clinical assessments to be obtained at study visits are outlined in Table 3–1 and are defined in 
the sections below. 

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10.1 Informed Consent and Screening 
Visit 0 / Screening 
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document.  
The Investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations. 
IF a patient has reported for routine LASIK screening, THEN data obtained from the routine 
evaluation can be used for screening data as long as protocol requirements for timeframe 
(within 45 days of surgery) and required details have been met. (Examples of this data 
include, but are not limited to IOP, subjective manifest refraction for stability, and 
Cycloplegic refraction). 
IF a screening phone script is used, THEN the subject should be pre-screened via phone and 
if interested in participating and a potential candidate for treatment, should be scheduled for 
an in-person visit as schedules allow, and consented prior to any study-specific testing. 
10.2 Description of Study Procedures and Assessments 
Detailed descriptions of assessments and procedures are provided in the MOP. The 
Investigator is responsible for ensuring responsibilities for all procedures and assessments are 
delegated to appropriately qualified site personnel. 

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10.2.1 Aberrometry 
Visit 0 
Measure aberrometry using standard of care method. The magnitude of the following 
aberrations will be collected in the database: astigmatism, coma, sphere/focus, spherical 
aberration, tilt, trefoil, and root mean square height (RMSh). The same type of instrument 
should be used throughout the study. 
10.2.2 Adverse Event Collection: Safety Assessment 
All Study Visits 
Assess and record any adverse events that are observed or reported, including those 
associated with changes in concomitant medication dosing since the previous visit. 
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent until their exit from the study, regardless of subject enrollment 
status (screen failure or received treatment). 
10.2.3 Best Corrected Distance Visual Acuity: 
 Safety 
Assessment 
Visit 0, Visit 2/2A – 7/7A, Early Exit 
Perform best corrected visual acuity testing with the Sponsor provided electronic visual 
acuity system for both eyes prior to any assessment requiring administration of eye drops to 
dilate the eyes, or any assessment requiring contact with the eye. 
 
 
 
 
 
The testing 
distance for this assessment is 4 m. Visual acuity must be obtained by study personnel who 
have successfully completed required training to conduct the assessment. 
10.2.4 Concomitant Medications 
All Study Visits 
Collect all ocular medications and systemic medications that the investigator has determined 
will affect the evaluation of this trial used by the subject within the past 30 days or ongoing at 

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time of screening. Include herbal therapies, vitamins, and all over-the-counter as well as 
prescription medications. Throughout the subject’s participation, obtain information on any 
changes in concomitant medications. Follow the MOP and Case Report Form Completion 
Guidelines for additional information on documentation and EDC entry for routine LASIK 
medications and take home and non-routine medications. 
10.2.5 Cycloplegic Refraction 
Visit 0, Visit 5/5A, Visit 7/7A, Early Exit 
Perform the cycloplegic refraction after instilling cycloplegic drops using standard of care 
method.  
10.2.6 Demographics 
Visit 0 
Obtain demographic information including age, race, ethnicity, and sex. 
10.2.7 Device Deficiencies: Safety Assessment 
All Study Visits 
Assess and record any device deficiencies that are reported or observed. Requirements for 
reporting device deficiencies in the study can be found in Section 11. 
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent, regardless of subject enrollment status (screen failure or 
received treatment). 
10.2.8 Dilated Fundus Examination: Safety Assessment 
Visit 0, 5/5A, 7/7A, Early Exit, USV 
Dilated fundus examination includes ophthalmoscopic assessments of the vitreous, retina, 
macula, choroid, and optic nerve of both eyes. 
10.2.9 Intraocular Pressure: Safety Assessment 
Visit 0, 3/3A – 7/7A, Early Exit, USV 
Intraocular pressure must be measured in both eyes using a Goldmann tonometer or any other 
instrument. The same type of instrument should be used throughout the study. 

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10.2.10 Keratometry 
Visit 0 
Measure keratometry (K1 and K2 with axis) using standard of care method. The same type of 
instrument should be used throughout the study. 
10.2.11 LASIK Surgery 
Visit 00/00A 
Use the FS200 to create corneal flap, then use the EX500 to perform WFO LASIK. 
Treatment must be performed by a qualified surgeon (no more than 2 per site). Record flap 
diameter, flap thickness, optical zone and residual stroma thickness. Additional details are 
listed in the MOP. 
10.2.12 Manifest / Subjective Refraction: Efficacy and Safety Assessment 
Visit 0, 2/2A – 7/7A, Early Exit 
Perform manifest refraction under photopic lighting conditions and measure vertex distance 
using a phoropter.  
Note: The chart used for subjective manifest refraction depends on intended use of the data:  
• For Inclusion stability at Screening (Visit 0) – performed on site chart 
• For VA testing - performed on Sponsor provided electronic chart  
• See MOP for more details.  
Note: Refraction for Inclusion Criteria 4 for hyperopic and astigmatic range must come from 
the manifest refraction. 
10.2.13 Medical History 
Visit 0 
Collect all ocular medical history and systemic medical history that the Investigator has 
determined will affect the evaluation of this trial. Throughout the subject’s participation, 
obtain information on any changes in medical health and record in subject source documents. 
Follow the MOP and Case Report Form Completion Guidelines for additional information on 
documentation and EDC entry. 

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10.2.14 Mesopic Pupil Size 
Visit 0 
Measure mesopic pupil size using an infrared-based pupilometer. 
10.2.17 Slit Lamp Examination: Safety Assessment 
Visit 0, Visit 1/1A – 7/7A, Early Exit, USV 
Slit Lamp Exam of the cornea, iris/anterior chamber, and lens must be performed in both eyes 
before instillation of any diagnostic eye drops. Follow the MOP for specific areas of detailed 
assessment according to required grading scales for Corneal Haze, Diffuse Lamellar 
Keratitis, and Epithelium Ingrowth. 
10.2.18 Topography 
Visit 0 
Measure corneal topography using standard of care method. The same type of instrument 
should be used throughout the study. Record the presence or absence of irregular 
astigmatism. The Investigator’s best judgement should be used for postoperative care. 

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10.2.19 Uncorrected Distance Visual Acuity: 
 Safety 
Assessment 
Visit 0, Visit 1/1A – 7/7A, Early Exit, USV 
Perform uncorrected visual acuity testing with the Sponsor provided electronic visual acuity 
system for both eyes prior to any assessment requiring administration of eye drops to dilate 
the eyes, or any assessment requiring contact with the eye. 
 
 
 
 
 Visual acuity must be obtained by study personnel who have 
successfully completed required training to conduct the assessment. 
10.2.20 Urine Pregnancy Test 
Visit 0 
Collect a urine pregnancy test on female subjects of childbearing potential who are not 
postmenopausal or surgically sterile. 
Note: The results from the urine pregnancy test will not be recorded in EDC. 
10.3 Unscheduled Visits 
After LASIK is performed, if a subject visit occurs between any regularly scheduled visits, 
then this visit must be documented as an Unscheduled Visit. During all unscheduled visits, 
the Investigator must conduct the USV procedures according to Table 3-1.  
The Investigator may perform additional procedures for proper diagnosis and treatment of the 
subject. The Investigator must document this information in the subject’s case history source 
documents. 
If during an USV the subject is discontinuing from the study, the Investigator must conduct 
Early Exit procedures according to Table 3-1, Schedule of Study Procedures and Assessments 
and Section 10.4.3, as possible. 

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10.4 Discontinued Subjects 
10.4.1 Screen Failures 
Subjects who were excluded from the study after signing the informed consent and prior to 
surgical procedures beginning (prior to eye drops for flap creation), are considered a screen 
failure. The Investigator must document the reason for screen failure in the subject’s chart. 
Subject numbers must not be re-used. 
10.4.2 Incomplete Treatments 
If a subject’s surgical treatment is started but discontinued due to complications or other 
reasons, every effort must be made to keep the subject in the study and to continue with the 
study required visits. For these subjects, appropriate follow-up assessments as per standard of 
care (including at minimum, AEs, slit lamp examination, UCDVA, manifest refraction, and 
BCDVA) should be conducted and collected. If the subject is not willing to complete all 
required follow-up visits, then document in the chart and exit the subject according to 
Section 10.4.3. See Section 11.6 for additional instructions for any adverse events.   
Note: If drops are given for surgical treatment, but no laser procedure started and the surgery 
needs to be rescheduled, then reschedule surgery within the protocol defined visit window or 
follow rescreening instructions in Section 8.3. 
Note: Please inform the Sponsor as soon as possible when an incomplete treatment occurs in 
order to discuss and confirm proper reporting and follow-up. 
10.4.3 Discontinuations 
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the Investigator after the surgical procedure (eye drops given for flap creation), has 
begun. 
Subjects may discontinue from study or study treatment at any time for any reason. Subjects 
may also be discontinued from study treatment at any time if, in the opinion of the 
Investigator, continued treatment poses a risk to their health. 
For subjects discontinuing from the study after treatment, the Investigator must complete all 
Early Exit procedures according to Table 3-1, Schedule of Study Procedures and 
Assessments, if the subject is willing and able, and if in the opinion of the Investigator it is 
safe for the subject to do so. 

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The Investigator must document the reason for study or treatment discontinuation in the 
subject’s chart. 
To ensure the safety of all subjects who discontinue early, Investigators must assess each 
subject and, if necessary, advise them of any therapies and/or medical procedures that may be 
needed to maintain their health. 
Subject numbers of discontinued subjects must not be re-used. 
10.5 Clinical Study Termination 
The Study Sponsor reserves the right to close the investigational site or terminate the study in 
its entirety at any time. 
If the clinical study is prematurely terminated or suspended by the Study Sponsor:  
• The Study Sponsor must: 
o Immediately notify the Investigator(s) and subsequently provide instructions 
for study termination. 
o Inform the Investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension.  
• The Investigator must: 
• Promptly notify the IRB/IEC of the termination or suspension and of the 
reasons.  
• Provide subjects with recommendations for poststudy treatment options as 
needed. 
The Investigator may terminate the site’s participation in the study for reasonable cause. 
10.5.1 Follow-Up of Subjects After Study Participation Has Ended  
Following this study, the subject will return to their eye care professional for their routine eye 
care. In cases where a subject has a continuing adverse event at the time of study completion, 
see Section 11.6. 
10.6 Contingency Measures 
To overcome challenges that may arise during unexpected events which could interrupt the 
conduct of the trial as planned (eg, natural disasters or a public health emergency), 
contingency measures may be implemented. The intent of contingency measures would be to 

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address the care of enrolled subjects during such unexpected events. It is not expected that 
contingency measures would affect study design; however, if necessary, the protocol would 
be amended accordingly. Written notification describing these contingency measures will be 
provided to the IRB and other regulatory agencies, as applicable. During such events, 
Investigators must continue to use medical judgement in the care of subjects and follow 
national and local guidance as well as IRB reporting requirements. Additional information 
can be found in the MOP. 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 General Information 
An AE is 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 investigational medical device (test product). Refer to the 
Glossary of Terms and figures below for categories of AEs and SAEs. 

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Figure 11–1 
Categorization of All Adverse Events 
 
*In this study, only AE related to the investigational product/device (ie, WaveLight EX500 
excimer laser system) is considered as device related ADE.  
Specific Events Relevant to this Protocol  
In addition to reporting all AEs (serious and non-serious) meeting the definitions, the 
Investigator must report any occurrence of the following as an ocular SAE: 
• Diffuse lamellar keratitis (Grade 3 or above) 
• Corneal infiltrate or ulcer 

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• Any persistent corneal epithelial defect at one month or later 
• Corneal edema at 1 month or later (specify flap or bed) 
• Epithelium in the interface with loss of 2 lines (10 letters) or more BCDVA 
• Miscreated flap (lost, incomplete, too thin)  
• Melting of the flap 
• IOP with increase of > 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 or greater (≥ 10 letters ETDRS) of 
BCDVA 
• Decrease in BCDVA of greater than or equal to 2 lines (≥ 10 letters ETDRS) not due 
to irregular astigmatism as shown by rigid contact lens refraction at 3 months or later 
• Retinal detachment 
• Retinal vascular accidents 
• Ocular penetration 
• Any other vision-threatening event 
The Investigator must also report the following ocular AEs: 
• Diffuse lamellar keratitis (Grade 2 or less) 
• Corneal edema between one week and 1 month after the procedure 
• Peripheral corneal epithelial defect at 1 month or later (location of the defect to be 
identified as on, off, or across the flap) 
• Epithelium in the interface  
• Foreign body sensation at 1 month or later 
• Pain at 1 month or later 
• Ghost/double images in the operative eye 
• Flap is not of the size and shape as initially intended or resultant flap is misaligned  
AEs that occur in association with a device that is used in conjunction with FS200 will be 
reported separately from those occurring with EX500.   

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This list is consistent with the categories provided in ANSI Z80.11 2012(R2017). Any other 
potentially sight-threatening event may also be considered serious based on the judgment of 
the Investigator and should be reported appropriately as delineated in Section 11.3. 
Device Deficiencies  
A device deficiency may or may not be associated with subject harm (ie, ADE or SADE); 
however, not all ADEs or SADEs are due to a device deficiency. The Investigator should 
determine the applicable category for the identified or suspect device deficiency and report 
any patient harm separately. Examples of device deficiencies include the following: 
• Calibration issue: Error in or Unable to calibrate laser  
• Computer software issue or system error message 
• Defective component  
• Detachment of device or device component  
• Device breakage (eg, joystick) 
• Device emits odor (eg, gas leak, and smoke) 
• Failure of laser firing 
• Failure to meet product specifications (eg, incorrect laser assembly) 
• Failure to transmit record  
• Foreign material present in device  
• Image display error or failure to display 
• Incorrect laser output energy 
• Instructions difficult to understand/follow  
• Mechanical issues (eg, failure to focus, align, track, position, or unintended system 
motion) 
• Power issue: Equipment will not power on; power loss; or intermittent connection 
• Other events that may meet the definition of device deficiency 

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11.2 Monitoring for Adverse Events 
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking the standard questions shown 
below and report as applicable: 
• “Have you had any health problems since your last study visit?” 
• “Have there been any changes in the medicines you take since your last study visit?” 
In addition, changes in any protocol-specific parameters and/or questionnaires evaluated 
during the study are to be reviewed by the Investigator. Any untoward (unfavorable and 
unintended) change in a protocol-specific parameter or questionnaire response that is 
clinically relevant, in the opinion of the Investigator, is to be reported as an AE. These 
clinically relevant changes will be reported regardless of causality. 
11.3 Procedures for Recording and Reporting 
AEs are collected from the time of informed consent. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (ie, before informed consent 
is signed) are not considered AEs in the study and should be recorded in the Medical History 
section of the eCRF. 
In addition, dry eye, superficial punctate keratitis, and optical visual disturbances (eg, glare, 
halo, and starburst) are examples of early postoperative findings that are typically observed 
following kerato-refractive surgery. These are not considered AEs if they can be reasonably 
expected to resolve within 6 months and not result in any untoward long term visual outcome 
impact. However, based on the Investigator’s medical judgment, signs and symptoms of dry 
eye and ocular visual disturbances prior to 6 months, or persisting beyond 6 months post 
kerato-refractive surgery, may be considered an AE. 
For each recorded event, the ADEs and SAEs documentation must include: date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the Investigator must document all device deficiencies reported or 
observed with test and control products on the Device Deficiency eCRF. The site must submit 
all available information on ADEs, SAEs, and device deficiencies to the Study Sponsor 
immediately as follows: 
• ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device 
Effect eCRF within 24 hours of the Investigator’s or site’s awareness. 

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• Device deficiencies are documented on the Device Deficiency eCRF within 24 hours 
of the Investigator’s or site’s awareness.  
• A printed copy of the completed Serious Adverse Event and Adverse Device Effect 
and/or Device Deficiency eCRF must be included with product returns.  
• Additional relevant information after initial reporting must be entered into the eCRF 
as soon as the data become available.   
• Document any changes to concomitant medications on the appropriate eCRFs. 
• Document all relevant information from Discharge Summary, Autopsy Report, 
Certificate of Death, etc., if applicable, in narrative section of the Serious Adverse 
Event and Adverse Device Effect eCRF. 
Note: Should the EDC system become non-operational, the site must complete the 
appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device 
Deficiency Form. The completed form is emailed to the Study Sponsor at 
MSUS.Safety@Alcon.com according to the timelines outlined above; however, the 
reported information must be entered into the EDC system once it becomes 
operational. 
Any AEs and device deficiencies for non-study marketed devices/products (eg, FS200, 
Custom Paks) will be considered and processed as spontaneous (following the postmarket 
vigilance procedures) and should be communicated to the device’s/product’s manufacturer as 
per local requirements. 
Study Sponsor representatives may be contacted for any protocol related question and their 
contact information is provided in the Manual of Procedures that accompanies this protocol. 
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC. 
Intensity and Causality Assessments 
Where appropriate, the Investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below: 

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Intensity (Severity) 
Mild 
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom. 
Moderate 
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities. 
Severe 
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below: 
Causality 
Related 
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure. 
Not Related  An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, there are other more likely causes for the AE). 
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that is 
upgraded from non-serious to serious or from unrelated to related. 
Furthermore, the Study Sponsor shall promptly conduct an evaluation of any unanticipated 
adverse device effect, including anticipated adverse events that occur in unanticipated 
severity or frequency. The results of this evaluation will be reported to the FDA, the IRB, and 
participating Investigators within 10 working days upon receiving notification of the effect. 

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11.5 Unmasking of the Study Treatment 
Not applicable; this study is open-label. 
11.6 Follow-Up of Subjects with Adverse Events 
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study.  
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock).  
Any additional data received up to 6 months after subject discontinuation or exit must be 
documented and available upon the Study Sponsor’s request. All complaints received after 
this time period will be considered and processed as spontaneous (following the postmarket 
vigilance procedures) and should be communicated to the medical device’s manufacturer as 
per local requirements. 
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements. 
11.7 Pregnancy in the Clinical Study 
Pregnancy is not reportable as an AE; however, complications may be reportable and will be 
decided on a case–by-case basis. An Alcon form will be utilized to capture all pregnancy-
related information until birth of the child. 
12 ANALYSIS PLAN 
This information will also be contained within a separate biostatistical analysis plan which 
will be prepared and finalized prior to database lock.  
Counts and percentages will be presented as categorical variables. N, mean, standard 
deviation, median, minimum, and maximum will be presented for continuous variables. 

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12.1 Subject Evaluability 
Final subject evaluability must be determined prior to locking the database, based upon the 
Deviations and Evaluability Plan. 
12.2 Analysis Sets 
All eligible subjects will be screened to determine if they meet all inclusion and no exclusion 
criteria. Subjects who provide informed consent will be considered enrolled in the study.  
Refractive surgery will be bilaterally performed for all subjects. Both eyes from each subject 
will be used for analysis.   
12.2.1 Safety Analysis Set 
The safety analysis set (SAF) will include all eyes for which refractive surgery is attempted 
with test device (regardless of success or failure). SAF will be the primary analysis set for the 
safety analyses. 
12.2.2 Full Analysis Set 
Full Analysis Set (FAS) will include all eyes with successful refractive surgery having at least 
1 postoperative visit. The primary analysis set for effectiveness analysis will be the FAS. 
12.3 Demographic and Baseline Characteristics 
Demographic and baseline characteristics will be summarized for each subject. Appropriate 
summary statistics will be presented for each characteristic. These summaries will be based 
on the SAF and the FAS. 
12.4 Refractive Stability 
Stability analyses will be performed on eyes that have every follow-up exam from 1 month 
up to the stability time point 
 as well as on the eyes that have 2 consecutive exams, 
but not necessarily every follow-up exam. The following stability analyses will be performed 
for the time intervals between all consecutive pairs of scheduled postoperative refractions: 

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• Percentage of eyes that achieve: 
o a change of ≤ 1.00 D of MRSE between two refractions performed at 1 
month and 3 months, and between subsequent refractions performed at 
least 3 months apart; 
o a change of ≤0.50 D of MRSE between two refractions performed at 1 
month and 3 months, and between subsequent refractions performed at 
least 3 months apart; 
• Mean overall change and change per month in MRSE between consecutive scheduled 
visits as determined by a paired analysis; 
• Mean ±SD MRSE for the preoperative and each postoperative visit; 
• Assessment of cylinder stability for correction of spherocylindrical refractive errors 
Refractive stability is achieved at the latter of two postoperative manifest refractions 
performed at least 3 months apart or at 3 months after surgery when compared with the 
1-month interval, when all of the following recommended criteria are met: 
• At least 95% of the treated eyes have a change ≤ 1.00 D of MRSE between the 
2 refractions; 
• The mean rate of change in MRSE, 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 of MRSE 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 in MRSE includes zero or a 
rate of change attributable to normal aging; and  
• Stability is confirmed at least 3 months after the stability time point by a statistically 
adequate subgroup 
. 
The primary effectiveness endpoints for the study can only be evaluated once refractive 
stability has been established 
, as well as on the eyes that had 2 consecutive 
exams, but not necessarily every follow-up exam. 

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12.5 Effectiveness Analyses 
12.5.1 Analysis of Primary Effectiveness Endpoint(s) 
In order to evaluate efficacy of the WaveLight EX500 excimer laser system for the correction 
of hyperopia with and without astigmatism, the following primary effectiveness endpoints are 
defined: 
• Percentage of eyes with MRSE within ±0.50 D at refractive stability* (Target: > 50%) 
• Percentage of eyes with MRSE within ±1.00 D at refractive stability* (Target: > 75%) 
12.5.1.1 Statistical Hypotheses 
The statistical test for primary variables will be performed using the exact test of a binomial 
proportion. The null and alternative hypotheses are: 
Test 1; 
H0: π1(EX500) = 50.0% 
H1: π1(EX500) > 50.0% 
Test 2: 
H0: π2(EX500) = 75.0% 
H1: π2(EX500) > 75.0% 
 
where π1(EX500) is the population proportion of eyes in the EX500 group with MRSE 
within ±0.50 D at refractive stability, and π2(EX500) is the population proportion of eyes in 
the EX500 group with MRSE within ± 1.00 D at refractive stability. The constants 50.0% in 
Test 1 and 75.0% in Test 2 are the target levels for these MRSE parameters referred to from 
the FDA Checklist of Information Usually Submitted in an IDE (1996). 
The p-values will be provided for Test 1 and Test 2. 
 
 
 
 
  
12.5.1.2 Analysis Methods 
The FAS will be used for this analysis. The number and percentage of eyes meeting each of 
the primary effectiveness endpoints will be calculated. The effectiveness criteria will be 
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refractive stability for all primary effectiveness endpoints. These analyses will be performed 
for the whole FAS as well as stratified by preoperative MRSE subgroups. An analysis will be 
performed once refractive stability is achieved; a final summary of these endpoints will be 
performed once the one-year follow-up is complete. 

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12.6 Handling of Missing Data 
No imputation of missing data is planned. 
12.7 Safety Analyses 
The safety analysis set will include all eyes for which refractive surgery is attempted with test 
device (regardless of success or failure). All adverse events occurring from the time a subject 
signs informed consent to study exit will be accounted for in the reporting. Safety analyses 
will be conducted using the SAF through descriptive summaries (counts and percentages) and 
listings. In addition, separate subject listings will be provided for AEs that occur prior to 
refractive surgery using the test device. 
12.7.1 Analysis of Primary Safety Endpoint(s) 
In order to assess safety of the WaveLight EX500 excimer laser system for the correction of 
hyperopia with and without astigmatism, the following primary safety endpoint is defined: 
• Percentage of eyes experiencing ocular adverse events  
12.7.1.1 Statistical Hypotheses 
No hypothesis testing of the primary safety endpoints is planned. 
12.7.1.2 Analysis Methods 
The SAF will be used for this analysis. The number and percentage of eyes experiencing each 
of the primary safety endpoints will also be calculated.  

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13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS 
13.1 Subject Confidentiality 
The Investigator must ensure that the subject’s anonymity is maintained throughout the 
course of the study. In particular, the Investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. At the end of the clinical study, the Study Sponsor will collect a copy 
of the enrollment log without any identifying subject information. All documents submitted 
to the Study Sponsor will identify the subjects exclusively by number and demographic 
information. No other personally identifying information will be transmitted to the Study 
Sponsor. 
The Study Sponsor may release anonymized study data to external researchers for purposes 
of future research directly related to the study objectives, or future research that is beyond the 
scope of the current study objectives. The Informed Consent Form explains this to study 
subjects. Anonymization means that all identifiable information will be removed from the 
dataset and all links to the subjects in the study will be removed. Anonymization of the data 
will maintain confidentiality of the subjects who participate in the study so that they cannot 
be identified by external researchers. The anonymized data set will contain records from all 
of the subjects in the current study, but the anonymization process might change the data set 
in some ways, so external researchers will be informed that they might not be able to 
duplicate some of the results from this study. 
13.2 Completion of Source Documents and Case Report Forms 
The nature and location of all source documents will be identified to ensure that original data 
required to complete the CRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. Site 
monitors are appointed by the Study Sponsor and are independent of study site staff. 
If electronic records are maintained, the method of verification must be determined in 
advance of starting the study.  
At a minimum, source documents include the following information for each subject: 
• Subject identification (name, sex, race/ethnicity) 
• Documentation of subject eligibility 
• Date of informed consent 

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• Dates of visits 
• Documentation that protocol specific procedures were performed 
• Results of study parameters, as required by the protocol 
• IP accountability records 
• Documentation of AEs and other safety parameters (if applicable) 
• Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the CRF are consistent with the original source data. 
Only designated individuals at the site will complete the CRFs. The CRFs must be completed 
at regular intervals following the clinical study visit schedule. It is expected that all data 
reported have corresponding entries in the source documents. The Principal Investigator is 
responsible for reviewing and certifying that the CRFs are accurate and complete. The only 
subject identifiers recorded on the CRFs will be subject number, and subject demographic 
information.  
13.3 Data Review and Clarifications 
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, additional data 
clarifications and/or additions may be needed as a result of the data cleaning process. Data 
clarifications are documented and are part of each subject’s CRF. 
13.4 Sponsor and Monitoring Responsibilities 
The Study Sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals according to the study monitoring plan. The clinical investigation will 
be monitored to ensure that the rights and well-being of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 
is conducted in compliance with the current approved protocol (and amendments[s], if 
applicable), with current GCP, and with applicable regulatory requirements. 
The site may not screen subjects or perform the informed consent process on any subject until 
it receives a notification from an appropriate Study Sponsor representative that the site may 

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commence conducting study activities. Monitoring will be conducted periodically while the 
clinical study is ongoing. Monitoring methods may include site visits, telephone, written and 
email correspondence. Close-out visits will take place after the last visit of the last subject at 
the site. 
A Coordinating Investigator may be identified by the Study Sponsor to review and endorse 
the final study report. In cases where a Coordinating Investigator is engaged, the Study 
Sponsor will select the Coordinating Investigator based upon their experience, qualifications, 
active study participation, and their willingness and availability to take on this role. 
Additionally, Alcon may have an expert Sponsor Observer or Representative present during 
screening or surgery to offer training to the Investigator on proper operation of the device 
and/ or to make technical observations during the study visit. 
• The Sponsor Representative must be supervised by the Investigator or designee to 
ensure the Sponsor Representative’s presence or activities do not bias the outcome of 
the study, affect the quality of the research data, and/or compromise the rights and 
welfare of the subject. The Sponsor Representative will not intervene with the 
standard of care provided to study subjects or make safety-related decisions or 
assessments. The activities of Sponsor Representatives will be described in the 
Informed Consent. 
13.5 Regulatory Documentation and Records Retention 
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Study Sponsor and the Investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately.  
Additionally, the Investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the Study Sponsor. If the Investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the Study Sponsor must be notified and suitable arrangements made for retention of 
study records and source documents needed to comply with national and international 
regulations. 
13.6 Quality Assurance and Quality Control 
The Study Sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
and auditing by the Study Sponsor, and inspection by domestic and foreign regulatory 

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authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. Agreements made by the Study Sponsor 
with the Investigator/Institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement. 
14 ETHICS 
This clinical study must be conducted in accordance with the ethical principles contained 
within:  
• The Declaration of Helsinki, and in compliance with the ICH E6 GCP Consolidated 
Guideline, ISO 14155:2011, and the applicable US FDA 21 CFR Regulations.  
• SOPs of the Study Sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations.  
• Notifications and timelines for reporting protocol deviations should be based upon 
applicable Ethics Committee requirements 
The Investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The Investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. Deviations from this protocol, regulatory requirements and/or 
GCP must be recorded and reported to the Sponsor prior to database lock. If needed, 
corrective and preventive action should be identified, implemented, and documented within 
the study records. Use of waivers to deviate from the clinical protocol is prohibited. 
Before clinical study initiation, this protocol, the informed consent form, any other written 
information given to subjects, and any advertisements planned for subject recruitment must 
be approved by an IRB/IEC. The Investigator must provide documentation of the IRB/IEC 
approval to the Study Sponsor. The approval must be dated and must identify the applicable 
protocol, amendments (if any), informed consent form, assent form (if any), all applicable 
recruiting materials, written information for subject, and subject compensation programs. The 
IRB/IEC must be provided with a copy of the User Manual, any periodic safety updates, and 
all other information as required by local regulation and/or the IRB/IEC. At the end of the 
study, the Investigator must notify the IRB/IEC about the study’s completion. The IRB/IEC 
also must be notified if the study is terminated prematurely. Finally, the Investigator must 
report to the IRB/IEC on the progress of the study at intervals stipulated by the IRB/IEC.  
Voluntary informed consent must be obtained in writing from every subject and the process 
shall be documented before any procedure specific to the clinical investigation is applied to 

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the subject. The Investigator must have a defined process for obtaining consent. Specifically, 
the Investigator, or their delegate, must explain the clinical study to each potential subject and 
the subject must indicate voluntary consent by signing and dating the approved informed 
consent form. The subject must be provided an opportunity to ask questions of the 
Investigator, and if required by local regulation, other qualified personnel. The Investigator 
must provide the subject with a copy of the consent form written in a language the subject 
understands. The consent document must meet all applicable local laws and provide subjects 
with information regarding the purpose, procedures, requirements, and restrictions of the 
study, along with any known risks and potential benefits associated with the IP and the study, 
the available compensation, and the established provisions for maintaining confidentiality of 
personal, protected health information. Subjects will be told about the voluntary nature of 
participation in the study and must be provided with contact information for the appropriate 
individuals should questions or concerns arise during the study. The subject also must be told 
that their records may be accessed by appropriate authorities and Sponsor-designated 
personnel. The Investigator must keep the original, signed copy of the consent (file in 
subject’s medical records) and must provide a duplicate copy to each subject according to 
local regulations.  
The Study Sponsor assures that the key design elements of this protocol will be registered on 
www.clinicaltrials.gov as required by current regulations and, if applicable, other public 
databases as required by local country regulations. In addition, results of this study will be 
made publicly available on www.clinicaltrials.gov regardless of outcome as required by 
current regulations and, if applicable, in other public databases as required by local country 
regulations. 
15 REFERENCES 
15.1 References Applicable for All Clinical Studies 
• ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good 
clinical practice 
15.1.1 US References Applicable for Clinical Studies 
• 21 CFR Part 11 - Electronic Records; Electronic Signatures 
• 21 CFR Part 50 - Protection of Human Subjects 
• 21 CFR Part 56 - Institutional Review Boards 
• 21 CFR Part 812 - Investigational Device Exemptions 

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• 21 CFR Part 54 - Financial Disclosure by Clinical Investigators 
• The California Bill of Rights 
15.2 References For This Clinical Study 
ANSI Z80.11-2012 (R2017) American National Standard for Ophthalmics – Laser Systems 
for Corneal Reshaping 
US Food and Drug Administration (FDA). Checklist of Information Usually Submitted in an 
Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers. Issued 
October 10, 1996. 
Durrie DS, Smith RT, Waring GO, Stahl JE, Schwendeman FJ. Comparing conventional and 
wavefront-optimized LASIK for the treatment of hyperopia. J Refract Surg. 2010;26:356-63. 
El-Naggar MT, Hovaghimian DG. Assessment of refractive outcome of femtosecond-assisted 
LASIK for hyperopia correction. Electron Physician. 2017;9:3958-65. 
Motwani M, Pei R. Treatment of moderate-to-high hyperopia with the wavelight allegretto 
400 and EX500 excimer laser systems. Clin Ophthalmol. 2017;11:999-1007.