A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs
Phase: NA
Conditions: Aphakia
Sponsor: Alcon Research



Page 2 of 78
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 Practice (GCP), the 
ethical principles contained within the Declaration of Helsinki, this protocol, all 
applicable regulatory authority regulations, and conditions of approval imposed by the 
reviewing IRB or regulatory authority.

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:
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8.4
Rescreening of Subjects ....................................................................................39
9
TREATMENTS ADMINISTERED...................................................................................39
9.1
Investigational Product(s)..................................................................................39
9.3
Treatment Administration..................................................................................48
9.4
Treatment Assignment / Randomization ...........................................................48
9.5
Treatment Masking............................................................................................49
9.6
Accountability Procedures.................................................................................50
9.7
Changes to concomitant medications, treatments/ procedures..........................51
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................51
10.1
Informed Consent and Screening ......................................................................51
10.2
Visits and Examinations ....................................................................................52
10.2.1
Visit 0: Preoperative Screening Visit (-28 - 0 Days Prior to Visit 
00)......................................................................................................52
10.2.2
Visit 00: Surgery Visit 1st Eye (0-28 days after Visit 0).....................53
10.2.3
Visit 1: Postoperative for 1st Eye (1-2 days after Visit 00) ................54
10.2.4
Visit 2: Postoperative for 1st Eye (7-14 days after Visit 00) ..............55
10.2.5
Visit 00A: Surgery Visit 2nd Eye (7-21 days after Visit 00) ...............55
10.2.6
Visit 1A: Postoperative for 2nd Eye (1-2 days after Visit 00A)..........55
10.2.7
Visit 2A: Postoperative for 2nd Eye (7-14 days after Visit 00A)........56
10.2.8
Visit 3A: Postoperative for Both Eyes (30-60 days after Visit 00A) .56
10.2.9
Visit 4A: Postoperative for Both Eyes (70-100 days after 
Visit 00A) ..........................................................................................56
10.2.10 Visit 5A: Postoperative for Both Eyes (120-180 days after 
Visit 00A) ..........................................................................................58
10.2.11 Unscheduled Visits.............................................................................58
10.3
Discontinued Subjects .......................................................................................59
10.3.1
Screen Failures ..................................................................................59
10.3.2
Discontinuations................................................................................60
10.3.3
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product.......................................60
10.3.4
Subject Lost to Follow Up.................................................................60
10.5
Clinical Study Termination................................................................................61
10.5.1
Follow-up of subjects after study participation has ended ................62
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................62
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11.1
General Information ..........................................................................................62
11.2
Monitoring for Adverse Events .........................................................................64
11.3
Procedures for Recording and Reporting ..........................................................64
11.4
Return Product Analysis....................................................................................67
11.5
Unmasking of the Study Treatment...................................................................67
11.6
Follow-Up of Subjects with Adverse Events.....................................................67
11.7
Pregnancy in the Clinical Study........................................................................68
12 ANALYSIS PLAN ............................................................................................................68
12.2
Analysis Sets .....................................................................................................68
12.3
Demographic and Baseline Characteristics.......................................................68
12.4
Effectiveness Analyses ......................................................................................68
12.4.1
Analysis of Primary Effectiveness Endpoints ...................................69
12.4.1.1
Statistical Hypotheses........................................................69
12.4.1.2
Analysis Methods ..............................................................70
12.4.2
Analysis of Secondary Effectiveness Endpoints ...............................70
12.4.2.1
Statistical Hypotheses........................................................70
12.4.2.2
Analysis Methods ..............................................................70
12.5
Handling of Missing Data .................................................................................71
12.6
Safety Analyses .................................................................................................71
12.8
Sample Size Justification...................................................................................72
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................73
13.1
Subject Confidentiality......................................................................................73
13.2
Completion of Source Documents and Case Report Forms..............................73
13.3
Data Review and Clarifications.........................................................................74
13.4
Sponsor and Monitoring Responsibilities .........................................................74
13.5
Regulatory Documentation and Records Retention ..........................................75
13.6
Quality Assurance and Quality Control.............................................................75
14 ETHICS .............................................................................................................................76
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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 .............................................20
Table 6–1
Primary Objective............................................................................................30
Table 6–2
Secondary Objectives.......................................................................................30
Table 6–4
Safety Objective...............................................................................................32
Table 9–1
Test Product .....................................................................................................40
Table 9–2
Control Product Model ZXR00 .......................................................................42
Table 9–3
Control Product Model 829MP........................................................................45
List of Figures
Figure 7–1
Study Design Diagram.....................................................................................34
Figure 11–1
Categorization of All Adverse Events..............................................................62
Figure 11–2
Categorization of All Serious Adverse Events.................................................63
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1
GLOSSARY OF TERMS
Names of Test Product
AcrySof ™IQ Vivity™Extended Vision IOL, Model 
DFT015; throughout this document, test product will be 
referred to as VIVITY.
Name of Control Products

TECNIS Symfony® Extended Range of Vision IOL 
Model ZXR00; throughout this document this control 
product will be referred to as SYMFONY.

AT LARA® extended depth of focus IOL Model 
829MP; throughout this document this control product 
will be referred to as AT LARA.
Note: Model number of device may be different if a pre-
loaded delivery system is used. It should be verified by site 
staff that the IOL contained within matches the models listed 
above. 
Adverse Device Effect
(ADE)
Adverse event related to the use of an investigational 
medical device (test product) or control product. 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 of the test product or 
control product.
Adverse Event (AE)
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). 
 
 
 
Requirements for reporting Adverse Events in the study can 
be found in Section 11.
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Anticipated Serious 
Adverse Device Effect
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has been identified in the risk 
management file.
Device Deficiency
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance. Note: 
This definition includes malfunctions, use errors, and 
inadequate labeling.
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.
Interventional Clinical Trial
A research trial that prospectively assigns, whether 
randomly or not, human participants or groups of humans to 
one or more health-related interventions to evaluate the 
effects on health outcomes, and/or a research trial in which 
diagnostic or monitoring procedures beyond standard of care 
are conducted and generate outcomes for use in analysis of 
data.
Investigational Product
Is defined as a preventative (vaccine), a therapeutic (drug or 
biologic), device, diagnostic, or palliative used as a test or 
control 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 a medical device to perform in accordance with its 
intended purpose when used in accordance with the 
instructions for use or clinical investigation plan.
Non-serious Adverse Event
Adverse event that does not meet the criteria for a serious 
adverse event.
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Postmarketing/Post-
authorization study
Any study conducted within the conditions laid down in 
product labelling and other conditions laid down for the 
marketing of the product or under normal conditions of use. 
A postmarketing study falls either within the definitions of 
an interventional or a non-interventional study and may also 
fall within the definition of a post-approval study.
Product Complaints
Any oral, electronic, or written communication that alleges 
deficiencies related to the identity (labeling), quality, 
durability, reliability, safety, effectiveness, or performance 
of a marketed product, including failure of the product, 
labeling, or packaging to meet specifications, whether or not 
the product is related to or caused the alleged deficiency. A 
complaint may allege that an adverse event or medical 
device malfunction has occurred.
Randomized Subjects
Any subject who is assigned a randomized treatment.
Serious Adverse Device 
Effect (SADE)
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event.
Serious Adverse Event 
(SAE)
Adverse event that led to any of the following:

Death.

A serious deterioration in the health of the subject that 
either resulted in:
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, ie, 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.
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c. in-patient hospitalization or prolonged 
hospitalization.
Note: Planned hospitalization for a pre-
existing condition, without serious 
deterioration in health, is not considered a 
serious adverse event. In general, 
hospitalization signifies that the individual 
remained at the hospital or emergency ward 
for observation and/or treatment (usually 
involving an overnight stay) that would not 
have been appropriate in the physician's office 
or an out-patient setting. Complications that 
occur during hospitalization are adverse 
events. If a complication prolongs 
hospitalization or fulfills any other serious 
criteria, the event is serious. When in doubt as 
to whether “hospitalization” occurred, the 
event should be considered serious.
d. a medical or surgical intervention to prevent 
a) or b), or 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, or a congenital abnormality or 
birth defect.
Note:  Refer to Section 11 for additional SAEs listing.
Serious Public Health 
Threat
Any event type which results in imminent risk of death, 
serious deterioration in state of health, or serious illness that 
requires prompt remedial action. This would include: Events 
that are of significant and unexpected nature such that they 
become alarming as a potential public health hazard, eg, 
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human immunodeficiency virus (HIV) or Creutzfeldt-Jacob 
Disease (CJD).
Unanticipated Serious 
Adverse Device Effect
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the risk 
management file.
Use Error
Act or omission of an act that results in a different medical 
device response than intended by manufacturer or expected 
by user. Note: This definition includes slips, lapses, and 
mistakes. An unexpected physiological response of the 
subject does not in itself constitute a use error.
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3
PROTOCOL SUMMARY
Investigational 
product type
Device
Study type
Interventional
Investigational 
products
Test Product: ACRYSOF IQ VIVITY Extended Vision IOL 
Model DFT015
Control Product: 

TECNIS SYMFONY Extended Range of Vision IOL 
Model ZXR00

AT LARA extended depth of focus IOL Model 829MP
Note: Model number of device may be different if a pre-loaded 
delivery system is used. It should be verified by site staff that the IOL 
contained within matches the models listed above.
Purpose and 
rationale
To compare the visual disturbance profile of ACRYSOF VIVITY
Extended Vision IOL Model DFT015 with those of diffractive 
extended depth of focus IOLs.
Objective(s)
Primary: 
To demonstrate superiority of VIVITY over SYMFONY or over AT 
LARA for the proportion of subjects responding “not bothered at all” 
by halos on the QUVID questionnaire (Q2.3) at 3 months post-op
Secondary:

To demonstrate superiority of VIVITY over SYMFONY or over 
AT LARA for the proportion of subjects responding “not 
bothered at all” by glare on the QUVID questionnaire (Q3.3) at 3 
months post-op

To demonstrate superiority of VIVITY over SYMFONY or over 
AT LARA for the proportion of subjects responding “not 
bothered at all” by starbursts on the QUVID questionnaire (Q1.3) 
at 3 months post-op
 
 
 
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
IOP (clinically significant change)

Slit-lamp exam findings

Dilated fundus exam findings

IOL observations 

IOL tilt/decentration

Subjective PCO assessment

Posterior capsulotomy

Intraoperative surgical problems

Other procedures at surgery (combined and/oradditional)
Assessment(s) 
Effectiveness:

QUVID subject questionnaire to assess visual disturbances
 
 
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Other Assessments:


Subjective manifest refraction

Biometry
Safety:

Adverse events (including SSIs)

Device deficiencies

Surgical Problems/Other procedures at surgery

IOP

Slit-lamp exam

Dilated fundus exam

IOL Observations, IOL Position Change (tilt/decentration)

Subjective PCO assessment, Posterior Capsulotomy
Study design
Prospective, randomized, controlled, subject and assessor-masked, 
three-arm, parallel group, bilateral implant, 6-month follow-up trial 
of VIVITY vs. SYMFONY and AT LARA IOLs.
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Sample size 
justification
Approximately 218 subjects will be enrolled to achieve 180 subjects 
who complete the study.
 
 
 
 
Key words

Cataracts

Intraocular lens 

IOL

Extended depth of focus

Presbyopia

Australia

New Zealand

Visual disturbances
 
 
 
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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), as required by the IRB/IEC.
 
 
 
 
 
 
 
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5
INTRODUCTION
5.1
Rationale and Background
Depth of focus is the amount of image displacement behind a lens that does not degrade the 
perceived image quality or in other words, the tolerance of the eye to retinal defocus 
(Wang 2006). Larger depth of focus allows sharp images of closer objects. A young, healthy 
human eye allows objects proximal to optical infinity to be in focus due to the 
accommodative power change; where as a pseudophakic eye with no accommodation must 
rely on the optical system’s depth of focus to achieve a desired range of vision. While 
subjects implanted with a monofocal IOL with negligible residual refractive error can 
experience good distance vision, quality of vision at intermediate and near is often 
insufficient to support activities of daily living without the use of spectacles. Premium IOL 
solutions, such as diffractive multifocal IOLs, can provide good intermediate and/or near 
vision, but can also result in complaints of visual disturbances. In view of this, there exists a 
medical need to provide functional vision at intermediate and near distances, while 
maintaining good distance vision and a visual disturbance profile similar to that of a 
monofocal IOL. Extended depth of focus IOLs are intended to address this need.
ANSI Z80.35 2018 defines EDF IOLs as those IOLs “whose function is the correction of 
aphakia, with extended range of focus above a defined functional visual acuity threshold to 
provide useful distance and intermediate vision with monotonically decreasing visual acuity 
from the best distance focal point.” EDF can be achieved by different optical mechanisms 
including diffractive optics; as is the case for both SYMFONY and AT LARA. While this 
optical approach has been shown to offer an extended range of vision, patients still 
experience bothersome visual disturbances at a higher rate than with a monofocal IOL 
(Symfony SSED 2016).
The VIVITY IOL incorporates a non-diffractive approach to extend the depth of focus and 
provide improved, intermediate and near vision while maintaining distance vision and a 
visual disturbance profile similar to that of an aspheric monofocal IOL (CSR for ILI875-
C002 2019). The non-diffractive wavefront shaping optic is on the anterior surface of the 
VIVITY IOL. 
 
 
 
 
. The combination of the central zone and the 
outer annular zone transfers enough distance MTF (modulation transfer function) under 
photopic conditions to provide a continuous range of extended vision. The distance MTF 
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increases with a larger aperture to improve distance contrast in dim light. VIVITY provides 
an additional benefit by not using diffractive structures that typically induce visual 
disturbances.
5.2
Purpose of the Study
This postmarket study is intended to support scientific messaging and to compare the visual 
disturbance profile of the non-diffractive VIVITY IOL to two marketed diffractive EDF 
IOLs, SYMFONY and AT LARA.
 
 
 
 
Results of the study are intended for publication and presentation at ophthalmology 
conferences globally.
5.3
Risks and Benefits
5.3.1
Known and Potential Risks
Surgical Risk 
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 surgical problems. 
 
 
 
 
 
 
 
 
 
 
 
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5.3.2
Potential Benefits
Extended depth of focus (EDF) IOLs offer increased depth of focus across a continuous range 
of vision to the recipient. Additionally, EDF IOLs have been designed to address key areas of 
patient dissatisfaction with multifocal IOLs: increased prevalence of photopic phenomena 
(eg, halos and glare) and lower contrast sensitivity (Rocha 2017, Kondylis 2019).
The VIVITY IOL is a new foldable capsular bag/posterior chamber implanted lens that is 
indicated to replace the cataractous human lens and correct aphakia with the advantage of 
providing good distance vision and improved intermediate and near vision without inducing 
visual disturbances over a monofocal IOL.
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6
STUDY OBJECTIVES
6.1
Primary Objective
Table 6–1
Primary Objective
Objective
Endpoint

To demonstrate superiority of VIVITY
over SYMFONY or over AT LARA 
for the proportion of subjects 
responding “not bothered at all” by 
halos on the QUVID questionnaire
(Q2.3) at 3 months post-op.

% of subjects not bothered at all by halos 
(QUVID)
6.2
Secondary Objectives
Table 6–2
Secondary Objectives
Objectives
Endpoints

To demonstrate superiority of VIVITY
over SYMFONY or over AT LARA 
for theproportion of subjects 
responding “not bothered at all” by 
glare on the QUVID questionnaire 
(Q3.3) at 3 months post-op.

% of subjects not bothered at all by glare
(QUVID)

To demonstrate superiority of VIVITY
over SYMFONY or over AT LARA 
for the proportion of subjects 
responding “not bothered at all” by 
starbursts on the QUVID 
questionnaire (Q1.3) at 3 months
post-op.

% of subjects not bothered at all by 
starbursts (QUVID)
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)
 
 
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Objectives
Endpoints
 
 
 
6.4
Safety Objectives
Table 6–4
Safety Objective
Objective
Endpoints

To assess safety parameters out to 
6 months post-op.

Adverse events (including SSIs)

Device deficiencies

IOP (clinically significant change)

Slit-lamp exam findings

Dilated fundus exam findings

IOL observations including IOL 
tilt/decentration

Subjective PCO assessment

Posterior capsulotomy

Intraoperative surgical problems

Other procedures at surgery (combined 
and/oradditional)
7
INVESTIGATIONAL PLAN
7.1
Study Design
This is a prospective, multi-center, randomized, parallel-group, controlled, assessor- and 
subject-masked study. Both eyes of a subject must require cataract surgery to qualify for 
enrollment into this study. To reduce bias, subjects will be randomly assigned in a 1:1:1 ratio 
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to receive either VIVITY Extended Vision IOL Model DFT015 (test article) or SYMFONY 
Extended Range of Vision IOL Model ZXR00 (control article), or AT LARA extended depth 
of focus IOL Model 829MP (control article) in both eyes. Note: Model number of control 
devices may be different if a pre-loaded delivery system is used. It should be verified by site 
staff that the IOL contained within matches the models listed above.
To further reduce bias, all subjects and site assessors will be masked to subject treatment 
assignment until the end of the study. 
The first operative eye is defined as the eye with the worse BCDVA. If the BCDVA is the 
same in both eyes, the right eye (OD) will be the first operative eye. The second eye implant 
must occur within 7-21 days of the first eye implant.
A total of 10 scheduled visits are planned and subject participation is expected to last 
6-7 months. The visits include a Screening visit (Visit 0), 2 operative visits (Visit 00 and 
Visit 00A), and 7 postoperative visits at the following intervals: Day 1-2 (Visit 1/1A), 
Day 7-14 (Visit2/2A), Day 30-60 (Visit 3A), Day 70-100 (Visit 4A), and Day 120-180 
(Visit 5A); see Figure 7-1, Study Design. 
 
 
 
 
 
 
 
 
 
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Figure 7–1
Study Design Diagram
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7.2
Rationale for Study Design 
To reduce bias this study was designed as a prospective, randomized, subject- and assessor-
masked study. The study IOLs are being used under approved indications for the intended 
population. Test procedures and inclusion/exclusion criteria will be standardized across the 
multiple sites and common Investigator training will be conducted.
 
 
 
 
 
 
.
7.3
Rationale for Duration of Treatment/Follow-Up
By 3 months post-op, refractions have typically stabilized; however, subjects will be 
followed for 6 months total in order to gather comprehensive effectiveness and safety data.
7.4
Rationale for Choice of Control Product
The comparator products, SYMFONY and AT LARA, are marketed EDF lenses in Australia 
and New Zealand.
7.5
Data Monitoring Committee
Not applicable.
8
STUDY POPULATION
The study population consists of male and female subjects (age 22 years and older) with a 
diagnosis of cataract requiring extraction. Approximately 218 subjects will be enrolled 
(consented) at up to 14 sites in Australia and New Zealand, with a target of 9-24 subjects per 
site. Site-specific targets may vary based upon individual site capabilities. Estimated time 
needed to recruit subjects for the study is approximately 6 months.
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It is expected that at least 198 subjects will be randomized and at least 180 subjects will 
complete the study as follows:

60 bilaterally implanted with VIVITY

60 bilaterally implanted with SYMFONY

60 bilaterally implanted with AT LARA
This accounts for a 10% screen failure rate and a 10% rate of subjects who are not bilaterally 
implanted with the study IOLs or are lost to follow-up.
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:
Note: When criteria are ocular, both eyes must meet criteria. 
1.
Adults, at least 22 years of age or older at the time of screening, of either gender,
diagnosed with cataract in both eyes.
2.
Planned cataract removal by routine small incision surgery.
3.
Willing and able to complete all required postoperative visits.
4.
Able to comprehend, read and write English and willing to sign an IRB/IEC approved 
statement of informed consent.
 
 
 
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8.2
Exclusion Criteria
Subjects fulfilling any of the following criteria (holistically or in either eye) 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 breast-feeding.
 
 
 
2.
Any disease or pathology, other than cataract, that (in the expert opinion of the 
Investigator) is expected to reduce the potential postoperative best corrected distance 
visual acuity 
 
 
 
 
 
 
 
 
 
 
 
 
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5.
Clinically significant ocular trauma or ocular surface disease that would affect study 
measurements based on Investigator expert medical opinion.
 
 
 
.
 
 
 
 
 
 
 
13.
Patients who desire monovision correction.
 
 
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8.4
Rescreening of Subjects
Rescreening of subjects is not allowed in this study.
9
TREATMENTS ADMINISTERED
9.1
Investigational Product(s)
Test Product(s):
ACRYSOF IQ VIVITY Extended Vision IOL 
Model DFT015
Control Product(s) (If applicable):
TECNIS SYMFONY Extended Range of Vision IOL 
Model ZXR00
AT LARA extended depth of focus IOL Model 
829MP 
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Table 9–1
Test Product
Test Product
ACRYSOF IQ VIVITY Extended Vision IOL Model DFT015
Manufacturer
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134-2099
USA
Indication for use 
and intended 
purpose in the 
current study 
The VIVITY IOL is intended for primary implantation for the visual 
correction of aphakia in adult patients with < 1.00 D of preoperative 
corneal astigmatism, in whom a cataractous lens has been removed 
by extracapsular cataract extraction. The VIVITY IOL is intended 
for capsular bag placement only. It is also indicated for refractive 
lens exchange.
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Product description 
and parameters 
available for this 
study

Optic Type: Biconvex wavefront focusing optic

Optics Material: Ultraviolet and blue light filtering Hydrophobic
Acrylate/ Methacrylate Copolymer

Optic Powers: 15.0 to 25.0 D in 0.5 D steps

Index of Refraction: 1.55

Haptic Configuration: STABLEFORCE™Modified L-Haptics

Haptic Material: Ultraviolet and blue light filtering 
Hydrophobic Acrylate/ Methacrylate Copolymer 
(Boettner 1962)

Optic Diameter (mm): 6.0

Overall Length (mm): 13.0

Haptic Angle: 0°
Formulation
N/A
Usage
IOLs are implantable medical devices and are intended for long-
term use over the lifetime of the pseudophakic subject.
Packaging 
description
Each IOL will be individually packaged and will have a unique 
serial number. The IOL package will contain the following items:

The IOL

A subject registration card (Lens Implant Card)

A subject identification card

Adhesive labels containing the IOL information and unique 
serial number

Directions on where to find the electronic package insert 
containing directions for product use
Labeling description
The test article will be supplied in a standard Alcon IOL carton. The 
carton is labeled with the following information: name of the lens, 
model number, overall diameter, optic diameter, diopter power, 
serial number, name of the manufacturer, storage conditions, 
expiration date, sterile, and single use. Each package is also labeled
with the clinical protocol number.
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Storage conditions
Refer to product Directions For Use.
The VIVITY consignment provided for the study must be stored in 
a safe, secure location with limited access separated from general 
stock. Transportation of product from one address to another must 
be documented and a Transportation Log (or similar 
documentation) utilized for appropriate accountability.
Additional 
information
N/A
Supply
The Sponsor will provide a consignment of test articles to each 
investigative site. The Investigator is responsible for maintaining 
the consignment, ensuring that an adequate number of IOLs are 
available in each dioptric power. To obtain additional IOLs, the 
Investigator must contact the Sponsor.
Table 9–2
Control Product Model ZXR00
Control Product(s)
TECNIS SYMFONY Extended Range of Vision IOL Model ZXR00
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Manufacturer
Johnson & Johnson Vision
1700 East St. Andrew Place
Santa Ana, California 92705
USA
Indication for Use
The SYMFONY IOL is indicated for primary implantation for the 
visual correction of aphakia, in adult patients with less than 1.0 D of 
pre-existing corneal astigmatism, in whom a cataractous lens has 
been removed. The lens mitigates the effects of presbyopia by 
providing an extended depth of focus. Compared to an aspheric 
monofocal IOL, the lens provides improved intermediate and near 
VA, while maintaining comparable distance VA.
Product description 
and parameters 
available for this 
study

Optic Type: Biconvex aspheric optic

Optics Material: Optically clear, soft foldable, UV-blocking 
hydrophobic acrylic

Optic Powers: For study purposes, limited to 15.0 to 25.0 D in 
0.5 D steps

Index of Refraction: 1.47

Haptic Configuration: TRI-FIX design, haptics offset from optic, 
one-piece lens

Haptic Material: Soft foldable, UV-blocking hydrophobic acrylic

Haptic Color: Clear

Optic Diameter (mm): 6.0

Overall Length (mm): 13.0

Haptic Angle: No angulation but offset from optic body
Formulation
N/A
Usage
IOLs are implantable medical devices and are intended for long-term 
use over the lifetime of the pseudophakic subject.
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Packaging 
description
Each IOL will be individually packaged in manufacturer’s packaging 
and will have a unique serial number. The IOL package will contain 
the following items:

The IOL

A subject registration card (Lens Implant Card)

A subject identification card

Adhesive labels containing the IOL information and unique 
serial number

A package insert containing directions for use
Labeling 
description
This control article will be supplied in a standard Johnson & Johnson 
Vision IOL carton. The carton is labeled with the following 
information: name of the lens, model number, overall diameter, optic 
diameter, diopter power, serial number, name of the manufacture, 
storage condition, expiration date, sterile, and single use. 
Storage conditions
Refer to product Directions For Use.
Once an IOL is designated for study use, it is considered IP and must 
be stored in a safe, secure location with limited access separated 
from general stock. Transportation of product from one address to 
another must be documented and a Transportation Log (or similar 
documentation) utilized for appropriate accountability.
Additional 
identifying 
information
N/A
Supply
The Investigator will procure this control product. 
 
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Table 9–3
Control Product Model 829MP
Control Product(s)
AT LARA extended depth of focus IOL Model 829MP
Manufacturer
Carl Zeiss Meditec AG
Göschwitzer Straße 51-52
07745 Jena
Germany
Indication for Use
The AT LARA IOL is indicated for implantation for the visual 
correction of aphakia in patients with and without presbyopia in 
whom a cataractous lens has been removed by extracapsular cataract 
extraction, and aphakia following refractive lensectomy in
presbyopic patients.
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Product description 
and parameters 
available for this 
study

Optic Type: Diffractive aspheric

Optics Material: Hydrophilic acrylic (25%) water content with 
hydrophobic surface properties

Optic Powers: For study purposes, limited to 15.0 to 25.0 D in 
0.5 D steps

Index of Refraction: 1.49

Haptic Configuration: 4-haptic

Haptic Material: Hydrophilic acrylic (25%) water content with 
hydrophobic surface properties

Haptic Color: Clear

Optic Diameter (mm): 6.0

Overall Length (mm): 11.0

Haptic Angle: 0o plate haptic
Formulation
N/A 
Usage
IOLs are implantable medical devices and are intended for long-
term use over the lifetime of the pseudophakic subject.
Packaging 
description
Each IOL will be individually packaged in manufacturer’s 
packaging and will have a unique serial number. The IOL package 
will contain the following items:

The IOL

A subject registration card (Lens Implant Card)

A subject identification card

Adhesive labels containing the IOL information and unique 
serial number

A package insert containing directions for use
Labeling 
description
This control article will be supplied in a standard Zeiss IOL carton. 
The carton is labeled with the following information: name of the 
lens, model number, overall diameter, optic diameter, diopter 
power, serial number, name of the manufacture, storage condition, 
expiration date, sterile, and single use. 
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Storage conditions
Refer to product Directions For Use.
Once an IOL is designated for study use, it is considered IP and
must be stored in a safe, secure location with limited access 
separated from general stock. Transportation of product from one 
address to another must be documented and a Transportation Log 
(or similar documentation) utilized for appropriate accountability.
Additional 
identifying 
information
N/A
Supply
The Investigator will procure this control product. 
 
 
 
 
 
 
 
 
 
 
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9.3
Treatment Administration
Subjects will be randomized to treatment group prior to surgery, no sooner than 10 business 
days prior to Visit 00. The lens to which the subject is randomized, must be implanted in both 
eyes. 
 
 
 
 
 
Each study surgeon will follow his/her routine cataract procedure for all study surgeries. It is 
permitted to have 1 study-trained surgeon at each site perform IOL implantations. For 
surgeons with experience prior to the start of the trial, femtosecond laser-assisted cataract 
surgery (FLACS) is permitted, however it is NOT required. The laser may ONLY be used for 
the following:

Primary and sideport incisions

Capsulorhexis

Lens fragmentation
Use of any intraoperative power assessment is not permitted during surgery.
9.4
Treatment Assignment / Randomization
Subjects will be randomized in a 1:1:1 ratio to receive treatment with the VIVITY or the 
SYMFONY or the AT LARA IOLs. 
Only after signing the ICF, will a subject be assigned a subject number by the electronic data 
capture system. 
A randomization list will be generated using a validated system that automates the random 
assignment of treatment arms to randomization numbers in the specified ratio. Subjects will 
be assigned treatment according to the randomization list uploaded in the IRT system. The 
randomization list will be generated and maintained by the Study Sponsor.
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No sooner than 10 business days of Visit 00, each eligible subject will be randomized via the 
IRT system to one of the treatment arms. The Investigator or unmasked delegate will access 
the respective system after confirming that the subject meets all the eligibility criteria. A 
randomization number will be automatically assigned to the subject according to the subject 
randomization list but will not be communicated to the site user. The IRT system will inform 
the site user of the treatment assignment.
9.5
Treatment Masking
This study is double-masked (effectiveness assessor and subject) with subjects randomized 
for bilateral implantation with one of the three studied IOLs.
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The effectiveness assessor and subject masking will be maintained throughout the conduct of 
the study until all study data is validated and final database lock occurs. 
 
 
 
 
 
 
 
 
 
9.6
Accountability Procedures
Upon receipt of test article from the Sponsor, the Investigator or delegate must conduct an 
inventory of all lenses by serial number, complete study-specific confirmation of receipt 
procedures 
 and retain any required documentation in the 
Investigator’s clinical study records. 
For all IP (test and control articles) the Investigator or delegate must maintain records of use 
and implantation for each subject throughout the study. 
 
 
 
 
 
Return to the Study Sponsor recoverable test articles associated with a device deficiency. 
Refer to Section 11 of this protocol for additional information on the reporting of device 
deficiencies 
 
At the conclusion of the study, the Investigator will be responsible for returning all used and 
unused study supplies (including test and control articles) as instructed by the Sponsor. 
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9.7
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 (include herbal therapies, vitamins, and all over-the-counter as well 
as prescription medications). 
Note: Throughout the subject’s participation, obtain information on any changes in 
medical health and/or the use of concomitant medications.

Alterations in dose or dose schedules for current medications, 

Any medical procedure or hospitalization that occurred or is planned

Any non-drug 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
The following section outlines the assessments performed in this clinical study. The 
Investigator is responsible for ensuring responsibilities for all procedures and assessments are 
delegated to appropriately qualified site personnel.
Assessments 
 are outlined in Table 3–1, Schedule of 
Study Procedures and Assessments. 
During the course of the study, it is possible that the window of visits may overlap; in such 
cases the subject may complete both visits on the same day at the discretion of the 
Investigator (and the data would be entered for each respective visit in EDC).
10.1 Informed Consent and Screening
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject or legally authorized representative 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.
(Note that data from exams and assessments specified in Section 10.2.1 that were completed 
within 30 days of screening can be used as per discretion of Investigator.)
Additionally, the individual obtaining consent from the subject and a witness, if applicable, 
must sign and date the informed consent document. The subject should be provided with 
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enough time for his/her decision on participation in the study, and should have options to 
discuss with his/her family members or relatives about the participation in the investigation.
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. Note that the applicable privacy regulation requirements must 
be met.
10.2 Visits and Examinations
Data from the Investigator’s previous routine clinical evaluation (ie, slit-lamp examination, 
dilated fundus examination, IOP, biometry and keratometry) may fulfill Visit 0 requirements, 
if the data comply with the following:
1. meet the conditions of this protocol 
2. apply for all 3 IOLs being tested; and 
3. were collected within 30 days of screening.
10.2.1
Visit 0: Preoperative Screening Visit (-28 - 0 Days Prior to Visit 
00)
1. After the subject signs the consent, assess inclusion/exclusion criteria. The subject must
meet all inclusion criteria and must not meet any exclusion criteria prior tosurgery.
2. Obtain the subject’s demographic information (including age, race and sex), 
medical/ocular history within 30 days prior to signing the ICF, and concomitant 
medications for ocular and non-ocular conditions used by the subject at the time of the
visit.
3. Perform a urine pregnancy test, IF the subject is a woman 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).
4. Adjust room to photopic lighting for distance (4m).
5. Perform manifest refraction (OD, OS).
6. Measure and record monocular BCDVA at 4 m (OD, OS).
7. Measure optical keratometry and optical biometry according to the Investigator’s 
standard of care noting all available measurements including corneal thickness, crystalline 
lens thickness, white-to-white, anterior chamber depth (ACD) and axial length (AL).
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8. Select and document the subject’s required lens power for each of the 3 IOLs (VIVITY, 
SYMFONY and AT LARA). 
 
 
  
 
.
 
 
 
9. Perform slit-lamp examination of the anterior segment of botheyes.
 
 
10. Subject questionnaires completed: QUVID 
 
 
 
13. Perform a dilated fundus examination of both eyes. Note: if this exam was completed on 
this subject ≤30 days prior to the date of screening that data may be used (per the 
Investigator’s discretion) and this test is not required to be repeated.
14. Record any adverse events.
15. Ensure that all inclusion/exclusion criteria have been met and that all preoperative 
screening assessments have been performed. Upon meeting eligibility criteria, subjects 
will be scheduled for surgery.
NOTE: The eye with the worse BCDVA will be the first eye implanted. If the distance BCDVA 
in both eyes is the same, the right eye (OD) will be implanted first.
10.2.2
Visit 00: Surgery Visit 1st Eye (0-28 days after Visit 0)
1. In preparation for the operative visit, randomize the subject. It is recommended that 
subjects are contacted prior to randomization to 1) confirm willingness to continue trial
participation, and 2) confirm scheduled surgical date and time.
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.
2. Record operative eye.
3. Record changes in medical/ocularhistory and concomitant medications for ocular and 
non-ocular conditions.
4. Verify inclusion/exclusion criteria. Subjects must meet all requirements to proceed to 
surgery.
5. Prepare subject for surgery in accordance to site specific operating procedures and ensure 
that all IOL power calculations have been completed.
6. Perform surgery and implantation with the IOL to which the subject was randomized.
7. Record any surgical problems, complications, or other procedures (including SSIs) that
occurred during surgery. Other procedures include those performed outside of routine 
cataract surgery. Other planned procedures at the time of surgery are exclusionary.
8. Record final incision size.
9. Record lens information that is located on the IOL sticker. Both successful andaborted 
(if applicable) test and control article information should be recorded.
10. Assess if any IOL damage has occurred. If an IOL is damaged/defective and not 
implanted, it must be returned to the respective manufacturer as a device deficiency.
11. Record any surgical problems, complications or secondary surgical interventions for 
the operative eye, if applicable.  
12. Record any adverse events.
13. Record any device deficiencies.
10.2.3
Visit 1: Postoperative for 1st Eye (1-2 days after Visit 00)
1. Record changes in medical/ocular history and concomitant medications for ocular and 
non-ocular conditions.
2. Perform slit-lamp examination of the anteriorsegment. Note that only unmasked site 
staff can perform slit-lamp exam.
3. Record IOL observations, if any.
4. Record lens decentration and/or tilt, ifapplicable. 
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5. Record subjective posterior capsule opacification and information for any posterior 
capsulotomy that has occurred since surgery, if applicable for operative eye.
6. Perform tonometry to measure the intraocular pressure.
7. Record secondary surgical interventions that have occurred since surgery, ifapplicable.
8. Record any adverse events.
9. Record any device deficiencies, if applicable.
10.2.4
Visit 2: Postoperative for 1st Eye (7-14 days after Visit 00)
1. Record changes in medical/ocular history and concomitant medications for ocular and 
non-ocular conditions.
2. Adjust room to photopic lighting for distance at 4 m.
3. Perform manifest refraction at 4 m.
5. Perform slit-lamp examination of the anteriorsegment.
 
6. Record IOL observations, if any.
7. Record lens decentration and /or tilt, ifapplicable. 
8. Record subjective posterior capsule opacification and information for any posterior 
capsulotomy that has occurred since surgery, if applicable for operative eye.
9. Perform tonometry to measure the intraocular pressure.
10. Record secondary surgical interventions that have occurred since surgery, ifapplicable.
11. Record any adverse events (both volunteered and elicited).
12. Record any device deficiencies, if applicable.
10.2.5
Visit 00A: Surgery Visit 2nd Eye (7-21 days after Visit 00)
Follow all procedures listed in Section 10.2.2, starting with Step 2, for the 2nd operative eye.
10.2.6
Visit 1A: Postoperative for 2nd Eye (1-2 days after Visit 00A)
Follow all procedures listed in Section 10.2.3 for the 2nd operative eye.
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10.2.7
Visit 2A: Postoperative for 2nd Eye (7-14 days after Visit 00A)
Follow all procedures listed in Section 10.2.4 for the 2nd operative eye.
10.2.8
Visit 3A: Postoperative for Both Eyes (30-60 days after Visit 00A)
1. Subject questionnaires completed: QUVID,
. 
2. Record changes in medical/ocular history and concomitant medications for ocular and 
non-ocular conditions.
3. Adjust room to photopic lighting for distance at 4 m.
4. Perform manifest refraction at 4 m for each eye.
7. Perform slit-lamp examination of the anteriorsegment. Note that only unmasked site 
staff can perform slit-lamp exam.
8. Record IOL observations, if any.
9. Record lens decentration and /or tilt, ifapplicable.
10. Record subjective posterior capsule opacification and information for any posterior 
capsulotomy that has occurred since surgery, if applicable.
11. Perform tonometry to measure the intraocular pressure.
12. Record secondary surgical interventions that have occurred since surgery, ifapplicable.
13. Record any adverse events (both volunteered and elicited).
14. Record any device deficiencies, if applicable.
10.2.9
Visit 4A: Postoperative for Both Eyes (70-100 days after Visit 00A)
Note: Due to the large number of assessments and exams indicated for this visit the subject 
may be allowed to complete Visit 4A in two sessions (both occurring between 70-100 days 
after Visit 00A).
1. Subject questionnaires completed: QUVID, 
. 
2. Record changes in medical/ocular history and concomitant medications for ocular and 
non-ocular conditions
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6. Perform manifest refraction at 4 m. 
 
.
 
 
17. Measure optical keratometry and optical biometry according to the Investigator’s 
standard of care noting all available measurements including anterior chamber depth 
(ACD) and axial length (AL), corneal thickness, crystalline lens thickness and white-to-
white.
18. Perform slit-lamp examination of the anteriorsegment. Note that only unmasked site 
staff can perform slit-lamp exam.
19. Record IOL observations, if any.
20. Record lens decentration and /or tilt, ifapplicable.
21. Record subjective posterior capsule opacification and information for any posterior 
capsulotomy that has occurred since surgery, if applicable.
22. Perform tonometry to measure the intraocular pressure.
23. Record secondary surgical interventions that have occurred since surgery, ifapplicable.
24. Record any adverse events (both volunteered and elicited).
25. Record any device deficiencies, if applicable.
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1. Record changes in medical/ocularhistory and concomitant medications for ocular and 
non-ocular conditions.
2. Perform manifest refraction at 4 m.
4. Perform slit-lamp examination of the anteriorsegment of both eyes. Note that only 
unmasked site staff can perform slit-lamp exam except in cases of medical emergency.
5. Record IOL observations, if any for the operative eye(s).
6. Record lens decentration and/or tilt, ifapplicable.
7. Record subjective posterior capsule opacification and information for any posterior 
capsulotomy that has occurred since surgery, if applicable for operative eye(s).
8. Perform tonometry to measure the intraocular pressure of botheyes.
9. Perform a dilated fundus examination of both eyes.
10. Record secondary surgical interventions for the operative eye(s) that have occurred
since surgery, if applicable.
11. Record any adverse events (both volunteered andelicited).
12. Record any device deficiencies, if applicable.
 
 
 
 
10.3 Discontinued Subjects
10.3.1
Screen Failures
Subjects who were excluded from the study after signing the informed consent and prior to 
randomization are considered screen failures. The Investigator must document the reason for 
screen failure in the subject’s case history source documents.
Subject numbers must not be re-used.
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10.3.2
Discontinuations
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the Investigator after randomization.
Subject numbers of discontinued subjects must not be re-used.
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.
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.
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.
10.3.3
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product 
Subjects who discontinue IP (ie, have study lens explanted), will continue in the study
through Visit 5A and be followed for safety. At minimum, safety examinations must include
the assessments associated with appropriate medical care. Standard post-surgical assessments 
are bulleted below:

UCDVA and/or BCDVA

Slit-lamp Examination

Dilated Fundus Examination
10.3.4
Subject Lost to Follow Up
If a subject unavoidably misses a scheduled exam, he/she should be rescheduled within the 
same exam period. The investigational site should show diligence in trying to schedule the 
subject for all exams. The site must document all attempts to contact the subject in the 
subject’s chart, including dates, times, method of contact, etc. If a subject is unable to return 
for the Final Study Visit, the Exit Case Report Form should be completed with the 
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appropriate reason for discontinuation indicated. If attempts to contact the subject are 
unsuccessful, then the Exit Case Report Form for that subject is completed after the last 
window closes and documented as Lost to Follow-up. The date at which the subject was 
considered lost to follow-up should also be recorded.
 
 
 
 
 
 
10.5 Clinical Study Termination
The Study Sponsor reserves the right to close the investigational site 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 post-study treatment options 
as needed.
The Investigator may terminate the site’s participation in the study for reasonable cause.
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Device Deficiencies
A device deficiency may or may not be associated with subject harm (ie, 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 subject 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:

“Have you had any health problems since your last study visit?”

“Have there been any changes in the medicines you take since your last study visit?”
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.
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 (ie, before informed 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
History section of the eCRF. 
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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 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
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 (ie, 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 AE that is 
upgraded from non-serious to serious or from unrelated to related.
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11.4 Return Product Analysis 
Study Sponsor representatives and their contact information are provided i
 
Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # 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
Masked information on the identity of the assigned medical device should not be disclosed 
during the study.
 
 
 
 
 
 
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 subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock). 
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.
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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
 
 
12.2 Analysis Sets
The primary analysis set for effectiveness analyses will be the All-Implanted Analysis Set 
(AAS). AAS includes all eyes with successful study IOL implantation. 
 
 
 
 
 
 
Safety Analysis Set includes all eyes that had contact with a study IOL (successful or aborted 
implant).
12.3 Demographic and Baseline Characteristics
Demographic and baseline characteristics will be summarized by IOL group and overall 
using descriptive statistics based on the type of variable. For categorical variables summary 
statistics will include sample size, number in category, and % in each category. For 
continuous variables, number of subjects/eyes, mean, median, standard deviation, minimum, 
and maximum will be reported.
12.4 Effectiveness Analyses
Each effectiveness hypothesis will be tested independently for each of the following IOL 
groups 1) VIVITY vs. SYMFONY, and 2) VIVITY vs. AT LARA. There will be no 
comparison between the two non-Alcon comparators.
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.
12.4.1
Analysis of Primary Effectiveness Endpoints
The primary endpoint is the percent (%) of subjects not bothered at all by halos as reported 
by the subject using the QUVID questionnaire at 3 months.
12.4.1.1 Statistical Hypotheses
The primary effectiveness objective is to demonstrate the superiority of Vivity to Symfony or 
AT LARA in % of subjects not bothered at all by halos at 3 months post-bilateral 
implantation.
The null and alternative hypotheses in support of the primary effectiveness objective are:
H0: pVivity < pComparator
HA: pVivity > pComparator
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Where pvivity and pcomparator refer to the percent of subjects not bothered at all by haloes in the 
VIVITY group and the comparator groups respectively. The two comparator groups are 
SYMFONY and AT LARA.
12.4.1.2 Analysis Methods
The superiority hypothesis for each comparator will be evaluated using a two-sample test of 
proportions. The null hypothesis is rejected if the 1-sided p-value is less than 0.0125. Primary 
analysis will be based on AAS. 
12.4.2
Analysis of Secondary Effectiveness Endpoints
The secondary effectiveness endpoints are:

% of subjects not bothered at all by glare (QUVID)

% of subjects not bothered at all by starbursts (QUVID)
12.4.2.1 Statistical Hypotheses
If the primary null hypothesis is rejected, the following null and alternative hypothesis for the 
secondary endpoints will be tested independently for each comparator in the order of glare, 
then starburst, if glare is successful:
H0: pVivity < pComparator
HA: pVivity > pComparator
Where pvivity and pcomparator refer to the percent of subjects not bothered at all by haloes in the 
VIVITY group and the comparator groups respectively. The two comparator groups are 
SYMFONY and AT LARA.
12.4.2.2 Analysis Methods
The superiority hypothesis for each comparator will be evaluated using a two-sample test of 
proportions. The null hypothesis is rejected if the 1-sided p-value is less than 0.0125. Primary 
analysis will be based on AAS. 
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12.5 Handling of Missing Data
There will be no imputation for missing data.
12.6 Safety Analyses
The safety endpoints are:
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
Adverse events (including SSIs) 

Device deficiencies 

IOP (clinically significant change) 

Slit-lamp exam findings

Dilated fundus exam findings

IOL observations including IOL tilt/decentration 

Subjective PCO assessment 

Posterior capsulotomy 

Intraoperative Surgical problems 

Other procedures at surgery (combined and/or additional)
There are no safety hypotheses for this study. For all safety measures, descriptive statistics 
generated will be based upon the type of variable. For categorical variables summary 
statistics will include sample size, number in category, and % in each category. For 
continuous variables, number of subjects/eyes, mean, median, standard deviation, minimum, 
and maximum will be reported.
 
 
 
 
12.8 Sample Size Justification
Approximately 218 subjects will be enrolled to achieve 180 subjects who complete the study.
 
 
 
 
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13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS
13.1 Subject Confidentiality
The Investigator must ensure that the subject’s anonymity is maintained throughout the 
course of the study. In particular, the Investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. 
 
. All documents submitted 
to the Study Sponsor will identify the subjects exclusively by number and demographic 
information. No other personally identifying information will be transmitted to the Study 
Sponsor.
 
 
 
 
 
 
 
 
 
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. 
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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 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 
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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.
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.
 
 
 
 
 
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 
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 
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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
This clinical study must be conducted in accordance with the ethical principles contained 
within: 

The Declaration of Helsinki, and in compliance with the ICH E6 GCP Consolidated 
Guideline, ISO 14155:2011, and the applicable US FDA 21 CFR Regulations. 

Notification of Intent to Supply Unapproved Therapeutic Goods under Clinical Trial 
Notification (CTN) Scheme (May 2011).

SOPs of the Study Sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations. 

Notifications and timelines for reporting protocol deviations should be based upon
applicable IRB/IEC 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. 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. Use of waivers to deviate from the clinical protocol is prohibited.
Before clinical study initiation, this protocol, the informed consent form, 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 Package Insert, any periodic safety updates, 
and all other information as required by local regulation and/or the IRB/IEC. 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.
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Voluntary informed consent must be obtained in writing from every subject and the process 
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 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. 
 
 
 
 
 
 
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Signature Page for V-CLN-0003092 v2.0
Signature Page for V-CLN-0003092 v2.0