Clinical Evaluation of the Vision Performance of TECNIS EYHANCE™ Intraocular Lenses With TECNIS SIMPLICITY™ as Compared to TECNIS® 1-piece Intraocular Lenses
Phase: NA
Conditions: Cataract
Sponsor: Johnson & Johnson Surgical Vision, Inc.

 
 
Study Protocol 
 
 
CLINICAL EVALUATION OF THE VISION PERFORMANCE OF 
TECNIS EYHANCE™ INTRAOCULAR LENSES WITH TECNIS 
SIMPLICITY™ AS COMPARED TO TECNIS® 1-PIECE 
INTRAOCULAR LENSES 
 
NCT Number: NCT05025345 
Document date: 24 JUN 2022 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
i     
PR/EMON-101-EHCE 
CONFIDENTIAL 
The following contains confidential, proprietary information  
that is the property of Johnson & Johnson Surgical Vision 
 
CLINICAL EVALUATION OF THE VISION PERFORMANCE OF  
TECNIS EYHANCE™ INTRAOCULAR LENSES WITH TECNIS SIMPLICITY™ AS 
COMPARED TO TECNIS® 1-PIECE INTRAOCULAR LENSES 
 
PROTOCOL NUMBER: EMON-101-EHCE 
 
SPONSOR: Johnson & Johnson Surgical Vision, Inc. 
31 Technology Drive, Suite 200 
Irvine, California 92618 
(949) 581-5799 
 
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 14155:2011 
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 Surgical Vision 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 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
Date 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
ii     
PR/EMON-101-EHCE 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
Date 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
iii     
PR/EMON-101-EHCE 
TABLE OF CONTENTS 
TITLE 
PAGE 
Table of Contents ......................................................................................................... iii 
Personnel and Facilities............................................................................................... vi 
1. 
Synopsis ........................................................................................................... 11 
2. 
Background/Introduction ................................................................................ 16 
3. 
Clinical Hypothesis .......................................................................................... 16 
4. 
Study Design .................................................................................................... 16 
5. 
Acronyms ......................................................................................................... 17 
6. 
Study Objectives and Endpoints .................................................................... 17 
6.1 
Primary Effectiveness Endpoint ....................................................................... 17 
6.2 
Secondary Effectiveness Endpoints ................................................................. 17 
6.3 
Safety Endpoints ............................................................................................. 18 
6.4 
Other Endpoints ............................................................................................... 18 
7. 
Study Products ................................................................................................ 19 
7.1 
Intraocular Lenses ........................................................................................... 19 
7.2 
Implantation Systems ...................................................................................... 20 
8. 
Study Population ............................................................................................. 20 
8.1 
Inclusion Criteria (All study criteria apply to each study eye) ............................ 21 
8.2 
Exclusion Criteria ............................................................................................. 21 
9. 
Investigator Selection ...................................................................................... 22 
9.1 
Investigator Qualifications ................................................................................ 22 
9.2 
Investigator Obligations ................................................................................... 22 
9.3 
Investigator Approval ....................................................................................... 23 
10. 
Experimental Plan ............................................................................................ 24 
10.1 Overview ......................................................................................................... 24 
10.2 Visit Schedule .................................................................................................. 25 
10.3 Preoperative Procedures ................................................................................. 25 
10.4 Randomization and Masking ............................................................................ 28 
10.5 Study Lens Supply ........................................................................................... 28 
10.6 Operative Procedures ...................................................................................... 29 
10.7 Postoperative Procedures ............................................................................... 30 
10.8 Exit of Subjects ................................................................................................ 36 
10.9 Unscheduled Visits .......................................................................................... 37 
10.10 Protocol Deviations .......................................................................................... 38 
11. 
Adverse Events and Product Complaints ...................................................... 38 
11.1 Adverse Event Definitions ................................................................................ 38 
11.2 Product Complaint/Device Deficiency Definition .............................................. 40 
11.3 Adverse Event and Complaint Reporting Requirements .................................. 40 
11.4 Causal Relationship ......................................................................................... 42 
11.5 Adverse Event Follow-up ................................................................................. 42 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
iv     
PR/EMON-101-EHCE 
12. 
Protocol Changes/Amendments ..................................................................... 43 
13. 
Ethics Review and Patient Welfare ................................................................. 43 
13.1 Institutional Review Board (IRB) ...................................................................... 43 
13.2 Informed Consent ............................................................................................ 43 
14. 
Documentation ................................................................................................. 44 
14.1 Source Documents .......................................................................................... 44 
14.2 Subject Confidentiality ..................................................................................... 45 
14.3 Case Report Form Completion ........................................................................ 45 
14.4 Study Summary ............................................................................................... 45 
15. 
Monitoring ........................................................................................................ 45 
15.1 Data Monitoring ............................................................................................... 45 
15.2 Administrative Monitoring ................................................................................ 46 
15.3 Safety Monitoring ............................................................................................. 47 
16. 
Publications ..................................................................................................... 47 
17. 
Risk Analysis ................................................................................................... 47 
18. 
Records Retention ........................................................................................... 48 
19. 
Termination of the Investigation ..................................................................... 49 
20. 
Statistical Methods .......................................................................................... 49 
20.1 Analysis Population ......................................................................................... 49 
20.2 Missing Data Handling Rules: .......................................................................... 50 
20.3 Study Endpoint ................................................................................................ 50 
1. 
Statistical superiority of Eyhance IOL based on mean DCIVA ...................51 
20.4 Site Poolability Analysis ................................................................................... 53 
20.5 Visual Acuity conventions and General Statistics ............................................. 53 
20.6 Interim Reports ................................................................................................ 53 
20.7 Sample Size Calculation .................................................................................. 54 
21. 
Literature references ....................................................................................... 54 
Appendix A Summary of Procedures Required at Each Visit .................................. 56 
Appendix B Equipment List ........................................................................................ 57 

Version 3.0 
v     
PR/EMON-101-EHCE 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
 
vi     
PR/EMON-101-EHCE 
PERSONNEL AND FACILITIES 
SPONSOR: 
Johnson & Johnson Surgical Vision, Inc. (JJSV) 
 
31 Technology Drive, Suite 200 
 
Irvine, CA 92618 
 
SPONSOR PERSONNEL: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EMERGENCY TELEPHONE NUMBERS: 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
 
7 
    PR/EMON-101-EHCE 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
 
8 
    PR/EMON-101-EHCE 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
9 
    PR/EMON-101-EHCE 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
10 
    PR/EMON-101-EHCE 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
11 
    PR/EMON-101-EHCE 
1. 
SYNOPSIS 
PROTOCOL: 
Clinical Evaluation of the Vision Performance of 
TECNIS Eyhance ™ Intraocular Lens With TECNIS 
Simplicity™ as Compared to TECNIS® 1-Piece 
Intraocular Lens 
 
Protocol Number:  EMON-101-EHCE 
 
STUDY TREATMENTS: 
Test Lens 
TECNIS Eyhance Intraocular Lens with TECNIS 
Simplicity™ Model DIB00  
 
 
 
Control Lens  
 
TECNIS 1-Piece Intraocular Lens Model ZCB00 
 
(daisywheel) and DCB00 (preloaded) 
 
STUDY OBJECTIVE: 
The purpose of this clinical study is to compare the 
clinical outcomes for subjects bilaterally implanted 
with TECNIS Eyhance Intraocular Lenses to those 
bilaterally implanted with TECNIS 1-piece Intraocular 
Lenses. 
 
CLINICAL HYPOTHESIS: 
The mean best-corrected distance visual acuity of the 
TECNIS Eyhance Intraocular Lens group will be non-
inferior to that of the control. In addition, the TECNIS 
Eyhance Intraocular lens group will demonstrate 
better distance-corrected intermediate visual acuity 
compared to the control. 
 
 
OVERALL STUDY DESIGN:  
Structure: 
Prospective, multicenter, bilateral, randomized, 
-masked, 6-month study.   
 
Number of Sites: 
Up to 15 sites in the US 
 
Duration: 
6 months postoperative  
 
Administration: 
Surgeons will perform routine, small-incision, 
 
cataract surgery and use validated implantation 
 
systems for lens implantation.  Refractive target 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
12 
    PR/EMON-101-EHCE 
 
outcomes will be emmetropia (closest to plano 
 
spherical equivalent) for first and second eyes.   
Visit Schedule: 
All subjects will be bilaterally implanted with a study 
lens model; the second eye is to be implanted within 
1 month of the first-eye surgery.   
 
 
 
There are five scheduled study visits: Preoperative 
for both eyes examined together; Operative visits for 
each eye; and 1-month and 6-month visits 
 
. 
 
STUDY POPULATION CHARACTERISTICS: 
Condition: 
Bilateral cataracts with otherwise-healthy eyes 
 
Number of Subjects: 
Approximately 220 subjects (110 test, 110 control) 
will be enrolled, allowing approximately 10% for 
screening failures and loss to follow-up, to achieve at 
least 100 evaluable subjects in the test or control 
group at 6 months. 
 
Among 15 sites, each should enroll approximately 15 
subjects, and no site may enroll more than 25% of 
the enrollment total.   
 
Inclusion Criteria (all study criteria apply to each study eye):  
• 
Minimum 22 years of age 
• 
Bilateral cataracts for which posterior chamber IOL implantation has been planned 
• 
Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or 
worse with or without a glare source  
• 
Potential for postoperative best corrected visual acuity of 20/30 Snellen or better 
• 
Corneal astigmatism parameters: 
o Normal corneal topography and no irregular corneal astigmatism 
o Postoperative astigmatism can be surgically managed to be less than 1 D in 
each eye  
• 
Clear intraocular media other than cataract in each eye 
• 
Availability, willingness, ability, and sufficient cognitive awareness to comply with 
examination procedures and study visits 
• 
Signed informed consent and HIPAA authorization or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment in 
the governing countries 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
13 
    PR/EMON-101-EHCE 
• 
Ability to understand and respond to a questionnaire in English 
 
Exclusion Criteria (all study criteria apply to each study eye):  
• 
Any conditions or circumstances, including those specified in the TECNIS Eyhance™ 
IOL Directions for Use, that, in the opinion of the investigator, may increase risk over 
benefit or result in an adverse event during the study.   
• 
Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, 
nystagmus, etc.) for study testing 
• 
Concurrent participation or participation within 60 days prior to preoperative visit in 
any other clinical trial 
• 
Desire for monovision correction 
 
EVALUATION CRITERIA: 
The purpose of this clinical study is to compare the clinical outcomes for subjects 
bilaterally implanted with the TECNIS Eyhance Intraocular Lenses to those bilaterally 
implanted with TECNIS 1-piece Intraocular Lenses.  
 
All primary and secondary endpoints will be evaluated at 6 months unless otherwise 
specified.  Details of the planned statistical analysis for each endpoint are provided in 
the statistical analysis section of this clinical protocol.  
 
Primary Effectiveness Endpoint 
Mean Best-corrected Distance Visual Acuity (BCDVA) 
Monocular first eyes in the test group will demonstrate distance (far) visual acuity that is 
comparable to that of the control group. This endpoint will support that the test lens 
provides far vision that is comparable to that of a standard monofocal 
 
Mean (logMAR) monocular BCDVA at 4 meters under photopic conditions for first eyes 
in the test vs. control lens groups at 6 months.   
 
Success Criteria: The mean monocular BCDVA for first eyes in the test lens group will 
be statistically non-inferior to that of the control lens group by a 0.1 logMAR margin. 
 
Secondary Effectiveness Endpoints 
Mean Distance-corrected intermediate Visual Acuity at 66 cm (DCVA66) 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
14 
    PR/EMON-101-EHCE 
Monocular first eyes in the test group will demonstrate better visual acuity at 66 cm than 
those in the control group. This endpoint will support that the test lens provides better 
intermediate vision than a standard monofocal.  
 
Mean (logMAR) monocular DCVA66 under photopic conditions for first eyes at 6 
months. 
 
Success Criteria: Statistically significant improvement in mean DCIVA at 66 cm 
(logMAR) in test lens group vs. the control lens group.   
 
 
 
   
 
Safety Endpoints 
• 
Rate of secondary surgical interventions (first eyes) related to optical properties of 
the lens 
• 
Rate of SPE-related adverse events (first eyes) vs. ISO SPE rates 
• 
Rate of monocular (first eyes) BCDVA 
 vs. ISO SPE 
rates 
 
OTHER ENDPOINTS  
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
15 
    PR/EMON-101-EHCE 
DATA ANALYSIS: 
The investigational IOL Model ICB00 will be compared to the control IOL Model ZCB00.  
The 6-month postoperative visit is the key analysis time point for all endpoints, although 
all data will be reviewed at other time points when assessed.   
 
 
 
 
 
 
 
   
 
 
 
 
All data will be reported by IOL group.   
STUDY VISITS AND PROCEDURES: 
Patient qualification as a study subject will be assessed at the preoperative visit 
according to the inclusion/exclusion criteria.  The Informed Consent Document and 
Authorization for Use/Disclosure of Health Information form (HIPAA authorization) must 
be signed by any patients who agree to participate in the study prior to undergoing any 
study-specific procedures.  Each subject will receive lenses from the same lens group in 
both eyes: either Eyhance lenses (Model DIB00) or control lenses (Models 
ZCB00/DCB00 [preloaded format]).  
 
 
 
 
 
 
Key preoperative data include ocular health and history, visual acuities, manifest 
refraction, keratometry, biomicroscopic slit-lamp findings, ocular symptoms, and 
biometry.  The operative visit will include standard procedures for cataract surgery and 
IOL implantation.  Key postoperative data collection includes monocular and binocular 
uncorrected and distance-corrected visual acuities, defocus curve, slit-lamp findings, 
non-directed visual symptoms, questionnaires, and adverse events.  
   

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
16 
    PR/EMON-101-EHCE 
2. 
BACKGROUND/INTRODUCTION 
Cataract surgery is one of the most commonly performed surgeries worldwide.  Current 
clinical options, while effective, include the choice of monofocal or multifocal lenses.1 
With standard monofocal lenses, the patient’s vision is in focus at only one distance 
(near, intermediate, or distance).  Patients implanted with standard monofocal lenses 
often require glasses after surgery to improve their near and/or intermediate vision.  
 
 
  
 
 
  
 
 
  
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
   
3. 
CLINICAL HYPOTHESIS 
The mean best-corrected distance visual acuity of the TECNIS Eyhance Intraocular Lens 
group will be non-inferior to that of the control lens. In addition, the TECNIS Eyhance 
Intraocular lens group will demonstrate better distance-corrected intermediate visual 
acuity compared to the control. 
 
 
4. 
STUDY DESIGN 
This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and 
evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 
1-piece IOL.  
  
The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 
220 subjects to achieve approximately 200 randomized and bilaterally implanted 
subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
17 
    PR/EMON-101-EHCE 
months.  Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance 
IOL or the TECNIS 1-Piece IOL.  The eye implanted first will be considered the primary 
study eye. 
 
5. 
ACRONYMS 
The following acronyms are used throughout this document:   
• 
AE: adverse event 
• 
BCDVA:  best-corrected distance visual acuity 
• 
UCDVA:  uncorrected distance visual acuity 
• 
UCVA:  uncorrected visual acuity 
• 
DCVA:  distance-corrected visual acuity 
• 
D: Diopters 
• 
 
 
 
 
6. 
STUDY OBJECTIVES AND ENDPOINTS 
This study will compare the clinical outcomes for subjects bilaterally implanted with the 
TECNIS Eyhance Intraocular Lenses to those bilaterally implanted with TECNIS 1-piece 
Intraocular Lenses at 6 months postoperative. 
 
6.1 
PRIMARY EFFECTIVENESS ENDPOINT 
Mean Best-corrected Distance Visual Acuity (BCDVA) 
Monocular first eyes in the test group will demonstrate distance (far) visual acuity that is 
comparable to that of the control group. This endpoint will support that the test lens 
provides far vision that is comparable to that of a standard monofocal 
 
Mean (logMAR) monocular BCDVA at 4 meters under photopic conditions for first eyes 
in the test vs. control lens groups at 6 months.   
 
Success Criteria: The mean monocular BCDVA for first eyes in the test group at 6 
months will be statistically non-inferior to that of the control by a 0.1 logMAR margin. 
 
6.2 
SECONDARY EFFECTIVENESS ENDPOINTS 
Mean Distance-corrected Intermediate Visual Acuity at 66 cm (DCVA66)  

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
18 
    PR/EMON-101-EHCE 
Monocular first eyes in the test group will demonstrate better visual acuity at 66 cm than 
those in the control group. This endpoint will support that the test lens provides better 
intermediate vision than a standard monofocal. 
 
Mean (logMAR) monocular DCVA66 under photopic conditions for first eyes in the 
investigational vs control lens group at 6 months. 
 
Success Criteria: Statistically significant improvement in mean DCIVA at 66 cm 
(logMAR) in test lens group vs. the control lens group at 6 months.   
 
 
 
   
 
6.3 
SAFETY ENDPOINTS  
• 
Rate of secondary surgical interventions (first eyes) related to optical properties of 
the lens 
• 
Rate of SPE-related adverse events (first eyes) vs. ISO SPE rates  
• 
Rate of monocular (first eyes) BCDVA 
 vs. ISO SPE 
rate 
 
6.4 
OTHER ENDPOINTS 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
19 
    PR/EMON-101-EHCE 
7. 
STUDY PRODUCTS 
7.1 
INTRAOCULAR LENSES  
TECNIS Eyhance IOL  
The TECNIS Eyhance IOL is a posterior chamber, 1-piece, aspheric, refractive, acrylic, 
foldable IOL designed for placement in the capsular bag (Figure 1).  The lens has a 
refractive optic design with an aspheric anterior surface to slightly extend the depth of 
focus.  
        
 
 
FIGURE 1: Drawing and Photograph of a TECNIS Eyhance IOL 
 
 
 
 
  
 
 
 
 
INDICATION 
The TECNIS Eyhance IOL is indicated for the visual correction of aphakia in adults in 
whom a cataractous lens has been removed by phacoemulsification. The lens is 
intended to be placed in the capsular bag.  
 
TECNIS 1-Piece IOL,  
The JJSV TECNIS 1-Piece IOL, Model ZCB00 (Figure 2) has been approved and 
marketed for many years. This IOL is a single-piece, acrylic, monofocal IOL with a 
modified prolate (aspheric) design on the anterior optic surface to reduce spherical 
aberration.  The TECNIS 1-Piece IOL is also commercially available in a preloaded 
configuration in the TECNIS Simplicity Delivery System, collectively designated as 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
20 
    PR/EMON-101-EHCE 
Model DCB00.  Either Model DCB00 or ZCB00 may be used as the control lens in this 
study.    
 
 
FIGURE 2: Drawing and Illustration of a TECNIS 1-Piece IOL 
 
STORAGE AND DISTRIBUTION 
All lenses will be obtained from the site’s own inventory.  All study lenses should be 
stored in the original packaging and kept in a dry place.  Lenses should not be stored in 
direct sunlight or at temperatures greater than 45° C (113°F).  Each lens is packaged in 
a lens tray and sealed in a peel-pouch.  The lens is sterile as long as the package has 
not been opened or damaged and the shelf-life expiration date has not been exceeded.   
 
The Principal Investigator is responsible for ensuring that the study-provided lenses are 
used only for subjects enrolled in this study. 
 
7.2 
IMPLANTATION SYSTEMS 
 
 
 
 
 
 
 
.  
  
8. 
STUDY POPULATION 
All study subjects will be enrolled from the normal surgical cataract population at up to 
15 sites in the U.S.A.  Approximately 220 subjects will be enrolled to achieve 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
21 
    PR/EMON-101-EHCE 
approximately 200 randomized and bilaterally implanted subjects, resulting in at least 
200 evaluable subjects (a minimum of 100 in each test and control groups) at 6 months.  
 
 
  
  
This study will include only subjects undergoing bilateral primary cataract extraction and 
IOL implantation and who meet all of the study inclusion and exclusion criteria in both 
eyes.  All subjects who meet the eligibility criteria will be offered enrollment in the study.  
 
 
 
 
 
 
   
8.1 
INCLUSION CRITERIA (ALL STUDY CRITERIA APPLY TO EACH STUDY 
EYE)  
• 
Minimum 22 years of age 
• 
Bilateral cataracts for which posterior chamber IOL implantation has been planned 
• 
Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or 
worse with or without a glare source  
• 
Potential for postoperative best corrected visual acuity of 20/30 Snellen or better 
• 
Corneal astigmatism parameters: 
o Normal corneal topography and no irregular corneal astigmatism 
o Postoperative astigmatism can be surgically managed to be less than 1 D in 
each eye  
• 
Clear intraocular media other than cataract in each eye 
• 
Availability, willingness, ability, and sufficient cognitive awareness to comply with 
examination procedures and study visits 
• 
Signed informed consent and HIPAA authorization or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment in 
the governing countries 
• 
Ability to understand and respond to a questionnaire in English 
 
8.2 
EXCLUSION CRITERIA  
• 
Any conditions or circumstances, including those specified in the TECNIS Eyhance™ 
IOL Directions for Use, that, in the opinion of the investigator, may increase risk over 
benefit or result in an adverse event during the study.   

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
22 
    PR/EMON-101-EHCE 
• 
Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, 
nystagmus, etc.) 
• 
Concurrent participation or participation within 60 days prior to preoperative visit in 
any other clinical trial 
• 
Desire for monovision correction 
 
9. 
INVESTIGATOR SELECTION 
9.1 
INVESTIGATOR QUALIFICATIONS 
JJSV will select ophthalmic surgeons who have completed a residency in ophthalmology 
(or its documented equivalent) and are licensed to practice medicine and perform 
surgery at his/her investigative site. Each site will have one designated principal 
investigator; some sites may have additional implanting sub-investigators/surgeons.   
 
 
 
 
 
 
9.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 
• 
Conduct the study in accordance with the relevant and current protocol.  Investigator 
will make changes to a protocol only after notifying and obtaining approval from JJSV 
and the Institutional Review Board (IRB), except when necessary to protect the 
safety, rights, or welfare of subjects 
• 
Personally, conduct and supervise the study 
• 
Maintain a list of appropriately qualified persons to whom the investigator has 
delegated significant trial-related duties 
• 
Be responsible for protecting the rights, safety, and welfare of subjects under the 
investigator’s care and be responsible for the control and documentation of the 
devices under investigation 
• 
Inform patients that the device(s) are being evaluated in this study are approved 
products and that study requirements relating to obtaining informed consent and IRB 
approval are met according to 21CFR50, 21CFR56, 21CFR812 and all other 
applicable laws and regulations 
• 
Maintain confidentiality as required by HIPAA or similar laws and regulations 
• 
Shall not obtain written informed consent from any subject to participate or allow any 
subject to participate before obtaining IRB approval 
• 
Document in each subject’s case history that informed consent was obtained prior to 
participation in the study as required by 21CFR812 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
23 
    PR/EMON-101-EHCE 
• 
Report to JJSV and the reviewing IRB any adverse experiences that occur during the 
course of the study in accordance with applicable laws and regulations 
• 
Maintain adequate and accurate records in accordance with applicable laws and 
regulations and make available all study documents and subject medical records for 
inspection by either JJSV, duly authorized regulatory agencies (e.g., FDA, PMDA, 
Health Canada, MOH, etc.) and/or the IRB 
• 
Submit progress reports on the study to JJSV and the reviewing IRB at regular 
intervals, but no less often than yearly, as required by 21CFR812.150  
• 
Ensure the IRB that is responsible for initial and continuing review of the study 
complies with applicable laws and regulations 
• 
Report all changes in research activity and all unanticipated problems involving risks 
to patients to the IRB and JJSV 
• 
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 
GCP standards (e.g., ISO 14155), and all conditions of approval imposed by the 
reviewing IRB  
• 
Ensure that all associates, colleagues, and employees assisting in the conduct of the 
study are adequately informed about the protocol, 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, or 
maintenance of study records, etc. 
  
9.3 
INVESTIGATOR APPROVAL  
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Study Files/Notebook.  Copies of IRB submissions and 
approvals should be forwarded to JJSV.  Study sites will obtain IRB approvals and fulfill 
any other site-specific regulatory requirements.  
 
 
. 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
24 
    PR/EMON-101-EHCE 
 
 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10. 
EXPERIMENTAL PLAN 
10.1 
OVERVIEW 
This study will be conducted in accordance with U.S. Code of Federal Regulations, the 
Declaration of Helsinki, ISO 14155:2011 and all other applicable laws and regulations.  
The study will not begin until IRB approvals have been obtained. 
 
This study will be a prospective, multicenter, bilateral, randomized, subject/evaluator-
masked clinical investigation conducted at up to 15 sites.  Approximately 220 subjects 
will be enrolled to achieve approximately 200 evaluable subjects (approximately 100 in 
each test and control groups) at 6 months.  After informed consent is obtained and 
confirmation that all eligibility criteria are met, the eye(s) may be treated.  
 
 
 
 
 
 
 
 
  All subjects will be examined through 6 months 
postoperatively according to the visit schedule described in Section 10.2, Visit Schedule. 
 
 
 
.  
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
25 
    PR/EMON-101-EHCE 
 
 
 
Key preoperative data include ocular health and history, visual acuities, manifest 
refraction, keratometry, topography, biomicroscopic slit-lamp findings, ocular symptoms, 
and biometry.  The operative visit will include standard procedures for cataract surgery 
and IOL implantation.  Key postoperative data collection includes monocular and 
binocular uncorrected and distance-corrected visual acuities, 
 
, slit-lamp findings, non-directed visual symptoms, 
, and 
adverse events.  A chart summary of all examination procedures required at each study 
visit is provided in Appendix A.  If needed, specific equipment necessary to perform the 
required procedures will be supplied for the duration of the study (Appendix B). 
 
10.2 
VISIT SCHEDULE 
The study visit schedule for all study subjects is outlined in Table 2.   
 
All subjects are intended to have bilateral cataract surgery 
 
.  
 
 
Subjects will be followed per standard of 
care prior to the 1-month study visit.  Unscheduled visits may be conducted as 
necessary at the discretion of the investigator for medically indicated follow-up.   
TABLE 2: Visit Schedule 
VISIT 
EYES EVALUATED 
EXAM 
VISIT WINDOW 
1 
Both Eyes 
Preoperative Exam 
 
 
 
2 
First Eye 
Operative 
 days after preoperative exam 
3 
Second Eye 
Operative 
 
 
 
4 
Both Eyes 
1 month 
 
 
5 
Both Eyes 
6 monthsa 
 
 
 
 
 
 
10.3 
PREOPERATIVE PROCEDURES 
All subjects treated in the study must sign the current IRB-approved informed consent 
form and meet the eligibility criteria.  The informed consent form must be signed before 
any study-specific examinations are performed, and this must be documented in the 
source documents.  An Authorization for Use/Disclosure of Health Information Form 
(HIPAA authorization) or similar medical treatment privacy law documentation must also 
be signed.   
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
26 
    PR/EMON-101-EHCE 
 
 
  If a test/exam is 
required by the protocol but is not part of the routine testing the investigator performs for 
the cataract evaluation, that test/exam is considered to be study-specific and is not to be 
done until after the informed consent form has been signed by the subject.  Following 
the informed consent process, completion of the preoperative study exam and 
determination that the subject meets all of the required entrance criteria (including lens 
power determination), the subject may be randomized and scheduled for surgery.    
 
As the Informed Consent Form is signed at the beginning of the preoperative study 
exam, some subjects may not qualify after study-specific testing is performed.  Subjects 
will be considered screen-failures if they do not qualify, or if they qualify but decide not to 
participate further in the study, or if they decide not to proceed with surgery.  These 
subjects will be exited from the study.   
 
Preoperative testing to be performed for each eye includes the following: 
 
POTENTIAL DISTANCE VISUAL ACUITY   
The subject must be capable of achieving Snellen 20/30 or better best-corrected 
distance vision in each eye after cataract extraction and IOL implantation.  
 
 
 
 
 
BEST-CORRECTED DISTANCE VISUAL ACUITY AND MANIFEST REFRACTION  
Preoperative manifest refraction is required.  Monocular, best-corrected distance visual 
acuity (BCDVA) is to be measured using a standard Snellen chart or equivalent and 
must be Snellen 20/40 or worse, with or without a glare source. 
 
KERATOMETRY  
Predicted postoperative corneal astigmatism, as measured by keratometry, should be 
less than 1.00 D.  No irregular astigmatism should be present preoperatively.  
Postoperative astigmatism can be surgically managed to be less than 1 D in each eye. 
 
CONTACT LENS WEAR AND CORNEAL STABILITY 
For contact lens wearers, keratometric corneal stability following cessation of contact 
lens wear must be verified before surgery.  PMMA contact lenses are not to be worn for 
at least 6 months; rigid gas-permeable contact lenses are not to be worn for at least 
1 month; and extended-wear or daily-wear soft contact lenses are not to be worn for at 
least 1 week prior to the preoperative visit.  Corneal stability must be verified for any 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
27 
    PR/EMON-101-EHCE 
subject who has worn PMMA lenses within 5 years or any other type of contact lenses 
within 6 months prior to the preoperative visit.  To verify stability, repeat the keratometric 
measurements at least 1 week after the initial preoperative baseline keratometric 
measurement.  Corneal curvature is considered to be stable if the difference in 
keratometric cylinder (vertical vs. horizontal keratometric readings) between the two time 
points does not exceed 0.50 D.  Additionally, the difference between the two horizontal 
readings as well as the difference between the two vertical readings must be no more 
than 0.50 D.  Changes in keratometric axis must be no more than ±15○.  If a change 
exceeding these criteria is noted, surgery is to be postponed until keratometric stability is 
demonstrated.  Final biometry measurements and surgery should not take place until 
keratometric stability is achieved.   
 
Note: if this method of determining corneal stability is not a standard procedure in your 
practice, the subject must sign the informed consent form prior to starting the stability 
procedure.  
 
IOL POWER AND TARGETED REFRACTION (EMMETROPIA) 
Axial length and anterior chamber depth (ACD) must be measured to determine the 
appropriate lens power to implant using an A-Constant.  
 
 
 
 
  The lens power 
should be calculated to achieve emmetropia at distance.  
 
 
 
  
ADDITIONAL PREOPERATIVE INFORMATION TO BE COLLECTED: 
• 
Informed consent documentation  
• 
Subject demographic information  
• 
Planned surgery dates for each eye 
• 
Ocular history and systemic medical history, including presence of ocular pathology 
for each eye  
• 
Intraocular pressure for each eye 
• 
Cataract type and density for each eye 
• 
Fundus exam findings for each eye 
• 
Medical findings, cataract assessment via biomicroscopic slit-lamp exam for each 
eye 
• 
Ocular/visual symptoms (non-directed) for each eye 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
28 
    PR/EMON-101-EHCE 
• 
Ocular and systemic medications 
 
10.4 
RANDOMIZATION AND MASKING 
A randomization list will be created by the JJSV biostatistician for each investigative site 
and the randomization code will be uploaded into the electronic data capture system 
(EDC).  
 
  
 
 
 
 
 
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 two lens models in the study: TECNIS Eyhance lens and the control lens.  
 
 
 
 
 
 
   
The subjects and the study technicians performing the postoperative vision tests are to 
be masked through study completion.  
 
 
 
 
 
 
 
 
 
   
 
Following completion of the final study exam, each 
subject will be given the permanent IOL implant identification card. 
 
10.5 
STUDY LENS SUPPLY 
 
  Sites will follow their respective procedures for storage, access, and use of 
intraocular lenses, and accountability for implanted study lenses must be documented 
(See Section 15.2 Lens Accountability). 
   

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
29 
    PR/EMON-101-EHCE 
10.6 
OPERATIVE PROCEDURES  
The investigator should use his or her standard, small-incision, cataract extraction 
surgical technique using the preloaded system or one of the JJSV-validated insertion 
systems described in Section 7.2. 
 
 
 
  
   
 
 
 
 
 
Operative case report forms will include the following information: 
INCISION TYPE AND SIZE   
Lenses should be inserted through an incision ranging in size from approximately 
2.2-3.0 mm, per the investigator’s standard technique.  The incision may be clear 
corneal, limbal or scleral tunnel at the discretion of the investigator. 
 
CAPSULORHEXIS SIZE AND METHOD  
The anterior capsulotomy should be a continuous, curvilinear capsulorhexis 
approximately 5.0 to 5.5 mm in diameter to allow slight overlap of the lens optic edge.  
 
  
LENS REMOVAL 
Lens removal may occur using laser fragmentation combined with 
phacoemulsification/aspiration or using only phacoemulsification/aspiration. 
  
VISCOELASTIC   
Viscoelastic materials should be used as is customary for each investigator and 
recorded on the case report form (CRF). 
 
IMPLANT INSTRUMENTATION USED   
TECNIS 1-Piece Model ZCB00 lenses should be folded for implantation and inserted 
into the capsular bag 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
30 
    PR/EMON-101-EHCE 
SURGICAL COMPLICATIONS   
Should a surgical complication occur, implantation of a study lens will be at the 
investigator’s discretion.  In the event of capsular bag or zonular rupture, the lens should 
not be implanted if the complication may result in lens instability.  Additionally, the lens is 
not to be implanted in the sulcus.  
 
 
 
 
 
 
  
 
 
 
MEDICATIONS   
Preoperative, operative, and intraoperative medications should be used as is customary 
for each investigator and will be recorded in source and on the CRF. 
   
TYPE OF CLOSURE   
Wound closure is left to the surgeon’s discretion and will be recorded on the CRF. 
 
ADDITIONAL OPERATIVE INFORMATION COLLECTED INCLUDES: 
• 
Date of surgery 
• 
Operative eye 
• 
Lens power and serial number 
• 
Lens placement 
• 
 
• 
Surgical technique according to protocol 
• 
Product complaints 
• 
Serious and/or device-related adverse events 
 
10.7 
POSTOPERATIVE PROCEDURES  
Postoperatively, subjects will be examined according to the schedule in Section 10.2, 
Visit Schedule.
   
Study technicians responsible for conducting all vision testing will be masked.  
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
31 
    PR/EMON-101-EHCE 
 
.  
 
 
 
 
  
 
A postoperative CRF will collect the following information, although not all data are 
required at every visit (see Appendix A): 
 
MANIFEST REFRACTION 
 
 
Postoperative study manifest refractions are to be performed 
 
.  Manifest refraction (MR) is to be performed 
 
 as detailed in Appendix C.   
 
 
  
 
 
 
DISTANCE VISUAL ACUITY TESTING (MASKED PROCEDURE) 
Distance visual acuity will be measured postoperatively under photopic lighting 
conditions (85 cd/m2, 80–110 cd/m2 acceptable) 
 
  
 
.  
Instructions for 
 are detailed in Appendix E, and for distance 
visual acuity in Appendix F.  
The following distance visual acuity measurements are to be performed per the visit 
schedule in Appendix A:  
Test 
Test 
Distance 
Illumination 
Type of Testing 
 
 
UCDVA 
4 m 
Photopic  
(85 cd/m2) 
Monocular, 
Binocular 
 
 
BCDVA 
4 m 
Photopic  
(85 cd/m2) 
Monocular, 
Binocular 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
32 
    PR/EMON-101-EHCE 
 
INTERMEDIATE VISUAL ACUITY AT 66 CM (MASKED PROCEDURE) 
Intermediate visual acuity at 66 cm (including low contrast at 25%) will be measured 
under photopic conditions (85 cd/m2, 80-110 cd/m2 acceptable) 
 
at a test distance of 66 cm.  Instructions for using the 
 are detailed in 
Appendix E and for intermediate visual acuity testing in Appendix G.   
 
The following visual acuity measurements are to be performed per the visit schedule in 
Appendix A: 
Test 
Test 
Distance 
Illumination 
Type of Testing 
 
 
UCVA 
66 cm 
Photopic  
(85 cd/m2) 
Binocular  
 
DCVA 
66 cm 
Photopic  
(85 cd/m2) 
Monocular, 
Binocular 
 
 
 
 
 
 
66 cm 
Photopic  
(85 cd/m2) 
Binocular 
 
 
  
 
INTERMEDIATE VISUAL ACUITY AT 50 CM (MASKED PROCEDURE) 
Intermediate visual acuity at 50 cm will be measured under photopic conditions 
(85 cd/m2, 80-110 cd/m2 acceptable) 
 at a test distance of 50 cm.  
Instructions for using 
 are detailed in Appendix E and for intermediate 
visual acuity testing in Appendix H.   
The following visual acuity measurements are to be performed per the visit schedule in 
Appendix A: 
Test 
Test 
Distance 
Illumination 
Type of Testing 
 
 
UCVA 
50 cm 
Photopic  
(85 cd/m2) 
Binocular  
 
DCVA 
50 cm 
Photopic  
(85 cd/m2) 
Monocular, 
Binocular 
 
 
 
 
NEAR VISUAL ACUITY AT 40 CM (MASKED PROCEDURE) 
Near visual acuity will be measured under photopic conditions (85 cd/m2, 80-110 cd/m2 
acceptable) 
 at a test distance of 40 cm.  Instructions for 
 
 are detailed in Appendix E and for near visual acuity testing in Appendix 
I.   

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
33 
    PR/EMON-101-EHCE 
 
The following visual acuity measurements are to be performed per the visit schedule in 
Appendix A: 
Test 
Test 
Distance 
Illumination 
Type of Testing 
 
 
UCVA 
40 cm 
Photopic  
(85 cd/m2) 
Binocular  
 
DCVA 
40 cm 
Photopic  
(85 cd/m2) 
Monocular, 
Binocular 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
   
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
34 
    PR/EMON-101-EHCE 
 
 
  
 
 
 
BIOMICROSCOPIC SLIT-LAMP EXAM   
A biomicroscopic slit-lamp exam must be performed at each postoperative visit to 
determine the presence or absence of any medical or lens findings, complications, or 
adverse events.  IOL decentration and tilt are to be determined subjectively.  The center 
of the lens relative to the pupil can be used to determine IOL decentration.  Note that the 
pupil center may not always be aligned with the visual axis of the eye; therefore, the 
investigator should consider deviations in pupil center from visual axis when reporting 
IOL decentration.   
Findings of aqueous cells and flare, corneal edema, posterior capsule striae (wrinkles), 
posterior capsular opacification and IOL glistenings are to be rated using standardized 
grading scales of 0 to +4 (0 = none, +4 = severe) during the slit-lamp biomicroscopy.  
The specific grading scales are provided in Appendix L.   
 
ND: YAG CAPSULOTOMY 
 
 
 
  
 
FUNDUS EXAM 
A fundus exam is to be performed at the 6-month visit to evaluate retinal status and 
fundus visualization.  
 
 
The same fundus examination method that was used preoperatively 
should be used for the 6-month study visit. 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
35 
    PR/EMON-101-EHCE 
INTRAOCULAR PRESSURE  
Intraocular pressure (IOP) is to be measured using the investigator’s usual method.  It is 
recommended that the same method be used for all study subjects at the site for the 
duration of the study. 
 
KERATOMETRY  
 
  
 
 
OCULAR SYMPTOMS (NON-DIRECTED; SPONTANEOUS) 
Subjective ocular symptoms are to be assessed at each postoperative visit 
 
 
 
 
 
MEDICATIONS   
Postoperative ocular medications should be used as is customary for each investigator 
and recorded in the source document for each subject.  Postoperative medications 
related to surgery, adverse events and serious adverse events will be recorded on a 
medication log CRF as applicable. 
 
ADVERSE EVENTS 
Subjects should be assessed at each visit for occurrence of and/or change in status of 
any adverse events, particularly serious and/or device-related adverse events.  See 
Section 11.0, Adverse Events, for further information. 
 
QUESTIONNAIRES  
 
 
   
1) 
  
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
36 
    PR/EMON-101-EHCE 
Testing Equipment: 
All visual acuities, as well as defocus measurements, will be performed using the
 
 
  
This system provides a descending LogMAR chart 
 
 for visual acuity testing at 
  
 
 
 
 
 
10.8 
EXIT OF SUBJECTS  
An Exit CRF 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 enrolled in this clinical study. 
 
A subject will be considered a "screen failure" if he/she does not meet the eligibility 
criteria or does not receive study treatment.  Reasons may include: the planned implant 
being aborted due to surgical complications, the subject withdrawing consent prior to 
treatment or the subject died prior to treatment.      
 
Subjects will be "discontinued" from the study if one study lens (if implanted unilaterally) 
or both study lenses (if implanted bilaterally) are removed or if the subject dies. 
If a subject receives at least one study lens, he/she is to be followed according to the 
schedule in Table 2 (Section 10.2) for visit windows.   
 
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 ill/unable to 
travel, subject uncooperative/refuses further study participation.  In the event of subject 
relocation, effort 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.   
If a subject is exited early from the study, the investigator must indicate the reason for 
study exit on the CRF.  In the event of a lens removal or other serious adverse event, 
the subject may be exited from the study; however, effort must be made by the 
investigator to follow the subject until resolution of the adverse event before exiting the 
subject from the study. 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
37 
    PR/EMON-101-EHCE 
 
  
 
 
   
 
10.9 
UNSCHEDULED VISITS  
During the study period, if a non-protocol-required visit is done for the purpose of 
medically-indicated follow-up for a study eye, data from this visit should be reported 
using the Unscheduled Visit CRF.  The need for unscheduled visits is at the 
investigator’s discretion.  Specific examinations to be performed at unscheduled visits 
are 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 CRF. 
Data to be collected may include: 
• 
Snellen manifest refraction 
• 
Uncorrected and best-corrected distance visual acuity using a Snellen chart 
• 
Intraocular pressure 
• 
Slit-lamp examination for medical and/or lens findings  
• 
Fundus exam 
• 
Ocular symptoms 
• 
Adverse events 
• 
Medications 
 
  
 
 
 
 
 
 
 
  
 
Conditions found postoperatively, but previously documented at the preoperative visit, 
do not trigger an unscheduled visit report.  However, if the severity of the condition 
increases from the preoperative visit, an Unscheduled Visit CRF is needed. 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
38 
    PR/EMON-101-EHCE 
 
 
 
 
 
 
 
 
 
 
10.10 PROTOCOL DEVIATIONS  
Any departure from the protocol procedures represents a protocol deviation.  Protocol 
deviations may be subject-based (e.g., inclusion/exclusion criteria, informed consent 
deviation, etc.) or procedural-based (e.g., out-of-interval visits, non-compliance with 
testing procedures, etc.).  Any deviation made to protect the life or physical well-being of 
a subject in an emergency without obtaining informed consent must be reported to JJSV 
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 of instances of protocol non-compliance in 
accordance with the IRB requirements. 
 
11. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS  
11.1 
ADVERSE EVENT DEFINITIONS 
Adverse Event (AE) 
An adverse event is defined (per 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 (per 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 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
39 
    PR/EMON-101-EHCE 
• 
results in fetal distress, fetal death or a congenital abnormality or birth defect 
 
Device-Related Adverse Event/Adverse Device Effect (ADE) 
A device-related adverse event is defined as any adverse event that is believed to be 
definitely, probably, possibly, or unlikely to be 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. 
   
Anticipated Study-Specific Serious Adverse Events 
The following is a list including, but not limited to, ocular serious adverse events (SAE) 
that are anticipated and must be reported to JJSV for this study.  Adverse event 
definitions in accordance with the American Academy of Ophthalmology Task Force 
Consensus Statement.   
• 
Chronic anterior uveitis: Persistent anterior segment inflammation characterized by  
grade 1+ cell or greater using Standardization of Uveitis Nomenclature (SUN) criteria 
that persists for greater than 3 months after surgery, or relapses in less than 3 
months after discontinuation of therapy, or the subject is maintained on therapy for 
more than 3 months to control inflammation 
• 
Cystoid macular edema: Macular edema diagnosed by clinical examination and 
adjunct testing (e.g., OCT, FA) resulting in BCDVA of 20/40 or worse at 1 month or 
later 
• 
Corneal Edema: Corneal swelling (stromal or epithelial) resulting in BCDVA of 20/40 
or worse at 1 month or later 
• 
Endophthalmitis/Intraocular infection:  Intraocular inflammation leading to diagnostic 
vitreous tap and intraocular antibiotics.  
• 
Hypopyon 
• 
Hyphema 
• 
Increased IOP: Elevation of IOP by ≥ 10 mmHg above baseline and greater than 25 
mmHg measured after 7 days postoperative 
• 
Mechanical pupillary block: Shallowing of anterior chamber due to obstruction of 
aqueous humor flow from the posterior to anterior chamber through the pupil by the 
vitreous face, or implanted device 
• 
Retinal detachment/Tear: Partial or complete retinal detachment associated with 
retinal tear  
• 
Toxic anterior segment syndrome (TASS): Acute, non-infectious inflammation of the 
anterior segment that starts within 24 hours after surgery, usually resulting in 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
40 
    PR/EMON-101-EHCE 
hypopyon and commonly presenting with corneal edema, and that improves with 
steroid treatment 
• 
Secondary IOL intervention (resulting from visual symptoms, tilt, decentration, 
refractive error, retained lens material): 
o Exchange – The study lens is replaced with the same lens model 
o Removal – The study lens is removed and replaced with a non-study lens or 
no lens is implanted 
o Reposition – The existing lens is surgically moved to another location or 
rotated 
 
NOTE 1:  Wound burps during the first week postoperatively, suture removal, planned 
blepharoplasty and Nd:YAG capsulotomy (for PCO) are not considered adverse events 
for this study. 
 
NOTE 2: Any adverse event that is immediately sight- or life-threatening will be 
considered serious.  Secondary interventions administered to hasten the resolution of 
such conditions that otherwise will not result in permanent damage will not be reported 
as serious adverse events. 
 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) 
Any UADE (USA 21CFR 812.3(s)) or USADE (ISO 14155) is defined as any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan (i.e., this protocol), 
application (including a supplementary plan or application), or risk assessment, or any 
other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects.   
 
11.2 
PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
A product complaint/device deficiency is defined (21 CFR 820.3(b) and ISO 14155) as 
any alleged deficiency related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a device. This may include malfunctions, use error and 
inadequacies in labeling.  Product complaints can pertain to any marketed JJSV device 
being used in the study.  The investigator is to assess whether the deficiency could have 
led to a serious adverse event without suitable action or intervention or under less 
fortunate circumstances. 
 
11.3 
ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
All adverse events and any complaint encountered using any JJSV product, regardless 
of severity and whether or not attributed to the study device(s), are to be reported to 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
41 
    PR/EMON-101-EHCE 
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 as per the IRB’s reporting requirements.  If required, adverse events will 
be reported to the appropriate regulatory agencies (e.g., FDA) according to all applicable 
laws and regulations.   
 
Reporting of adverse events shall follow the USA Code of Federal Regulations 
(21CFR812) for sites in the USA.  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 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 recording complaints 
on the CRF at the visit the complaint occurs (e.g., operative visit) and/or by a phone 
call/email to JJSV.   
 
 
 
 
 
 
 
Serious and/or Device-Related Adverse Event Reporting 
 
 
  Any SAE/ADE is to be reported to 
JJSV by phone, email and/or by submitting the completed SAE/ADE CRF.  Any SAE or 
device-related AE should also be reported to the investigator’s IRB per their reporting 
requirements. 
 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) Reporting 
If during the study, a serious adverse event occurs that may reasonably be regarded as 
device-related and was not previously expected in nature, severity, or degree of 
incidence, the investigator is to report the UADE/USADE to JJSV 
, and to 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
42 
    PR/EMON-101-EHCE 
the investigator’s IRB as soon as possible (and no later than 10 working days after 
learning of the event for sites in the USA as required by 21CFR812). 
 
11.4 
CAUSAL RELATIONSHIP  
The investigator should always be alert to adverse events that may be related to the 
study device or the use of the study device (i.e., the procedure specific to the initial 
application of the device).  An attempt should be made in every case to determine the 
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.  
  
11.5 
ADVERSE EVENT FOLLOW-UP 
For every adverse event, appropriate measures should be undertaken to treat and/or 
monitor the subject until resolution occurs.  The subject's files are to include all pertinent 
medical data relating to the event including the subject’s medical records, medical 
reports and/or judgments from colleagues or outside specialists who assisted in the 
treatment and follow-up of the subject.  
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
43 
    PR/EMON-101-EHCE 
 
 
 
Any subject who is to be exited from the study due to a serious 
and/or device-related adverse event should be followed until the outcome is determined 
prior to being exited from the study. 
 
12. 
PROTOCOL CHANGES/AMENDMENTS  
If the investigator wishes 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 all other appropriate regulatory agencies, as well as approval of the 
governing IRBs prior to implementation.   
 
13. 
ETHICS REVIEW AND PATIENT WELFARE 
13.1 
INSTITUTIONAL REVIEW BOARD (IRB) 
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Notebook.  Copies of IRB submissions and approvals 
should be forwarded to JJSV. 
 
The investigator is responsible for notifying the IRB of reportable adverse events as well 
as any other circumstance in which additional procedures outside the protocol were 
conducted to eliminate apparent hazards to subjects. 
 
13.2 
INFORMED CONSENT 
The current version of the IRB-approved study informed consent form must be signed by 
each study subject prior to any study-specific examinations being performed.  The 
IRB-approved informed consent form 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 form 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 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
44 
    PR/EMON-101-EHCE 
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. 
 
14. 
DOCUMENTATION 
14.1 
SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may include 
a subject’s medical records, hospital charts, clinic charts, the investigator’s subject study 
files, as well as results of any diagnostic tests or procedures such as topographies or 
laboratory tests with photographs or instrument printouts. 
 
Each site is expected to adhere to the clinic’s own standard documentation requirements 
for medical charts/clinic notes.  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)  
• 
Evidence of subject eligibility 
• 
Dates of all subject visits and surgeries throughout the duration of the study 
• 
Implant serial number identification (NOTE: This is masked information, and may 
only be reviewed by unmasked study staff) 
• 
Concurrent medications 
• 
Corrected and uncorrected distance visual acuity (NOTE: M&S electronic data are 
considered source documentation and are to be retained by the site.  A paper copy 
of the M&S results will be printed and validated by the site) 
• 
Manifest refraction 
• 
Occurrence and status of any operative complications, postoperative medical or lens 
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. 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
45 
    PR/EMON-101-EHCE 
14.2 
SUBJECT CONFIDENTIALITY 
Subjects will be assigned a site/subject number to maintain subject confidentiality.  
Subject names may possibly be disclosed to 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. 
 
14.3 
CASE REPORT FORM COMPLETION 
This study will use an electronic data capture system.  All study staff responsible for 
entering data into the system must complete certification prior to using the 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 the Sponsor. 
  
14.4 
STUDY SUMMARY 
A final investigator’s summary (study close-out) will be provided to JJSV and the 
reviewing IRB after termination or the completion of the study or the investigator’s part of 
the investigation, as directed by JJSV.  
 
15. 
MONITORING  
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
46 
    PR/EMON-101-EHCE 
 
 
 
 
 
15.2 
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.   
 
Device Accountability 
Lens accountability will be maintained at the investigative site by keeping records for all 
study lenses implanted.  Study lens information will be maintained in the subject 
accountability study binder and will be reviewed during periodic investigative site 
monitoring visits. 
  
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
  
The Sponsor 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. 
   
  
 
  

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
47 
    PR/EMON-101-EHCE 
Upon study completion, a site visit will be made to each site to monitor the last of the 
subject data records and finalize any outstanding study issues.  
 
A separate Study Monitoring Plan will be established prior to study start that will define 
the type and frequency of monitoring visits and frequency of record monitoring.  
 
15.3 
SAFETY MONITORING 
The medical monitor will review results throughout the clinical study 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 the 
Sponsor, shall also review any interim progress reports, as applicable.   
 
16. 
PUBLICATIONS 
. 
 
17. 
RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
RISKS OF THE TECNIS EYHANCE IOL, MODEL DIB00 
Please refer to the TECNIS Eyhance IOL Model DIB00 Directions for Use.   
 
GENERAL RISKS OF CATARACT SURGERY AND IOL IMPLANTATION 
There are risks and complications associated with cataract surgery and IOL implantation 
in general.  These can include worsening of vision, hemorrhage, loss of corneal clarity, 
inflammation, infections, retinal detachment, pupil changes, glaucoma, etc.  
Complications can result in poor vision, loss of vision or loss of the eye.  
  
RISK MANAGEMENT 
Subjects will be closely monitored throughout the study duration.  The occurrence of 
adverse events and complaints will be assessed at each study visit and reported to the 
Sponsor according to Section 11.0, Adverse Events and Product Complaints.  
Additionally, the Sponsor 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).  
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
48 
    PR/EMON-101-EHCE 
POTENTIAL BENEFITS 
The general clinical performance of the TECNIS Eyhance IOL is similar to that of the 
TECNIS 1-Piece monofocal IOL with regard to distance visual acuity and safety 
outcomes; however, improvements in intermediate visual acuity from the slightly 
extended depth of focus may be achieved with the TECNIS Eyhance IOL.  
 
CONCLUSION 
The hazards/risks associated with the TECNIS Eyhance IOL are acceptable and within 
those of Johnson & Johnson Vision other advanced optic IOLs. The potential clinical 
benefits of the TECNIS Eyhance IOL outweigh the residual risks when the device is 
used as intended.  
 
18. 
RECORDS RETENTION 
All study-related correspondence, subject records, consent forms, Authorization for 
Use/Disclosure of Health Information Forms or similar medical treatment privacy law 
documentation, records of the distribution and use of all study products, and original 
case report forms should be maintained by the investigator. 
   
 
 
 
 
 
 
 
  
 
 
   
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
49 
    PR/EMON-101-EHCE 
• 
 
 
 
 
 
 
19. 
TERMINATION OF THE INVESTIGATION 
The clinical study 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 study may be suspended if the 
Medical Monitor or the IRB, upon review and evaluation of the clinical data, finds 
unacceptable clinical performance or the level of single or total complications and/or 
adverse events unacceptable for continuation of the study. 
 
If causality is shown not to be related to the study device, the study may be resumed in 
accordance with the IRB.  
 
Additionally, the investigator or the Sponsor may stop a subject’s participation at any 
time.  The Sponsor 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. 
 
20. 
STATISTICAL METHODS 
This section highlights the analyses to be performed for key study endpoints.  The key 
study timeframe for all endpoints will be the 6-month postoperative visit, although data 
will be reviewed at other time points as well.  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
50 
    PR/EMON-101-EHCE 
 
 
 
  
 
 
    
 
 
 
 
 
 
20.3 
STUDY ENDPOINT 
 will be the primary analysis sets for the primary 
and secondary effectiveness endpoints.   
Primary Effectiveness Endpoint 
Mean Best-corrected Distance Visual Acuity (BCDVA)  
The primary effectiveness endpoint is the mean monocular best-corrected distance 
visual acuity at 4 m under photopic conditions at 6 months. The non-inferiority 
comparison between the IOL groups will be conducted using the two-sided 90% 
confidence interval on the mean BCDVA difference based on a t-distribution.  The mean, 
SD, median, minimum, maximum and two-sided 90% C.I. will be presented by IOL 
group. Note that lower logMAR value is a better acuity and a higher logMAR value is a 
poorer acuity.  The null hypothesis is that the mean difference between the test and 
control IOLs is less than or equal to -0.1 logMAR, with the alternative hypothesis being 
that the mean difference is greater than -0.1 logMAR. A lower bound of the two-sided 
90% confidence interval will be used for evaluation based on a two-sample t-test 
statistic.  The success criterion is that the lower limit of the two-sided 90% confidence 
interval is above -0.1 logMAR. 
 
Ho: μc – μt ≤ -0.10 (test is inferior (higher logMAR value) to control) 
H1: μc – μt > -0.10 (test is not inferior (lower logMAR value) to control) 
 
where 
 
μt = the mean logMAR BCDVA for test group 
μc = the mean logMAR BCDVA for control group 
 
Secondary Effectiveness Endpoints 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
51 
    PR/EMON-101-EHCE 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
Mean Distance-corrected Intermediate Visual Acuity at 66 cm (DCVA66) 
The DCVA66 (first eyes) will be summarized (n, mean, SD, median, minimum, 
maximum) with the two-sided 95% CI by IOL group. Comparisons of mean DCVA66 
between the test and control groups at 6 months will be performed using a two-sample t-
test with a one-sided alpha level of 0.025.  
 
The null hypothesis is that the mean monocular DCVA66 logMAR value for eyes in the 
test group is worse than or equal to that for the control group. The alternate hypothesis 
is that the mean monocular DCVA66 logMAR value for the test group is better than that 
for the control group. 
 
Ho: μc – μt ≤ 0 (test is worse than (higher LogMAR value) or equal to control) 
H1: μc – μt >0 (test is better (lower LogMAR value) than control) 
 
where 
 
μt = the mean LogMAR DCVA66 for test group 
μc = the mean LogMAR DCVA66 for control group 
 
The success criterion is a statistically significantly better mean DCVA66 (lower LogMAR 
value) for test lens compared to the control lens group (p ≤ 0.025).   
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
52 
    PR/EMON-101-EHCE 
Safety Endpoints 
The Safety Population will be the primary analysis set for the safety endpoints.  Best-
case population will also be used in the analysis of BCDVA 
vs. ISO SPE 
rate.  First-eye data will be the primary analysis for safety endpoints.  
 
 
   
 
• 
Secondary Surgical Intervention Related to Optical Properties of the IOL 
The counts and percentages of secondary surgical interventions (SSIs) related to optical 
properties of the lens will be reported by IOL group.   
 
• 
SPE Related Adverse Event vs. ISO SPE Rates 
The counts and percentages of SPE-related adverse events will be reported by IOL 
group.  The rate in the test lens group will be compared to the ISO Safety and 
Performance Endpoints (SPE) rates listed in the ISO 11979-7 using two-sided 90% 
Clopper Pearson Exact confidence interval with no CIs multiplicity adjustment.  Success 
criteria is that the lower confidence limit of the test group is below the SPE rate. 
 
• 
Monocular BCDVA vs. ISO SPE Rate 
The counts and percentages of monocular first-eye BCDVA 
 will 
be presented by IOL group.  The rate in the test lens group will be compared to the ISO 
SPE rate using two-sided 90% Clopper Pearson Exact confidence interval with no CIs 
multiplicity adjustment.  Success criteria is that upper confidence limit of the test group is 
higher than the SPE rate. 
 
Other Endpoints: 
The Safety population will be used for the analysis of all other endpoints. 
 
For other visual acuity endpoints, descriptive statistics will be reported for each IOL 
group and the difference between IOL groups.  In addition, the count and proportion of 
eyes/subjects achieving each line will be reported over time by IOL group for all visual 
acuity endpoints. 
 
 
 
 
 
 
 
  

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
53 
    PR/EMON-101-EHCE 
• 
 
 
  
For manifest refraction, descriptive analysis of refractive sphere, cylinder, spherical 
equivalent (SEQ) and postoperatively SEQ minus intended SEQ will be reported for 
each IOL group and the difference between IOL groups for both eyes.  In addition, the 
count and proportion of each eye within certain diopter categories will be tabulated for 
refractive cylinder, SEQ and postoperatively SEQ minus intended SEQ by IOL groups 
for both eyes.  
 
 
 
 
 
 
 
 
 
 
20.4 
SITE POOLABILITY ANALYSIS 
A mixed effect model will be used to evaluate site heterogeneity by investigation of site 
effect and site by group interaction effect for the primary and secondary endpoints. 
 
 
 
 
 
 
20.5 
VISUAL ACUITY CONVENTIONS AND GENERAL STATISTICS  
Visual acuity data will be converted to LogMAR values prior to analysis and adjusted for 
the test distance used if it is not the standard distance for the chart.  Descriptive 
statistics will typically include sample size (N), mean, standard deviation (SD), median, 
minimum (Min) and maximum (Max) as appropriate for continuous variables.  For 
continuous variables, 2-sample t-test assuming normality will be used.  For categorical 
data, the frequency and proportion will be reported, and Fisher’s exact test or Chi-square 
test will be applied.  For ordinal categorical data, the frequency and proportion will be 
reported with the Wilcoxon Rank-Sum test will be used. 
   
20.6 
INTERIM REPORTS 
No interim study progress reports will be conducted for this study. 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
54 
    PR/EMON-101-EHCE 
20.7 
SAMPLE SIZE CALCULATION 
Study sample sizes are based on the minimum of 100 evaluable subjects per study 
group for visual acuity.  
 
 
 
   
 
1.   Monocular Best-corrected Distance Visual Acuity (BCDVA) at 4 m 
For monocular best-corrected near visual acuity at 4 m (BCDVA), with 100 subjects in 
each lens group there is over 90% power to conclude non-inferiority in visual acuity 
between the test and control lens group at two-sided alpha of 0.10 with a non-inferiority 
margin of 1 line, assuming there is no difference between the IOLs and a standard 
deviation of 1.2 lines. 
  
2. 
Monocular Distance-corrected Intermediate Visual Acuity at 66 cm (DCVA66)  
For monocular distance-corrected intermediate visual acuity at 66 cm, with 100 subjects 
in each lens group, there is over 90% power at one-sided 0.025 alpha to detect a 0.8-
line or greater difference in mean visual acuity between the test lens and control lens 
groups, assuming a standard deviation of 1.6 lines.   
 
 
 
 
 
21. 
 LITERATURE REFERENCES 
1. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION                                                                                         CONFIDENTIAL 
Version 3.0 
55 
    PR/EMON-101-EHCE 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION 
 
CONFIDENTIAL 
Version 2.0 
56 
    PR/EMON-101-EHCE 
APPENDIX A SUMMARY OF PROCEDURES REQUIRED AT EACH VISIT 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                               
 
 
 
  
 
  

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
57 
    PR/EMON-101-EHCE 
 
APPENDIX B EQUIPMENT LIST 
The following equipment will be supplied to an investigative site for the duration of the 
study provided that the site does not already have such equipment available for use.  
This equipment loan will be documented in the Clinical Trial Agreement, which indicates 
that the equipment is to be returned to JJSV at the completion of the study. 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
58 
    PR/EMON-101-EHCE 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
  
 
 
 
c. 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
59 
    PR/EMON-101-EHCE 
 
5) 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
61 
    PR/EMON-101-EHCE 
 
 
 
 
 
 
 
 
 
 
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
62 
    PR/EMON-101-EHCE 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
63 
    PR/EMON-101-EHCE 
 
APPENDIX F INSTRUCTIONS FOR DISTANCE VISUAL ACUITY TESTING 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
   
 
Distance visual acuity measurements are to be performed per the visit schedule in 
Appendix A.  To test subjects monocularly, occlude the second eye in the phoropter or 
with an occluder if trial lenses are used.   
 
  
 
  
 
 
 
.   
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
64 
    PR/EMON-101-EHCE 
 
APPENDIX G INSTRUCTIONS FOR VISUAL ACUITY TESTING 
  
 
 
  
 
   
 
 
 
   
 
Visual acuity measurements are to be performed per the visit schedule in Appendix A.     
  
 
 
 
 
   
 
 
 
 
.   
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
65 
    PR/EMON-101-EHCE 
 
APPENDIX H INSTRUCTIONS FOR VISUAL ACUITY TESTING
 
 
 
 
 
   
 
 
 
 
  
  
Visual acuity measurements 
 are to be performed per the visit schedule in 
Appendix A.  
  
  
 
 
 
 
   
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
66 
    PR/EMON-101-EHCE 
 
APPENDIX I INSTRUCTIONS FOR VISUAL ACUITY TESTING AT 40 CM 
 
 
 
 
  
  
 
 
 
   
 
Visual acuity measurements at 40 cm are to be performed per the visit schedule in 
Appendix A.   
 
  
 
 
 
 
   
      
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
67 
    PR/EMON-101-EHCE 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
     
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
68 
    PR/EMON-101-EHCE 
 
 
 
 
  
 
   
  
 
 
 
  
 
 
 
 
 
   
 
 
 
 
 
 
   
 
 
 
   
  
 
  
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
69 
    PR/EMON-101-EHCE 
 
APPENDIX L SLIT-LAMP EXAM RATINGS 
A.  Ratings of Aqueous Cells and Flare 
 
 
  
 
 
CELLS 
Grade 
Cells in Field (Field is a 1x1 mm slit 
beam) 
0 
<1 
0.5+ 
1 - 5 
1+ 
6 - 15 
2+ 
16 - 25 
3+ 
26 - 50 
4+ 
>50 
 
FLARE 
Grade 
Description 
0 
None 
1+ 
Faint 
2+ 
Moderate (iris and lens details clear) 
3+ 
Marked (iris and lens details hazy) 
4+ 
Intense (fibrin or plastic aqueous) 
 
B.  Ratings of Corneal Edema 
Corneal edema should be classified according to the haziness of the epithelium, the 
number of microcysts observed, and the clouding of the stroma. 
Amount 
Grade 
Description 
None 
0 
Normal transparency: 
a. No epithelial or sub-epithelial haziness 
b. No microcysts 
c. No stromal cloudiness 
Trace 
+1 
a. Barely discernible localized epithelial or sub-epithelial 
haziness, and/or 
b. 1 to 20 microcysts, and/or 
c. Barely discernible localized stromal cloudiness 
Mild 
+2 
a. Faint but definite localized or generalized epithelial, sub-
epithelial or stromal haziness/cloudiness, and/or 
b. 21-50 microcysts 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
70 
    PR/EMON-101-EHCE 
 
Moderate 
+3 
a. Significant localized or generalized epithelial, sub-
epithelial or stromal haziness/cloudiness and/or 
b. 51-100 microcysts 
Severe 
+4 
a. Definite widespread epithelial or stromal cloudiness, giving 
dull glass appearance to cornea or numerous coalescent 
bullae (please note the number and location of bullae), 
and/or 
b. >100 microcysts or bullae, and/or 
c. Numerous striae (please note the number and location of 
striae or folds) 
 
C.  Posterior Capsule Striae Grading Scale 
The following five-point grading scale is to be used for rating striae in the posterior 
capsule: 
Amount 
Grade Description 
None 
0 
None 
Trace 
+1 
One detectable, barely noticeable striae 
Mild 
+2 
One or two prominent striae 
Moderate 
+3 
Three or more prominent striae, but visibility of 
retina is not impacted 
Severe 
+4 
Three or more prominent striae affecting 
visualization of retina 
 
 
D.  Posterior Capsule Opacification Grading Scale 
Below is the five-point grading scale to be used for PCO determination: 
Amount 
Grade Description 
None 
0 
Normal posterior capsule with no area of opacity.  Red 
reflex bright. 
Trace 
+1 
Some loss of transparency involving the posterior 
capsule.  Red reflex fairly bright 
Mild 
+2 
Mild loss of transparency with cloudiness extending 
through most of the posterior capsule.  There may be a 
few Elschnig’s pearls in the posterior capsule.  Red 
reflex mildly diminished. 
Moderate 
+3 
Moderate loss of transparency with difficulty visualizing 
the retina.  There may be multiple Elschnig’s pearls in 
the posterior capsule.  Red reflex markedly diminished. 
Severe 
+4 
Posterior capsule very opaque with inability to view the 
retina.  The posterior capsule may have confluent 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
71 
    PR/EMON-101-EHCE 
 
Elschnig’s pearls and fibrous scarring.  Red reflex barely 
visible. 
 
E.  IOL Glistenings  
Use the following scale to grade IOL glistenings, using a slit beam 2.0 mm wide and 
10.0 mm long: 
Amount 
Grade 
Description 
None 
0 
No glistenings visible 
Rare 
+0.5 
<10 glistenings visible 
Trace 
+1 
10-19 glistenings visible 
Mild 
+2 
20-29 glistenings visible 
Moderate 
+3 
30-39 glistenings visible 
Severe 
+4 
≥40 glistenings visible 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
72 
    PR/EMON-101-EHCE 
 
APPENDIX M 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
73 
    PR/EMON-101-EHCE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
74 
    PR/EMON-101-EHCE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
76 
    PR/EMON-101-EHCE 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
77 
    PR/EMON-1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
78 
    PR/EMON-101-EHCE 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
79 
    PR/EMON-101-EHCE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
80 
    PR/EMON-101-EHCE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
 
    
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
82 
    PR/EMON-101-EHCE 
 
1. 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
83 
    PR/EMON-101-EHCE 
 
 
 
 
 
 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
Version 3.0 
84 
    PR/EMON-101-EHCE 
 

JOHNSON & JOHNSON SURGICAL VISION  
CONFIDENTIAL 
 
Version 3.0 
85 
    PR/EMON-101-EHCE