Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses
Conditions: Corneal Astigmatism
Sponsor: Bausch & Lomb Incorporated

Bausch Health 
Protocol BHC-RCR-001 
CONFIDENTIAL 
v.2.0; 13-Jan-2022
Page 1 of 9 
Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses 
Retrospective Chart Review 
Protocol:   BHC-RCR-001 
Version:   v.2.0 
Date:   13-Jan-2022 
Study Sponsor 
Bausch Health 
400 Somerset Corporate Blvd. 
Bridgewater, New Jersey 08807 
Clinical Research Organization 
ethica CRO Inc. 
3551 St. Charles Blvd, Suite 501 
Kirkland, Quebec H9H 3C4 
Confidentiality Statement 
The information contained in this document is provided in confidence. It is 
understood that this information will not be disclosed to others without prior 
agreement with the Sponsor, except to other study personnel and to the extent 
necessary to obtain informed consent from participating subject. 

Bausch Health 
 
Protocol BHC-RCR-001 
CONFIDENTIAL 
v.2.0; 13-Jan-2022 
 
Page 3 of 9  
2 
INVESTIGATOR SIGNATURE PAGE 
 
I agree to: 
• Implement and conduct this study diligently and in strict compliance with the protocol, good 
clinical practices and all applicable laws and regulations. 
• Maintain all information supplied by Bausch Health in confidence and, when this information 
is submitted to an Institutional Review Board (IRB) or another 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. 
 
 
 
 
 
 
 
 
Principal Investigator (Printed Name)  
Signature 
 
Date 
 
 
 
 

Bausch Health 
 
Protocol BHC-RCR-001 
CONFIDENTIAL 
v.2.0; 13-Jan-2022 
 
Page 4 of 9  
  
3 
TABLE OF CONTENTS 
 
1 
PROTOCOL APPROVAL SIGNATURE PAGE ........................................................................................... 2 
2 
INVESTIGATOR SIGNATURE PAGE .......................................................................................................... 3 
3 
TABLE OF CONTENTS ................................................................................................................................... 4 
4 
BACKGROUND AND STUDY RATIONALE ............................................................................................... 5 
5 
STUDY OBJECTIVES ...................................................................................................................................... 5 
6 
STUDY DESIGN AND METHODS ................................................................................................................. 5 
6.1 
GENERAL STUDY DESIGN ............................................................................................................................ 5 
6.1.1 
Total Number of Subjects ...................................................................................................................... 5 
6.2 
STUDY POPULATION .................................................................................................................................... 5 
6.2.1 
Inclusion Criteria .................................................................................................................................... 5 
6.2.2 
Exclusion Criteria ................................................................................................................................... 6 
7 
STUDY PROCEDURES .................................................................................................................................... 6 
7.1 
DATE RANGE OF THE STUDY ........................................................................................................................ 6 
7.2 
SUBJECT SELECTION .................................................................................................................................... 6 
7.3 
DATA SOURCES ............................................................................................................................................ 6 
7.4 
VARIABLE ABSTRACTION ............................................................................................................................ 6 
8 
STATISTICS ....................................................................................................................................................... 6 
8.1 
PRIMARY EFFECTIVENESS ENDPOINT .......................................................................................................... 6 
8.2 
HYPOTHESES ................................................................................................................................................ 6 
8.3 
STATISTICAL METHODS ............................................................................................................................... 7 
8.4 
SAMPLE SIZE AND POWER ........................................................................................................................... 7 
9 
STUDY ADMINISTRATION ........................................................................................................................... 7 
9.1 
DATA COLLECTION AND MANAGEMENT ..................................................................................................... 7 
9.2 
CONFIDENTIALITY ....................................................................................................................................... 8 
9.3 
RECORDS RETENTION .................................................................................................................................. 8 
9.4 
INFORMED CONSENT .................................................................................................................................... 8 
9.4.1 
Waiver of Consent .................................................................................................................................. 8 
10 
STUDY FINANCES ........................................................................................................................................... 8 
10.1 
FUNDING SOURCE ........................................................................................................................................ 8 
11 
STUDY REPORTABLE EVENTS ................................................................................................................... 9 
11.1 
REPORTABLE EVENTS .................................................................................................................................. 9 
12 
PUBLICATION PLAN ...................................................................................................................................... 9 
 
 

Bausch Health 
 
Protocol BHC-RCR-001 
CONFIDENTIAL 
v.2.0; 13-Jan-2022 
 
Page 5 of 9  
4 
Background and Study Rationale 
Mild amounts of corneal astigmatism are often corrected at the time of cataract surgery with limbal 
relaxing incisions (LRIs), on-axis incisions or with low-cylinder powered toric IOLs. Leon P. et. 
al has shown that results from LRIs and toric IOLs significantly decreased refractive astigmatism, 
but Toric IOLs were more effective and predictable when compared to LRIs.  One IOL available 
in Canada for the correction of mild corneal astigmatism is the enVista Toric IOL. The lowest 
available cylinder power for enVista Toric IOL is 0.9D.  The goal of this retrospective study is to 
gain a better understanding of the postoperative outcomes in patients implanted with a low-
cylinder powered toric IOL (enVista Toric 0.9D) vs non-toric IOLs (enVista). 
5 
Study Objectives 
The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs the 
enVista non-Toric IOL. 
6 
Study Design and Methods 
6.1 General Study Design 
The performance of the enVista Toric IOL will be compared with that of the enVista non-Toric 
(spherical) IOL. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be 
investigated. 
This is a retrospective chart review for preoperative and postoperative data conducted at least 4 
weeks after IOL implantation. 
6.1.1 Total Number of Subjects 
The study will enroll at least 384 eyes presenting with at least 192 enVista Toric 0.9D IOLs and 
192 enVista non-Toric (spherical) IOLs. 
It is expected that the medical records of approximately 600 subjects will need to be evaluated in 
order to identify the required 384 eyes that are eligible for inclusion in this study. 
6.2 Study Population 
 
6.2.1 Inclusion Criteria 
• Males and Females subjects age 18 or older on the date of the surgery 
• Implant of enVista 0.9D Toric IOL or enVista non-Toric (spherical) IOL in at least one eye 
• Data available at least 4 weeks after IOL implantation 
• Eyes must qualify for the 0.9D toric lens based on the Barrett Toric Calculator (flipped 
axis must be less than 0.2D) (https://ascrs.org/tools/barrett-toric-calculator) 
o Study eyes were implanted with the 0.9D toric lens 
o Control eyes were not implanted with the 0.9D toric lens and implanted with a 
spherical (non-toric) equivalent instead  
 

Bausch Health 
 
Protocol BHC-RCR-001 
CONFIDENTIAL 
v.2.0; 13-Jan-2022 
 
Page 6 of 9  
6.2.2 Exclusion Criteria  
• History of uncontrolled or clinically significant ocular comorbidities for the treated eye(s) 
before the surgery (e.g., dry eyes, retinal pathology, etc.) 
• BCDVA of 20/25 or worse for the treated eye(s) after the surgery 
• Excessive IOL rotation > 10 degrees (Toric IOLs only) for the treated eye(s) after the 
surgery 
7 
Study Procedures  
7.1 Date Range of the study 
Cases will be included in the study if they received an initial enVista IOL on or after 01-Sep-2018. 
7.2 Subject Selection 
Eligibility will be determined and confirmed at each site by the site Investigator. 
7.3 Data Sources 
Sources of data include paper medical records and/or EMR systems. Such medical records and 
systems will be used in order to identify participants who match study defined eligibility criteria.  
7.4 Variable Abstraction 
The following clinical endpoints to be collected from subject’s medical records: 
• Subject Demographics and Medical History 
– Include lens calculation data: IOL power selected, predicted residual spherical 
equivalent refraction, surgically induced astigmatism (SIA), incision angle. 
– If toric IOL: Also include predicted residual cylinder and axis, target axis of placement, 
and actual axis of placement 
• Keratometry (K steep/K flat with axis): Preoperative and Postoperative 
• Manifest Refraction (sphere/cylinder/axis): Preoperative and Postoperative 
• UCDVA: Preoperative and Postoperative 
• BCDVA: Preoperative and Postoperative 
• IOL Rotation: If available, also include actual vs. target (Toric IOLs only) 
• The presence of any device related adverse events. 
8 
Statistics 
8.1 Primary Effectiveness Endpoint 
The primary effectiveness endpoint is the mean reduction in cylindrical power of the eye. 
Reduction in the cylindrical power of the eye is defined as the difference between the magnitudes 
of the preoperative keratometric cylinder and the residual refractive cylinder (referenced to the 
corneal plane). 
8.2 Hypotheses 
The null hypothesis (𝐻!) is that the mean reduction in cylindrical power of the eye for the toric 
group (𝜇") is less than or equal to the mean for the sphere control group (𝜇#). The alternative 
hypothesis (𝐻$) is that the mean reduction in cylindrical power of the eye for the toric IOL group 
is greater than the mean for the control group. 
 

Bausch Health 
 
Protocol BHC-RCR-001 
CONFIDENTIAL 
v.2.0; 13-Jan-2022 
 
Page 7 of 9  
𝐻!: 𝜇" ≤𝜇# 
𝐻$: 𝜇" > 𝜇# 
 
8.3 Statistical Methods 
Continuous variables will be summarized by treatment using the sample size, mean, standard 
deviation, minimum, and maximum. Categorical variables will be summarized by treatment using 
frequencies and percentages. Missing data will not be imputed. 
 
The preoperative keratometric cylinder (D) will be calculated as the difference between the 
preoperative steep and flat keratometric powers (both in diopters). The postoperative manifest 
refraction cylinder (PMRC) will be referenced to the corneal plane assuming a vertex distance of 
13 mm as follows. 
 
𝑃𝑀𝑅𝐶
&
1000(𝑆𝑝ℎ+ 𝐶𝑦𝑙)
1000
13 (𝑆𝑝ℎ+ 𝐶𝑦𝑙)
1000 𝑆𝑝ℎ
1000
13 𝑆𝑝ℎ& 
 
Where:  
• PMRC = the postoperative manifest refractive cylinder at the corneal plane (D) 
• Sph = the postoperative manifest refraction sphere at the spectacle plane (D) 
• Cyl = the postoperative manifest refraction cylinder at the spectacle plane (D) 
 
Reduction in the cylindrical power of the eye (D) will be computed as the preoperative 
keratometric cylinder minus the PMRC and summarized using continuous summary statistics by 
treatment. The statistical hypotheses will be tested using a two-sample t-test assuming unequal 
variances. If the one-sided p-value is less than 0.025 (or, equivalently, the two-sided p-value is 
less than 0.05 and the treatment difference is greater than zero), then the null hypothesis will be 
rejected and the toric IOL will be statistically successful in this outcome. A two-sided 95% 
confidence interval around the treatment difference will be reported. 
8.4 Sample Size and Power 
 A sample size of 192 eyes in each group will have 90% power to detect a difference in means of 
0.25 D assuming that the common standard deviation is 0.753 D using a two-group Satterthwaite 
t-test with a 2.5% one-sided significance level. 
9 
Study Administration 
9.1 Data Collection and Management  
Paper source document worksheets will be created to capture all study related data. Data recorded 
in these worksheets will be entered into an electronic Case Report Form (Dacima eCRF) by 
qualified site personnel. 
Access to the eCRF will be password restricted to designated and appropriately trained site 
personnel. 
Subject identifiers will not be entered into the eCRF. Subjects will be identified by a subject 
number that will be sequentially assigned to each eligible medical record (i.e., subject).  

Bausch Health 
 
Protocol BHC-RCR-001 
CONFIDENTIAL 
v.2.0; 13-Jan-2022 
 
Page 8 of 9  
9.2 Confidentiality 
All data and records generated throughout the course of the study will be kept confidential in 
alignment with local, provincial and federal policies and the site personnel will be the only ones 
to have access to the study data and records for the purposes of conducting the study. 
All data will be stored within a password protected electronic data capture system which is secured 
by a firewall. Paper copies of data will be limited in nature to only copies of charts which were not 
available in EMR systems. These documents will be stored in a locked filing cabinet, the key to 
which will remain with the PI and designated CRC. 
9.3 Records Retention 
Essential documents (including but not limited to study-related correspondence [including emails], 
subject records, subject privacy documentation, and copies of eCRFs should be retained and 
available for audit by the Sponsor’s auditor and regulatory authorities until at least 2 years after 
completion or termination of the study. These documents should be retained for a longer period, 
however, if mandated by the applicable regulatory requirements, by conditions imposed by the 
IRB, or by an agreement with the Sponsor. It is the responsibility of the Sponsor to inform the PI 
when these documents no longer need to be retained.  
The Sponsor must be notified in writing if the PI chooses to store the records at a different physical 
address than the site address or if the PI wishes to relinquish ownership of the data so that mutually 
agreed-upon arrangements can be made for transfer of ownership to a suitably qualified, 
responsible person. 
Any and all linkage to subject identifiers will be destroyed after data have been cleaned and 
analyzed. 
9.4 Informed Consent  
9.4.1 Waiver of Consent 
A waiver of informed consent may be applicable as per the following: 
• the research involves no more than minimal risk to the subjects; 
• the waiver or alteration will not adversely affect the rights and welfare of the subjects; 
• the research could not practicably be carried out without the waiver or alteration; and 
• whenever appropriate, the subjects will be provided with additional pertinent information 
after participation. 
10 Study Finances 
10.1 Funding Source 
A separate financial agreement (Clinical Study Agreement) will be made between the Sponsor and 
the PI at each site. 
The study is covered under a Bausch Health liability insurance policy. The certificate of insurance 
will be provided upon request. 

Bausch Health 
 
Protocol BHC-RCR-001 
CONFIDENTIAL 
v.2.0; 13-Jan-2022 
 
Page 9 of 9  
11 Study Reportable Events 
11.1 Reportable Events  
Any breach or suspected breach of confidentiality will be considered to be a reportable event and 
will be reported to the IRB as it poses a risk to subjects who participated in the study.  
12 Publication Plan 
Bausch Health, as the Sponsor, has a proprietary interest in this study. Authorship and manuscript 
composition will reflect joint cooperation among multiple PIs and sites and Bausch Health 
personnel. Authorship will be established prior to the writing of the manuscript. As this study 
involves multiple sites, no individual publications will be allowed prior to completion of the final 
report of the multicenter study except as agreed with Bausch Health. 
All information, including but not limited to information regarding the intraocular lenses or the 
Sponsor’s operations supplied by the Sponsor to the PI and not previously published, along with 
any data generated as a result of this study are considered confidential and remain the sole property 
of the Sponsor. The PI agrees to maintain this information in confidence and will use the 
information only to perform the study. 
The Sponsor or its designate is responsible for preparing a clinical study report. 
The Sponsor or its designate is responsible for publicly registering this study on 
http://www.clinicaltrials.gov prior to initiating enrolment.