Next Generation Cataract Surgery Study
Phase: NA
Conditions: Cataract
Sponsor: Alcon Research

 
 
 
 
 
Next Generation Cataract Surgery Study 
 
 
STUDY ID  
CTV678-E002 
 
 
PROTOCOL 
 
 
NCT06071104 

Document ID: 
V-CLN-0040413 
Status: Approved, Version: 1.0 
Approved Date: 08 Aug 2023 
Page 1 of 58 
 
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Device Protocol for CTV678-E002 
Title: Next Generation Cataract Surgery Study 
Protocol Number: 
CTV678-E002 
Clinical Investigation 
Type:  
Traditional Feasibility  
Test Product: 
UNITY™ Vitreoretinal Cataract System (VCS) 
Sponsor Name and 
Address: 
Alcon Research, LLC, and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
 
 
 
 
  
 
 
 
 
 
Property of Alcon 
Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of Alcon 

Document ID: 
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Status: Approved, Version: 1.0 
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Investigator Agreement: 
• 
I have read the clinical study described herein, recognize its confidentiality, and 
agree to conduct the described trial in compliance with Good Clinical Practices; 
applicable international and national regulations, laws, guidelines, and standards; the 
conditions of approval imposed by the reviewing IRB or regulatory authority; and in 
accordance with the ethical medical research principles outlined in the Declaration 
of Helsinki.  
• 
I will supervise all testing of the device involving human subjects and ensure that 
the requirements relating to obtaining informed consent and IRB review and 
approval are met in accordance with applicable local and governmental regulations. 
• 
I have read and understand the appropriate use of the investigational product(s) as 
described in the protocol, current investigator’s brochure, product information, or 
other sources provided by the sponsor. 
• 
I understand the potential risks and side effects of the investigational product(s). 
• 
I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection. 
• 
I agree to comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements of the sponsor and government 
agencies. 
• 
I agree to ensure that all associates, colleagues, and employees assisting in the 
conduct of the study are informed of their obligations in meeting the above 
commitments. 
Have you ever been disqualified as an investigator by any Regulatory Authority? 
 No        Yes 
Have you ever been involved in a study or other research that was terminated? 
 No        Yes 
If yes, please explain here: 
Principal investigator: 
 
Signature 
 
 
 
 
 
Date 
Name and professional 
position: 
 
Address: 
Phone Number:  
Off-hours Emergency 
Phone Number: 
 

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Table of Contents 
Device Protocol for CTV678-E002 ........................................................................................... 1 
Table of Contents ....................................................................................................................... 3 
List of Tables .............................................................................................................................. 6 
List of Figures ............................................................................................................................ 6 
1 
GLOSSARY OF TERMS .................................................................................................... 7 
2 
LIST OF ACRONYMS AND ABBREVIATIONS ........................................................... 12 
3 
PROTOCOL SUMMARY ................................................................................................. 14 
4 
PROTOCOL AMENDMENTS ......................................................................................... 22 
5 
INTRODUCTION ............................................................................................................. 22 
5.1 
Rationale and Background ................................................................................. 22 
5.2 
Purpose of the Study .......................................................................................... 24 
5.3 
Risks and Benefits ............................................................................................. 24 
6 
STUDY OBJECTIVES...................................................................................................... 27 
6.1 
Primary Objective(s) .......................................................................................... 27 
6.2 
Secondary Objective(s) ...................................................................................... 27 
 
 
6.4 
Safety Objective(s) ............................................................................................ 27 
7 
INVESTIGATIONAL PLAN ............................................................................................ 28 
7.1 
Study Design...................................................................................................... 28 
7.2 
Rationale for Study Design................................................................................ 29 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations ........................................................................................ 29 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 29 
7.4 
Rationale for Choice of Comparator Product .................................................... 29 
7.5 
Data Monitoring Committee .............................................................................. 30 
8 
STUDY POPULATION .................................................................................................... 30 
8.1 
Inclusion Criteria ............................................................................................... 30 
8.2 
Exclusion Criteria .............................................................................................. 31 
8.3 
Rescreening of Subjects ..................................................................................... 32 
9 
TREATMENTS ADMINISTERED................................................................................... 32 

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9.1 
Investigational Product(s) .................................................................................. 32 
 
 
9.3 
Treatment Assignment / Randomization ........................................................... 35 
9.4 
Treatment masking ............................................................................................ 35 
9.5 
Accountability Procedures ................................................................................. 35 
9.6 
Changes to concomitant medications, treatments/ procedures .......................... 36 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 36 
10.1 Informed Consent and Screening ...................................................................... 37 
10.2 Description of Study Procedures and Assessments ........................................... 37 
10.2.1 
Demographics .................................................................................... 37 
10.2.2 
Medical and Ocular History .............................................................. 37 
10.2.3 
Adverse Event Collection: Safety Assessment .................................. 38 
10.2.4 
Slit Lamp Biomicroscopy: Safety Assessment .................................. 38 
10.2.5 
Device Deficiencies: Safety Assessment ........................................... 38 
10.2.6 
Dilated Fundus: Safety Assessment ................................................... 38 
10.2.7 
Uncorrected Distance Visual Acuity: Safety Assessment .................. 38 
10.2.8 
Best Corrected Distance Visual Acuity: Safety Assessment ............. 39 
10.2.9 
Intraocular Pressure: Safety Assessment ........................................... 39 
10.2.10 Urine Pregnancy Test: Other Assessment .......................................... 39 
10.2.11 Keratometry: Eligibility Assessment ................................................. 39 
10.2.12 Pupil Size: Eligibility Assessment ..................................................... 39 
10.2.13 Biometry: Eligibility Assessment ...................................................... 39 
10.2.14 Assessment through the operating microscope: Other Assessment .. 39 
10.2.15 Time from incision entry to incision closure: Secondary 
Performance Assessment ................................................................... 39 
 
 
10.3 Unscheduled Visits ............................................................................................ 40 
10.4 Discontinued Subjects ....................................................................................... 41 
10.4.1 
Screen Failures .................................................................................. 41 
10.4.2 
Discontinuations ................................................................................ 41 
10.4.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ....................................... 42 
10.5 Clinical Study Termination ................................................................................ 42 
10.5.1 
Follow-up of subjects after study participation has ended ................ 42 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 43 

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11.1 General Information .......................................................................................... 43 
11.2 Monitoring for Adverse Events ......................................................................... 45 
11.3 Procedures for Recording and Reporting .......................................................... 46 
11.4 Return Product Analysis .................................................................................... 48 
11.5 Unmasking of the Study Treatment ................................................................... 48 
11.6 Follow-Up of Subjects with Adverse Events ..................................................... 48 
11.7 Pregnancy in the Clinical Study ........................................................................ 49 
12 ANALYSIS PLAN ............................................................................................................ 49 
12.1 Subject Evaluability ........................................................................................... 49 
12.2 Analysis Sets...................................................................................................... 49 
12.2.1 
All-Implanted Analysis Set ................................................................ 49 
12.2.2 
Safety Analysis Set ............................................................................ 49 
12.3 Demographic and Baseline Characteristics ....................................................... 49 
12.4 Effectiveness Analyses ...................................................................................... 50 
12.4.1 
Analysis of Primary Effectiveness Endpoint ..................................... 50 
12.4.1.1 
Statistical Hypotheses ........................................................ 50 
12.4.1.2 
Analysis Methods............................................................... 50 
12.4.2 
Analysis of Secondary Effectiveness Endpoints ............................... 50 
12.4.2.1 
Statistical Hypotheses ........................................................ 50 
12.4.2.2 
Analysis Methods............................................................... 50 
12.5 Handling of Missing Data .................................................................................. 50 
12.6 Safety Analyses.................................................................................................. 50 
12.6.1 
Analysis of Safety Endpoints ............................................................ 51 
12.6.1.1 
Statistical Hypotheses ........................................................ 51 
12.6.1.2 
Analysis Methods............................................................... 51 
12.7 Interim Analyses and Reporting ........................................................................ 51 
12.8 Sample Size Justification ................................................................................... 51 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 51 
13.1 Subject Confidentiality ...................................................................................... 51 
13.2 Completion of Source Documents and Case Report Forms .............................. 52 
13.3 Data Review and Clarifications ......................................................................... 53 
13.4 Sponsor and Monitoring Responsibilities.......................................................... 53 
13.5 Regulatory Documentation and Records Retention .......................................... 54 
13.6 Quality Assurance and Quality Control ............................................................. 54 

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14 ETHICS ............................................................................................................................. 55 
15 REFERENCES .................................................................................................................. 57 
15.1 Regulations and Standards................................................................................. 57 
15.2 Scientific and Other References ........................................................................ 57 
 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 12 
Table 3–1 
Schedule of Study Procedures and Assessments ............................................. 19 
Table 6–1 
Primary Objective ............................................................................................ 27 
Table 6–2 
Secondary Objective(s) .................................................................................... 27 
Table 6–3 
Safety Objective(s)........................................................................................... 27 
Table 9–1 
Test Product ..................................................................................................... 32 
 
List of Figures 
Figure 7-1 
Study Design Flow Chart ................................................................................. 28 
Figure 11-1 
Categorization of All Adverse Events .............................................................. 43 
 
 
 
 

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1 GLOSSARY OF TERMS 
Names of Test Product(s) 
Throughout this document, test product(s) will be referred to 
as the UNITY Vitreoretinal Cataract System (VCS). 
Name of Comparator 
Product(s) 
N/A 
Adverse Device Effect 
(ADE) 
 
Adverse event related to the use of an investigational 
medical device or comparator. 
Note: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation; any malfunction; 
and use error or intentional misuse.  
Adverse Event (AE) 
 
Untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not 
related to the investigational medical device or comparator 
and whether anticipated or unanticipated.  
Note: For subjects, this definition includes events related to 
the investigational medical device, comparator, or the 
procedures involved. For users or other persons, this 
definition is restricted to the use of the investigational 
medical device or comparator. 
Requirements for reporting Adverse Events in the study can 
be found in Section 11. 
Anticipated Serious 
Adverse Device Effect 
(ASADE) 
 
An effect which by its nature, incidence, severity, or 
outcome has been identified in the risk assessment. 

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Clinical Investigation Plan 
(CIP) 
 
The document(s) stating the rationale, objectives, design, 
and prespecified analysis, methodology, organization, 
monitoring, conduct, and record-keeping of the clinical 
investigation.  
Note: The protocol and other documents referenced in the 
protocol (for example, the Statistical Analysis Plan, the 
Manual of Procedures, the Deviations and Evaluability 
Plan, and the Protocol Monitoring Plan) comprise the CIP. 
Clinical Investigation 
Report (CIR) / Clinical 
Study Report 
The document describing the design, execution, statistical 
analysis, and results of a clinical investigation. The Clinical 
Investigation Report is synonymous with the Clinical Study 
Report. 
Device Deficiency 
 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, usability, safety, or 
performance.  
Note: This definition includes malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer 
including labelling related to the investigational medical 
device or the comparator. 
Requirements for reporting Device Deficiencies in the study 
can be found in Section 11. 
Enrolled Subject 
Any subject who signs an informed consent form for 
participation in the study. 
Point of Enrollment 
The time at which, following recruitment and before any 
clinical investigation-related procedures are undertaken, a 
subject signs and dates the informed consent form. 

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Interventional Clinical Trial  A pre- or post-market clinical investigation where the 
assignment of a subject to a particular medical device is 
decided in advance by a clinical investigation plan, or 
diagnostic or monitoring procedures requested in the CIP are 
in addition to those available as normal clinical practice and 
burden the subject. 
Investigational Product 
A preventative (vaccine), a therapeutic (drug or biologic), 
device, diagnostic, or palliative used as a test or comparator 
product in a clinical trial, including a product with a 
marketing authorization when used or assembled 
(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form. 
Malfunction 
 
Failure of an investigational medical device to perform in 
accordance with its intended purpose when used in 
accordance with the instructions for use or clinical 
investigation plan (CIP), or investigator’s brochure (IB). 
Nonserious Adverse Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 
Serious Adverse Device 
Effect (SADE) 
 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 

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Serious Adverse Event 
(SAE) 
 
Adverse event that led to any of the following:  
• 
Death. 
• 
A serious deterioration in the health of the subject, users 
or other persons as defined by one or more of the 
following:  
a) a life-threatening illness or injury   
Note: Life-threatening means that the individual was 
at immediate risk of death from the event as it 
occurred, i.e., it does not include an event which 
hypothetically might have caused death had it 
occurred in a more severe form. 
b) any potentially sight-threatening event or permanent 
impairment to a body structure or a body function 
including chronic diseases. 
c) inpatient hospitalization or prolonged 
hospitalization. 
d) a medical or surgical intervention to prevent a) or b). 
This includes any ocular secondary surgical 
intervention excluding posterior capsulotomy. 
e) any indirect harm as a consequence of incorrect 
diagnostic test results when used within 
manufacturer’s instructions for use. 
• 
Fetal distress, fetal death, congenital abnormality or 
birth defect including physical or mental impairment. 
Note: Planned hospitalization for a preexisting condition, or 
a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse 
event.  
Refer to Section 11 for additional SAEs. 

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Serious Health Threat 
 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration 
in the health in subjects, users, or other persons, and that 
requires prompt remedial action for other subjects, users, or 
other persons. 
Note: This would include events that are of significant and 
unexpected nature such that they become alarming as a 
potential serious health hazard or possibility of multiple 
deaths occurring at short intervals.  
Study Start 
The start of the study is considered to coincide with the 
enrollment of the first patient.  
Study Completion 
The completion of the study is considered to coincide with 
the study-level last subject last visit or the decision to 
terminate the trial, whichever is later. 
Unanticipated Serious 
Adverse Device Effect 
(USADE) 
 
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the risk 
assessment.  
Use Error 
 
User action or lack of user action while using the medical 
device that leads to a different result than that intended by 
the manufacturer or expected by the user.  
Note: 
a) Use error includes the inability of the user to 
complete a task. 
b) Use errors can result from a mismatch between the 
characteristics of the user, user interface, task, or 
use environment. 
c) Users might be aware or unaware that a use error 
has occurred. 
d) An unexpected physiological response of the patient 
is not by itself considered a use error. 
e) A malfunction of a medical device that causes an 
unexpected result is not considered a use error.” 

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Vulnerable Subject 
 
An individual who is unable to fully understand all aspects 
of the investigation that are relevant to the decision to 
participate, or who could be manipulated or unduly 
influenced as a result of a compromised position, 
expectation of benefits or fear of retaliatory response. 
 
2 LIST OF ACRONYMS AND ABBREVIATIONS 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol 
Abbreviation 
Definition 
ACD 
Anterior chamber depth 
AL 
Axial length 
ADE  
Adverse device effect 
AE 
Adverse event 
ASADE 
Anticipated serious adverse device effect 
AUS 
Australia 
BSS 
Balanced salt solution  
BCDVA 
Best corrected distance visual acuity 
C 
Celsius 
cc 
Cubic centimeter 
CDE 
Cumulative dissipated energy  
CFR 
Code of Federal Regulations 
CIP 
Clinical investigation plan 
CIR 
Clinical investigation report 
CRF 
Case report form 
D 
Diopter 
DFU 
Directions for use 
ECCE 
Extracapsular cataract extraction  
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EU 
European Union  
EUREQUO 
European Registry of Quality Outcomes for Cataract and Refractive 
Surgery  
F 
Fahrenheit 
FLACS 
Femtosecond laser-assisted cataract surgery  
FMS 
Fluidics Management System 
GCP 
Good clinical practice 
GPCMS 
Global Product Complaint Management System 
HP 
Hand piece 
I/A 
Irrigation/Aspiration 
IB 
Investigator’s brochure 

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Abbreviation 
Definition 
ICF 
Informed consent form 
IEC 
Independent ethics committee 
IOL 
Intraocular lens 
IOP 
Intraocular pressure 
IP 
Investigational product 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
mm 
Millimeter 
mmHg 
Millimeters of mercury 
MOP 
Manual of procedures 
MSICS 
Manual small incision cataract surgery 
N/A 
Not applicable 
N 
Sample size 
Nd:YAG 
Neodymium-doped yttrium aluminum garnet 
NEI 
National Eye Institute 
PCO 
Posterior capsule opacification 
Phaco 
Phacoemulsification 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SICS 
Manual small incision cataract surgery 
SLE 
Slit lamp examination 
SOC 
Standard of Care 
SOP 
Standard operating procedure 
SSI 
Secondary surgical intervention 
TASS 
Toxic anterior segment syndrome 
UCDVA 
Uncorrected distance visual acuity 
USA 
United States of America 
U/S 
Ultrasound 
USADE 
Unanticipated serious adverse device effect 
USV 
Unscheduled visit 
VA 
Visual acuity 
VCS 
Vitreoretinal Cataract System  
WHO 
World Health Organization  
 
 
 

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3 PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Interventional, traditional feasibility  
Investigational 
products 
Test Product: UNITY VCS (including the console, remote control, 
foot controller, UNITY Cataract FMS Pack, and UNITY Anterior 
Vitrectomy Kit).   
Comparator Product: N/A 
Purpose and 
Scientific Rationale 
for the Study 
The purpose of this study is to obtain device-specific safety and 
performance clinical data to support marketability in Europe, and 
to collect user preference data. The study is not being conducted to 
mitigate any risk as the risk assessment did not find any new 
harms or increases in likelihood of any harms when compared to 
predecessor devices having the same intended use and indications 
for use.  
Brief Summary of 
the Protocol 
The aim of this study is to obtain device-specific clinical data and 
user preference data. This is a prospective, single-arm, non-
randomized, multi-center clinical study of adults with a clinically 
documented diagnosis of age-related, non-complicated cataract 
who meet the inclusion/exclusion criteria.  
Objective(s) 
The objective is to obtain device-specific safety and performance 
clinical data to support marketability in Europe, and to collect user 
preference data.  
Endpoint(s)  
 
Primary Performance Endpoint  
• 
Percent of ‘yes’ responses to the question: Did UNITY VCS 
using anterior segment surgical functionality perform per 
the intended use as defined in Protocol Section 5.1? 
Secondary Performance Endpoint  
• 
Time from incision entry to incision closure 

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Safety Endpoints 
• 
Adverse events (ocular and nonocular; serious and 
nonserious) 
• 
Secondary surgical interventions 
• 
Unplanned intraoperative surgical procedures 
• 
Device deficiencies  
Assessment(s)  
Effectiveness 
• 
User preference questionnaires 
• 
Overall procedure time from incision entry to incision 
closure (via stopwatch)  
Safety 
• 
UCDVA 
• 
BCDVA by manifest refraction  
• 
Tonometry/IOP  
• 
Slit lamp examination 
• 
Dilated fundus examination  
• 
Adverse events 
• 
Secondary surgical interventions 
• 
Device deficiencies  

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Study Design 
This is a prospective, interventional, open-label, single-arm, 
nonrandomized, multicenter clinical trial study of adults with a 
clinically documented diagnosis of age-related, noncomplicated 
cataract who meet the inclusion/exclusion criteria.  
Subject population 
Adult patients presenting for routine cataract surgery.  
Planned number of subjects enrolled/consented: Approximately 
120 subjects/120 eyes (unilateral subjects) 
Planned number of completed subjects: Approximately 
100 subjects/100 eyes (unilateral subjects) 
Sites and Locations 
Planned number of clinical sites: up to 5 sites  
Planned locations (initial list of locations, which may change 
during start up or conduct according to study needs): United States 
and/or Australia 
Key inclusion 
criteria 
(See Section 8.1 for a 
complete list of 
inclusion criteria) 
• Adults (>18 years of age) with a clinically documented 
diagnosis of age-related noncomplicated cataract 
• Eligible to undergo primary hydrophobic acrylic intraocular 
lens implantation into the capsular bag 
• Keratometry: 41 to 46 D, anterior chamber depth: 2.5 to 4 mm 
and axial length: 22 to 25 mm  
Key exclusion 
criteria 
(See Section 8.2 for a 
complete list of 
exclusion criteria) 
• Laser assisted fragmentation in the operative eye 
• More than 1+ guttata in the operative eye  
• A history of chronic or recurrent inflammatory eye disease or 
trauma (e.g., iritis, scleritis, uveitis, iridocyclitis, rubeosis 
iridis, herpes simplex keratitis) in the operative eye  
• Any ocular comorbidity (other than cataract) that may 
confound the results (e.g., zonular instability or zonular 
dehiscence or pseudoexfoliation, ocular surface disease, 
synechiae, iris atrophy, shallow anterior chamber, lens 
subluxation) in the operative eye  
• Diagnosis of glaucoma or ocular hypertension 
(IOP > 21 mmHg) in the operative eye  

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• Diagnosed with severe systemic (e.g., history of cerebral 
vascular accident) or retinal disorders (e.g., macular 
degeneration, diabetic retinopathy, or other retinal pathology 
that might limit postoperative visual acuity or predispose the 
subject to postoperative retinal complications) in the operative 
eye  
• A poorly dilating pupil or other pupil defect that prevents the 
iris from retracting peripherally to at least 6 mm diameter 
dilation in the operative eye  
Data analysis and 
sample size 
justification 
The primary analysis set for effectiveness outcomes will be the all-
implanted analysis set. The all-implanted analysis set includes all 
eyes with successful completion of the cataract surgery including 
IOL implantation. The safety analysis set will include all eyes with 
attempted use of the UNITY VCS (successful or aborted after 
contact with the eye) and will be used for the safety outcomes. 
Attempted use of the UNITY VCS is defined as any time the 
device makes contact with the eye.  
There will be no hypothesis testing for any study outcome. All 
study outcomes will be presented as data listings or with summary 
statistics that are appropriate to the scale of the endpoint 
(continuous, dichotomous, etc.).  
Based on a sample of 100 subjects, the expected half-width of the 
95 % confidence interval for the percentage of surgeons reporting 
‘yes’ to the question “Did UNITY VCS using anterior segment 
surgical functionality perform per the intended use as defined in 
Protocol Section 5.1?" will be 1.96∙√(p(1-p)/100). This half-width 
is widest at p = 50%. Under this conservative assumption, the 
expected half-width is <10% given the sample size of 100.  
Allow enrollment for an additional 10% for screen failure and 10% 
for lost to follow-up to ensure 100 completed subjects.  

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Table 3–1 
Schedule of Study Procedures and Assessments 
Visit 
Visit 0 
Screening 
Visit 00 
Surgery  
Visit 1 
1 Day 
Visit 2 
1 Week 
Visit 3 
1 Month / 
Exit 
Early Exit Unscheduled 
Visit 7 
Day Number 
Day -60 to 0  
Day 0 
Day 1 to 3 
Day 4 to 10 
Day 28 to 42 
N/A 
N/A 
Eye 
Both Eyes 
Study eye 
Study eye 
Study eye 
Study eye 
Study eye 
Study eye 
Informed Consent 
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Medical and Ocular 
History 
X 
 
 
 
 
 
 
Concomitant 
Medications 
X 
X 
X 
X 
X 
X 
X 
Inclusion/Exclusion 
X 
 
 
 
 
 
 
Urine Pregnancy Test 1* 
X 
 
 
 
 
 
 
Dilated Pupil Size 
X 
 
 
 
 
 
 
Keratometry 
X 
 
 
 
 
 
 
Biometry (ACD, AL) 
X 
 
 
 
 
 
 
Slit Lamp Examination 
X 
 
X 
X 
X 
X 
(✓) 
UCDVA2 
 
 
X 
 
 
 
 

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Visit 
Visit 0 
Screening 
Visit 00 
Surgery  
Visit 1 
1 Day 
Visit 2 
1 Week 
Visit 3 
1 Month / 
Exit 
Early Exit Unscheduled 
Visit 7 
Day Number 
Day -60 to 0  
Day 0 
Day 1 to 3 
Day 4 to 10 
Day 28 to 42 
N/A 
N/A 
Eye 
Both Eyes 
Study eye 
Study eye 
Study eye 
Study eye 
Study eye 
Study eye 
BCDVA3 
X 
 
 
X 
X 
X 
(✓) 
Intraocular Pressure 
X 
 
X 
X 
X 
X 
(✓) 
Dilated Fundus Exam4 
X 
 
 
 
X 
X 
(✓) 
Treatment (cataract 
surgery) 
 
X 
 
 
 
 
 
Time from incision entry 
to incision closure 
 
X 
 
 
 
 
 

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Visit 
Visit 0 
Screening 
Visit 00 
Surgery  
Visit 1 
1 Day 
Visit 2 
1 Week 
Visit 3 
1 Month / 
Exit 
Early Exit Unscheduled 
Visit 7 
Day Number 
Day -60 to 0  
Day 0 
Day 1 to 3 
Day 4 to 10 
Day 28 to 42 
N/A 
N/A 
Eye 
Both Eyes 
Study eye 
Study eye 
Study eye 
Study eye 
Study eye 
Study eye 
User Preference 
Questionnaire  
 
X 
 
 
 
 
 
Adverse Events  
X 
X 
X 
X 
X 
X 
X 
Device Deficiencies 
X 
X 
X 
X 
X 
X 
X 
Exit Form 
(✓) 
(✓) 
(✓) 
(✓) 
X 
X 
(✓) 
(✓) Assessment performed as necessary 
1 Women of child-bearing potential only 
2 VA to be conducted per site’s SOC using Snellen chart 
3 VA to be conducted per site’s SOC using manifest refraction and Snellen chart 
4 Assessment must be performed dilated 
 
  
7 Unscheduled Visit – additional study assessments may be performed per investigator’s discretion 
* Source only entries 
 

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4 PROTOCOL AMENDMENTS 
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the study sponsor and must be 
approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions.  
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent) in order to remain in the study, as 
required by the IRB/IEC. 
  
5 INTRODUCTION 
5.1 Rationale and Background 
To meet the demands of increasing number of cataract surgeries coupled with high patient 
expectations, cataract surgeons desire the safest and most efficient device to remove the 
crystalline lens. The investigational device was developed to meet these needs by improving 
occlusion break surge responses and intraocular pressure control as well as reducing 
phacoemulsification time and energy.  
The intended purpose of UNITY VCS, in general, is to facilitate management of fluid and 
gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials.  
For this study, UNITY VCS will only be used during anterior segment ophthalmic surgery. As 
such, the intended purpose of UNITY VCS, in this study, is to facilitate management of fluid 
as well as removal, cutting, and coagulation of ocular materials.  
The target patient population for this study are those undergoing anterior segment ophthalmic 
surgery.   
Modern cataract procedures usually involve the use of an ultrasonic device that breaks up the 
crystalline lens (often cloudy) into small pieces, which are then gently removed from the eye 
with suction; this procedure is called phacoemulsification. Standard extracapsular cataract 
extraction (ECCE) and manual small incision cataract surgery (SICS or MSICS) are other 
surgical methods that remove the cataract without an ultrasonic device. Phacoemulsification, 
or "phaco", is the surgical technique most often employed based on the European Registry of 

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Quality Outcomes for Cataract and Refractive Surgery (EUREQUO) (Lundström 2012). 
Phacoemulsification is also the standard of care based on guidelines from the American 
Academy of Ophthalmology (AAO 2016). Femtosecond laser-assisted cataract surgery 
(FLACS) uses a femtosecond laser to create incisions, capsulotomies, and/or fragmentation 
patterns where only the laser fragmentation step assists in breaking up the cloudy lens into 
small pieces before removal, but the phacoemulsification machine would still be required to 
remove the lens. The intended clinical benefit of UNITY VCS, as used in the study, is to aid 
in the execution of anterior segment ophthalmic surgery.  
According to the World Health Organization (WHO), cataracts is one of the leading causes of 
visual impairment and blindness, impacting 94 million globally (WHO 2022). Visual 
impairment is expected to continue to increase due to population growth and ageing (WHO 
2022). The number of cases with cataracts in the United States was 24.4 million in 2010 and 
expected to be 50 million by 2050 (NEI 2017). Cataract surgery is the only way to treat 
cataracts (NEI 2023). The most performed ophthalmic procedure is cataract surgery (AAO 
2023). This study is relevant as it aims to enhance equipment used to perform cataract 
surgery with the potential to benefit a very large patient population in the United States and 
globally.  
Available alternative treatment options to UNITY VCS anterior segment functionality include 
other phacoemulsification machines that utilize ultrasound energy. While manual cataract 
surgery that does not utilize ultrasound energy may be used, phacoemulsification is 
considered standard of care (AAO 2016) and the preferred surgical technique in majority of 
cases (Lundström 2012). The Centurion Vision System, a predecessor to UNITY VCS 
anterior segment functionality, is the most utilized phacoemulsification machine in the world 
(2022 Cataract Surgical Equipment Market Report). The Centurion Vision System is Alcon’s 
premium phacoemulsification system launched in 2013, with the addition of Active Sentry in 
2019. The UNITY VCS’s anterior segment functionality was designed to improve upon the 
latest iteration of the Centurion Vision System currently used successfully in the market. As 
such, the UNITY VCS is intended to provide greater benefits than the current standard of 
care.  

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5.2 Purpose of the Study 
The study aims to: 
(1) Obtain device-specific safety and performance clinical data to support marketability 
in Europe. 
AND  
(2) Collect user preference data  
At the end of the study, a clinical study report and lay summary, if applicable, will be 
prepared in accordance with applicable regulatory requirements and standards. The Informed 
Consent will specify that a lay summary, if applicable, will be made available after the study 
is completed.  
There are no immediate plans to submit the results of this traditional feasibility study for 
publication; however, the results may be offered for publication if they are of scientific 
interest, or if the results relate to a product that is subsequently approved or cleared for 
marketing. Alcon reserves the right of prior review of any publication or presentation of 
information related to the study. The author(s) of the publication will be the individual with 
substantial contribution to the conception or design of the work, OR the acquisition, analysis, 
or interpretation of data. Additionally, the author will draft the work or revise it critically for 
important intellectual content; provide final approval of the version to be published; and 
agree to be accountable for all aspects of the work, ensuring that questions related to the 
accuracy or integrity of any part of the work are appropriately investigated and resolved. 
5.3 Risks and Benefits 
The benefit of cataract surgery is the removal of the opacified, cloudy crystalline lens. In 
comparison with predecessor phacoemulsification systems, the UNITY VCS anterior 
segment functionality provides enhancements that are designed to benefit patients. The two 
most used enhancements of UNITY VCS during cataract surgery will relate to fluidics and 
ultrasound. The fluidics enhancement was designed with the intent to allow surgeons to 
operate at lower IOP and higher vacuum while maintaining anterior chamber stability. In 
specific, operating at lower, more physiological IOP may be associated with greater reported 
patient comfort during surgery (Hou 2012), improved visual recovery due to better 
preservation of corneal endothelial health, and less macular edema postoperatively (Suzuki 
2009, Chen 2012) as well as reduced complications due to less impact on retinal blood 
flow/reduction of ischemia (Findl 1997, Takhtaev 2019). The ultrasound enhancement was 

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designed to improve crystalline lens cutting efficiency and reduce energy. The overall 
potential benefit would be a safer and more efficient procedure.  
Risk management principles have been applied to both the planning and the intended conduct 
of the clinical investigation, to ensure the reliability of the clinical data generated and the 
safety of the subjects. 
The clinical investigation risks are managed through appropriate training and monitoring 
according to the protocol-specific monitoring plan. 
 
 
. 
Participation in the clinical study will require the subject to undergo cataract surgery and 
implantation of a hydrophobic acrylic intraocular lens into the capsular bag. The use of 
femtosecond laser-assisted incisions and capsulotomies per product label is optional at the 
discretion of patient and surgeon; use of femtosecond laser-assisted procedures is not 
required for this study.   
Complications may occur on the surgery day or throughout the postoperative period. As with 
any type of intraocular surgery, there is a possibility of complications due to anesthesia, drug 
reactions, and/or surgical problems. The surgical procedure can exacerbate a pre-existing 
ocular condition. 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 

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. 
In addition, a secondary surgical intervention (SSI) may be required following the initial 
cataract removal and subsequent IOL implantation. An IOL replacement may be appropriate 
in some cases of biometry error, incorrect IOL power, operating room error, residual 
refractive error, refractive shift, ocular infection, patient dissatisfaction, or visual symptoms. 
Other SSIs include, but are not limited to, removal of residual crystalline lens fragments, 
refractive laser treatment, paracentesis, vitreous aspirations, iridectomy for pupillary block, 
wound leak repair, intracameral and intravitreal antibiotic injections, and retinal detachment 
repair.  
Postoperatively, the subject may experience transient ocular discomfort or pain, visual 
dysfunction and inflammation. Additionally, intraocular lens related complications can 
include decreased contrast sensitivity, decreased color perception, or clinically significant 
PCO that may require a Nd:YAG capsulotomy to improve vision and resolve subjective 
symptoms. Pigment precipitates on the IOL or in the anterior chamber may occur. Excessive 
pigment accumulation in the anterior chamber angle may contribute to a raised IOP, requiring 
treatment. 
All the above-mentioned complications, adverse events, SSIs, and postoperative reported 
events have been reported as a result of the phacoemulsification surgical procedure with use 
of an anterior segment surgical system. The UNITY VCS, the investigational device, is not 
expected to increase any harms or the likelihood of those harms when compared to 
predecessor devices. 
 
 
  
The UNITY VCS’s anterior segment functionality is expected to provide greater benefits and 
no changes in the harms or likelihood of harms when compared to the widely and 
successfully marketed predecessor device, the Centurion Vision System. As such, the 
expected benefits of using the UNITY VCS anterior segment functions are expected to 
outweigh the risks of adverse device effects for subjects that qualify for cataract surgery in 
this study. 
Refer to the IB for additional information. 

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6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
Table 6–1 
Primary Objective 
Objective(s) 
Endpoint(s) 
Performance:  
To obtain device-specific performance 
clinical data  
Performance: 
Percent of ‘yes’ responses to the question 
of: Did UNITY VCS using anterior 
segment surgical functionality perform per 
the intended use as defined in Protocol 
Section 5.1?  
6.2 Secondary Objective(s) 
Table 6–2 
Secondary Objective(s) 
Objective(s) 
Endpoint(s) 
Performance: 
To obtain device-specific performance 
clinical data 
Performance: 
Time from incision entry to incision closure 
6.4 Safety Objective(s)  
Table 6–3 
Safety Objective(s) 
Objective(s) 
Endpoint(s) 
To obtain device-specific safety clinical 
data  
Adverse events (ocular and nonocular; 
serious and nonserious) 
Device deficiencies  
Secondary surgical interventions 
Unplanned intraoperative surgical 
procedures 

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7 INVESTIGATIONAL PLAN 
7.1 Study Design 
This is a prospective, interventional, open-label, single-arm, nonrandomized and multicenter 
clinical study in the United States of America (USA) and/or Australia with approximately a 
1-month follow-up.   
Figure 7-1 
Study Design Flow Chart 
 
 
 
 

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7.2 Rationale for Study Design  
The UNITY VCS is a Class II nonimplantable medical device in the USA and a Class IIb 
nonimplantable medical device in the EU and AUS. For this class category, there are no 
currently well-established study designs governed by health authorities or international 
standards. The prospective design of this traditional feasibility study will reduce sources of 
bias and confounding variables. The intended patient population represents the majority of 
patients that will require use of the investigational device for cataract removal surgery where 
inclusion/exclusion criteria were carefully selected to reduce confounding variables.   
The study design was also carefully thought out to allow it to represent a real world setting to 
ensure minimal intervention to the site’s standard of care; this ensures the study gains the 
most realistic response with regard to device performance and safety. 
 
 
 
 
A potential weakness of the current study design is the fact that it is a single-arm study. 
However, this single-arm design is justified given that there are well established data 
regarding safety and performance of cataract surgery. As such, the safety and performance 
results from this study can be compared against this rich body of evidence to ensure the 
device meets state of the art standards.  
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations 
Not applicable. There are currently no planned interim analyses. 
7.3 Rationale for Duration of Treatment/Follow-Up 
The follow-up schedule was designed to allow collection of data at key time points that yield 
relevant performance and safety outcomes. The follow-up period will allow for adequate 
safety monitoring of adverse events; if patients develop complications, those will typically be 
present within approximately 1 month of cataract surgery. 
7.4 Rationale for Choice of Comparator Product 
There is no comparator in this study.  

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7.5 Data Monitoring Committee 
Not applicable 
8 STUDY POPULATION 
The study population will consist of male and female subjects (over the age of 18 years) with 
a diagnosis of age-related noncomplicated cataract (unilaterally). It is aimed to enroll 
(consent) approximately 120 subjects in up to 5 sites in the United States and/or Australia 
with a target of 100 subjects treated, with 10 to 40 subjects per site. Site-specific targets may 
vary based upon individual site capabilities and each site may include more than one surgeon. 
Each surgeon will perform at least 10 surgeries, but no more than 33% of the total subjects 
treated. Estimated time needed to recruit subjects for the study is approximately 5 months; 
however, unanticipated circumstances may shorten or lengthen this time and would not 
require amendment of this protocol. Because a 10% screening failure rate is expected and 
10% for lost to follow-up, approximately 120 subjects are expected to be enrolled to ensure 
100 completed subjects.  
8.1 Inclusion Criteria 
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study. 
Subjects eligible for inclusion in this study must fulfill all of the following criteria: 
1.  
Subject must be able to understand and sign an IRB/IEC approved Informed 
Consent form.  
2. 
Willing and able to attend all scheduled study visits as required per protocol. 
3. 
Adults (>18 years of age) with a clinically documented diagnosis of age-related 
noncomplicated cataract  
4.  
Eligible to undergo primary hydrophobic acrylic intraocular lens implantation into 
the capsular bag.  
5.  
Subject has clear intraocular media (including clear corneas) other than the cataract 
in the operative eye  
6.  
Keratometry: 41 to 46 D, anterior chamber depth: 2.5 to 4 mm and axial length: 22 
to 25 mm 

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8.2 Exclusion Criteria 
Subjects fulfilling any of the following criteria are not eligible for participation in this study. 
1. 
Women of childbearing potential, defined as all women who are physiologically 
capable of becoming pregnant and who are not postmenopausal for at least 1 year or 
are less than 6 weeks since sterilization, are excluded from participation if any of the 
following apply: 
a. they are currently pregnant, 
b. have a positive urine pregnancy test result at Screening, 
c. intend to become pregnant during the study period, 
d. are breastfeeding. 
Subjects who become pregnant during the study will not be discontinued; however, 
data will be excluded from the effectiveness analyses because pregnancy can alter 
refraction and visual acuity results. 
2. 
Laser assisted fragmentation in the operative eye.   
3. 
Planned postoperative procedures during the course of the study (e.g., corneal 
refractive surgery) in the operative eye. 
4. 
More than 1+ guttata in the operative eye.  
5. 
A history of chronic or recurrent inflammatory eye disease or trauma (e.g., iritis, 
scleritis, uveitis, iridocyclitis, rubeosis iridis, herpes simplex keratitis) in the 
operative eye. 
6. 
Previous intraocular or corneal surgery in the operative eye.  
7. 
Any ocular comorbidity (other than cataract) that may confound the results (e.g., 
zonular instability or zonular dehiscence or pseudoexfoliation, ocular surface 
disease, synechiae, iris atrophy, shallow anterior chamber, lens subluxation) in the 
operative eye. 
8. 
Diagnosis of glaucoma or ocular hypertension (IOP > 21 mmHg) in the operative 
eye.  

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9. 
Any topical or systemic medications known to interfere with visual performance or 
complicate cataract surgery.  
10. 
Diagnosed with severe systemic (e.g., history of cerebral vascular accident) or retinal 
disorders (e.g., macular degeneration, diabetic retinopathy, or other retinal pathology 
that might limit postoperative visual acuity or predispose the subject to postoperative 
retinal complications) in the operative eye. 
11. 
A poorly dilating pupil or other pupil defect that prevents the iris from retracting 
peripherally to at least 6 mm diameter dilation in the operative eye.  
12. 
Mechanical or surgical manipulation required to enlarge the pupil at time of surgery.  
13. 
Conditions that, per investigator’s clinical judgment, would confound the results of 
this investigation. 
14. 
Currently participating in another drug or device clinical trial or having participated 
in another drug or device clinical trial within 30 days of enrolment into this study. 
8.3 Rescreening of Subjects 
Rescreening of subjects is not allowed in this study. 
If subjects initially met all inclusion/exclusion criteria but surgery cannot be completed 
within 60 days of initial screening, then the investigator per their SOC should verify that 
subject continues to meet all inclusion/exclusion criteria at the time of surgery.  
9 TREATMENTS ADMINISTERED 
9.1 Investigational Product(s) 
Test Product(s): 
UNITY Vitreoretinal Cataract System (VCS)  
Comparator Product(s) (If 
applicable): 
Not applicable  
 
Table 9–1 
Test Product 
Test Product 
UNITY VCS (including the console, remote control, foot controller, 
UNITY Cataract FMS Pack, and UNITY Anterior Vitrectomy Kit)* 

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Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fort Worth, TX 76134 
USA 
 
Indication for use 
and intended 
purpose in the study  
Intended Use: The UNITY VCS, consisting of the console and 
compatible devices, is intended to facilitate management of fluid 
and gases, as well as removal, grasping, cutting, illumination and 
coagulation of ocular materials.  
Indications For Use: The UNITY VCS, consisting of the console 
and compatible devices, is indicated for use during anterior and 
posterior segment ophthalmic surgery.  
While the UNITY VCS is able to perform anterior and posterior 
segment functionalities, only the anterior segment functionalities 
will be enabled during this study. All posterior segment 
functionalities will be disabled in this study. 
Product description 
and parameters 
available for this 
study 
The UNITY VCS in this study is a surgical instrument for use in 
anterior segment ophthalmic surgeries. The product’s capabilities 
include driving a variety of handpieces that provide the ability to 
emulsify and remove the crystalline lens, cut and remove vitreous 
as well as coagulation to stop bleeding.  
While UNITY VCS is able to perform anterior and posterior 
segment functionalities, only the anterior segment functionalities 
will be enabled during this study. All posterior segment 
functionalities will be disabled in this study. 
Formulation 
N/A 
Usage 
The UNITY VCS anterior segment functionalities will be used as 
directed in the user manual.  

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Packaging 
description 
Each UNITY VCS console and all compatible anterior segment 
devices will be packaged individually and have an investigational 
product specific serial or lot number  
 
 
 
 
Labeling description Investigational labeling regulations apply for UNITY VCS console, 
remote control, foot controller, UNITY Cataract FMS Pack and 
UNITY Anterior Vitrectomy Kit. These devices will be labeled 
appropriately (e.g., “CAUTION – Investigational device. Limited 
by Federal [or United States] law to investigational use” or 
“Exclusively for Clinical Investigation” or “For Clinical Trial Use 
Only”). Each unit will be identifiable via a serial or lot number. 
Training and/or 
experience 
requirements for 
device 
The UNITY VCS should only be used by authorized study 
personnel. It should only be operated according to the operating 
instructions as listed in the associated user manual and DFUs. 
Storage conditions 
Temperature and relative humidity listed below apply to room 
environmental conditions preceding and during device use. 
Temperature: 50 to 95 °F (10 to 35 °C) Operating; 14 to 131 °F (-10 
to 35 °C) Nonoperating 
Relative Humidity: 10 to 95% without condensation  
See User Manual for complete requirements and instructions. 
Additional 
information 
Not applicable 
 
Supply 
UNITY VCS which includes the console and all compatible anterior 
segment devices will be shipped to the site by the sponsor.  
Refer to the MOP for a detailed description. 

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More information on the test product be found in the Investigator’s Brochure and Directions 
for Use for the UNITY VCS. 
9.3 Treatment Assignment / Randomization 
Only after signing the ICF will a subject be assigned a subject number by the electronic data 
capture system.  
All subjects who meet the inclusion/exclusion criteria and sign informed consent will 
undergo cataract surgery with the UNITY VCS. Bias will be minimized as this is a single-arm 
study.   
If both eyes qualify for the study, the study eye will be determined per investigator’s 
discretion.  
There will be no randomization of subjects.  
9.4 Treatment masking 
Not applicable as this is an open-label, single-arm study.  
9.5 Accountability Procedures 
Upon receipt of IP, the investigator or delegate must conduct an inventory of equipment and 
accessories by serial or lot number, complete study-specific confirmation of receipt 

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procedures as described in the MOP, and retain any required documentation in the 
investigator’s clinical study records.  
• 
All IPs sent to the investigator must be accounted for by study sponsor personnel, and 
in no case be used in an unauthorized manner. 
• 
Refer to Section 11 of this protocol for additional information on the reporting of 
device deficiencies and to the MOP for information on return of investigational 
products associated with these events. 
The investigator is responsible for allowing de-installation of the provided UNITY VCS and 
to return (or destroy) all unused sponsor-provided accessories and supplies as directed at the 
conclusion of the study or according to the instructions provided in the MOP. 
9.6 Changes to concomitant medications, treatments/ procedures 
After the subject is enrolled into the study, the investigator must instruct the subject to notify 
the study site about: 
• 
Any new medications  
• 
Alterations in dose or dose schedules for current medications,  
• 
Any medical procedure or hospitalization that occurred or is planned 
• 
Any nondrug therapies (including physical therapy and blood transfusions).  
The investigator must document this information in the subject’s case history source 
documents. 
10 STUDY PROCEDURES AND ASSESSMENTS 
Study assessments will be obtained prior to cataract surgery with the UNITY VCS and 
postoperatively at the study visits outlined below: 
• Screening – Visit 0 (Day -60 to 0 prior to treatment) 
• Surgery – Visit 00 (Day 0) 
• 1 Day – Visit 1 (Day 1 to 3) 
• 1 Week – Visit 2 (Day 4 to 10) 
• 1 Month/Exit – Visit 3 (Day 28 to 42) 
In addition to the scheduled visits listed above, the following visit may apply as needed: 

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• Unscheduled Visit (completed when a treated subject reports for additional follow-up) 
Clinical assessments to be obtained at study visits are outlined in Table 3–1 Schedule of 
Study Procedures and Assessments and are defined in the sections below.  
10.1 Informed Consent and Screening 
The investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document.  
The investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations. 
If a patient has reported for routine cataract screening, then data obtained from the routine 
evaluation can be used for screening data as long as protocol requirements for timeframe 
(within 60 days of surgery) and required details have been met. Routine cataract screening 
data include, but are not limited to slit lamp exam, IOP, dilated pupil size, keratometry, 
biometry (ACD, AL), Snellen BCDVA with manifest refraction, and dilated fundus exam. 
10.2 Description of Study Procedures and Assessments 
Study-specific procedures and assessments described here may include SOC; other SOC 
procedures performed in the clinical management of the subject are not excluded. 
Detailed descriptions of assessments and procedures are provided in the MOP. The 
investigator is responsible for ensuring that all procedures and assessments are delegated to 
appropriately qualified site personnel. 
10.2.1 Demographics 
Obtain demographic information including age, race, ethnicity, and sex. 
10.2.2 Medical and Ocular History 
Collect medical history information, including information on all medications used within the 
past 30 days of signing the informed consent form. Include herbal therapies, vitamins, and all 
over-the-counter as well as prescription medications. Throughout the subject’s participation, 

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obtain information on any changes in medical health and/or the use of concomitant 
medications. 
Medical History and Concomitant Medications will be collected in the eCRF as outlined in 
the MOP. 
10.2.3 Adverse Event Collection: Safety Assessment 
Assess and record any adverse events that are observed or reported since the previous visit, 
including those associated with changes in concomitant medication dosing. 
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent, regardless of subject enrollment status (screen failure). 
10.2.4 Slit Lamp Biomicroscopy: Safety Assessment 
SLE of the cornea, iris/anterior chamber, and lens must be performed before instillation of 
any diagnostic eye drops at the screening visit. 
Refer to the MOP for grading scales for study specific assessments.  
10.2.5 Device Deficiencies: Safety Assessment 
Assess and record any device deficiencies that are reported or observed since the previous 
visit. Requirements for reporting device deficiencies in the study can be found in Section 11. 
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent, regardless of subject enrollment status (screen failure). 
10.2.6 Dilated Fundus: Safety Assessment 
Dilated fundus examination includes ophthalmoscopic assessments of the vitreous, retina, 
macula, choroid, and optic nerve. 
10.2.7 Uncorrected Distance Visual Acuity: Safety Assessment 
Snellen visual acuity testing without manifest refraction must be performed prior to any 
assessment requiring administration of eye drops to dilate the eye, or any assessment 
requiring contact with the eye. 

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10.2.8 Best Corrected Distance Visual Acuity: Safety Assessment 
Snellen visual acuity testing with manifest refraction must be performed prior to any 
assessment requiring administration of eye drops to dilate the eye, or any assessment 
requiring contact with the eye.  
10.2.9 Intraocular Pressure: Safety Assessment 
Intraocular pressure must be measured using SOC. 
10.2.10 Urine Pregnancy Test: Other Assessment 
A urine pregnancy test is required for female subjects of childbearing potential that are not 
postmenopausal or surgically sterile.  
10.2.11 Keratometry: Eligibility Assessment 
Capture keratometry measurements of the central cornea using SOC. 
10.2.12 Pupil Size: Eligibility Assessment 
Measure dilated pupil size under photopic condition using SOC.  
10.2.13 Biometry: Eligibility Assessment 
Perform biometry using SOC. Document the following: ACD, AL.  
10.2.14 Assessment through the operating microscope: Other Assessment 
If femtosecond laser is used then perform an assessment of the cornea and conjunctiva, and 
other femtosecond laser related findings through the operating microscope after femtosecond 
laser-assisted incision and/or capsulotomy but before entry into the eye for cataract removal 
surgery.  
10.2.15 Time from incision entry to incision closure: Secondary 
Performance Assessment 
Obtain time from incision entry into the eye to incision closure using a stopwatch. 

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10.3 Unscheduled Visits 
An Unscheduled Visit (USV) is defined as follows: 
• Ocular examination that is not SOC and not required by the protocol 
• Examination conducted by the study staff 
• New findings, or change to a previous finding was discovered 
A USV may or may not result in the capture of an adverse event. Likewise, an adverse event 
may be captured without the report of a USV (e.g., AE identified subsequent to study eye 
examination by nonstudy personnel). 
If a subject visit occurs between any regularly scheduled visit and the visit is conducted by 
study personnel, this visit must be documented as an USV. If the subject seeks medical 
attention outside the clinic (for example, at an Emergency Room) or at the clinic but is seen 
by nonstudy personnel, the investigator is to capture adverse event-related information on the 
adverse event form upon becoming aware. 
During all USVs, the investigator must conduct the following procedures:  
• Collect adverse event information, if applicable 
• Collect device deficiency information, if applicable 
• Collect SSI information, if applicable 
• Record changes in medical condition or concomitant medication 

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The investigator may perform additional procedures for proper diagnosis and treatment of the 
subject. These include but are not limited to those noted in Table 3–1 Schedule of Study 
Procedures and Assessments. The investigator must document this information in the 
subject’s case history source documents. 
If during a USV the subject is discontinuing from the study, the investigator must conduct 
Exit procedures according to Table 3–1 Schedule of Study Procedures and Assessments and 
Section 10.4.3, as possible. 
10.4 Discontinued Subjects 
10.4.1 Screen Failures 
Subjects who were excluded from the study after signing the informed consent and prior to 
exposure.   
The investigator must document the reason for the screen failure in the subject’s case history 
source documents. 
Subject numbers must not be re-used. 
10.4.2 Discontinuations 
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the investigator after signing informed consent, meeting eligibility criteria, and are 
exposed to IP. 
Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not 
allowed). 
Subjects may discontinue from study or study treatment at any time for any reason. Subjects 
may also be discontinued from study treatment at any time if, in the opinion of the 
investigator, continued treatment poses a risk to their health. 
For subjects choosing to discontinue from the study after exposure to IP, the investigator must 
complete all Exit procedures according to Table 3–1 Schedule of Study Procedures and 

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Assessments, if the subject is willing and able, and if in the opinion of the investigator it is 
safe for the subject to do so. 
The investigator must document the reason for study or treatment discontinuation in the 
subject’s case history source documents. 
To ensure the safety of all subjects who discontinue early, investigators must assess each 
subject and, if necessary, advise them of any therapies and/or medical procedures that may be 
needed to maintain their health. 
10.4.3 Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product  
If a subject discontinues from study treatment, every effort must be made to keep the subject 
in the study and to continue with the study assessments as specified in the schedule of study 
procedures and assessments until the final visit.  
10.5 Clinical Study Termination 
The study sponsor reserves the right to suspend or close the investigational site or suspend or 
terminate the study in its entirety at any time. 
If the clinical study is prematurely terminated or suspended by the study sponsor:  
• 
The study sponsor must: 
o Immediately notify the investigator(s) and subsequently provide instructions for 
study termination. 
o Inform the investigator and the regulatory authorities of the termination/suspension 
and the reason(s) for the termination/suspension.  
• 
The investigator must: 
o Promptly notify the IRB/IEC of the termination or suspension and of the reasons.  
o Provide subjects with recommendations for poststudy treatment options as needed. 
The investigator may terminate the site’s participation in the study for reasonable cause. 
10.5.1 Follow-up of subjects after study participation has ended  
Following this study, the subject will return to their eye care professional for their routine eye 
care. 

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11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 General Information 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 
whether or not related to the investigational medical device (test product). Refer to the 
Glossary of Terms and figures below for categories of AEs and SAEs. 
Figure 11-1 
Categorization of All Adverse Events  
 
*In this study, only AEs related to the investigational product/device (i.e., UNITY VCS) are considered as 
device related ADE.  
 

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Specific Events Relevant to this Protocol  
In addition to reporting all AEs (serious and nonserious) meeting the definitions, the 
investigator must report any occurrence of the following as an SAE including but not limited 
to: 
Serious Adverse Events 
• 
Postoperative corneal incision site wound leakage 
• 
Hypopyon 
• 
Hyphema 
• 
Toxic anterior segment syndrome 
• 
Posterior capsular tear 
• 
Vitreous prolapse 
• 
Iridodialysis 
• 
Posterior lens dislocation 
• 
Chronic corneal edema (corneal stromal or epithelial swelling resulting in BCDVA of 
≤20/40 at ≥1 month) 
• 
Clinically significant cystoid macular edema 
• 
Uncontrolled increase in IOP ≥10 mmHg over baseline and at least 25 mmHg 
• 
Endophthalmitis 
• 
Retinal detachment  
• 
Pupillary block 
• 
Suprachoroidal hemorrhage 
• 
Vitreous hemorrhage  
• 
Vision-threatening surgical problems 
• 
Secondary surgical intervention (excluding posterior capsulotomy) 
NOTE: 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. 
Any other potentially sight-threatening event may also be considered serious based on the 
judgment of the investigator and should be reported appropriately as delineated in Section 
11.3. 
AEs occurring in association with a device that is used in conjunction with the UNITY VCS 
(e.g., femtosecond laser) will be classified separately from those associated with the 
investigational device itself.  

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Device Deficiencies  
A device deficiency may or may not be associated with subject harm (i.e., ADE or SADE); 
however, not all ADEs or SADEs are due to a device deficiency. The investigator should 
determine the applicable category for the identified or suspect device deficiency and report 
any patient harm separately. 
 
11.2 Monitoring for Adverse Events 
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the investigator should inquire about AEs by asking the standard questions shown 
below and report as applicable: 
• 
“Have you had any health problems since your last study visit?” 
• 
“Have there been any changes in the medicines you take because of a new health issue 
since your last study visit?” 
In addition, changes in any protocol-specific parameters and/or questionnaires evaluated 
during the study are to be reviewed by the investigator. Any untoward (unfavorable and 
unintended) change in a protocol-specific parameter or questionnaire response that is 
clinically relevant, in the opinion of the investigator, is to be reported as an AE. These 
clinically relevant changes will be reported regardless of causality.  

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11.3 Procedures for Recording and Reporting 
AEs are collected from the time of informed consent. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (i.e., before informed 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
History section of the eCRF. 
In addition, aqueous cells and flare, corneal edema, eye redness, raised IOP, subconjunctival 
hemorrhage, and superficial punctate keratitis are examples of early postoperative findings 
that are typically observed following ocular surgery. These are not considered AEs if they can 
be reasonably expected to resolve within 2 weeks and not result in any untoward long term 
visual outcome impact. Expected complications from use of femtosecond laser-assisted 
procedures as noted in Section 5.3 will not be considered device related AEs..  
For each recorded event, the ADEs and SAEs documentation must include: date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the investigator must document all device deficiencies reported or 
observed with the test product on the Device Deficiency eCRF. The site must submit all 
available information on ADEs, SAEs, and device deficiencies to the Study Sponsor 
immediately as follows: 
• ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device Effect 
eCRF within 24 hours of the investigator’s or site’s awareness.  
• Device deficiencies are documented on the Device Deficiency eCRF within 24 hours of 
the investigator’s or site’s awareness.  
• Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available.   
• Document any changes to concomitant medications on the appropriate eCRFs. 
• Document all relevant information from Discharge Summary, Autopsy Report, Certificate 
of Death etc., if applicable, in the narrative section of the Serious Adverse Event and 
Adverse Device Effect eCRF. 
Note: Should the EDC system become nonoperational, the site must complete the appropriate 
paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency Form. The 
completed form is emailed to the Study Sponsor at msus.safety@Alcon.com for USA-based 
sites and at Australia.auff-complaints@alcon.com for AUS-based sites, according to the 

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timelines outlined above; however, the reported information must be entered into the EDC 
system once it becomes operational. 
In addition to recording all AEs into the EDC system, any AEs and device deficiencies for 
nonstudy marketed devices/products (e.g., Alcon’s or other manufacturers’ products used 
concomitantly during the study will be considered and processed as spontaneous following 
the postmarket vigilance procedures) and should be communicated to the device’s/product’s 
manufacturer as per local requirements. 
Study sponsor representatives may be contacted for any protocol related question and 
their contact information is provided in the Manual of Procedures that accompanies 
this protocol. 
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or the IRB/IEC. 
Intensity and Causality Assessments 
Where appropriate, the investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below: 
Intensity (Severity) 
Mild  
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom. 
Moderate  
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities. 
Severe  
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below: 
Causality 

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Related 
An AE classified as related may be either definitely related or possibly 
related where a direct cause and effect relationship with the medical 
device or study procedure has not been demonstrated, but there is a 
reasonable possibility that the AE was caused by the medical device or 
study procedure. 
Not Related  
An AE classified as not related may either be definitely unrelated or 
simply unlikely to be related (i.e., there are other more likely causes 
for the AE). 
The Study Sponsor will assess the AEs and may upgrade the investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the investigator of any AEs that 
are upgraded from nonserious to serious or from unrelated to related. 
11.4 Return Product Analysis 
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.  
Alcon study products associated with device deficiencies and/or product related AEs should 
be returned and must include the Complaint number which will be provided by Study 
Sponsor after the case is entered in the Study Sponsor’s Global Product Complaint 
Management System (GPCMS).  
11.5 Unmasking of the Study Treatment  
Not applicable; this study is open-label. 
11.6 Follow-Up of Subjects with Adverse Events 
The investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study.  
 
The investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ongoing at time of discontinuation, any 
additional information received at follow-up should be documented in the eCRFs up to study 
completion (i.e., database lock). Any additional data received up to 6 months after a subject 
completed the study should be documented and available upon the Study Sponsor’s request.    
 

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All complaints received after this time period will be considered and processed as 
spontaneous (following the postmarket vigilance procedures) and should be communicated to 
the medical device’s manufacturer as per local requirements. The investigator should also 
report complaints on non-Alcon products directly to the manufacturer as per the 
manufacturer’s instructions or local regulatory requirements. 
11.7 Pregnancy in the Clinical Study 
Pregnancy is not reportable as an AE; however, complications may be reportable and will be 
decided on a case-by-case basis. An Alcon form will be utilized to capture all pregnancy-
related information until birth of the child.  
12 ANALYSIS PLAN 
12.1 Subject Evaluability 
Final subject evaluability must be determined prior to locking the database, based upon the 
Deviations and Evaluability Plan. 
12.2 Analysis Sets 
All eligible subjects will be screened to determine if they meet all inclusion and no exclusion 
criteria. Subjects who provide informed consent will be considered enrolled in the study. 
12.2.1 All-Implanted Analysis Set 
The primary analysis set for effectiveness outcomes will be the all-implanted analysis set. 
The all-implanted analysis set includes all eyes with successful completion of the cataract 
surgery, including IOL implantation.  
12.2.2 Safety Analysis Set 
The safety analysis set will include all eyes with attempted use of the UNITY VCS 
(successful or aborted after contact with the eye) and will be used for the safety outcomes. 
Attempted use of the UNITY VCS is defined as any time the device makes contact with the 
eye. 
12.3 Demographic and Baseline Characteristics 
Demographic and baseline characteristics will be summarized for each subject. Counts and 
percentages will be presented for categorical variables such as sex, age, race and ethnicity. 
Sample size (N), mean, standard deviation, median, minimum, and maximum will be 
presented for continuous variables such as age. 

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12.4 Effectiveness Analyses 
12.4.1 Analysis of Primary Effectiveness Endpoint 
The primary performance endpoint is the percent of ‘yes’ responses to the question: Did 
UNITY VCS using anterior segment surgical functionality perform per the intended use as 
defined in Protocol Section 5.1? 
12.4.1.1 Statistical Hypotheses 
No hypothesis testing of the primary effectiveness endpoint is planned. 
12.4.1.2 Analysis Methods 
Standard descriptive statistics will be presented for the primary effectiveness endpoint based 
on the type. For categorical summaries, statistics will include sample size, number in 
category, and percentage in each category. For continuous summaries, number of subjects, 
mean, median, standard deviation, minimum, maximum, and two-sided 95% confidence 
intervals for both mean and median will be reported. Individual subject data listings will also 
be provided. 
12.4.2 Analysis of Secondary Effectiveness Endpoints 
The secondary performance endpoint is time from incision entry to incision closure.  
12.4.2.1 Statistical Hypotheses 
There are no hypothesis tests of the secondary effectiveness endpoints planned. 
12.4.2.2 Analysis Methods 
The number of subjects, mean, median, standard deviation, minimum, maximum, and 
two-sided 95% confidence intervals for both mean and median will be reported for the 
secondary endpoint. Individual subject data listings will also be provided.  
12.5 Handling of Missing Data 
No imputation of missing data is planned. 
12.6 Safety Analyses 
The safety endpoints are: 
• 
Adverse events (ocular and nonocular; serious and nonserious) 

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• 
Secondary surgical interventions 
• 
Unplanned intraoperative surgical procedures 
• 
Device deficiencies 
12.6.1 Analysis of Safety Endpoints 
The focus of the safety analysis will be a comprehensive descriptive assessment of the 
occurrence of adverse events as well as the other listed parameters above.   
12.6.1.1 Statistical Hypotheses 
There are no safety hypotheses planned in this study. 
12.6.1.2 Analysis Methods 
For all safety measures, descriptive statistics will be presented based on the type. For 
categorical variables, summary statistics will include sample size (subjects/eyes), number in 
category, and percentage in each category. For continuous variables, number of subjects/eyes, 
mean, median, standard deviation, minimum, and maximum will be reported. Individual 
subject data listings will also be provided.  
12.7 Interim Analyses and Reporting 
No interim analyses are planned. 
12.8 Sample Size Justification 
Based on a sample of 100 surgeries, the expected half-width of the 95 % confidence interval 
for the percentage of surgeons reporting ‘yes’ to the question “Did UNITY VCS using 
anterior segment surgical functionality perform per the intended use as defined in Protocol 
Section 5.1?" will be 1.96∙√(p(1-p)/100). This half-width is widest at p = 50%. Under this 
conservative assumption, the expected half-width is <10% given the sample size of 100. 
Allow enrollment for an additional 10% for screen failure and 10% for lost to follow-up to 
ensure 100 completed subjects. (See also Section 8 of this protocol for more details.)  
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS 
13.1 Subject Confidentiality 
The investigator must ensure that the subject’s identity is kept confidential throughout the 
course of the study. In particular, the investigator must keep an enrollment log with 

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confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. The study sponsor may collect a copy of the enrollment log without 
any directly identifying subject information.  
The study sponsor may share patient-level data collected in this trial with qualified 
researchers to help facilitate product development or enhancements in research that is not 
directly related to the study objectives. The Informed Consent explains this to the study 
subject.  
13.2 Completion of Source Documents and Case Report Forms 
The nature and location of all source documents will be identified to ensure that original data 
required to complete the CRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. Site 
monitors are appointed by the study sponsor and are independent of study site staff. 
If electronic records are maintained, the method of verification must be determined in 
advance of starting the study.  
At a minimum, source documents include the following information for each subject: 
• 
Subject identification (name, sex, race, ethnicity, age) 
• 
Documentation of subject eligibility 
• 
Date of informed consent 
• 
Dates of visits 
• 
Documentation that protocol specific procedures were performed 
• 
Results of study parameters, as required by the protocol 
• 
IP accountability records 
• 
Documentation of AEs and other safety parameters (if applicable) 
• 
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• 
Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the CRF are consistent with the original source data. 

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Only designated individuals at the site will complete the CRFs. The CRFs must be completed 
at regular intervals following the clinical study visit schedule. It is expected that all data 
reported have corresponding entries in the source documents. The principal investigator is 
responsible for reviewing and certifying that the CRFs are accurate and complete. The only 
subject identifiers recorded on the CRFs will be subject number, and subject demographic 
information.  
13.3 Data Review and Clarifications 
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, additional data 
clarifications and/or additions may be needed as a result of the data cleaning process. Data 
clarifications are documented and are part of each subject’s CRF. 
13.4 Sponsor and Monitoring Responsibilities 
The study sponsor will select principal investigators that are qualified by education, training, 
and experience to assume responsibility for the proper conduct of this clinical trial. For this 
study, the principal investigator must be a health care professional licensed to perform 
cataract surgery. 
The study sponsor is financially funding this clinical trial and will compensate the 
investigator and/or the Institution(s) at which the study is conducted in accordance with a 
signed clinical trial agreement. 
The study sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals according to the study monitoring plan. The clinical investigation will 
be monitored to ensure that the rights and well-being of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 
is conducted in compliance with the current approved protocol (and amendments[s], if 
applicable), with current GCP, and with applicable regulatory requirements. 
The site may not screen subjects or perform the informed consent process on any subject until 
it receives a notification from an appropriate study sponsor representative that the site may 
commence conducting study activities. Monitoring will be conducted periodically while the 
clinical study is ongoing. Monitoring methods may include site visits, telephone, written, and 
fax correspondence. Close-out visits will take place after the last visit of the last subject at the 
site. 

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Videos of surgery should be maintained with subject records for verification as source data 
and sent to sponsor for review as requested. Such data will be coded with a subject number 
only and will not contain subject personal information.  
A coordinating investigator may be identified by the study sponsor to review and endorse the 
final study report. In cases where a coordinating investigator is engaged, the study sponsor 
will select the coordinating investigator based upon their experience, qualifications, active 
study participation, and their willingness and availability to take on this role. 
13.5 Regulatory Documentation and Records Retention 
The investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the study sponsor and the investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately.  
Additionally, the investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the study sponsor. If the investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the study sponsor must be notified, and suitable arrangements made for retention of 
study records and source documents needed to comply with national and international 
regulations. 
13.6 Quality Assurance and Quality Control 
The study sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 

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and auditing by the study sponsor, and inspection by domestic and foreign regulatory 
authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. Agreements made by the study sponsor 
with the investigator/institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement. 
14 ETHICS 
Investigations are conducted in compliance with Good Clinical Practices; international and 
national regulations, laws and guidelines; ISO 14155; the conditions of approval imposed by 
reviewing IRBs/IECs or regulatory authorities; and in accordance with the ethical medical 
research principles outlined in the Declaration of Helsinki.  
• 
The SOPs of the study sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations shall apply.  
• 
Notifications and timelines for reporting protocol deviations should be based upon 
applicable IRB/Ethics Committee requirements. 
The investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. The investigator is not allowed to deviate from the protocol 
except to protect the rights, safety, and well-being of human subjects under emergency 
circumstances. Emergency deviations may proceed without prior approval of the sponsor and 
the IRB/IEC but shall be documented and reported to the sponsor and the IRB/IEC as soon as 
possible. Deviations from this protocol, regulatory requirements, and/or GCP must be 
recorded and reported to the Sponsor prior to database lock. If needed, corrective and 
preventive action should be identified, implemented, and documented within the study 
records. Failure to implement identified corrective and preventative actions may result in site 
closure by the sponsor. Use of waivers to deviate from the clinical protocol is prohibited. 
Before clinical study initiation, this protocol, the informed consent form, if applicable, any 
other written information given to subjects, and any advertisements planned for subject 
recruitment must be approved by an IRB/IEC. The investigator must provide documentation 
of the IRB/IEC approval to the study sponsor. The approval must be dated and must identify 
the applicable protocol, amendments (if any), informed consent form, assent form (if any), all 
applicable recruiting materials, written information for subject, and subject compensation 
programs. The IRB/IEC must be provided with a copy of the Investigator’s Brochure, any 
periodic safety updates, and all other information as required by local regulation and/or the 

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IRB/IEC. Any additional requirements imposed by the IRB/IEC or regulatory authority shall 
be followed. At the end of the study, the investigator must notify the IRB/IEC about the 
study’s completion. The IRB/IEC also must be notified if the study is terminated prematurely. 
Finally, the investigator must report to the IRB/IEC on the progress of the study at intervals 
stipulated by the IRB/IEC. 
Voluntary informed consent must be obtained in writing from every subject. The obtaining of 
consent shall be documented before any procedure specific to the clinical investigation is 
applied to the subject.  
The investigator must have a defined process for obtaining the required consent. Specifically, 
the investigator, or their delegate, must explain the clinical study to each potential subject and 
the subject must indicate voluntary consent by signing and dating the approved informed 
consent form. The subject must be provided an opportunity to ask questions of the 
investigator, and if required by local regulation, other qualified personnel. The investigator 
must provide the subject with a copy of the consent form written in a language the subject 
understands. The consent document must meet all applicable local laws and provide subjects 
with information regarding the purpose, procedures, requirements, and restrictions of the 
study, along with any known risks and potential benefits associated with the IP and the study, 
the available compensation, and the established provisions for maintaining confidentiality of 
personal, protected health information. Subjects will be told about the voluntary nature of 
participation in the study and must be provided with contact information for the appropriate 
individuals should questions or concerns arise during the study. The subject also must be told 
that their records may be accessed by appropriate authorities and sponsor-designated 
personnel. The investigator must keep the original, signed copy of the consent (file in 
subject’s medical records) and must provide a duplicate copy to each subject according to 
local regulations.  
The investigator must have a defined process in case a subject would like to withdraw their 
consent(s). The investigator is the designated contact point for any such withdrawals. 
The investigator must have a defined process in case a subject would like to exercise any of 
their rights under applicable Data Protection laws. The investigator is the designated contact 
point for any such requests. 
The sponsor will secure a human clinical trial insurance certificate according to applicable 
country regulations when required.  

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The study sponsor assures that the key designs of this protocol will be registered on public 
databases where required by current regulations, and, as applicable, results will be posted.   
15 REFERENCES 
15.1 Regulations and Standards 
The following references may be applicable in whole or in part for this clinical trial. 
• 
EN ISO 14155:2020 - Clinical Investigation of Medical Devices for Human Subjects - 
Good Clinical Practice 
• 
EU MDR: Regulation (EU) 2017/745 of the European Parliament and of the Council 
• 
21 CFR Part 11 - Electronic Records; Electronic Signatures 
• 
21 CFR Part 50 - Protection of Human Subjects 
• 
21 CFR Part 56 - Institutional Review Boards 
• 
21 CFR Part 812 - Investigational Device Exemptions 
• 
21 CFR Part 54 - Financial Disclosure by Clinical Investigators 
• 
The California Bill of Rights, if applicable 
15.2 Scientific and Other References 
American Academy of Ophthalmology (AAO). Cataract in the Adult Eye Preferred Practice 
Pattern. AAO Journal. 2016. Accessed June 21, 2021. Cataract in the Adult Eye Preferred 
Practice Pattern® (aaojournal.org) 
American Academy of Ophthalmology. What to Expect: The Practice of Ophthalmology. 
Retrieved from: Ophthalmic Practice - American Academy of Ophthalmology (aao.org). 
2023. Accessed July 07, 2023. 
Chen D, Zhu J, Li J, Ding XX, Lu F, Zhao YE. Effect of simulated dynamic intraocular 
pressure on retinal thickness measured by optical coherence tomography after cataract 
surgery. Int J Ophthalmol. 2012;5(6):687-93. 
Findl O, Strenn K, Wolzt M, et al. Effects of changes in intraocular pressure on human ocular 
haemodynamics. Curr Eye Res. 1997 Oct;16(10):1024-9. 
Hou CH, Lee JS, Chen KJ, Lin KK. The sources of pain during phacoemulsification using 
topical anesthesia. Eye (Lond). 2012 May;26(5):749-50. 

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Lundström M, Barry P, Henry Y, Rosen P, Stenevi U. Evidence-based guidelines for cataract 
surgery: guidelines based on data in the European Registry of Quality Outcomes for Cataract 
and Refractive Surgery database. J Cataract Refract Surg. 2012 Jun;38(6):1086-93.  
Market Scope, LLC. Cataract Surgical Equipment Market Report, Global Analysis for 2021 
to 2027. July 2022. Market Scope (market-scope.com) 
Masket S, Rorer E, Stark W, Holladay JT, MacRae S, Tarver ME, Glasser A, Calogero D, 
Hilmantel G, Nguyen T, Eydelman M. Special Report: The American Academy of 
Ophthalmology Task Force Consensus Statement on Adverse Events with Intraocular Lenses. 
Ophthalmology. 2017 Jan;124(1):142-144. 
National Eye Institute. NEI charts a clearer future for cataract prevention and treatment. 
2017. Accessed Jul 19, 2023. NEI charts a clearer future for cataract prevention and treatment 
| National Eye Institute (nih.gov) 
National Eye Institute. Cataracts| National Eye Institute. 2023. Accessed July 07, 2023. 
Cataracts | National Eye Institute (nih.gov) 
Suzuki H, Oki K, Shiwa T, Oharazawa H, Takahashi H. Effect of bottle height on the corneal 
endothelium during phacoemulsification. J Cataract Refract Surg. 2009 Nov;35(11):2014-7. 
Takhtaev YV, Kiseleva TN, Shliakman B. The effect of preset intraoperative intraocular 
pressure during phacoemulsification on the blood flow velocity in the central retinal artery. 
Ophthalmology Reports. 2019;12(4):5-12. 
World Health Organization. Blindness and Vision Impairment. Retrieved from: Blindness and 
vision impairment (World Health Organization (WHO)). 13 Oct 2022. Accessed July 7, 2023.