Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)
Phase: NA
Conditions: Cataract
Sponsor: Abbott Medical Optics

 
 
 
 
 
Study Protocol 
 
Title: Clinical Investigation of the Bacterially-Derived Healon5 
Ophthalmic Viscosurgical Device (OVD) 
NCT02782676 
Document Date: 9/21/2016 
Uploaded:  4/12/2018 

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ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
ii 
    PR/VSCO-109-HLN5 
TABLE OF CONTENTS 
TITLE 
PAGE 
Table of Contents .......................................................................................................... ii 
Personnel and Facilities............................................................................................... iv 
Protocol Change History ............................................................................................... v 
1. 
Synopsis ............................................................................................................. 1 
2. 
Background/Introduction .................................................................................. 5 
3. 
Clinical Hypothesis ............................................................................................ 5 
4. 
Study Design ...................................................................................................... 5 
5. 
Acronyms ........................................................................................................... 6 
6. 
Study Objectives and Endpoints ...................................................................... 6 
 
Primary Endpoints ............................................................................................. 6 
6.1
 
Secondary Safety Endpoints .............................................................................. 6 
6.2
 
Other endpoints ................................................................................................. 6 
6.3
7. 
Study Products .................................................................................................. 7 
 
Ophthalmic Viscosurgical Devices ..................................................................... 7 
7.1
 
IOLs and Implantation Systems ......................................................................... 8 
7.2
8. 
Study Population ............................................................................................... 8 
 
Inclusion Criteria ................................................................................................ 9 
8.1
 
Exclusion Criteria ............................................................................................... 9 
8.2
9. 
Investigator Selection ...................................................................................... 10 
 
Investigator Qualifications ................................................................................ 10 
9.1
 
Investigator Obligations ................................................................................... 10 
9.2
 
Investigator Approval ....................................................................................... 12 
9.3
10. 
Experimental Plan ............................................................................................ 12 
 Overview ......................................................................................................... 12 
10.1
 Visit Schedule .................................................................................................. 13 
10.2
 Preoperative Procedures ................................................................................. 14 
10.3
 Randomization and Masking ............................................................................ 15 
10.4
 Study Medications and IOP management ........................................................ 16 
10.5
 Operative Procedures ...................................................................................... 17 
10.6
 Postoperative Procedures ............................................................................... 18 
10.7
 Exit of Subjects ................................................................................................ 20 
10.8
 Unscheduled Visits .......................................................................................... 21 
10.9
 Protocol Deviations .......................................................................................... 21 
10.10
11. 
Adverse Events and Product Complaints ...................................................... 21 
 Adverse Event Definitions ................................................................................ 21 
11.1

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
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    PR/VSCO-109-HLN5 
 Product Complaint/Device Deficiency Definition .............................................. 23 
11.2
 Adverse Event and Complaint Reporting Requirements .................................. 23 
11.3
 Causal Relationship ......................................................................................... 24 
11.4
 Adverse Event Follow-up ................................................................................. 25 
11.5
12. 
Protocol Changes/Amendments ..................................................................... 25 
13. 
Ethics Review and Patient Welfare ................................................................. 26 
 Institutional Review Board (IRB) ...................................................................... 26 
13.1
 Informed Consent ............................................................................................ 26 
13.2
14. 
Documentation ................................................................................................. 26 
 Source Documents .......................................................................................... 26 
14.1
 Subject Confidentiality ..................................................................................... 27 
14.2
 Case Report Form Completion ........................................................................ 27 
14.3
 Study Summary ............................................................................................... 27 
14.4
15. 
Monitoring ........................................................................................................ 28 
 Data Monitoring ............................................................................................... 28 
15.1
 Administrative Monitoring ................................................................................ 28 
15.2
 Safety Monitoring ............................................................................................. 29 
15.3
16. 
Publications ..................................................................................................... 30 
17. 
Risk Analysis ................................................................................................... 30 
18. 
Records Retention ........................................................................................... 31 
19. 
Termination of the Investigation ..................................................................... 32 
20. 
Statistical Methods .......................................................................................... 32 
 Analysis Population ......................................................................................... 32 
20.1
 Study Endpoints .............................................................................................. 33 
20.2
 General Statistics ............................................................................................ 35 
20.3
 Interim Reports ................................................................................................ 35 
20.4
 Sample Size Calculations ................................................................................ 36 
20.5
21. 
References ....................................................................................................... 36 
Appendix A   Summary of Procedures Required at Each Visit ................................ 37 
Appendix B   Equipment List ...................................................................................... 38 
Appendix C   Endothelial Cell Counts ........................................................................ 39 
Appendix D   Slit-Lamp Exam Ratings ....................................................................... 40 
Appendix E   Adverse Event and Complaint Reporting Instructions ....................... 42 
 
 
 

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
iv 
    PR/VSCO-109-HLN5 
PERSONNEL AND FACILITIES 
SPONSOR: 
Abbott Medical Optics Inc. 
 
1700 E. Saint Andrew Place 
 
Santa Ana, CA 92705 
 
SPONSOR PERSONNEL: 
 
 
Medical Monitor: 
David Tanzer, M.D. 
 
Chief Medical Officer 
 
Abbott Medical Optics 
 
1700 East St. Andrew Place 
 
Santa Ana, CA 92705 
 
Office:  714-247-8992 
 
Director, Clinical Research: 
Debbie Trentacost 
 
Director, Clinical Research – Cataract 
 
Office:  714-247-8625 
 
Study Manager: 
Cheryl Harper 
 
Clinical Research Manager 
 
Cell:  913-396-3276 
 
 
Biostatisticians: 
Stanley Bentow, Ph.D. 
 
Research Fellow,  
 
Biostatistics and Data Management 
 
Office:  714-247-8618 
 
 
Pamela Smith, M.P.H. 
 
Principal Research Statistician 
Office:  805-388-3965 
 
EMERGENCY TELEPHONE NUMBERS: 
Cheryl Harper 
Cell: 913-396-3276 
 
 
 
 

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
v 
    PR/VSCO-109-HLN5 
PROTOCOL CHANGE HISTORY 
Version 
Section(s) 
Page(s) 
Description of Change(s)  
Rationale for Change(s) 
1.0 
N/A 
N/A 
Original 
N/A 
2.0 
1.0, 6.2, 20.1, 20.2, 
3, 6, 33-
35 
Study endpoints updated to move adverse events, 
inflammation, IOP spikes over time, and mean change in 
IOP from baseline from other endpoints to secondary 
safety endpoints. 
To address FDA considerations in letter 
dated January 6, 2016 
6.0 
6 
Primary study endpoints specifically identified as safety or 
effectiveness. 
10.2 
13-14 
Visit schedule updated to specify there will be at least 14 
days between first and second eye surgery; one day visit 
will have a 24 hour window ±4 hours (20-28 hours) 
10.5 
16-17 
Medications were standardized and IOP management 
medications are left to the investigator’s choice for best 
patient care. 
11.1 
23 
Note 2 regarding corneal edema and iritis as serious 
adverse events was updated for clarification. 
17.0 
31 
Potential benefits updated for clarification. 
19.0 
32 
Updated to clarify considerations for termination of 
investigation. 
3.0 
10.5 
16 
Updated postoperative medications for clarification 
To address FDA considerations in letter  
dated March 8, 2016 
4.0 
N/A, Appendix E 
iv, 42 
Updated study manager, emergency name and contact 
information 
Due to study personnel changes 
 
1.0, 7.2, 9.1, and 10.6 
1, 8, 10, 
17 
Updated IOL options to include the TECNIS Symfony IOL 
Requested by study investigators due to 
recent FDA approval of the TECNIS 
Symfony IOL, which is part of the TECNIS 
1-Piece family of IOLs already being used 
in the study.  
 
1.0, 5.0, 10.6 
4, 6,17 
Allow for Laser Cataract Surgery and  AK or LRI  
Clarifying that laser assisted cataract 
surgery and relaxing incisions are allowed 

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
vi 
    PR/VSCO-109-HLN5 
 
 
 
 
10.5, 10.7, 11.3, 11.5, 
18.0 and Appendix E 
17, 19, 
24, 25, 
32, 42 
Change the name of the SAE/ADE reporting form 
To be consistent with the name of the form 
in the EDC system. 
 
Appendix B 
38 
Updated to include a refrigerator and sensor 
Clarifying additional equipment the sites 
received 
 
Appendix C 
39 
Updated the process for exporting the ECC images to the 
reading center directly.  The process for collecting and 
analyzing the images remains the same. 
To be consistent with the reading center 
submission process (images are to be 
submitted directly to the reading center, 
not to AMO). 

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
1 
    PR/VSCO-109-HLN5 
1. 
SYNOPSIS 
PROTOCOL: 
Clinical Investigation of the Bacterially-Derived Healon5 
Ophthalmic Viscosurgical Device (OVD) 
Protocol Number:  VSCO-109-HLN5 
 
STUDY TREATMENTS: 
Investigational Product: Bacterially-derived Healon5 
 
Control Product:  Currently-available, animal-derived 
Healon5  
 
STUDY OBJECTIVE: 
The purpose of this clinical trial is to evaluate the safety 
and effectiveness of the bacterially-derived Healon5. 
 
CLINICAL HYPOTHESIS: 
The bacterially-derived Healon5 OVD will be statistically 
non-inferior to the currently-available animal-derived 
Healon5 OVD with regard to cumulative intraoperative 
pressure (IOP) spikes and endothelial cell count (ECC) 
change at 3 months postoperatively. 
 
OVERALL STUDY DESIGN: 
Structure: 
Prospective, multicenter, paired-eye, randomized, masked, 
clinical trial of the bacterially-derived Healon5 OVD versus 
the currently available Healon5 OVD control.  
 
Number of sites: 
Up to 10 sites in the USA 
 
Duration: 
3 months 
 
Administration: 
Surgeons will use the OVD as they normally would to 
perform standard, small-incision, cataract surgery and 
implant subjects with one of the following intraocular 
lenses (IOLs):  TECNIS® ZCB00 monofocal IOL, TECNIS® 
Multifocal IOLs (ZKB00, ZLB00, or ZMB00) or the 
TECNIS® Symfony Extended Range of Vision IOL 
(ZXR00). 
 
Visit Schedule: 
All subjects will undergo a minimum of 11 visits:  
Preoperative for both eyes; 1st eye operative; 
Postoperative for 1st eye at 6 hours, 1 day and 1 week; 2nd 
eye operative; Postoperative for 2nd eye at 6 hours, 1 day 
and 1 week; 1 month and 3 months postoperative for both 
eyes together. 
 
STUDY POPULATION CHARACTERISTICS: 
 
Condition: 
Bilateral cataracts with otherwise healthy eyes 
 
Number of Subjects: 
Up to 241 subjects will be enrolled to ensure treatment of 
approximately 230 subjects in order to achieve 
approximately 200 evaluable subjects at 3 months  

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ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
4 
    PR/VSCO-109-HLN5 
any patients who agree to participate in the study prior to undergoing any study-specific 
procedures.  After determination that all inclusion/exclusion criteria have been met, 
enrolled subjects will be randomized in a 1:1 ratio.  Subjects will receive the study OVD 
in one eye and the currently-available control OVD in the fellow eye.  Subjects and study 
personnel will be masked for the duration of the study.   
Key preoperative data include ocular health and history, visual acuities, manifest 
refraction, IOP, ECC, biomicroscopic slit-lamp findings, ocular symptoms and biometry.  
The operative visit will include standard procedures for cataract surgery and IOL 
implantation.  All aspects of laser cataract surgery will be allowed as well as astigmatic 
keratotomy (AK) and Limbal Relaxing Incisions (LRI).  If laser cataract surgery, AK or 
LRI is elected, it must be performed on both eyes of the subject.  
A standardized medication regimen will be used preoperatively and intraoperatively 
(Section 10.5, Medication Regimen).  Key postoperative data collection includes IOP, 
ECC, manifest refraction, visual acuity, visual symptoms, biomicroscopic slit-lamp 
findings, and adverse events.   
As this study is masked, an independent Data Safety Monitoring Board (DSMB) will 
monitor adverse events that occur during the study.   
 
 

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
5 
    PR/VSCO-109-HLN5 
2. 
BACKGROUND/INTRODUCTION 
Viscoelastics are indicated for use as a surgical aid in anterior segment procedures 
including cataract surgery with or without an intraocular lens, secondary intraocular lens 
implantation, corneal transplant surgery, and glaucoma filtration surgery.  Some 
established benefits of using viscoelastic materials in cataract surgery are endothelial 
cell protection and maintenance of intraocular space.2   The protection these materials 
provide result in reduced trauma to the cornea from inadvertent “touch” during 
intraocular surgery, therefore minimizing endothelial cell loss.3   
Viscoelastics traditionally have been developed from sodium hyaluronate (NaHA) 
derived from rooster combs such as the currently-available Healon5.  Due to concerns of 
cross-over contamination, animal-derived products have been losing favor in many parts 
of the world.  The OVD under investigation is a bacterially-derived sodium hyaluronate 
version of the currently-available, animal-derived Healon5.  This clinical study will 
evaluate safety and effectiveness of the bacterially-derived Healon5 OVD under 
normal-use conditions during the cataract surgical procedure.  
3. 
CLINICAL HYPOTHESIS 
This study will demonstrate that the bacterially-derived Healon5 has non-inferior rates of 
IOP spikes and mean percent endothelial cell change compared to that of the animal-
derived Healon5.  Rates of serious and device-related adverse events and adverse 
event rates associated with the bacterially-derived Healon5 group will not be statistically 
significantly higher than ISO SPE rates.  
4. 
STUDY DESIGN 
This study is a 3-month, prospective, multicenter, paired-eye, masked, randomized 
clinical investigation of the bacterially-derived Healon5 versus the currently-available, 
animal-derived Healon5 control.   
The study will be conducted at up to 10 sites in the USA and will include approximately 
230 treated subjects of up to 241 enrolled subjects.  Subjects will be randomly assigned 
to receive the study OVD in one eye and the control OVD in the fellow eye. 
JUSTIFICATION OF STUDY DESIGN 
This study is being conducted for USA regulatory purposes; a randomized, paired-eye, 
masked study design was chosen to optimize comparison of IOP spike rates and ECC 
loss between the bacterially-derived Healon5 and the animal-derived Healon5 control, 
while minimizing the number of subjects and allowing for a more robust control than a 
unilateral design would provide.  

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ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
8 
    PR/VSCO-109-HLN5 
STORAGE AND DISTRIBUTION 
A consignment of both the investigational, bacterially-derived Healon5 and the currently-
available, animal-derived Healon5 control will be supplied to the sites.  Both OVD 
products must be stored between 2° to 8° C (36° to 46° F) in the temperature-controlled 
refrigerator provided by AMO.  The OVDs should be protected from freezing and 
exposure to light.  Refrigerated OVD should be held at room temperature for 
approximately 30 minutes before use.  Both the investigational and control OVDs are 
supplied in 0.6 mL glass syringes. The syringes are terminally steam sterilized and 
aseptically packaged.  A sterile, single-use 25 gauge cannula is included with each 
syringe.  The OVDs are 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 both OVD products provided are only used for subjects 
enrolled in this study. 
 
IOLS AND IMPLANTATION SYSTEMS  
7.2
In this study, only the following IOLs will be implanted: TECNIS® 1-Piece Monofocal 
Model PCB00 (preloaded), TECNIS® 1-Piece Monofocal Model ZCB00, TECNIS® 1-
Piece Multifocal IOL Models ZKB00, ZLB00 and ZMB00 or the TECNIS® Symfony 
Extended Range of Vision IOL Model ZXR00.    The TECNIS® 1-Piece Models ZCB00, 
ZKB00, ZLB00, ZMB00 and ZXR00 are to be implanted using the UNFOLDER Platinum 
1 Series Implantation System (DK7796 handpiece with the UNFOLDER Platinum 1 
Series cartridge, Model 1MTEC30) or the ONE SERIES Ultra Implantation System 
(DK7786 or DK7791 handpiece with the One Series Ultra cartridge).  Another insertion 
system may be used for the lenses if validated by AMO prior to study use. 
8. 
STUDY POPULATION 
All study subjects will be enrolled from the normal surgical cataract population at up to 
10 sites in the USA.  Up to 241 subjects will be enrolled to achieve approximately 
230 randomized and contralaterally-operated subjects to ensure approximately 
200 evaluable subjects at 3 months.  Each site should implant a minimum of 20 subjects, 
and no site may implant more than 25% of the enrollment total.   
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 inclusion/exclusion criteria will be offered 
enrollment in the study.  Eligibility criteria may not be waived by the investigator.  Any 
questions regarding patient eligibility are to be discussed with AMO prior to subject 
enrollment.  Those subjects who meet the inclusion/exclusion criteria and agree to 
participate will be randomly assigned to receive the investigational OVD in one eye and 

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ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
13 
    PR/VSCO-109-HLN5 
After signing the informed consent, subjects meeting all inclusion and exclusion criteria 
will be randomly assigned in a 1:1 ratio to receive either the bacterially-derived Healon5 
or the animal-derived Healon5 control for the first-eye surgery and the other study 
product for the second-eye surgery.  Prior to randomization for each subject, the 
investigator will choose which eye to operate on first based on his/her standard clinical 
practice (e.g., the eye with the worse cataract, poorer best corrected distance vision 
and/or more severe optical/visual complaints).  All subjects are intended to have bilateral 
cataract surgery with the second-eye surgery occurring after the 1-week postoperative 
exam for the first eye, but no more than 45 days after the first-eye surgery.  All subjects 
will be examined through 3 months postoperatively according to the visit schedule 
described in Section 10.2, Visit Schedule. 
An independent Data Safety Monitoring Board (DSMB) will monitor complications and 
adverse events that occur during the study. 
Key data collection for all subjects includes IOP, ECC, manifest refraction, visual 
acuities, biomicroscopic slit-lamp findings, complications 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).   
 
VISIT SCHEDULE 
10.2
The study visit schedule for all study subjects is outlined in Table 1.   
All subjects enrolled are intended to have bilateral cataract surgery with the second-eye 
surgery occurring 14-45 days after the first-eye surgery (and after the 1 week exam for 
the first eye).  After each surgery, each eye will be examined at 6 hours (4-8 hours) 
postoperatively, 1 day (20-28 hours) and again at 1 week (7-14 days).  Additionally, 
following the second-eye surgery, both eyes will be evaluated at 1 month (23-37 days) 
and 3 months (75-105 days).  Unscheduled visits may be conducted as necessary at the 
discretion of the investigator for medically-indicated follow-up.   

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
14 
    PR/VSCO-109-HLN5 
TABLE 1: Visit Schedule 
VISIT 
EYES 
EVALUATED 
EXAM 
VISIT WINDOW 
1 
Both Eyes 
Preoperative Exam 
Within 45 days prior to 1st surgery 
2 
First Eye 
Operative 
0-45 days after preoperative exam 
3 
First Eye 
6 hours 
4-8 hours postoperative 
4 
First Eye 
1 day 
20-28 hours postoperative  
5 
First Eye 
1 weeka 
7-14 days postoperative 
6 
Second Eye 
Operativea 
14-45 days after 1st eye surgery 
7 
Second Eye 
6 hours 
4-8 hours postoperative 
8 
Second Eye 
1 day 
20-28 hours postoperative  
9 
Second Eye 
1 week 
7-14 days postoperative  
10 
Both Eyes 
1 month 
23-37 days postoperative from 2nd implant 
11 
Both Eyes 
3 months 
75-105 days postoperative from 2nd implant 
a The 1-week exam for the first eye must be completed prior to surgery on the second eye. 
 
 
PREOPERATIVE PROCEDURES  
10.3
All subjects enrolled in the study must sign the current IRB-approved informed consent 
document and meet the inclusion/exclusion criteria.  The informed consent must be 
signed before any study-specific examinations are performed, and this must be 
documented in the source documents.  An Authorization for Use/Disclosure of Health 
Information Form (HIPAA authorization) must also be signed. 
All preoperative testing for the study must be completed within 45 days prior to the first 
surgery.  Data from routine (non-study-specific) preoperative cataract examinations 
performed prior to the informed consent process may be included, provided these tests 
are conducted no more than 45 days prior to the first-eye surgery.  If a test/exam is 
required by the protocol, but is not part of routine testing the investigator performs for 
cataract evaluations, that test/exam is considered to be study-specific and is not to be 
done until after the informed consent has been signed by the subject.  Following the 
informed consent process, completion of the preoperative study exam, determination 
that the subject meets all of the required entrance criteria and determination of the first 
eye to be operated on, 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 
proceed with surgery. These subjects will be exited from the study.   

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ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
19 
    PR/VSCO-109-HLN5 
DISTANCE VISUAL ACUITY TESTING  
Snellen monocular UCDVA and BCDVA will be measured for all subjects postoperatively 
under photopic lighting conditions.  For eyes unable to achieve a postoperative BCDVA 
of Snellen 20/40, a reason must be specified.    
IOP 
IOP will be measured at each postoperative visit by Goldmann applanation.  Any IOP 
measurements of 30 mmHg or greater are to be considered a “spike”.  An SAE/ADE 
Detailed Page must be completed; spikes are to be managed as described in 
Section 10.5, Study Medications and IOP Management. 
ECC 
All endothelial cell counts will be performed with a Konan non-contact specular 
microscope preoperatively and at three months postoperatively.  Three photos will be 
taken at each exam and electronic or paper copies sent to AMO.  Further instructions 
are provided in Appendix C.  
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.   
Findings of aqueous cells and flare, corneal edema, synechia and fibrin 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 D.   
DILATED FUNDUS EXAM 
A dilated fundus exam is to be performed only if medically indicated.  
OCULAR SYMPTOMS (NON-DIRECTED; SPONTANEOUS) 
Subjective ocular symptoms are to be assessed at each postoperative visit by asking 
“Are you having any difficulties with your eyes/vision?”  Subjects should not be prompted 
for specific responses; however, if a subject reports halos, night glare or starbursts, the 
level of severity should be determined (mild, moderate or severe). 
MEDICATIONS   
Postoperative medications should be used as described in Section 10.5, Study 
Medications and IOP Management.  Every attempt should be made to adhere to the 
regimen.  Any changes or additions to the medications prescribed will be considered a 
protocol deviation. Medications will be recorded on each postoperative case report form 
as applicable. 

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
20 
    PR/VSCO-109-HLN5 
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, and Appendix E, Adverse Event Reporting Instructions, 
for further information.  
 
EXIT OF SUBJECTS  
10.8
An Exit Case Report Form will be submitted 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 AMO for 
each subject, and every attempt should be made to gather that complete follow-up data 
for all subjects enrolled as missing data can have a negative effect on the study results. 
Patients who would be traveling, relocating or otherwise unavailable for postoperative 
follow-up visits should not be chosen for this clinical study. 
If a subject dies prior to study completion, he/she will be documented as discontinued 
from the study along with the reason for death.  Subjects will be considered “lost-to-
follow-up” from the study only if irretrievably lost for unavoidable reasons such as: 
subject moved/unable to locate, subject uncooperative/refuses further study 
participation, subject ill/unable to travel.  In the event of subject relocation, efforts must 
be made by the investigator to secure follow-up information (i.e., IOP, slit-lamp findings 
and general visual acuity, etc.) from the subject’s new physician.   
A subject will be considered a non-randomized screen failure if he/she does not meet 
the inclusion/exclusion criteria or if consent is withdrawn prior to randomization.   
A subject will be considered a randomized screen failure if the subject is randomized but 
does not undergo surgery or receive one of the study OVDs for various reasons 
including: the surgery being aborted, the subject withdrawing consent prior to treatment 
or the subject dying prior to treatment.  If a subject receives the study OVDs in either 
eye, he/she is to be followed according to the protocol.   
If a subject is exited early from the study, the investigator will submit an Exit Case 
Report Form indicating the reason for study exit.  In the event of a serious adverse 
event, the subject may be exited from the study; however, efforts must be made by the 
investigator to follow the subject until resolution of the adverse event. 
Following study completion or early exit, subjects will be informed about which OVD was 
used in each eye.  Additionally, all study subjects are to be instructed to undergo regular 
eye examinations at least yearly and to return to their doctor if any eye complications are 
experienced in the interim.   

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NOTE 2: Corneal edema and iritis will be reported as serious adverse events if sight-
threatening at any time or persistent at the final study visit (75-105 days 
postoperative).  Treatment merely to hasten the resolution of such conditions (and not 
intended to prevent permanent damage to the eye) 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.   
 
PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
11.2
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, user error 
and inadequacies in labeling.  Product complaints can pertain to any marketed AMO 
device being used in the study as well as the investigational device.  The investigator is 
to assess whether the deficiency could have led to a serious adverse event without 
suitable action or intervention or under less fortunate circumstances. 
 
ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
11.3
All adverse events and any complaint encountered using any AMO product, regardless 
of severity and whether or not attributed to the study device(s), are to be reported to 
AMO and submitted on the case report form corresponding to the visit during which 
awareness of the event occurred.  Adverse events are also to be reported to the 
reviewing IRB as per the IRB’s reporting requirements.  If required, adverse events will 
be reported to the appropriate regulatory agencies (e.g., FDA) according to all applicable 
laws and regulations.  Specific instructions on notification procedures to AMO are 
included in Appendix E, Adverse Event Reporting.   
Reporting of adverse events shall follow the USA Code of Federal Regulations 
(21CFR812).   
General guidelines are provided below: 

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Adverse Event Reporting 
An adverse event that is not serious or device-related is to be reported to AMO in a 
timely manner.  Notification of non-serious and non-device-related adverse events will 
occur by submitting events on the CRF when noted.  Such adverse events are also to be 
reported to the reviewing IRB per their reporting requirements.  
Complaints/Device Deficiency Reporting  
A general product complaint or device deficiency is to be reported to AMO in a timely 
manner.  Notification of complaints/device deficiencies will occur by either submitting 
complaints on the CRF when the complaint occurred (e.g., operative form) or by a phone 
call to the Sponsor.  Any device deficiency that could have led to a serious adverse 
event without suitable action or intervention, or under less fortunate circumstances, must 
be reported to the sponsor immediately (no later than 48 hours after detection).  Device 
deficiencies that could have led to a serious adverse event should also be reported to 
the investigator’s IRB per their reporting requirements. 
Serious and/or Device-Related Adverse Event Reporting 
Serious and/or device-related events (ADEs) are to be documented using the SAE/ADE 
Detailed Page .  In the event of a serious adverse event (SAE), which may or may not be 
related to use of the study device, AMO must be notified immediately (no later than 48 
hours after detection).  Any SAE is to be reported by phone (and/or email) and by 
submitting a completed SAE/ADE Detailed Page.  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 AMO within 48 hours, and to 
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). 
 
CAUSAL RELATIONSHIP  
11.4
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.   

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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.   
 
ADVERSE EVENT FOLLOW-UP 
11.5
For every adverse event, appropriate measures should be undertaken to treat and/or 
monitor the subject until resolution occurs.  Obtain and maintain in the subject's files all 
pertinent medical data relating to the event including the subject’s medical records and 
medical reports and/or judgments from colleagues or outside specialists who assisted in 
the treatment and follow-up of the subject. The investigator should keep AMO closely 
informed as to the outcome of serious and/or device-related adverse events, thereby 
allowing AMO to comply with the appropriate regulatory reporting requirements.  A 
SAE/ADE Resolution Form should be submitted each time the subject returns to the 
investigator or other specialist(s) for follow-up of a serious and/or device-related adverse 
event until resolution of the event.  Any subject who is exited from the study due to a 
serious and/or device-related adverse event will be followed until the outcome is 
determined. 
12. 
PROTOCOL CHANGES/AMENDMENTS  
If the investigator desires to modify any procedure and/or the design of the study, he or 
she must contact and obtain consent from AMO regarding the proposed changes prior to 

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implementation.  Any modifications (including additional data collection) require approval 
by the FDA as well as approval of the governing IRBs prior to implementation.   
13. 
ETHICS REVIEW AND PATIENT WELFARE 
 
INSTITUTIONAL REVIEW BOARD (IRB) 
13.1
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 at the site.  Copies of IRB submissions and approvals should be forwarded 
to AMO. 
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. 
 
INFORMED CONSENT 
13.2
The current version of the IRB-approved study informed consent must be signed by 
each study subject prior to any study-specific examinations being performed.  The 
IRB-approved informed consent is to be signed and dated by the subject as well as by 
the person who conducted the informed consent discussion.  The signed informed 
consent will be maintained by the investigator as a permanent part of the subject’s 
medical records.  A copy of the signed and dated form is to be provided to the subject.  
The investigator will provide AMO written acknowledgement on the preoperative case 
report form that a signed agreement of informed consent has been obtained and is in the 
investigator’s possession for each subject.  As required by 21CFR812 Part G, the site 
shall document in the source documents that informed consent was obtained prior to 
participation in the study for each subject enrolled. 
NOTE:  The informed consent process also includes obtaining the subject’s signature on 
an Authorization for Use/Disclosure of Health Information for Research Form.  
NOTE:  The sponsor will secure appropriate insurance for study subjects prior to study 
start. 
14. 
DOCUMENTATION 
 
SOURCE DOCUMENTS 
14.1
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. 

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15. 
MONITORING  
AMO will perform three types of monitoring to ensure compliance with regulations: data 
monitoring, administrative monitoring, and safety monitoring. 
 
DATA MONITORING 
15.1
In order to ensure a well-controlled clinical trial, AMO will follow specific data monitoring 
procedures.  As this study is masked, any necessary review of safety and effectiveness 
data by OVD type will be done only by the Data Safety Monitoring Board (Section 15.3) 
until the final study visits are completed.  Study staff and AMO personnel will remain 
masked until the final study visits have been completed.    
An electronic data capture system (EDC) will be used to transmit case report forms from 
the investigative site to AMO.  Requests for data clarification will be handled through this 
same system.   
To minimize data omissions and inconsistencies on clinical reports and to ensure that 
data are accurately transcribed to computer data files, AMO will follow internal data 
processing procedures that include automated and manual quality control checks to 
identify any data discrepancies.  Any such items will be resolved and documented as 
needed on the case report forms at the investigative site and in the data management 
system at AMO. 
Prevention of Missing Data 
Methods used to safeguard against missing data that can have deleterious effects on the 
study integrity and reliability of its outcomes will include training study staff with WebEx 
and on-site programs.  In addition, subjects will be encouraged at the time of informed 
consent to avoid missing study visits, as missing data may affect the study reliability and 
diminish the scientific value of their contribution to the study.  
 
ADMINISTRATIVE MONITORING 
15.2
Administrative monitoring procedures will ensure that study OVDs, subjects, and forms 
can be traced and will allow monitoring of investigator progress and compliance.  
Accountability and traceability of study OVDs will be monitored by AMO personnel.  
Device Accountability 
Complete OVD accountability will be maintained at the investigative site by maintaining 
records of all OVDs received from and returned to AMO.  A site log will be used to track 
OVDs for date of receipt, use and disposition/return to AMO.  This site log and any other 
OVD information will be maintained in the operative room study binder and monitored by 
AMO personnel.  During periodic site monitoring visits, AMO personnel will review 

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inventory records and logs to ensure OVD accountability compliance and complete OVD 
traceability.   
Site Monitoring Plan 
Prior to performing any study surgeries, the requirements of the study and reporting 
mechanisms will be explained to each investigator either personally at the investigative 
site or at a formal study investigator meeting.  When necessary, a pre-study site 
qualification visit may be performed to assess the adequacy of the site to perform the 
study for sites that have not previously worked with AMO or have undergone significant 
changes, or have not been visited in the past year.  A study initiation visit will be 
conducted for all sites prior to or at the time of the first study surgery.  
Throughout the duration of the study, site visits to monitor compliance to this protocol will 
be made at each site.  During a routine site monitoring visit, AMO will review informed 
consent documents and subject eligibility, and the data on study case report forms will 
be verified against subject charts and other source documents to ensure complete and 
accurate reporting.  The subject files will also be reviewed to assure that all adverse 
events and any issues encountered with AMO products have been reported in a timely 
fashion.   
AMO will also review source documents to verify that all required items have been 
documented in the subject medical charts.  Refer to Section 14.1, Source Documents, 
for a list of items that are required for source documentation.  Upon study completion, a 
final close-out site visit to each site will be made to monitor the last of the subject data 
records and finalize any outstanding study issues.  
A separate Study Monitoring Plan will be established prior to study start that will define 
the type and frequency of monitoring visits and frequency of record monitoring.  
 
SAFETY MONITORING 
15.3
This study will use a Data Safety Monitoring Board (DSMB) for safety monitoring.  In 
alignment with ISO 14155:2011(E), the DSMB is an independent committee that is 
established by AMO to assess, at intervals, the progress of the clinical investigation, the 
safety data, or the critical performance endpoints, and to recommend to the sponsor 
whether to continue, suspend, or stop the clinical investigation.  The DSMB will have 
access to the randomization code to be able to assess safety by OVD group if required.  
The responsibilities of the DSMB will be detailed in a separate written procedure to 
establish the frequency of meetings, handling of emergency situations and 
documentation of such meetings.  
This study will also utilize a Medical Monitor for safety monitoring.  The Medical Monitor 
will remain masked until the final study visits have been completed.  The Medical 

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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.  If 
necessary, the medical monitor will discuss these events with the reporting 
investigator(s), without being specific about OVD type.  If unmasking is required by the 
Medical  Monitor to protect the safety of the subject(s), a request will be submitted and 
approved by Head of Clinical Research and Head of Biostatistics prior to release of the 
randomization code for only the subject(s) involved, and the IRB will be notified. The 
medical monitor will also be available to answer all questions from investigators. The 
medical monitor, as well as any other qualified personnel designated by AMO, shall also 
review interim progress reports, as applicable. 
16. 
PUBLICATIONS 
Refer to the Clinical Trial Agreement for information regarding AMO publication policies. 
17. 
RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
RISKS OF THE BACTERIALLY-DERIVED HEALON5 OVD 
The bacterially-derived Healon5 OVD is intended for use in anterior segment ophthalmic 
surgical procedures of the human eye. Like the non-investigational, animal-derived 
Healon5 OVD, the bacterially-derived Healon5 OVD is designed to create and maintain 
a deep anterior chamber which facilitates manipulation inside the eye with reduced 
trauma to the corneal endothelium and other ocular tissues. The Healon5 OVD can also 
be used to efficiently separate and control ocular tissues. The Healon5 OVD is not 
designed to have any pharmacological effect.   
Complete removal of the Healon5 OVD (both bacterial-and animal-derived) is important 
to avoid intraocular pressure peaks (or spikes) postoperatively. Due to the greater 
concentration of sodium hyaluronate in the Healon5 OVD, the rise in IOP may be higher 
with the Healon5 OVD (either bacterial-or animal-derived) than if the same volume of 
other sodium hyaluronate viscoelastic products, with lower zero-sheer viscosity, is left in 
the anterior chamber of the eye.  Long-term risks of IOP spikes include secondary 
glaucoma, visual field loss and optic nerve damage. 
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.   

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ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
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33 
    PR/VSCO-109-HLN5 
(i.e., missing postoperative data), data imputation will be performed using MCMC 
multiple imputation techniques1.  Per-protocol and sensitivity analyses (e.g., worst-case, 
best-case and tipping-point analysis) will also be provided for the primary IOP and ECC 
endpoints.  Sensitivity analyses will include all randomized subjects whether a study 
OVD was used or not.  The safety population (SP) will include available subjects who 
had one or both study OVDs with available data at the time of analysis (i.e., no data 
imputation).  Only the safety population will be used for analyses of secondary safety 
endpoints and other endpoints.  For the secondary safety endpoints, no multiplicity or 
imputation will be done since they are considered safety endpoints and are not intended 
for claims.  Only safety population (SP) will be used for the secondary safety endpoints. 
 
STUDY ENDPOINTS 
20.2
Primary Endpoints 
SAFETY: CUMULATIVE RATE OF IOP SPIKES 30 MMHG OR GREATER MEASURED 
POSTOPERATIVELY  
The cumulative frequency and proportion of eyes with an IOP spike will be reported for 
both OVD groups for safety population, PP population and sensitivity analysis.  For ITT 
(with data imputation), only the difference between the OVD groups will be reported.  
The difference in the cumulative IOP spike rate will be analyzed by the McNemar test 
using a GLIMMIX procedure taking into account the paired data.  The GLIMMIX model 
will model spike as the dependent variable and OVD group as an independent variable 
and include the SUBJECT = option for the paired eye data. The hypothesis testing of 
non-inferiority for cumulative percentage of IOP spikes will be tested using a 1-sided, 
McNemar test at an alpha of 0.025 with a delta of 0.10 (10%).  The null hypothesis is 
that the paired difference between eyes is less than or equal to -10%.  The alternative 
hypothesis is that the paired difference between eyes is greater than -10%.  
Ho: pc – pt ≤ δ 
Ha: pc – pt > δ 
where… 
pt = Test rate of IOP spikes 30 mm Hg or greater                                                                                        
pc = Control rate of IOP spikes 30 mm Hg or greater 
δ  = non-inferiority margin: -10% 
 
Success Criteria: If the lower 2-sided 95% confidence interval (equivalent to the 1-sided 
97.5% CI) for the difference between the proportions is greater than -10% 2.   
EFFECTIVENESS: MEAN PERCENT ECC CHANGE PREOPERATIVLEY VS. 
POSTOPERATIVELY  
The mean percent change in ECC from preoperative to 3 months postoperative will be 
reported by descriptive statistics for both OVD groups for safety population, PP 

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0 
34 
    PR/VSCO-109-HLN5 
population and sensitivity analysis.  For ITT (with data imputation), only the mean 
difference between the two OVD groups will be reported.  The percent change in ECC 
from preoperative to postoperative is calculated as followed: 
Percent change in ECC = (Postop ECC minus Preop ECC)/Preop ECC  
The difference in mean percent change in ECC will be analyzed by a paired t-test.  The 
hypothesis testing of non-inferiority for mean percent ECC change will be tested using a 
1-sided, paired t-test at an alpha of 0.025 and a delta of 5%.  The null hypothesis is that 
the paired mean difference for mean percent change in ECC is equal to or less than  
-5%.  The alternative hypothesis is that the paired mean difference in percent change 
between eyes is greater than -5%.  
Ho: µtest – µcontrol ≤ δ 
Ha: µtest – µcontrol > δ 
where… 
µtest = ECC percent change in test OVD  
µcontrol = ECC percent change in control OVD 
δ  = non-inferiority margin: -5% 
 
Success Criteria: If the lower 2-sided 95% confidence interval (equivalent to 1-sided 
97.5% CI) for the mean difference between eyes in percent change for ECC is greater 
than -5%.    
If the distribution of the percent ECC change does not meet the normality assumption, a 
non-parametric test will be performed to evaluate the non-inferiority of ECC endpoint.  A 
similar alpha level of 0.025 and a delta of 5% will be used for the 1-sided non-parametric 
test. 
In addition, ECC for preoperative, 3 months postoperative and the difference between 
preoperative and 3 months will also be reported as supportive data using the safety 
population. 
Secondary Safety Endpoints 
Serious and/or device-related adverse events will be tabulated with the frequency and 
proportion of eyes with these events reported over time for both OVD groups.  The 
adverse event rates will be compared to the ISO SPE rates.  Comparison of the ISO 
SPE rates will be performed using an exact test based on the binomial distribution.  The 
null hypothesis is that the study rate for test OVD is equal or lower than the ISO SPE 
rate, and the alternative hypothesis is that the study rate for test OVD is greater than the 
ISO SPE rate.   

ABBOTT MEDICAL OPTICS INC.  
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    PR/VSCO-109-HLN5 
The grades of inflammation (for epithelial and stromal edema, cells and flare, anterior 
and posterior synechiae, and fibrin presence) will be tabulated with the frequency and 
proportion of eyes with each grading for each event over time and cumulatively will be 
presented for both OVD groups.   
For the percentage of IOP spikes at 6 hours, 1 day, 1 week, 1 month and 3 months 
postoperatively, a 1-sided, McNemar test of non-inferiority of proportions will be 
performed at an alpha of 0.025 with a delta of 0.10 (10%).  This analysis is similar to the 
approach used for the primary endpoint of cumulative percentage of IOP spikes. 
The change in IOP from baseline will be presented by descriptive statistics for the 
6-hour, 1-day, 1-week, 1-month and 3-month postoperative time points by OVD group.   
Other endpoints, optical/visual symptoms (non-directed) and medical findings/adverse 
events (non-serious, non-device-related) will be tabulated with frequency and proportion 
over time and cumulatively by OVD group.   
The frequency and proportion of monocular BCDVA will be reported over time by visual 
acuity line.  Monocular BCDVA percent 20/40 or better will also be compared to ISO 
SPE rate. 
The frequency and proportion of monocular UCDVA at 1 day will be reported by visual 
acuity line.    
 
GENERAL STATISTICS 
20.3
Descriptive statistics will typically include sample size (N), mean, standard deviation 
(SD), minimum (Min) and maximum (Max) as appropriate for continuous variables.  For 
dichotomous variables, the frequency and proportion will be reported and McNemar’s 
test will be applied.  For continuous variables, statistical tests (paired t-test) assuming 
normality will generally be used.  For ordinal categorical data, the frequency and 
proportion will be reported and Wilcoxon signed-rank test will generally be applied.   
 
INTERIM REPORTS 
20.4
Due to the short duration of this study, no interim study reports are anticipated. However, 
should a progress report be required for regulatory purposes (e.g., FDA progress report), 
all masking will be maintained.  If any interim analyses need be performed for product 
registration or release in other countries that require unmasking and reporting of 
effectiveness outcomes, they will be conducted by an independent body to avoid bias.  
Interim reports will not be disseminated to investigators/site personnel or to AMO staff 
working directly with study sites and monitoring incoming data. 

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
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36 
    PR/VSCO-109-HLN5 
 
SAMPLE SIZE CALCULATIONS 
20.5
Cumulative IOP spikes are defined as an IOP of 30 mm Hg or greater at any visit.  The 
percentage of eyes with IOP spikes will be assumed to be 30% (15798:2001(E), 
Annex D), and a correlation of 0.5 (medium strength).  Using a one-sided, McNemar test 
and assuming an alpha of 0.025, power = 0.80, and a minimum detectable difference of 
δ=0.10 yields a sample size of n=195 eyes per group.  Adding 20% for lost-to-follow-up 
and screen failures yields a sample size of up to 241 enrolled subjects with the intent to 
approximately 230 subjects to ensure 200 evaluable subjects. 
Assuming a 1-sided, non-inferiority, paired t-test with alpha=0.025, a common standard 
deviation of  305 cells4, and a correlation of 0.50 (medium strength), a sample of n=195 
subjects (390 eyes) provides over 99% power to detect a minimum clinically significant 
decrease in mean Endothelial Cell Count (ECC) of at least δ =125 cells.  This 
corresponds to a 5% decrease using a standard deviation of 12% from a baseline ECC 
of 2500 cells. 
Since the sample size required to detect a minimum clinically significant effect for IOP 
spikes also provides over 99% power to detect a minimum clinically significant effect for 
ECC loss, the sample size for the study will be based on the number calculated for IOP 
spikes.  Therefore, the sample size required is 195 subjects. Adding 20% for lost-to-
follow-up and screen failures yields a sample size of 241 subjects (482 eyes).  
21. 
REFERENCES 
1. Little, R. and Rubin, D. Statistical Analysis with Missing Data, John Wiley & Son, 
Inc. New York, Second Edition, (2002) 
2. Liesegang TJ.  Viscoelastic substances in ophthalmology.  Surv ophthalmol 1990; 
34:268-293 
3. Colin J, et al. Comparative clinical trial of AMO Vitrax and Healon use in 
extracapsular cataract extraction.  J Cataract Refract Surg 1995 Mar; 21(2):196-201 
4. Nichols JJ, Kosunick M, Bullimore MA. Reliability of Corneal Thickness and 
Endothelial Cell Density Measures.  J Cataract Refract Surg 2003 ;19:344-352 
 

ABBOTT MEDICAL OPTICS INC. 
 
CONFIDENTIAL 
Version 4.0                                                                                                        37                                                                                                  PR/VSCO-109-HLN5 
APPENDIX A   SUMMARY OF PROCEDURES REQUIRED AT EACH VISIT 
Examination 
Preop 
Both 
Eyes 
Op 1 
1st Eye 
6 hrs
1st  
Eye 
1 day 
1st Eye 
1 wk 
1st 
Eye 
Op 2 
2nd 
Eye 
6 hrs
1st 
Eye 
1 day 
2nd 
Eye 
1 wk 
2nd 
Eye 
1 mo 
Both  
Eyes 
3 mo 
Both 
Eyes 
Ocular history, inclusion/exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
Potential visual acuity 
X 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
Lens power/serial number/operative 
procedures 
 
X 
 
 
 
X 
 
 
 
 
 
UCDVA – photopic, monocular (Snellen) 
 
 
 
X 
 
 
 
X 
 
 
 
BCDVA - photopic, monocular (Snellen) 
X 
 
 
 
X 
 
 
 
X 
X 
X 
Intraocular pressure (Goldmann) 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
Endothelial cell count 
X 
 
 
 
 
 
 
 
 
 
X 
Biomicroscopic slit-lamp exama
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
Dilated fundus exam
X 
 
 
 
 
 
 
 
 
 
Xb 
Adverse events 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Ocular medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Ocular/visual symptoms (non-directed) 
 
 
 
X 
X 
 
 
X 
X 
X 
X 
a Includes determination of medical and lens findings/complications 
b Only if medically indicated 
 

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ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0                                                              39                                                    PR/VSCO-109-HLN5 
APPENDIX C   ENDOTHELIAL CELL COUNTS 
Endothelial cell counts (ECC) will be performed with a Konan non-contact specular 
microscope capable of capturing ECC images electronically at both the preoperative and 
the 3-month visits.  Three acceptable images should be taken at each of these two visits. 
If possible; throughout the study the same technician/photographer at each site should 
take all the images.   
A Konan technician will work directly with each study site to ensure proper calibration of 
the specular microscope and train/retrain appropriate site staff on the proper technique 
for capturing quality images. Prior to study initiation, each site must submit two sample 
images to the central reading center (EyeKor, Inc.) to ensure good quality images with 
clearly defined endothelial cells.  
For preoperative subject qualification, the study technician should record the lowest of 
the three ECC values on the case report form for each eye.  If the lowest value for either 
eye is below 1800 cells/mm2, the subject should not be enrolled.  
 
Throughout the course of the study, sites are to send all study images directly to the 
central reading center for analysis. The preoperative and three-month postoperative 
images will be sent to EyeKor using EXCELSIOR software without any indication of the 
treatment group 
 
Analyses will be performed using the mean of the three images for each subject at each 
time point.   
 
 

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0                                                              40                                                    PR/VSCO-109-HLN5 
APPENDIX D   SLIT-LAMP EXAM RATINGS 
A.  Ratings of Aqueous Cells and Flare 
For consistency across study sites, the SUN (Standardization of Uveitis Nomenclature) 
Working Group Grading Scheme is to be used for grading of anterior chamber cells and 
flare as reported in: Standardization of uveitis nomenclature for reporting clinical data.  
Results of the first international workshop; The standardization of uveitis nomenclature 
(SUN) working group,  Am J Ophthalmol 2005;140:509-516. 
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 discernable localized epithelial or sub-epithelial haziness, and/or 
b. 1 to 20 microcysts, and/or 
c. Barely discernable 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 
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) 

ABBOTT MEDICAL OPTICS INC.  
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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 Elschnig’s pearls 
and fibrous scarring.  Red reflex barely visible. 
 
 
 

ABBOTT MEDICAL OPTICS INC.  
CONFIDENTIAL 
Version 4.0                                                              42                                                    PR/VSCO-109-HLN5 
APPENDIX E   ADVERSE EVENT AND COMPLAINT REPORTING 
INSTRUCTIONS 
All adverse events and complaints related to using AMO products must be reported to 
AMO.   
ALL ADVERSE EVENTS AND COMPLAINTS: 
For events that are not considered serious or related to the study device: 
1. Record the event and/or complaint on the case report form that corresponds to 
the visit during which awareness of the event occurred.  Additionally, a complaint 
may be reported via a telephone call to AMO. 
2. Send the completed case report form to AMO in a timely manner 
SERIOUS ADVERSE EVENTS OR DEVICE DEFICIENCIES THAT MAY HAVE LED TO 
A SERIOUS EVENT 
In the event of a serious event (i.e., life- or sight-threatening incident) whether or not 
related to the device, or a device deficiency that may have led to a serious event, the 
investigator shall: 
1. Notify AMO immediately (no more than 48 hours after learning of the event) as 
follows:  
a. Contact the following AMO personnel by phone and/or email: 
Cheryl Harper 
Mobile: 913-396-3276 
cheryl.harper@abbott.com 
 
Debbie Trentacost 
Mobile: 714-679-9179 
Office: 714-247-8625 
debbie.trentacost@abbott.com 
 
b. Submit an SAE/ADE Detailed Page to AMO  
 
 
NON-SERIOUS, DEVICE-RELATED EVENTS: 
For events that are not considered serious but are believed related to the study device 
(ADEs): 
1. Complete an SAE/ADE Detailed Page  
2. Ensure the data are submitted to AMO within a timely manner.