A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
Phase: NA
Conditions: Refractive Error
Sponsor: Johnson & Johnson Surgical Vision, Inc.

 
 
 
Study Protocol 
 
 
 
A PROSPECTIVE, MULTI-CENTER EVALUATION OF CORNEAL 
FLAP CREATION USING CHEETAH FEMTOSECOND LASER 
SYSTEM AND CHEETAH PATIENT INTERFACE 
 
PROTOCOL NUMBER: CHTA-103-FLAP 
 
NCT Number: NCT 03789669 
 
Document Date: May 5th, 2023 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
i 
    PR/ CHTA-103-FLAP 
CONFIDENTIAL 
The following contains confidential, proprietary information  
that is the property of Johnson & Johnson Surgical Vision, Inc. 
Clinical Investigation of the  
A PROSPECTIVE, MULTI-CENTER EVALUATION OF CORNEAL FLAP 
CREATION USING CHEETAH FEMTOSECOND LASER SYSTEM AND 
CHEETAH PATIENT INTERFACE   
 
PROTOCOL NUMBER:  CHTA-103-FLAP 
 
SPONSOR:  Johnson & Johnson Surgical Vision, Inc. 
31 Technology Drive 
Irvine, CA 92618 
 
Investigator Agreement 
 
As an Investigator, I agree to: 
• Implement and conduct this study diligently and in strict compliance with this 
agreement; the protocol; Good Clinical Practices; 21CFR812, ISO 14155 and all 
other applicable FDA regulations; conditions of approval imposed by the 
reviewing Institutional Review Board (IRB), FDA or other regulatory authorities; 
and all other applicable laws and regulations. 
• Supervise all testing of the device where human subjects are involved. 
• Ensure that the requirements for obtaining informed consent are met. 
• Obtain authorization for use/disclosure of health information (e.g., HIPAA 
authorization or equivalent). 
• Maintain all information supplied by Johnson & Johnson in confidence and, when 
this information is submitted to an independent IRB or any other group, it will be 
submitted with a designation that the material is confidential. 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
 
 
 
 
Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
Subinvestigator Printed Name 
Signature 
Date 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
ii 
    PR/ CHTA-103-FLAP 

05MAY2023/Version 6.0 
iii 
    PR/ CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
v 
    PR/ CHTA-103-FLAP 
PERSONNEL AND FACILITIES 
SPONSOR: 
Johnson & Johnson Surgical Vision, Inc. (JJSV) 
 
31 Technology Drive 
 
Irvine, CA 92618 
 
SPONSOR PERSONNEL: 
 
 
Medical Monitor: 
Brian Schwam, MD 
 
Medical Monitor 
 
Cell:  904-233-6658 
 
Clinical Science: 
Michal Laron, PhD 
 
Sr. Principal Clinical Research Scientist 
 
Office: 408-273-5802 
 
Cell:  699-274-7997 
 
 
 
Priya Janakiraman, OD 
 
Director Clinical Science 
 
Cell: 408-300-3442 
 
 
 
 
Clinical Operations: 
Carmen Jones 
 
Manager, Clinical Operations 
 
Cell: 669-252-5145  
 
 
Jennifer Walcott  
 
Sr.Director Global Clinical Operations 
 
Cell: 949 3155005 
 
 
 
 
Biostatisticians: 
Cristiana Mayer, PhD 
 
Head of Biostatistics  
 
Cell:  949-217-0082 
 
 
Ying Wang, MS 
 
Principal Statistician 
Cell: 949-280-0485 
 
EMERGENCY TELEPHONE NUMBERS: 
Michal Laron, PhD 
Cell: 669-274-7997 
Office: 408-273-5802 
Brian Schwam, MD 
Cell:  904-233-6658 
Carmen Jones 
Cell: 669-252-5145 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
vii 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
1 
    PR/CHTA-103-FLAP 
SYNOPSIS 
PROTOCOL: 
A Prospective, Multi-Center Evaluation of Corneal Flap 
Creation Using Cheetah Femtosecond Laser System and 
Cheetah Patient Interface.   
 
Protocol Number:  CHTA-103-FLAP 
 
STUDY TREATMENTS: 
Investigational Product:  
1) Cheetah system  
 
 
 
 
2) Cheetah Patient Interface (one or two piece) 
Control Product:   
 
1) IntraLase FS 
 
2) Cheetah system with 
 PI 
 
STUDY OBJECTIVE: 
This is a 
 prospective clinical trial to clinically 
optimize the Cheetah femtosecond laser settings for flap 
creation 
 and evaluate the flap quality of the 
Cheetah system 
 
 
 
 
 
 
 
 
 
 
 
OVERALL STUDY DESIGN: 
Structure: 
Prospective, randomized (ratio of 1:1 for right eye and left 
eye, 
 multicenter, interventional study.   
 
Number of sites: 
Up to 5 sites 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
2 
    PR/CHTA-103-FLAP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
4 
    PR/CHTA-103-FLAP 
Inclusion Criteria 
 (all criteria apply to both eyes): 
• 
Age ≥18 years old. 
• 
Subjects with myopia or hyperopia with or without astigmatism (including mixed 
astigmatism) eligible for commercial LASIK treatment. 
• 
A residual anticipated stromal bed thickness of at least 250 microns based on 
preoperative central corneal pachymetry minus the maximum treatment depth to be 
ablated plus the intended flap thickness. 
• 
Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better 
• 
Distance Uncorrected Visual Acuity (UCVA) of 20/32 or worse 
• 
Signed informed consent and HIPAA authorization or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment. 
• 
Willing and capable of complying with follow-up examinations for the duration of the 
study 
 
Exclusion Criteria 
 (all criteria apply to both eyes): 
• 
Concurrent use of systemic (including inhaled) medications that may impair healing, 
including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months 
of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of 
treatment. 
o NOTE:  The use of inhaled or systemic corticosteroids, whether chronic or 
acute, is deemed to adversely affect healing and subjects using such 
medications are specifically excluded from eligibility. 
• 
History of any of the following medical conditions, or any other condition that could 
affect wound healing: collagen vascular disease, autoimmune disease, 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
5 
    PR/CHTA-103-FLAP 
immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine 
disorders (including, but not limited to unstable thyroid disorders and diabetes), 
lupus, and rheumatoid arthritis. 
o NOTE: The presence of diabetes (either type 1 or 2), regardless of disease 
duration, severity, or control, will specifically exclude subjects from 
eligibility.  
• 
Subjects with a cardiac pacemaker, implanted defibrillator or other implanted 
electronic device. 
• 
History of prior intraocular or corneal surgery (including cataract extraction), active 
ophthalmic disease or abnormality (including, but not limited to, symptomatic 
blepharitis/conjunctivitis, recurrent corneal erosion, dry eye syndrome, 
neovascularization > 1 mm from limbus), retinal detachment/repair, clinically 
significant lens opacity, clinical evidence of trauma, corneal opacity within the central 
9 mm and visible on topography, at risk for developing strabismus, or with evidence 
of glaucoma or propensity for narrow angle glaucoma. 
o NOTE:  Subjects with open angle glaucoma, regardless of medication 
regimen or control, or an IOP greater than 21 mmHg at screening, are 
specifically excluded from eligibility. 
• 
Evidence of keratoconus, corneal dystrophy or irregularity, corneal edema, corneal 
lesion, hypotony, or abnormal topography.  
• 
Known sensitivity or inappropriate responsiveness to any of the medications used in 
the postoperative course. 
• 
A fellow eye that does not meet all inclusion criteria and does not fall within approved 
indications for treatment using excimer Laser. 
• 
Desire for monovision correction 
• 
Women who are pregnant, breast-feeding, or intend to become pregnant during the 
study. 
• 
Participation in any other clinical study, with the exception of a fellow eye treated in 
this protocol. 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
6 
    PR/CHTA-103-FLAP 
DATA ANALYSIS: 
 
 
 
 the key evaluation 
stromal bed surface quality, 
 using the investigational vs control product. The analysis population 
will include both eyes of all treated 
 subjects and will be used for all end points. 
An interim database lock may be performed after approximately 40 subjects have been 
treated with optimized settings and reached the 1-month postoperative follow-up. 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
7 
    PR/CHTA-103-FLAP 
1. 
BACKGROUND/INTRODUCTION 
JJSV’s current femtosecond laser platform is the IntraLase iFS. It creates flaps through 
precise individual microphotodisruptions of corneal tissue created by tightly focused 
ultrashort pulses which are delivered through a disposable applanation lens while 
fixating the eye under vacuum. 
The Cheetah system is a new femtosecond laser developed by JJSV for the same 
clinical purpose as the IntraLase iFS system. Similar to the IntraLase iFS, it is used in 
conjunction with a sterile disposable patient interface (PI), that serves as a physical 
connection between a patient’s eye and the system to facilitate accurate laser incisions 
to the patient’s cornea.  
 
 
 
 
 
 
  
The design objective was to develop a flap maker that will be equivalent or better 
compared to the commercial products. In this study the flap quality and workflow of the 
study eye will be compared to the control product. 
2. 
CLINICAL HYPOTHESIS 
The hypothesis is that the flap quality of the study eye will be equivalent or better than 
the control eye. 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
8 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
9 
    PR/CHTA-103-FLAP 
4. 
ACRONYMS 
The following acronyms are used throughout the document:   
• 
D: Diopters 
• 
BSCVA:  Best Spectacle Corrected Visual Acuity 
• 
UCVA: Uncorrected Visual Acuity 
• 
MRSE: Manifest Refractive Spherical Equivalent 
• 
OBL: Opaque Bubble Layer 
• 
PI: Patient Interface 
• 
OCT: Optical Coherence Tomography 
• 
QID: 4 times a day (in Latin – quarter in die) 
5. 
STUDY OBJECTIVES AND ENDPOINTS 
The purpose of this prospective clinical trial is to 
 
 evaluate the flap quality of the 
Cheetah femtosecond laser 
 
 
 
 
 
 
 
5.1 
PRIMARY STUDY ENDPOINTS 
 stromal bed surface quality, 
 
 of the study  eye will be graded on a scale of 1-5 relative to the 
control eye. A score of 3 means that the study eye is similar to the control eye; a score 
of 4 or 5 means that the study eye is superior to the control eye; and a score of 1 or 2 
means that the control eye is superior to the study eye. 90% of all subjects are expected 
to have a score equal to or greater than 3 
. 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
10 
    PR/CHTA-103-FLAP 
5.2 
OTHER ENDPOINTS 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
• 
Optical Coherence Tomography (OCT) measurements – Anterior OCT scans will 
be taken pre- and post-surgery and measurements of the cornea and flap 
thickness will be recorded.  
• 
BSCVA – Percent of eyes with a loss of >2 lines of best spectacle corrected 
visual acuity relative to preoperative acuity will be compared between the 2 eyes. 
• 
UCVA – Percent of eyes with uncorrected visual acuity of 20/40, 20/32, 20/25, 
20/20, and 20/16 or better will be compared between the 2 eyes. 
 
 
 
 
 
 
 
  
6. 
STUDY PRODUCTS 
6.1 
CHEETAH SYSTEM 
The Cheetah system (Models Beta 2a,Figure 1; or Production Equivalent (ELITA), 
Figure 2 is an ophthalmic laser surgical system that is developed for use in the creation 
of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial 
resection of the cornea. Either model can be used in this study.  

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
11 
    PR/CHTA-103-FLAP 
 
 
 
 
The Cheetah System is an investigational device. It is approved in the EU and UK, but is 
not yet approved in the U.S.A. The Principal Investigator is responsible for ensuring that 
the Cheetah system is only used to treat subjects enrolled in this study.   
6.2 
CHEETAH PATIENT INTERFACE 
The Patient Interface (PI) is an accessory to the Cheetah System. The PI serves as a 
physical connection between a patient’s eye and the system to facilitate accurate laser 
incisions to the patient’s cornea.  
 
Figure 1. Cheetah Beta2a Femtosecond Laser system 
Figure 2. Production Equivalent (ELITA) Femtosecond Laser System 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
13 
    PR/CHTA-103-FLAP 
 
 The two piece 
Cheetah patient interface is approved in the EU, UK, and U.S.A. The Principal 
Investigator is responsible for ensuring that the Patient Interface is only used to dock 
subjects enrolled in this study. 
 
7. 
STUDY POPULATION 
 
 
 
 
 
  
This study will include only subjects who meet all the study inclusion and none of the 
exclusion criteria 
  All subjects who qualify will be 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
15 
    PR/CHTA-103-FLAP 
Exclusion Criteria 
 (all criteria apply to both eyes): 
1) Concurrent use of systemic (including inhaled) medications that may impair 
healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) 
within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 
12 months of treatment. 
NOTE:  The use of inhaled or systemic corticosteroids, whether chronic or 
acute, is deemed to adversely affect healing and subjects using such 
medications are specifically excluded from eligibility. 
2) History of any of the following medical conditions, or any other condition that 
could affect wound healing: collagen vascular disease, autoimmune disease, 
immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine 
disorders (including, but not limited to unstable thyroid disorders and diabetes), 
lupus, and rheumatoid arthritis. 
NOTE: The presence of diabetes (either type 1 or 2), regardless of disease 
duration, severity, or control, will specifically exclude subjects from 
eligibility.  

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
16 
    PR/CHTA-103-FLAP 
3) Subjects with a cardiac pacemaker, implanted defibrillator or other implanted 
electronic device. 
4) History of prior intraocular or corneal surgery (including cataract extraction), 
active ophthalmic disease or abnormality (including, but not limited to, 
symptomatic blepharitis/conjunctivitis, recurrent corneal erosion, dry eye 
syndrome, neovascularization > 1 mm from limbus), retinal detachment/repair, 
clinically significant lens opacity, clinical evidence of trauma, corneal opacity 
within the central 9 mm and visible on topography, at risk for developing 
strabismus, or with evidence of glaucoma or propensity for narrow angle 
glaucoma. 
NOTE:  Subjects with open angle glaucoma, regardless of medication 
regimen or control, or an IOP greater than 21 mmHg at screening, are 
specifically excluded from eligibility. 
5) Evidence of keratoconus, corneal dystrophy or irregularity, corneal edema, 
corneal lesion, hypotony, or abnormal topography.  
6) Known sensitivity or inappropriate responsiveness to any of the medications 
used in the postoperative course. 
7) A fellow eye that does not meet all inclusion criteria and does not fall within 
approved indications for treatment using excimer Laser. 
8) Desire for monovision correction 
9) Women who are pregnant, breast-feeding, or intend to become pregnant during 
the study. 
10) Participation in any other clinical study, with the exception of a fellow eye treated 
in this protocol.   
 
8. 
INVESTIGATOR SELECTION 
8.1 
INVESTIGATOR QUALIFICATIONS 
JJSV will select ophthalmic surgeons who have completed a residency in ophthalmology 
(or its documented equivalent), are licensed to practice medicine and perform LASIK at 
his or her investigative site.  
Investigators will be selected from surgeons who are experienced in using the 
IntraLase® keratome. All sites are required to have adequate staff support for reporting 
and subject follow-up, as well as the necessary instrumentation to conduct study testing.  
Each site will have one designated principal investigator; some sites may have additional 
surgical sub-investigators.   
8.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
17 
    PR/CHTA-103-FLAP 
• 
Conduct the study in accordance with the relevant and current protocol.  Investigator 
will only make changes to a protocol after notifying and obtaining approval from JJSV 
and the Investigational Review Board (IRB) or Independent Ethics Committee (IEC), 
except when necessary to protect the safety, rights or welfare of subjects 
• 
Personally conduct and supervise the study 
• 
Maintain a list of appropriately qualified persons to whom the investigator has 
delegated significant trial-related duties 
• 
Be responsible for protecting the rights, safety and welfare of subjects under the 
investigator’s care and be responsible for the control and documentation of the 
devices under investigation 
• 
Inform patients that the device(s) are being used for investigational purposes and 
that requirements relating to obtaining informed consent and IRB/IEC approval are 
met according to 21CFR50, 21CFR56, 21CFR812 and all other applicable laws and 
regulations 
• 
Maintain confidentiality as required by HIPAA or similar laws and regulations 
• 
Shall not obtain written informed consent from any subject to participate or allow any 
subject to participate before obtaining IRB/IEC approval and approval from the 
regulatory agency of the country in which the study is being conducted by the 
investigator 
• 
Document in each subject’s case history that informed consent was obtained prior to 
participation in the study as required by 21CFR812 
• 
Report to JJSV and the reviewing IRB/IEC any adverse experiences that occur 
during the course of the study in accordance with applicable laws and regulations 
• 
Maintain adequate and accurate records in accordance with applicable laws and 
regulations and make available all study documents and subject medical records for 
inspection by either JJSV, duly authorized regulatory agencies (e.g., FDA) and/or the 
IRB/IEC 
• 
Submit progress reports on the investigation to JJSV and the reviewing IRB/IEC at 
regular intervals, but no less often than yearly as required by 21CFR812.150  
• 
Report all changes in research activity and all unanticipated problems involving risks 
to patients to the IRB/IEC and JJSV 
• 
Supervise and permit investigational device use and disposition in accordance with 
applicable regulations and protocol requirements.  Upon completion of enrollment or 
termination of the study or the investigator’s part of the study, or at JJSV’s request, 
return to JJSV any remaining supply of the investigational device 
• 
Provide sufficient accurate financial information to JJSV to allow JJSV to submit 
complete and accurate certification or disclosure statements as required by 
21CFR54.  Promptly update this information if any relevant changes occur during the 
course of the investigation or for up to one year following completion of the study 
• 
Comply with all other obligations of clinical investigators and requirements according 
to all applicable FDA regulations (e.g., 21CFR812), all other applicable laws and 
regulations, and all conditions of approval imposed by the reviewing IRB/IEC, and 
the regulatory agency of the country in which the study is being conducted 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
18 
    PR/CHTA-103-FLAP 
• 
Ensure that all associates, colleagues and employees assisting in the conduct of the 
study are adequately informed about the protocol, the investigational device, their 
study-related duties and functions and agree to fulfill their obligations in meeting the 
above commitments. 
Investigators shall provide adequate time and resources to conduct and report on the 
study. The Investigator, or delegate, shall notify JJSV of any change in the conduct of 
the study including changes in study personnel assigned to the study project, location of 
the investigational device(s), or maintenance of study records, etc.  
8.3 
INVESTIGATOR APPROVAL  
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB/IEC as appropriate.  All correspondence 
with the IRB/IEC should be retained in the Investigator Study Files/Notebook.  Copies of 
IRB/IEC submissions and approvals should be forwarded to JJSV.  Study sites will 
obtain IRB/IEC approvals and fulfill any other site-specific and/or region-specific 
regulatory requirements.  The investigator is required to report to JJSV within five 
working days any withdrawal of approval by the reviewing IRB/IEC for his/her 
participation in the investigation. 
Prior to the start of subject enrollment, the following documents must be signed and 
returned to JJSV: 
• 
Confidentiality Agreement 
• 
Clinical Trial Agreement 
• 
Investigator Agreement/Protocol Signature page 
• 
Clinical Investigator Brochure Signature page 
• 
Financial Disclosure form 
• 
Signed and dated copy of investigator’s current curriculum vitae 
• 
Copy of the investigator’s current medical license (as available per country) 
• 
Hospital/Ambulatory Surgery Center Clinical Study Acknowledgement, if required 
By signing the study documents, the investigator agrees to conduct this study according 
to the obligations above and all other applicable regulatory and legal requirements. 
9. 
EXPERIMENTAL PLAN 
9.1 
OVERVIEW 
This study will be conducted in accordance with U.S. Code of Federal Regulations, the 
Declaration of Helsinki, ISO 14155 and all other applicable laws and regulations.  The 
study will not begin until regulatory and IRB/IEC approvals have been obtained. 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
19 
    PR/CHTA-103-FLAP 
 
 
 
 
 
 
 
After signing the informed consent, subjects meeting all inclusion and none of the 
exclusion criteria 
may be scheduled for surgery.  
 
   
Although the study is not masked, to maintain consistency, it is recommended that a 
single individual (study technician or coordinator designated by the investigator) conduct 
all study-related vision testing, although a back-up person should also be designated 
and trained. 
 
 
   
 
 
 
 
   

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
21 
    PR/CHTA-103-FLAP 
9.4 
RANDOMIZATION 
A randomization list will be created by an internal independent JJSV biostatistician for 
each investigative site.  Subjects’ eyes 
 will be randomized on a 1:1 basis 
between the study eye eye and the control eye.  Randomization will take place after the 
subject has signed the informed consent document and has met all inclusion and 
exclusion criteria. 
As part of the informed consent process, the investigator or delegate will explain to the 
subject the requirements of a randomized study and the differences expected between 
the study eye and the control eye.    
9.5 
STUDY PATIENT INTERFACE (PI) SUPPLY 
For each subject, one investigational Cheetah PI 
 and one 
commercial IntraLase iFS PI (when needed) shall be available. Investigational Cheetah 
PIs will be obtained from the site investigational PI consignment, supplied by JJSV prior 
to study initiation and as needed during the study.  Commercial IntraLase iFS PIs will be 
obtained from the site’s own inventory.  Two PIs 
 should be available 
for each case: a primary and a back-up PI.  Unused back-up investigational PIs are to be 
returned to the site consignment.  At the completion of study enrollment, any remaining 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
22 
    PR/CHTA-103-FLAP 
investigational PIs will be shipped back to JJSV.  At all times, the storage, access and 
use of all investigational PIs must be controlled and complete PI accountability 
maintained (See Section 15.2 PI Accountability).   
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
   
 
 
  
 
 
 
 
  
  

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
24 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
25 
    PR/CHTA-103-FLAP 
9.8 
RETREATMENT PROCEDURES 
NON-REFRACTIVE RETREATMENTS 
Non-refractive retreatments or procedures without further laser treatment (e.g., flap lifts, 
adjustments, realignments, replacement, treatment of complications, removal of 
epithelial ingrowth, etc.) may be performed at any time with the advance notification of 
the Sponsor. All flap adjustment procedures will be noted and reported to the Sponsor. 
REFRACTIVE RETREATMENTS 
Refractive retreatments may be performed after completion of the 
 postoperative 
exam and after the subject has exited from the study.  
9.9 
EXIT OF SUBJECTS  
An Exit Case Report Form will be completed for all subjects, either when they complete 
the study or if they exit early.   
It is the responsibility of the investigator to provide complete follow-up data to JJSV for 
each subject, and every attempt should be made to gather that complete follow-up data 
for all subjects enrolled as missing data can have a negative effect on the study results. 
Patients who would be traveling, relocating or otherwise unavailable for postoperative 
follow-up visits should not be chosen for this clinical study. 
Subjects will be considered “lost-to-follow-up” from the study only if irretrievably lost for 
unavoidable reasons such as: subject moved/unable to locate, subject 
uncooperative/refuses further study participation, subject ill/unable to travel.  In the event 
of subject relocation, efforts must be made by the investigator to secure follow-up 
information (i.e., slit-lamp findings and general visual acuity, etc.) from the subject’s new 
physician.   

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
26 
    PR/CHTA-103-FLAP 
A subject 
 will be considered a non-randomized screen failure if he/she does 
not meet the inclusion/exclusion criteria or if consent is withdrawn prior to randomization.   
A subject will be considered a randomized screen failure if the subject is randomized but 
does not undergo surgery for various reasons including: the subject withdrawing consent 
prior to treatment or the subject died prior to treatment.  
 
 
 
If a subject is exited early from the study, the investigator will complete an Exit Case 
Report Form indicating the reason for study exit.  In the event of a serious adverse 
event, the subject may be exited from the study; however, efforts must be made by the 
investigator to follow the subject until resolution of the adverse event. 
All study subjects are to be instructed to undergo regular eye examinations at least 
yearly and also to return to their doctor if any eye complications are experienced in the 
interim.   
9.10 
UNSCHEDULED VISITS  
During the study period, if a non-protocol-required visit is done for the purpose of 
medically-indicated follow-up for a study eye, data from this visit should be reported 
using the Unscheduled Visit CRF.  The need for unscheduled visits is at the 
investigator’s discretion.  Specific examinations to be performed at unscheduled visits 
are also at the discretion of the investigator (based on the reason for the unscheduled 
visit) and data are to be recorded in the appropriate section of the case report form. 
Data to be collected may include: 
• 
manifest refraction 
• 
Uncorrected and best corrected distance visual acuity using a LogMAR chart 
• 
Intraocular pressure 
• 
Slit-lamp examination for medical and/or lens findings  
• 
Dilated fundus exam 
• 
Ocular symptoms 
• 
Adverse events 
• 
Medications 
9.11 
PROTOCOL DEVIATIONS  
Any departure from the protocol procedures represents a protocol deviation.  Protocol 
deviations may be subject-based (e.g., inclusion/exclusion criteria, informed consent 
deviation, etc.) or procedural-based (e.g., out-of-interval visits, non-compliance with 
testing procedures, etc.).  All protocol deviations will be documented using protocol 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
27 
    PR/CHTA-103-FLAP 
deviation case report forms.  Any deviation made to protect the life or physical well-being 
of a subject in an emergency as well as any use of the investigational device without 
obtaining informed consent must be reported to JJSV and local ethics committee within 
5 working days. Protocol deviations will be monitored by JJSV, and if the non-
compliance is persistent or egregious, JJSV may take action, including but not limited to 
termination of the investigator’s participation in the study.  The investigator is also 
responsible for informing the reviewing IRB/IEC of instances of protocol non-compliance 
in accordance with the IRB/IEC requirements. 
10. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS  
10.1 
ADVERSE EVENT DEFINITIONS 
Adverse Event (AE) 
An adverse event is defined (following ISO 14155) as any untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not related to the study device.   
Serious Adverse Event (SAE) 
An adverse event is considered serious (following ISO 14155) if it is an untoward 
occurrence which may or may not be related to use of the study device that 
• 
is sight- or life-threatening,  
• 
results in death,  
• 
requires inpatient hospitalization or prolongation of hospitalization (a planned 
hospitalization for a pre-existing condition without a serious deterioration in health is 
not considered a serious adverse event), 
• 
results in permanent impairment of a body structure or body function,  
• 
necessitates medical or surgical intervention to prevent permanent impairment to a 
body structure or function, or 
• 
results in fetal distress, fetal death or a congenital abnormality or birth defect 
Device-Related Adverse Event/Adverse Device Effect (ADE) 
A device-related adverse event is defined as any adverse even that is believed to be 
definitely, probably or possibly related to the study device (following the guidelines in 
Section 11.4, Causal Relationship).  A device-related event is also considered an 
adverse device effect (ADE; following ISO 14155) resulting from the use of the study 
device that may result from user error, insufficiencies or inadequacies in the instructions 
for use, deployment, implantation, installation, operation of any malfunction of the 
device.   

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
28 
    PR/CHTA-103-FLAP 
Study-Specific Anticipated Adverse Events 
The following is a list including, but not limited to, ocular adverse events that are 
anticipated and must be reported to JJSV for this study.  Any events that are unlikely but 
anticipated (i.e., endophthalmitis) will be reported to the FDA and other appropriate 
regulatory agencies. 
• 
Diffuse lamellar keratitis (DLK) (Grade 3 or above) 
• 
Pressure Induced Stromal Keratitis (PISK) 
• 
Corneal infiltrate or ulcer 
• 
Corneal epithelial defects upon flap creation 
• 
Any persistent corneal epithelial defect at 1 month or later 
• 
Corneal edema at 1 month or later  
• 
Epithelium in the interface with loss of 2 or more lines of BSCVA (≥10 ETDRS 
letters) 
• 
Miscreated flap (decentered, lost, incomplete, too thin or other)  
• 
Melting of the flap  
• 
IOP with increase > 10 mmHg above baseline on two consecutive examinations or 
an IOP greater than 30 mmHg on two consecutive examinations 
• 
Haze at 3 months or later with loss of 2 or more lines of BSCVA (≥10 ETDRS letters) 
• 
Interface haze 
• 
Decrease in BSCVA of 2 or more lines (≥10 ETRDS letters) not due to irregular 
astigmatism as shown by hard contact lens refraction (or pin hole acuity if hard 
contact lens refraction is not medically advisable) at 3 months or later 
• 
Retinal detachment 
• 
Retinal vascular accidents 
• 
Any other vision-threatening event 
• 
Ocular penetration 
• 
Rainbow glare 
• 
Severe glare, severe dry eye, or severe halos at 3 months or later 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
29 
    PR/CHTA-103-FLAP 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) 
Any UADE (USA 21CFR 812.3(s)) or USADE (ISO 14155) is defined as any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan (i.e., this protocol), 
application (including a supplementary plan or application), or risk assessment, or any 
other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects.   
10.2 
PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
A product complaint/device deficiency is defined (21 CFR 820.3(b) and ISO 14155) as 
any alleged deficiency related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a device. This may include malfunctions, use error and 
inadequacies in labeling.  Product complaints can pertain to any marketed JJSV device 
being used in the study as well as the investigational device.  The investigator is to 
assess whether the deficiency could have led to a serious adverse event without suitable 
action or intervention or under less fortunate circumstances. 
10.3 
ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
All adverse events and any complaint encountered using any JJSV product, regardless 
of severity and whether or not attributed to the study device(s), are to be reported to 
JJSV and recorded on the case report form corresponding to the visit during which 
awareness of the event occurred.  Adverse events are also to be reported to the 
reviewing IRB/IEC as per the IRB/IEC’s reporting requirements.  If required, adverse 
events will be reported to the appropriate regulatory agencies (e.g., FDA) according to 
all applicable laws and regulations.  Specific instructions on notification procedures to 
JJSV are included in Appendix K, Adverse Event Reporting.   
Reporting of adverse events shall follow the USA Code of Federal Regulations 
(21CFR812) for sites in the USA.  For sites located outside the USA, reporting of 
adverse events shall follow ISO 14155 and country-specific guidelines, of which the 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
30 
    PR/CHTA-103-FLAP 
shortest/strictest timeline requirement for reporting adverse events will be followed. 
General guidelines are provided below: 
Adverse Event Reporting 
An adverse event that is not serious or device-related is to be reported to JJSV in a 
timely manner.  Notification of non-serious and non-device related adverse events will 
occur by recording events on the CRF when noted.  Such adverse events are also to be 
reported to the reviewing IRB/IEC per their reporting requirements.  
Complaints/Device Deficiency Reporting  
A general product complaint or device deficiency is to be reported to JJSV in a timely 
manner.  Notification of complaints/device deficiencies will occur by either recording 
complaints on the CRF when the complaint occurred (e.g. operative form) or by a phone 
call to the Sponsor.  Any device deficiency that could have led to a serious adverse 
event without suitable action or intervention, or under less fortunate circumstances, must 
be reported to the sponsor immediately (no later than 48 hours after detection). Device 
deficiencies that could have led to a serious adverse event should also be reported to 
the investigator’s IRB/IEC per their reporting requirements. 
Serious and/or Device-Related Adverse Event Reporting 
Serious and/or device related events (ADEs) are to be documented using the Detailed 
Adverse Event CRF.  In the event of a serious adverse event (SAE), which may or may 
not be related to use of the study device, JJSV must be notified immediately (no later 
than 48 hours after detection).  Any SAE is to be reported by phone (and/or email) and 
by submitting the completed Detailed Adverse Event CRF.  Any SAE or device-related 
AE should also be reported to the investigator’s IRB/IEC per their reporting 
requirements. 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) Reporting 
If during the study, a serious adverse event occurs that may reasonably be regarded as 
device-related and was not previously expected in nature, severity, or degree of 
incidence, the investigator is to report the UADE/USADE to JJSV within 48 hours, and to 
the investigator’s IRB/IEC as soon as possible (no later than 10 working days after 
learning of the event for sites in the USA as required by 21CFR812, and per country 
requirements, otherwise). 
10.4 
CAUSAL RELATIONSHIP  
The investigator should always be alert to adverse events that may be related to the 
study device or the use of the study device (i.e., the procedure specific to the initial 
application of the device).  An attempt should be made in every case to determine the 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
31 
    PR/CHTA-103-FLAP 
causality of the event.  The following definitions are to be used as guidelines in 
determining the relationship between the event and the study device and/or use of the 
device.   
Definitely related: 
If the event is associated with the device and/or the use of the 
device beyond a reasonable doubt, a causal relationship exists 
between the adverse event and the device and/or the use of the 
study device. 
Probably related:   
There is a reasonable possibility of a causal relationship 
between the adverse event and the device and/or the use of the 
study device and/or the adverse event cannot be reasonably 
explained by another cause. 
Possibly related:   
The adverse event has not been determined to be related to the 
device or the use of the device, but no other cause has been 
identified and the device and/or the use of the study device 
cannot be ruled out as a possible cause. 
Unlikely to be related: The possibility of a potential causal relationship between 
adverse event and the device and/or the use of the device could 
exist, but the adverse event can be reasonably explained by 
another cause. 
Not related: 
There is no possibility of a causal relationship between the 
adverse event and the device and/or the use of the study device 
and/or the adverse event can be attributed to another cause. 
If an adverse event is believed to be definitely, probably or possibly related to the study 
device and/or the use of the device, the event will be considered related to the study 
device and/or the use of the device.   
10.5 
ADVERSE EVENT FOLLOW-UP 
For every adverse event, appropriate measures should be undertaken to treat and/or 
monitor the subject until resolution or stabilization occurs.  Obtain and maintain in the 
subject's files all pertinent medical data relating to the event including the subject’s 
medical records and medical reports and/or judgments from colleagues or outside 
specialists who assisted in the treatment and follow-up of the subject. The investigator 
should keep JJSV closely informed as to the outcome of serious and/or device-related 
adverse events, thereby allowing JJSV to comply with the appropriate regulatory 
reporting requirements.  A Detailed Adverse Event Update CRF should be completed 
each time the subject returns to the investigator or other specialist(s) for follow-up of 
serious and/or device-related adverse event until resolution of the event.  Any subject 
who is exited from the study due to a serious and/or device-related adverse event will be 
followed until the outcome is determined. 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
32 
    PR/CHTA-103-FLAP 
11. 
PROTOCOL CHANGES/AMENDMENTS  
If the investigator desires to modify any procedure and/or the design of the study, he or 
she must contact and obtain consent from JJSV regarding the proposed changes prior to 
implementation.  Any modifications (including additional data collection) require approval 
by the FDA and/or all other appropriate regulatory agencies, as well as approval of the 
governing IRB/IECs prior to implementation.   
12. 
ETHICS REVIEW AND PATIENT WELFARE 
12.1 
INSTITUTIONAL REVIEW BOARD (IRB)/ INDEPENDENT ETHICS 
COMMITTEE (IEC) 
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB/IEC.  All correspondence with the 
IRB/IEC should be retained in the Investigator Notebook.  Copies of IRB/IEC 
submissions and approvals should be forwarded to JJSV. 
The investigator is responsible for notifying the IRB/IEC of reportable adverse events as 
well as any other circumstance in which additional procedures outside the protocol were 
conducted to eliminate apparent hazards to subjects. 
12.2 
INFORMED CONSENT 
The current version of the IRB/IEC-approved study informed consent must be signed by 
each study subject prior to any study-specific examinations being performed.  The 
IRB/IEC-approved informed consent is to be signed and dated by the subject as well as 
by the person who conducted the informed consent discussion.  The signed informed 
consent will be maintained by the investigator as a permanent part of the subject’s 
medical records.  A copy of the signed and dated form is to be provided to the subject.  
The investigator will provide JJSV written acknowledgement on the preoperative case 
report form that a signed agreement of informed consent has been obtained and is in the 
investigator’s possession for each subject.  As required by 21CFR812 Part G, the site 
shall document in the source documents that informed consent was obtained prior to 
participation in the study for each subject enrolled. 
NOTE:  The informed consent process also includes obtaining the subject’s signature on 
an Authorization for Use/Disclosure of Health Information for Research Form or 
equivalent documentation necessary to comply with applicable privacy laws pertaining to 
medical treatment in the governing countries.   
NOTE:  The sponsor will secure appropriate insurance for study subjects prior to study 
start. 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
33 
    PR/CHTA-103-FLAP 
13. 
DOCUMENTATION 
13.1 
SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may include 
a subject’s medical records, hospital charts, clinic charts, the investigator’s subject study 
files, as well as results of any diagnostic tests or procedures such as topographies or 
laboratory tests with photographs or instrument printouts. 
Each site is expected to adhere to the clinic’s own standard documentation requirements 
for medical charts/clinic notes.  However, for the purposes of this clinical study, the 
medical charts/clinic notes must also include, at a minimum, the following data that will 
be considered source data and will be reviewed by JJSV: 
• 
Subject’s name and study identification number 
• 
Subject’s contact information 
• 
Study protocol number and the Sponsor name (JJSV) 
• 
A statement that informed consent was obtained prior to participation in the study 
(including the date)  
• 
Dates of all subject visits and surgeries throughout the duration of the study 
• 
Concurrent medications 
• 
Corrected and uncorrected distance visual acuity (NOTE: ETDRS visual acuity score 
cards are considered source documentation and are to be retained by the site in the 
subject CRF notebooks) 
• 
Manifest refraction 
• 
Occurrence and status of any operative complications, postoperative medical 
findings and adverse events 
• 
Occurrence and status of any subject complaints, e.g., ocular/visual symptoms 
• 
The date the subject exited the study, and a notation as to whether the subject 
completed the study or reason for early exit. 
13.2 
SUBJECT CONFIDENTIALITY 
Subjects will be assigned a site/subject number to maintain subject confidentiality.  
Subject names may possibly be disclosed to the JJSV or regulatory agencies during 
inspection of medical records related to the study, but reasonable precautions will be 
taken to maintain confidentiality of personal information to the extent permitted by 
applicable laws and regulations. 
13.3 
CASE REPORT FORM COMPLETION 
This study will use an electronic data capture (EDC) management system.  The 
investigator is responsible for ensuring that data are properly recorded on each subject’s 
case report forms and related documents.  Prior to database lock, the investigator will 
verify completeness and accuracy of data submitted to JJSV.  

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
34 
    PR/CHTA-103-FLAP 
 
 
 
 
  
14. 
MONITORING  
JJSV will perform three types of monitoring to ensure compliance with regulations: data 
monitoring, administrative monitoring, and safety monitoring. 
14.1 
DATA MONITORING 
In order to ensure a well-controlled clinical trial, JJSV will follow specific data monitoring 
procedures.   
To minimize data omissions and inconsistencies on clinical reports and to ensure that 
data are accurately transcribed to computer data files, JJSV will follow internal data 
processing procedures that include automated and manual quality control checks to 
identify any data discrepancies.  Any such items will be resolved and documented as 
needed on the case report forms at the investigative site and in the data management 
system at JJSV. 
Prevention of Missing Data 
Methods used to safeguard against missing data that can have deleterious effects on the 
study integrity and reliability of its outcomes will include training study staff with 
centralized and on-site programs.  In addition, subjects will be encouraged at the time of 
informed consent to avoid missing study visits, as missing data may affect the study 
reliability and diminish the scientific value of their contribution to the study.  
14.2 
ADMINISTRATIVE MONITORING 
Administrative monitoring procedures will ensure that study devices, subjects, and forms 
can be traced and will allow monitoring of investigator progress and compliance.  
Accountability and traceability of study devices will be monitored by JJSV. 
Device Accountability 
Complete patient interface (PIs) accountability will be maintained at the investigative site 
by maintaining records of all investigational PIs received from and returned to JJSV.  A 
site log will be used to track PIs for date of receipt, serial number, use and 
disposition/return to JJSV.  This site log and any other investigational PI information will 
be maintained in the study binder and monitored by JJSV personnel.  During periodic 
investigative site monitoring visits, JJSV personnel will review investigative site PI 
inventory records and logs to ensure PI accountability compliance and complete 
investigational PI traceability.   

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
35 
    PR/CHTA-103-FLAP 
Since the Patient Interface of the IntraLase iFS are commercially available, supply 
records for the IntraLase iFS PIs will solely be the responsibility of the site and managed 
by their customary methods.   
Site Monitoring Plan 
Prior to performing any study LASIK flaps, the requirements of the study and reporting 
mechanisms will be explained to each investigator either personally at the investigative 
site or at a formal study investigator meeting.  When necessary, a pre-study site 
qualification visit may be performed to assess the adequacy of the site to perform the 
study for sites that have not previously worked with JJSV or have undergone significant 
changes, or have not been visited in the past year.  A study initiation visit will be 
conducted for all sites prior to or at the time of the first LASIK flap treatment.  
Throughout the duration of the study, site visits to monitor compliance to this protocol will 
be made at each investigative site.  During a routine site monitoring visit, JJSV will 
review informed consent documents and subject eligibility, and the data on study case 
report forms will be verified against subject charts and other source documents to 
ensure complete and accurate reporting.  The subject files will also be reviewed to 
assure that all adverse events and any issues encountered with JJSV products have 
been reported in a timely fashion.   
JJSV will also review source documents to verify that all required items have been 
documented in the subject medical charts.  Refer to Section 14.1, Source Documents, 
for a list of items that are required for source documentation.  In addition to subject files, 
study logs will be checked and conformance to lighting levels for visual acuity tests will 
be verified.   
Training on study-specific procedures may also be conducted during monitoring visits.   
Upon study completion, a final close-out site visit to each site will be made to monitor the 
last of the subject data records and finalize any outstanding study issues.  
A separate Study Monitoring Plan will be established prior to study start that will define 
the type and frequency of monitoring visits and frequency of record monitoring.  
MONITORING SCHEDULE (EXAMPLE IF NO SEPARTE STUDY MONITORING PLAN)  
JJSV will visit each study site for site initiation visit to set up equipment and train all site 
staff on the study.  JJSV will attend the first 1-month examinations at each study site. 
Interim monitoring visits will be conducted at least once a year or more often as needed 
according to subject exam compliance, clarity and consistency of data received by JJSV, 
resolution of data queries within the data management system, etc.  JJSV will perform 
close out visits, and collect the equipment provided to the site to conduct the study. 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
36 
    PR/CHTA-103-FLAP 
14.3 
SAFETY MONITORING 
This study will utilize a Medical Monitor for safety monitoring.  The medical monitor will 
review results throughout the clinical trial as necessary to ensure the continued safety of 
the device and to ensure that no subjects are exposed to unreasonable risk.  The 
medical monitor will be available to answer all questions from investigators.  The medical 
monitor will review and assess any reports of serious and/or device-related adverse 
events as well as device deficiencies that could have led to a serious adverse event, and 
discuss these with the reporting investigator(s) as necessary.  The medical monitor, as 
well as any other qualified personnel designated by JJSV, shall also review any interim 
progress reports, as applicable.   
15. 
PUBLICATIONS 
Refer to the Clinical Trial Agreement for information regarding JJSV publication policies. 
16. 
RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
As part of the risk assessment and analysis, all risks were eliminated or reduced to as 
low as possible (or ALAP) through identified control measures.  After all available control 
measures have been implemented; any residual risk was addressed via a Risk Benefits 
Analysis (RBA).  
RISKS OF THE CHEETAH FEMTOSECOND LASER AND CHEETAH PI 
The Cheetah femtosecond laser and Cheetah patient interface (PIs) are designed for the 
creation of corneal flaps for LASIK treatments. The potential risks and complications to 
subjects when using the Cheetah laser system in the study, include similar risks to 
routine use of femtosecond laser for refractive surgery with a market-approved 
procedure. The central wavelength 
, which is different than the IntraLase 
wavelength (1053nm), is commonly used in other commercial systems (VisuMax, Victus, 
WaveLight FS 200, Femto LDV). The Cheetah femtosecond laser and Cheetah patient 
interfaces are not expected to introduce new risks for flap creation. 
 
GENERAL RISKS OF FLAP CREATION WITH A FEMTOSECOND LASER 
General risks of flap creation for LASIK include a number of potential complications 
which may require medical treatment and/or secondary surgical intervention. These risks 
can include: corneal abrasion, corneal edema, corneal pain, epithelial ingrowth, epithelial 
defect, infection, flap de-centration, incomplete flap creation, flap tearing or incomplete 
lift-off, free cap, photophobia, corneal inflammation such as diffuse lamellar keratitis 
(DLK), corneal infiltrates and iritis, thin or thick flaps, flap striae, delayed healing, retinal 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
37 
    PR/CHTA-103-FLAP 
detachment, increased intraocular pressure, and hemorrhage. Complications can result 
in poor vision, loss of vision or loss of the eye. 
RISK MANAGEMENT 
Subjects will be closely monitored thought the trial duration.  The occurrence of adverse 
events and complaints will be assessed at each study visit and reported to JJSV 
according to Section 11.0, Adverse Events and Product Complaints.  Additionally, JJSV 
will monitor incoming data following the procedures outlined in Section 15.0, Monitoring.  
The Medical Monitor will ensure subjects are not exposed to additional risks by 
monitoring serious adverse events, device-related adverse events, and device-
deficiencies that could have led to serious adverse events (Section 15.3, Safety 
Monitoring).  
POTENTIAL BENEFITS 
The primary benefits of laser refractive surgery with the investigational Cheetah system 
are the correction of myopic and hyperopic with or without astigmatic refractive errors 
which may reduce or eliminate the need for glasses or contact lenses for distance vision. 
CONCLUSION 
The hazards/risks associated with the Cheetah femtosecond laser and PIs, are 
acceptable and similar to those of IntraLase FS and iFS. The potential clinical benefits of 
the Cheetah femtosecond laser and Cheetah PIs, outweigh the residual risks when the 
device is used as intended.  
17. 
RECORDS RETENTION 
All study-related correspondence, subject records, consent forms, Authorization for 
Use/Disclosure of Health Information Forms or similar medical treatment privacy law 
documentation, records of the distribution and use of all study products, and original 
case report forms should be maintained by the investigator.   
The investigator must maintain and have access to the following essential documents 
until notified by the Sponsor.   Note:  This may be for a minimum of 25 years after 
completion of the study unless country-specific requirements are longer.  JJSV requires 
notification if the investigator wishes to relinquish ownership of the data so that mutually 
agreed-upon arrangements can be made for transfer of ownership to a suitably qualified, 
responsible person. 
• 
All case report forms 
• 
All adverse event information (detailed adverse event forms, follow-up letters, etc.) 
• 
Investigational supply records/inventory 
• 
IRB/IEC and regulatory approval documentation 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
38 
    PR/CHTA-103-FLAP 
• 
Study correspondence  
• 
Study agreements 
• 
Site visit documentation 
• 
Protocol(s) and the reason for any deviations from the protocol 
• 
Subject log(s) 
• 
Clinical Investigator’s Brochure 
• 
Completed subject informed consent forms and medical privacy forms (e.g., 
Authorization for Use/Disclosure of Health information or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment in 
the governing countries) 
• 
Subject medical chart/clinic notes 
18. 
TERMINATION OF THE INVESTIGATION 
The clinical investigation will be suspended in the event of high levels of complications 
and/or adverse events that are unexpected in nature and/or severity and evaluated as to 
causality relative to the study device.  The clinical investigation may be suspended if the 
Medical Monitor or IRB/IEC, upon review and evaluation of the clinical data, finds 
unacceptable clinical performance or the level of single or total complications and/or 
adverse events unacceptable for continuation of the investigation. 
If causality is shown not to be related to the study device, the study may be resumed in 
accordance with the IRB/IEC and regulations of the FDA and governing countries.  The 
study will be terminated if causality is shown to be related to the study device. 
Additionally, the investigator, or JJSV, may stop a subject’s participation at any time.  
JJSV may also stop the study at any time for reasons it determines appropriate.  
However, no suspension of the study would be made to disadvantage the study 
subjects.  Following suspension of the study for any reason, all study subjects who have 
already received treatment would continue to be followed through completion of the 
study visit schedule. 
19. 
STATISTICAL METHODS 
This section highlights the analyses for the primary study endpoints as well as other 
study endpoints.  
 
    
19.1 
ANALYSIS POPULATION 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
39 
    PR/CHTA-103-FLAP 
The analysis population 
 will be both eyes of 
 treated subjects and will 
be used for all endpoints. 
 
 
 
 
  
 
 
 
 
19.2 
PRIMARY STUDY ENDPOINTS 
 surface quality, 
 of the study eye will be evaluated 
relative to the control eye on a scale of 1 to 5 
 A score of 3 means that 
the study eye is similar to the control eye; a score of 4 means that the study eye is 
superior to the control eye; a score of 5 means that the study eye is much better than the 
control eye; a score of 1 means that the control eye is much better than the study eye 
and a score of 2 means the control eye is superior to the study eye. 
 
  
At least 90% of subjects are expected to have a score equal to or greater than 3 for
 
   
19.3 
ADDITIONAL ENDPOINTS 
 
 
 
  
 
 
 
 Summary statistics (mean, standard deviation, minimum and maximum) 
will be reported for 
 
 flap thickness (from OCT) 
.  
 
 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
40 
    PR/CHTA-103-FLAP 
 
 
 
 
 
  
 
 
 
 
 
  
 
The incidence of adverse events will be summarized by AE type. 
19.4 
 GENERAL STATISTICS 
Descriptive statistics will typically include sample size (N), mean, standard deviation 
(SD), median, minimum (Min.), and maximum (Max.) as appropriate for continuous 
variables. For categorical data, the frequency counts and proportions will be computed.   
 
 
   
 
 
 
 
 
 
 
    

JOHNSON & JOHNSON SURGICAL VISION, INC. 
 
CONFIDENTIAL 
05MAY2023/Version 6.0 
41 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
42 
    PR/CHTA-103-FLAP 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
43 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
44 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
45 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
46 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
47 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
48 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
51 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
52 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
53 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
54 
    PR/CHTA-103-FLAP 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
55 
    PR/CHTA-103-FLAP 

JOHNSON & JOHNSON SURGICAL VISION, INC.  
CONFIDENTIAL 
05MAY2023/Version 6.0 
56 
    PR/CHTA-103-FLAP