Evaluation of Long-term Safety and Performance of AcrySof PanOptix Trifocal & PanOptix Trifocal Toric Intraocular Lens (IOL)
Phase: NA
Conditions: Aphakia, Astigmatism, Presbyopia
Sponsor: Alcon Research

 
 
 
 
 
Evaluation of Long-Term Safety and Performance of 
AcrySof PanOptix Trifocal and PanOptix 
Toric Trifocal IOLs 
 
 
 
STUDY ID 
 
ILH297-I001 
 
 
Protocol v.3 
18-Mar-2025 
 
 
NCT06166901 

 
 
 
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Evaluation of long-term safety and performance of AcrySof PanOptix 
Trifocal & PanOptix Toric Trifocal Intraocular Lens (IOLs) 
Version 3.0 / 18 March 2025 
Sponsor: 
Alcon Research LLC 
6201 South Freeway 
Fort Worth, Texas 76134 
 
Study Product: 
AcrySof IQ PanOptix Trifocal and AcrySof IQ PanOptix 
Trifocal Toric IOLs 
 
Protocol Identifiers: 
ILH297-I001 
 
 
Sponsor Approval: 
 
_________________________________________ 
____________________ 
 
Date 
 
_________________________________________ 
____________________ 
 
 
Date 
 
CONFIDENTIAL 
This document is confidential and the property of Alcon Research LLC. This document contains 
confidential information and is limited in its distribution to Investigators, Ethics Committees and 
Competent Authorities only. Copying of the confidential information is not permitted without the 
written approval of the Sponsor. 

 
 
 
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STATEMENT OF COMPLIANCE 
This document is a protocol for a human research study. This study will be conducted in 
accordance with ethical principles that have their origin in the Declaration of Helsinki and 
according to international standards of Good Clinical Practice (GCP), applicable government 
regulations and Institutional research policies and procedures. 
All individuals responsible for the design and conduct of this study have completed Human 
Subjects Protection Training and are qualified to be conducting this research prior to the 
enrollment of any subjects. 
As Principal Investigator, I agree to conduct this clinical study in accordance with the design and 
specific provisions of this protocol. Modifications to the study are acceptable only with an 
approved protocol amendment. I agree to obtain approval from the Institutional Review Board 
(IRB)/Independent Ethics Committee (IEC) and/or regulatory bodies of competent jurisdiction, 
for the protocol and informed consent before initiating the study, to obtain consent from subjects 
prior to their enrollment in the study, to collect and record data as required by this protocol and 
case report forms, to prepare adverse event and study reports as required by this protocol, to 
provide documentation of my experience and qualifications to the Sponsor, to disclose any relevant 
financial interests or agreements related to the Sponsor or the investigation and to maintain study 
documentation for the period of time required. 
I agree to personally conduct or supervise the described investigation. I agree to maintain adequate 
and accurate records and to make those records available for inspection by the Sponsor, its 
representatives, applicable regulatory authorities, and the IRB/IEC. I agree to ensure that the 
confidential information contained in this document will not be used for any other purpose other 
than the evaluation or conduct of the clinical investigation without the prior written consent of the 
Sponsor. 
I certify that I have not been terminated from an investigation due to compliance failure 
(debarment). 
 
_________________________________________ 
____________________ 
Signature 
Date (DD MMM YYYY) 
 
_________________________________________ 
Print Name/Title of Principal Investigator 

 
 
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CONFIDENTIALITY STATEMENT 
The information contained in this document, especially unpublished data, is the property of 
Sponsor and therefore is confidential and may not be disclosed unless such disclosure is required 
by law or regulation. That Sponsor confidential information may be disclosed to the 
Investigator(s), potential Investigator(s) and necessary Investigator assistant(s) or study personnel. 
In any event, persons to whom the information is disclosed must be informed that the information 
is privileged or confidential and may not be further disclosed by them without written authorization 
from Sponsor. These restrictions on disclosure will apply equally to all future information supplied 
to the Investigator(s), potential Investigator(s) and necessary Investigator assistant(s) or study 
personnel, which is indicated as privileged or confidential. 
 

 
 
 
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LIST OF TABLES 
Table 1. 
Study Devices ......................................................................................................... 15 
Table 2. 
Targeted Medical History ....................................................................................... 22 
Table 3. 
Schedule of Events ................................................................................................. 29 
 
LIST OF FIGURES 
Figure 1. 
Overall Study Design ............................................................................................. 16 
Figure 2. 
Categorization of All AEs ...................................................................................... 33 
Figure 3. 
Categorization of All SAEs .................................................................................... 33 
 

 
 
 
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ABBREVIATIONS 
Abbreviation 
Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
BCDVA 
Best Corrected Distance Visual Acuity 
CFR 
Code of Federal Regulations 
CME 
Cystoid Macular Edema 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
D 
Diopter 
DCIVA 
Distance corrected intermediate visual acuity 
DCNVA 
Distance corrected near visual acuity 
DFE 
Dilated Fundus Examination 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EU 
European Union 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
GPCMS 
Global Product Complaint System 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICH 
International Conference on Harmonization 
ICF 
Informed consent form 
IDE 
Investigational Device Exemption 
IEC 
Independent Ethics Committee 
IOL 
Intraocular Lens 
IOP 
Intraocular Pressure 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
logMAR  
Logarithm of the minimum angle of resolution 
LRI 
Limbal Relaxing Incision 
m 
Meter 
MDR 
Medical Device Regulation 
MRSE 
Manifest Refraction Spherical Equivalent 
PCO 
Posterior Capsule Opacification 
PMCF 
Post-Market Clinical Follow-Up 
 
 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedures 
UADE 
Unanticipated Adverse Device Effect  
UCDVA 
Uncorrected distance visual acuity 
UCIVA 
Uncorrected intermediate visual acuity 
UCNVA 
Uncorrected near visual acuity 
UV 
Ultraviolet 

 
 
 
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Abbreviation 
Definition 
VA 
Visual Acuity 
 

 
 
 
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1 
STUDY CONTACT INFORMATION 
1.1 
Sponsor Contact Information 
1.2 
Coordinating Principal Investigator Contact Information  
The Coordinating Principal Investigator and coordinating institution will be listed in an attachment 
listing all participating sites. 
1.3 
Key Study Personnel 
1.3.1 
Clinical Study Monitor 
The clinical study will be monitored by: 
ICON Clinical Research 
South County Business Park 
Leopardstown 
Dublin 18, Ireland 
Clinical monitors will be assigned based on therapeutic area familiarity and availability. 
1.3.2 
Global Medical Safety 
Medical safety oversight will be provided by Alcon Global Medical Safety Representatives. 
1.3.3 
Statistician 
Biostatistical analysis will be provided by the ICON Clinical Research Biostatistics group. 

 
 
 
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2 
INTRODUCTION / BACKGROUND AND RATIONALE 
After removing the crystalline lens, an intraocular lens (IOL) is implanted in the capsular bag. All 
the study devices are indicated for primary implantation for the visual correction of aphakia and 
presbyopia in adult patients with or without corneal astigmatism. The AcrySof IQ PanOptix and 
PanOptix Toric IOL Family models in this PMCF study have been on the market since 2015 and 
have a well-established safety and performance profile. Based on clinical evidence available, there 
are no uncertainties concerning residual risks, performance limitations, or need for preventative 
and/or corrective actions. However, review of clinical data available based on MEDDEV 2.12-
2:2012, Section 5, and MDCG 2020-7 EU 2017/745 identified a need for longer term safety and 
performance outcomes ( 3 years) for the AcrySof PanOptix family of IOLs including the AcrySof 
IQ PanOptix Trifocal and PanOptix IQ Trifocal Toric IOLs. This proactive PMCF study will 
provide a comprehensive assessment of the long-term safety and performance of the included 
IOLs. 
The ambispective design is justified based on the risk-profile of the device, in order to 
expeditiously obtain long term safety and performance data which best reflects the current standard 
of care. An uncontrolled design is also justified as the purpose of the study is to assess long term 
safety and performance over time. The study population aligns with our indications for the AcrySof 
IQ PanOptix and PanOptix Toric IOL Family by only recruiting subjects 18 years of age and 
bilaterally implanted with AcrySof IQ PanOptix and PanOptix Toric IOL Family for the visual 
correction of aphakia and treatment of the effects of presbyopia. Study endpoints focus on the 
safety and performance criteria identified from the AcrySof IQ PanOptix Trifocal Intraocular 
Lenses State of the Art 
 The ability of this study to provide long-term 
follow-up data is supported by the ISO 11979- 7:2018(E). ISO 11979-7-2018 defines long-term 
follow-up studies ranging from 1 year for most posterior chamber IOLs to 3 years for an 
accommodating IOL only if long term safety and effectiveness concerns. In this case, the most 
restrictive criteria were used and long term 3-to-5-year outcomes of the AcrySof IQ PanOptix and 
PanOptix Toric IOL Family will be obtained.  
In conjunction with current literature and continued post-market surveillance, this study will 
provide a comprehensive assessment of the long-term safety and performance of AcrySof IQ 
PanOptix family of IOLs.  

 
 
 
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5 
STUDY OBJECTIVES 
The purpose of this Post-Market Clinical Follow-up (PMCF) study is to describe the long-term 
safety and performance of the AcrySof Panoptix and AcrySof Panoptix Toric IOL models in 
subjects bilaterally implanted with these IOLs for 3 to 5 years. In addition, it will ensure the 
continued acceptability of the benefit-risk ratio and to identify possible systematic misuse or off-
label use of the device.  
6 
STUDY DESIGN 
6.1 
Overview of Study Design 
This will be a multicenter, ambispective study with a retrospective chart review for preoperative, 
operative, and post-operative safety data, and a prospective visit to collect key safety and 
performance endpoints in a sample of subjects commercially implanted with the subject devices 
for at least 3-5 years in the real world. The overall study design is shown in the figure below. 
Subjects will be recruited who have bilateral implantation of the study model IOLs for 3 to 5 years 
(+/- 90 days) prior to Visit 1. 
Figure 1. 
Overall Study Design 
 
6.2 
Anticipated Duration of the Clinical Investigation 
The anticipated study duration is 8-9 months. The anticipated accrual rate is approximately 
23 subjects per month across all sites. The Sponsor reserves the right to close the investigational 
site or terminate the study in its entirety at any time. In the event the study is terminated early, 
there are no subject transitions required. When the study is completed, data and Sponsor materials 
will be returned and sites closed out with a final report to the IRB/IEC. Sponsor will inform the 
IRB/IECs of the study closure or, if applicable, study termination and reasons. 
Pre-study Lens Implantation 
Eligibility, Enrollment, and Informed 
Consent (3-5 year post-operative) 
Endpoint Assessment and Chart 
Review (Visit 1) 
Study Exit 

 
 
 
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6.3 
Evaluation Criteria / Effectiveness and Safety 
The endpoints chosen align with those identified in the AcrySof IQ PanOptix Trifocal Intraocular 
Lenses State of the Art 
Study assessments will be described in Section 
7.3. Retrospective data will be collected from the pre-operative and surgical visits and any safety 
outcomes reported prior to enrollment. Prospective data will be collected at study enrollment 3 to 
5 years (+/- 90 days) after IOL implantation.  
6.3.1 
Primary Clinical Endpoint 
6.3.1.1 
Primary Effectiveness Endpoint 
The primary effectiveness endpoint will consist of the mean binocular Best Corrected Distance 
Visual Acuity (BCDVA) at 4 m at Visit 1 (3-5 years +/- 90 days post-operative). 
6.3.1.2 
Primary Safety Endpoints 
Primary safety endpoints will be assessed at Visit 1 and from retrospective data review and will 
include the following:  
x All adverse events (AEs), including the following: 
o 
Cystoid Macular Edema (CME) 
o 
Hypopyon 
o 
Endophthalmitis 
o 
Lens dislocation  
o 
Pupillary block 
o 
Retinal detachment 
o 
Secondary Surgical Interventions (explantation/exchange/repositioning) 
x Device Deficiencies 

 
 
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6.4 
Study Population 
The study population consists of adult subjects (18 years or older) who have been bilaterally 
implanted with the study IOL models (see Section 3) for 3 to 5 years (+/- 90 days). 
The purpose of study is to describe to describe the long-term safety and performance of AcrySof 
Panoptix IOL models in a real-world setting through routine clinical practice. To fulfill the 
requirements of post-market clinical follow-up, only subjects implanted with the target IOLs will 
be recruited. Subjects will be recruited from clinical sites in the European Union (English and 
Spanish speaking countries only). The inclusion and exclusion criteria of this study are less strict 
to allow the inclusion of a real-world sample per the indication, including patients that have 
undergone either cataract surgery or refractive lens exchange. 
6.4.1 
Sample Size 
The study will recruit a total of 210 subjects for both AcrySof PanOptix IOL models to obtain 
200 evaluable subjects (n=100 non-toric and n=100 toric). A minimum of 100 subjects bilaterally 
implanted with AcrySof PanOptix non-Toric should be evaluable. In addition, a minimum of 
100 subjects with at least one eye implanted with AcrySof PanOptix Toric should be evaluable. 
Alcon will attempt to enroll all variants in the AcrySof Panoptix Toric family. ISO 22979 and 
ISO 11979-7 recommend a sample size of n=100 for IOLs where safety and performance risks can 
be adequately addressed with the sample size required of a Level B clinical investigation. 
Therefore, a target enrollment of up to 105 (enrolled) to achieve a goal of 100 evaluable subjects 
for both AcrySof Panoptix toric and non-toric models is justified by ISO standards for IOLs. Based 
on a pooled standard deviation of 0.07 logMAR and a t-distributed error, a sample size of 
100 subjects gives an expected half width of a 95% confidence interval of 0.014 logMAR. Thus, 
it can be expected with 95% confidence that the estimated mean binocular BCDVA will be within 
0.014 logMAR (< 1 letter on a logMAR visual acuity chart) of the true mean with a sample size 
of at least 100 subjects and a standard deviation of 0.07 logMAR. Descriptive results from this 
long-term RWE study are sufficient to provide a comparison to shorter term follow-up data of 
these models, and SotA safety and performance thresholds. Performance and safety outcome 
measures will be stratified by models (toric and non-toric).  
6.4.2 
Subject Recruitment 
Subjects will be recruited from the clinical practices of the participating Investigators and 
surrounding metropolitan areas. Additional advertisement is not expected to be required. 
6.4.3 
Prior and Concomitant Therapy or Medications 
Due to the nature of the study, there are no protocol-specific exclusions, precautions, or guidance 
provided regarding the use of concomitant medications or therapies. 

 
 
 
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6.4.4 
Inclusion Criteria 
Subjects will be eligible to participate in the study if all of the following conditions exist: 
1. 
Subjects must be 18 years old or older. 
2. 
Subject or legally authorized representative must be able to understand and sign an 
IRB/IEC approved informed consent form (ICF). 
3. 
Subject must have had bilateral implantation of AcrySof PanOptix or AcrySof PanOptix 
Toric models for 3 to 5 years prior to enrollment, including implantation up to 90 days 
before the 3-year timepoint and up to 90 days after the 5-year timepoint. A subject may 
have a Toric lens in one eye and a non-Toric in the fellow eye. 
4. 
Subject must have a documented medical history and required pre-operative and operative 
information available for retrospective data collection. 
6.4.5 
Exclusion Criteria 
Subjects will be excluded from participation in the study if any of the following conditions exist: 
1. 
Subject is currently participating in another investigational drug or device study. 
2. 
Subject has had corneal refractive surgery after of AcrySof PanOptix or AcrySof PanOptix 
Toric IOL implantation. 
3. 
Subject exposed to a study IOL for a minimum of 3 years (-90 days) prior to Visit 1 that 
have subsequently undergone an IOL exchange and are no longer implanted with a study 
IOL at the time of enrollment. 
4. 
Subject is pregnant or nursing at the time of enrollment. 
5. 
Childbirth after IOL implantation. 
    6.     Subject’s retrospective data were not properly documented. 
6.4.6 
Exit / Discontinuation Criteria 
Subjects will exit the study if any of the following conditions exist: 
1. 
Subject voluntarily withdraws from the study. 
2. 
Subject death. 
3. 
Subject completes the protocol.  
4. 
Subject is non-compliant with the protocol (as defined in Section 7.6) 
5. 
Subject’s well-being, in the opinion of the Investigator, would be compromised by study 
continuation. 

 
 
 
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7 
STUDY PROCEDURES 
7.1 
Informed Consent 
All subjects will be provided with a consent form describing this study and providing sufficient 
information for subjects to make an informed decision about their participation in this study. The 
Investigator or his/her representative will explain the nature of the study to the subject and answer 
all questions regarding the study. Subjects must be informed that their participation is voluntary. 
Subjects will be required to sign a statement of informed consent that meets the requirements of 
21 Code of Federal Regulations (CFR) 50, local regulations, International Conference on 
Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) 
requirements, where applicable, and the IRB/IEC or study center. The medical record must include 
a statement that written informed consent was obtained before the subject was enrolled in the study 
and the date the written consent was obtained. The authorized person obtaining the informed 
consent must also sign the ICF. Subjects must be re-consented to the most current version of the 
ICF during their participation in the study. A signed copy of the ICF must be provided to the 
subject. 
7.2 
Vulnerable Populations 
Members of vulnerable populations will not be specifically targeted for recruitment. However, the 
intended subject population may include subjects who are considered to be vulnerable by 
definition. The procedures included in this protocol are sufficient to provide the necessary human 
subjects’ welfare protections to these subjects without the need for additional procedures. 
Women of childbearing potential are not excluded from participation. Women who gave birth after 
IOL implantation or who are pregnant or nursing at the time of enrollment are excluded from 
participation. 
7.3 
Prospective Clinical Procedures and Assessments 
After obtaining informed consent and confirming eligibility, assessments will be conducted for the 
enrolled subject as described in the sections below. Retrospective data will be collected regarding 
the pre-operative, operative, and post-operative activities. All assessments and data collection are 
described in the sections below. 
7.3.1 
Demographics 
The Investigator or designee will verify that all required demographic details have been 
documented for each subject enrolled, including age, race, ethnicity, and sex.  

 
 
 
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7.3.2 
Eligibility 
Verify that all inclusion criteria listed in Section 6.4.4 are fulfilled by the subject, and that none 
of the exclusion criteria listed in Section 6.4.5 apply. 
7.3.3 
Medical History and Concomitant Medications 
Document concomitant medications (taken within the past 30 days prior to the date of surgery) 
and Medical History (within 30 days prior to the date of surgery) in the subject source documents 
(i.e., subject's chart). 
Any medical condition that has a start date preceding surgery and implantation of the study model 
IOLs (surgery date) will be captured as medical history. Any medical condition that started 
from/after surgery and implantation of the study model IOLs should be captured as AEs. For 
subjects with history of IOL exchange, information regarding explanted IOL model and reason for 
explantation should be extracted from chart review (if available) and recorded as medical history. 
In the electronic data capture (EDC) system, only limited information regarding concomitant 
medications and medical history will be captured, as noted below.   
x Medical History: Document all ocular history and targeted systemic history. In the EDC, 
there is a prepopulated dropdown field with items of interest that is consistent with Table 2. 
x Concomitant medications: Document all ocular medications (excluding routine cataract 
surgical medications) and targeted systemic medications used to treat conditions 
documented in Medical History and AEs. 
Table 2. 
Targeted Medical History 
Diabetes 
Sarcoidosis 
Sjogren’s Syndrome 
Autoimmune Disorder 
Multiple Sclerosis 
Hypertension 
Grave’s Disease 
Sickle Cell Disease 
Atherosclerosis 
HIV Infection 
Rheumatoid Arthritis 
 
 
7.3.4 
Manifest Refraction 
MRSE will be assessed prospectively and retrospectively from the preoperative assessment. 
Reference Attachment 17.2.3 for further details on prospective manifest refraction procedures.  

 
 
 
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7.3.5 
Binocular Uncorrected Distance Visual Acuity (UCDVA) 
For all visual acuity procedures from Section 7.3.5 to Section 7.3.11, please refer to Section 17.2.4 
(LogMAR Visual Acuity) for more specific details. Binocular UCDVA is performed for distance 
VA using ETDRS Sloan Letters Chart for 4 m provided by the Sponsor validated for the specific 
testing distance at 4 m (see Section 17.2.4). 
Note: All visual acuity testing should precede IOP measurement, the administration of eye drops 
to dilate or anesthetize the eye, or any examination requiring contact with the eye. Results of the 
binocular UCDVA should be transferred to the database in logMAR notation. 
7.3.6 
Monocular Best Corrected Distance Visual Acuity (BCDVA) 
Subjective refraction should be performed to ensure that the subject is using their best corrected 
vision to complete the BCDVA testing at each visit. Monocular BCDVA is performed for distance 
VA using ETDRS Sloan Letters Chart for 4 m provided by the Sponsor validated for the specific 
testing distance at 4 m (see Section 17.2.4). 
Note: All visual acuity testing should precede IOP measurement, the administration of eye drops 
to dilate or anesthetize the eye, or any examination requiring contact with the eye. Results of the 
monocular BCDVA should be transferred to the database in logMAR notation. 
7.3.7 
Binocular Best Corrected Distance Visual Acuity (BCDVA) 
Binocular BCDVA is performed with best distance correction using ETDRS Sloan Letters Chart 
for 4 m provided by the Sponsor validated for the specific testing distance at 4 m (see 
Section 17.2.4). 
Note: All visual acuity testing should precede IOP measurement, the administration of eye drops 
to dilate or anesthetize the eye, or any examination requiring contact with the eye. Results of the 
binocular BCDVA should be transferred to the database in logMAR notation. 
7.3.8 
Binocular Uncorrected Intermediate Visual Acuity (UCIVA) 
ETDRS Sloan Intermediate Chart for use at 66 cm with Cord will be provided by the Sponsor for 
the purposes of this study (see Section 17.2.4). To contribute data for the supportive performance 
objective of this study, enter results of binocular UCIVA at 66 cm into the study database in 
logMAR notation. 
Testing distance (for confirmation), last line attempted plus total number of letters missed will be 
recorded. 

 
 
 
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7.3.9 
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) 
Binocular DCIVA, this should be determined with best distance correction at 66 cm using the 
ETDRS Sloan Intermediate Chart for use at 66 cm with Cord supplied by the Sponsor as described 
in Section 7.3.8. The result is to be added to the study database in logMAR notation to support 
analysis of supportive performance. Testing distance (for confirmation), last line attempted plus 
total number of letters missed will be recorded. 
7.3.10 
Binocular Uncorrected Near Visual Acuity (UCNVA) 
ETDRS Sloan Standard Near Chart with Cord for use at 40 cm will be supplied by the Sponsor 
(see Section 17.2.4) to support standardization of UCNVA testing. To contribute data for the 
supportive performance objective of this study, enter results of binocular uncorrected visual acuity 
at 40 cm into the study database in logMAR notation. Testing distance (for confirmation), last line 
attempted plus total number of letters missed will be recorded. 
7.3.11 
Binocular Distance Corrected Near Visual Acuity (DCNVA) 
Binocular DCNVA, should be performed with best distance correction at 40 cm using the ETDRS 
Sloan Standard Near Chart with Cord for use at 40 cm, as described in Section 7.3.10. The result 
is to be added to the study database in logMAR notation to contribute data to the supportive 
performance analysis of this study. Testing distance (for confirmation), last line attempted plus 
total number of letters missed will be recorded. 
7.3.12 
Biomicroscopy  
Slit lamp biomicroscopy should be performed at Visit 1 and any abnormal findings should be 
recorded in the electronic case report form (eCRF). If available, retrospective post-operative data 
will be extracted from the chart review. 
Subjective PCO Including Posterior Capsulotomy 
During the slit lamp examination at Visit 1, assess the presence of PCO. 
If absent, grade as None. If present, grade as clinically non-significant, clinically significant or 
clinically significant requiring YAG according to the definitions provided below. 
x Clinically Non-significant: Early development of PCO, including fibrosis and proliferation 
of lens epithelial cells, observable by slit lamp biomicroscopy. Causes no apparent 
decrease in VA subjectively (e.g., glare) or objectively (e.g., decrease in visual acuity). 
x Clinically Significant: Increased PCO with early subjective and objective VA changes but 
does not require posterior capsulotomy. 

 
 
 
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x Clinically Significant Requiring YAG: Clinically significant PCO adversely affecting 
subject's VA and requiring posterior capsulotomy. 
For posterior capsulotomy assessment, indicate whether a posterior capsulotomy has been 
performed. If performed, report the date of the procedure. 
If subjective PCO is graded as present, also record whether it is due to residual cataract (e.g., 
posterior subcapsular cataract).  
7.3.13 
Tonometry 
Perform tonometry assessment in both eyes according to the Investigator’s standard of care. 
Record IOP. 
7.3.14 
Dilated Fundus Examination 
Dilated fundus examination includes ophthalmoscopic assessments of the vitreous, retina, macula, 
choroid, and optic nerve of both eyes. This assessment must be performed by medically qualified 
study staff. 
7.3.15 
Actual Axis of IOL Orientation 
Post-operatively, examine each toric IOL via slit lamp subjectively and document the actual IOL 
orientation in degrees (0-180 degrees) of the IOL axis (designated by the 3 indentions on each side 
of the toric IOL optic). It is recommended that a slit lamp photograph be printed and kept in the 
source. Actual axis of orientation should be completed after dilation. 
Post-operative Day 1 IOL orientation in degrees (0-180 degrees) of the IOL axis will be extracted 
from the chart review, if available. 

 
 
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7.3.18 
Adverse Events 
AEs are collected from the time of initial exposure to the study model IOL(s) and throughout the 
duration of the study. Any preexisting medical conditions or signs/symptoms present in a subject 
prior to exposure of the study model IOL(s) (i.e., before cataract surgery) are not considered AEs 
in the study and should be recorded in the Medical History section of the eCRF. See Section 9.2 
and 9.3 for further details. 

 
 
 
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7.3.19 
Device Deficiencies 
Record any Device Deficiencies that are reported or observed since the time of initial exposure to 
the study model IOL(s). Requirements for reporting device deficiencies in the study can be found 
in Section 9.  
7.4 
Retrospective Data Collection 
If available, retrospective data will be collected regarding the pre-operative, operative, and post-
operative activities, as detailed in the sections below. 
7.4.1 
Biometry and Keratometry 
Details of pre-operative biometry performed as per the standard of care will be documented from 
the chart review including information regarding the biometer model. Keratometry details will also 
be documented. If more than one set of keratometry data are documented in the source data for 
one eye (e.g., values from different measurements or devices), select those used in the IOL power 
and model selection process for entry into the study database. 
7.4.2 
Pre-Operative Manifest Refractive Error 
At the time of study entry, site staff will transfer preoperative sphere, cylinder, and axis for each 
eye to the study database (retrospective data collection based on the preoperative manifest 
refraction). 
7.4.3 
IOL Calculation Method 
At the time of study entry, sites will indicate in database, which formula was used for IOL power 
calculation as per standard of care when available (retrospective data collection). 
7.4.4 
Predicted Residual Refractive Error 
At the time of study entry, sites will document in the study database which residual refraction was 
expected after study model IOL implantation for both eyes when available. For toric IOLs, the 
predicted residual cylinder and corresponding axis should be extracted from the chart review, if 
available (retrospective data collection). 
7.4.5 
Lens Model and Refractive Power 
At the time of study entry, the lens model and refractive power selected preoperatively as per 
standard of care will be indicated in the study database (retrospective data collection). 

 
 
 
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7.4.6 
Other Surgical Procedures During Cataract or Refractive Lens Exchange Surgery 
For any additional procedures that were performed in the context of cataract or refractive lens 
exchange surgery, such as placement of capsular tension devices or creation of arcuate corneal 
incisions, these are captured in the study database for better understanding of treatment outcomes. 
This also includes any limbal relaxing incision (LRI). 
7.4.7 
Actual Axis of IOL Orientation 
If available, collect actual toric IOL orientation in degrees (0-180 degrees) of the IOL axis 
(designated by the 3 indentions on each side of the IOL optic) from the 1-day post-operative visit.  
7.4.8 
Retrospective Post-operative Visual Acuity 
If available, collect immediate post-operative visual acuity from standard of care post-operative 
visit (1-6 months post-operative) and any additional post-operative visits that may have occurred: 
manifest refraction, binocular UCDVA, monocular BCDVA, binocular BCDVA, binocular UCIVA 
at 66 cm, binocular DCIVA at 66 cm, binocular UCNVA at 40 cm, and binocular DCNVA at 40 cm. 
Enter immediate post-operative visual acuity into the study database in Snellen or logMAR 
notation. All VAs will be converted to logMAR for analysis. 
7.5 
Follow-Up Procedures and Therapy Transitions 
In this study, there are no specific follow-up procedures or therapy transitions required. Following 
study completion, subjects will return to their previous care provider. 
Alcon products associated with device deficiencies and/or product-related AEs should, if possible, 
be returned to Alcon and must include the complaint number, which will be provided by the study 
Sponsor after the case is entered in the study Sponsor’s Global Product Complaint Management 
System (GPCMS). 
Return any recoverable Alcon Product associated with a product-related AE (adverse device effect 
[ADE], serious adverse device effect [SADE]) or device deficiency to the Sponsor. Procedures 
vary so Investigators must contact their assigned monitor for detailed guidance. Follow biohazard 
regulations if the product has touched the eye (i.e., place the product in a biohazard labeled bag). 
Include the SAE/ADE or device deficiency eCRF in the return package. Maintain a copy of 
shipment tracking information and all documents submitted with the product. 
7.6 
Study Timetable / Schedule of Events 
A Schedule of Events is provided in the table below. Retrospective assessments will be performed 
by standard clinical practice of the respective country and the medical institution; however, for the 
prospective Visit 1, assessments should be conducted in the order set forth in Table 3. 

 
 
 
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Table 3. 
Schedule of Events 
Event 
Retrospective 
Prospective 
Preoperative 
and Operative 
Visit 
Post-operative 
Standard of Care 
& Unplanned 
Visits 
Visit 1 
(3-5 Years  
+/- 90 Days Post-
operative) 
Unschedul
ed Visita 
Informed Consent 
 
 
ض 
 
Eligibility Determination 
 
 
ض 
 
Demographics 
 
 
ض 
 
Medical History  
ضb 
 
 
 
Concomitant Medications 
ض*** 
ض 
ض 
ض** 
Biometry & Keratometry 
ض 
 
 
 
Pre-operative Manifest Refraction 
ض 
 
 
 
Predicted Residual Refractive Error  
ض* 
 
 
 
Lens Model & Power 
ض 
 
 
 
IOL Calculation Method 
ض* 
 
 
 
Other Surgical Procedures During Cataract 
or Refractive Lens Exchange Surgery 
ض* 
 
 
 
Visual Disturbances (QUVID) 
 
 
ض 
 
Manifest Refraction 
ض* 
ض* 
ض 
 
Binocular UCDVA 
 
ض† 
ض 
 
Monocular BCDVA 
 
ض† 
ض 
ض** 
Binocular BCDVA 
 
ض† 
ض 
 
Binocular UCIVA at 66 cm 
 
ض† 
ض 
 
Binocular DCIVA at 66 cm 
 
ض† 
ض 
 
Binocular UCNVA at 40 cm 
 
ض† 
ض 
 
Binocular DCNVA at 40 cm 
 
ض† 
ض 
 
Slit Lamp Examination (Biomicroscopy) 
ض 
ض 
ض 
ض** 
Posterior Capsule Opacification (PCO) 
 
 
ض 
ض** 
Capsulotomy Assessment 
 
 
ض 
 
Tonometry 
 
 
ض 
ض** 
Dilated Fundus Examination 
 
 
ض 
ض** 
Actual Axis of IOL Orientation 
ض* 
ض†† 
ض 
 
Assessment of Adverse Events 
ض 
ض 
ضc 
ض** 
Assessment of Device Deficiencies 
ض* 
ض* 
ض 
ض** 
Study Exit 
 
 
ض 
ض** 
a Prospective visit after Visit 1 to monitor subjects with ongoing AEs 
b Medical history includes all relevant systemic and all ocular conditions that began prior to surgery and 
implantation of study IOL(s). 
c AEs should be assessed at all post-operative visits through Visit 1 and recorded in EDC. 
* If available 
** As needed 
*** Do not enter medications used for cataract surgery in EDC 
† Immediate post-operative visual acuity (1-6 months post-operative), if available 
†† From 1 day post-operative visit, if available 

 
 
 
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7.7 
Study Protocol Compliance / Treatment Adherence 
Based on the study design, protocol compliance consists of completing all the prospective 
assessments, which are anticipated to require a single study visit. Subjects who decline to complete 
the prospective assessments will be withdrawn/exited from the study. Withdrawn subjects will not 
be replaced. 
7.8 
Deviations from the Clinical Protocol 
The Investigator and site personnel should conduct the study in compliance with the protocol and 
should use continuous vigilance to identify and report protocol deviations. The Investigator may 
not deviate from the protocol, except when necessary to eliminate an immediate hazard to a study 
subject, or when the change involves only logistical or administrative aspects of the study. Any 
significant deviation from the protocol must be reported immediately to the Sponsor or Sponsor’s 
representative and if applicable, to the relevant IRB/IEC, in accordance with the local regulation. 
7.9 
Subject Withdrawal 
7.9.1 
Subject Withdrawals 
Subjects withdrawn or terminated early will continue to receive Standard of Care treatment. The 
termination of study participation is not anticipated to affect subject safety. Withdrawn subjects 
will not be replaced. 
7.9.2 
Data Collection and Follow-Up for Withdrawn Subjects 
If a subject withdraws consent to participate in the study, or is withdrawn by the Investigator, 
reasons for withdrawal or early termination will be obtained whenever possible. 
7.10 
Subject Compensation 
Subject compensation will be provided for the prospective visits. 
7.11 
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: 
x The study Sponsor must: 
o Immediately notify the Investigator(s) and subsequently provide instructions for 
study termination. 

 
 
 
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o Inform the Investigator and the regulatory authorities of the termination/suspension 
and the reason(s) for the termination/suspension.  
x 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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8 
DATA COLLECTION AND ANALYSIS 
8.1 
Subject Populations for Analysis 
Subject populations for analysis include: 
x Full Analysis Set (FAS) population: the FAS population will include all eyes of enrolled 
subjects who pass the screening. The FAS will be the primary population for all safety 
analyses and performance analyses. 
8.2 
Statistical Methods 
There is no statistical hypothesis for the endpoints in this study. Appropriate descriptive statistics 
will be computed and presented for all categorical and continuous endpoints. A full description of 
statistical methods will be presented in the Statistical Analysis Plan. 
x For categorical variables, the number and percentage of subjects/eyes within each category 
of interest will be presented. 
x For continuous variables, the number of subjects/eyes with non-missing data, mean, 
standard deviation, range, median, minimum, and maximum. There will be no imputation 
for missing data. 
All visual acuity results will be presented in logMAR scale after applying appropriate 
transformations/conversions. 
Performance and safety outcome measures will be stratified by toric and non-toric models. 
Subjects who have been implanted with at least one toric IOL will be included in the toric group. 
Descriptive results from this long-term study should be sufficient to provide long-term data on 
these models, as well as safety and performance thresholds derived from the current State of the 
Art. 

 
 
 
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Serious Adverse Events 
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: 
x Cystoid macular edema 
x Hypopyon 
x Endophthalmitis 
x Lens dislocation from posterior chamber 
x Pupillary block 
x Retinal detachment 
x Secondary Surgical Interventions 
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 9.3. 
Device Deficiencies  
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. 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 listed in the Device 
Deficiency eCRF for the identified or suspect device deficiency and report any subject harm 
separately. Examples of device deficiencies include the following: 
x Failure to meet product specifications (e.g., incorrect IOL power) 
x IOL defect 
x Broken IOL optic 
x Broken IOL haptic 
x Scratched IOL optic 
x Unsealed device packaging 
x Suspected product contamination 
x Lack of performance 

 
 
 
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9.2 
Monitoring for Adverse Events 
At Visit 1, 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: 
x “Have you had any health problems since your last study visit?” 
x “Have there been any changes in the medicines you take because of a new health issue or 
worsening of an existing 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. 
9.3 
Procedures for Recording and Reporting 
AEs are collected from the time of initial exposure to the study model IOL(s) and throughout the 
course of the study. Any preexisting medical conditions or signs/symptoms present in a subject 
prior to exposure to the study model IOL(s) (i.e., before cataract surgery) 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, raised IOP and superficial punctate keratitis 
are examples of early post-operative 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.  
For each recorded event, the ADEs and SAEs documentation must include: AE diagnosis of main 
symptom, date of occurrence, intensity (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 medical devices 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: 
x All SAEs must be reported immediately (within 24 hours) of the Investigator’s or site’s 
awareness.  
x ADEs that do not meet seriousness criteria and device deficiencies must be reported within 
10 calendar days of the Investigator’s or site’s awareness.  
x A printed copy of the completed SAE and ADE and/or Device Deficiency eCRF must be 
included with product returns. 

 
 
 
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x Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available. 
x Any changes to concomitant medications must be documented on the appropriate eCRFs. 
x All relevant information from Discharge Summary, Autopsy Report, Certificate of Death 
etc., if applicable, must be documented in the narrative section of the SAE and ADE eCRF. 
Study Sponsor representatives may be contacted for any protocol-related question and their contact 
information is provided in the Project Team Contact List included in the Investigator Site File. 
Further, depending upon the nature of the AE or device deficiency being reported, the study 
Sponsor (or designee) 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. 
The Investigator must assess the causality for every AE in the study (Related or Not Related to the 
medical device or study procedure). An assessment of causality will also be performed by the 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. 

 
 
 
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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 is 
upgraded from nonserious to serious or from unrelated to related. 
9.4 
Return Product Analysis 
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 GPCMS. 
9.5 
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 study 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 (i.e., database lock).  
All complaints received after this time period will be considered and processed as spontaneous 
(following the post-market vigilance procedures) and should be communicated to the medical 
device’s manufacturer as per local requirements. 
9.6 
Pregnancy in the Clinical Study 
Women of childbearing potential are not excluded from participation. Women who gave birth after 
IOL implantation or who are pregnant or nursing at the time of enrollment are excluded from 
participation. 
9.7 
Anticipated Risks / Risk Mitigation 
Potential post-operative AEs include corneal stromal edema, cystoid macular edema, 
endophthalmitis, hypopyon, iritis, lens dislocation, membrane formation on the IOL, pupillary 
block, retinal detachment, cyclitic membrane, transient or persistent glaucoma, retinal tear, vitritis, 
iris touch, pupil ovalization, posterior synechiae, ocular inflammation, and endothelial cell loss. 
Post-operatively, the subject may experience ocular discomfort or pain, inflammation, decreased 
vision, decreased contrast sensitivity, decreased color perception, and visual disturbances. 

 
 
 
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Surgical intervention (e.g., IOL repositioning, replacement, or explantation) may be appropriate, 
if the IOL position significantly differs from the intended placement, or in some cases of post-
operative residual refractive error, ocular infection, subject dissatisfaction, or visual disturbances 
(e.g., glare, halos, starbursts, hazy vision, blurred vision, double vision, visual distortions, and 
color distortions). 
Alternatively, spectacles or contact lenses may be prescribed to resolve post-operative residual 
refractive error. Other secondary surgical interventions include, but are not limited to: refractive 
laser treatment, paracentesis, vitreous aspirations, iridectomy for pupillary block, wound leak 
repair, and retinal detachment repair. 
Refer to the Directions for Use (DFU) for the study device for additional information. 
Due to the retrospective, non-interventional nature of the study, the potential risks described above 
are expected to have occurred prior to study enrollment. Any risk to subjects in this clinical study 
will be minimized by clinical oversight and monitoring. 
9.8 
Anticipated Clinical Benefits 
There is no direct clinical benefit to study participants. Participant benefits from improved visual 
acuity will have already been realized at the time of enrollment. Indirectly, participants may benefit 
from the identification of safety and/or performance signals generated by the study. 

 
 
 
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10 
DATA HANDLING AND RECORD KEEPING 
10.1 
Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the General Data Protection Regulation (GDPR; EU 2016/679), and applicable 
national and local regulations. Those regulations require a signed subject authorization informing 
the subject of the following:  
x What information will be collected from subjects in this study 
x Who will have access to that information and why 
x Who will use or disclose that information 
x The rights of a research subject to access their personal data collected, to have any 
inaccurate or incomplete data corrected, to request the deletion of their personal data 
collected or the restriction of its use.  
In the event that a subject decides to withdraw his/her consent to participate in the study, no new 
data will be collected, but data that have already been collected will be used as necessary to fulfill 
the purposes of the study. For subjects who withdraw their consent to participate in the study, 
attempts should be made to obtain permission to collect at least vital status (i.e., that the subject is 
alive) at the end of their scheduled study period. 
10.2 
Source Documents 
Source Data are the clinical findings and observations, laboratory and test data, and other 
information contained in Source Documents. Source Documents are the original records (and 
certified copies of original records); including, but not limited to, hospital medical records, 
physician or office charts, physician or nursing notes, subject diaries or evaluation checklists, 
pharmacy dispensing records, recorded data from automated instruments, x-rays, etc. When 
applicable, information recorded on the eCRF shall match the Source Data recorded on the Source 
Documents. 
10.3 
Case Report Forms 
The study eCRF is the primary data collection instrument for the study. All data requested on the 
eCRF must be recorded. All missing data must be explained. If a space on the eCRF is left blank 
because the procedure was not done or the question was not asked, enter “N/D”. If the item is not 
applicable to the individual case, enter “N/A”. 
An eCRF will be completed for each subject enrolled into the clinical study. The Investigator will 
review, approve and sign/date each completed eCRF; the Investigator’s signature serving as 

 
 
 
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attestation of the Investigator’s responsibility for ensuring that all clinical data entered on the eCRF 
are complete, accurate and authentic. 
The electronic data capture method utilized will be in compliance with the Food and Drug 
Administration (FDA)’s electronic records and electronic signatures regulations at 21 CFR Part 11.  
10.4 
Clinical Reports 
The Investigator is responsible for the preparation and submission of annual progress reports as 
required by local IRBs/IECs. The Sponsor or designee is responsible for the preparation of the 
final Clinical Study Report, which will be submitted to appropriate IRBs/IECs by the Investigator. 
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.  
10.5 
Records Retention  
The Sponsor shall keep relevant clinical records for a period of at least 15 years after the last device 
has been placed on the market. The Investigator shall maintain relevant clinical records for 
10 years. Investigators will notify the Sponsor at least 60 days prior to any destruction of records 
at the address listed below: 
Alcon Research LLC 
6201 South Freeway 
Fort Worth, Texas 76134 
Or via email to: 
Record.Retention@Alcon.com. 

 
 
 
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11 
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS  
11.1 
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 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 subject-level data collected in this study with qualified researchers 
to help facilitate product development or enhancements in research that is not directly related to 
the study objectives.  
11.2 
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 case report forms (CRFs) exist and are accessible for verification if 
required. Discrepancies shall be appropriately documented via the query resolution process.  
If electronic records are maintained, the method of verification must be determined in advance of 
starting the study. The Investigator or delegate would verify the accuracy of data.  
At a minimum, source documents include the following information for each subject:  
x 
Subject identification (name, sex, race/ethnicity)  
x 
Documentation of subject eligibility  
x 
Dates of visits  
x 
Documentation that protocol-specific procedures were performed  
x 
Results of study parameters, as required by the protocol  
x 
Documentation of AEs and other safety parameters (if applicable)  
x 
Records regarding medical histories and the use of concomitant therapies during the data 
collection period  
x 
Date of visit time points 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 
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.  
11.3 
Data Review and Clarifications  
A review of CRF data to the subject’s source data will be completed by the Investigator or delegate 
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.  
11.4 
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 study.  
The study Sponsor is financially funding this clinical study and will compensate the Investigator 
and/or the institution(s) at which the study is conducted in accordance with a signed clinical study 
agreement.  
The study Sponsor will designate a monitor to conduct remote monitoring, which will be limited 
to the Site Regulatory binder to avoid exposure to subject health information.  
11.5 
Regulatory Documentation and Records Retention  
The Investigator is required to maintain up-to-date, complete documentation as indicated by the 
study Sponsor and consistent with the terms of the clinical study agreement.  
11.6 
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 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.  

 
 
 
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12 
PROTOCOL AMENDMENTS AFTER STUDY INITIATION 
Should changes in the study plan or protocol become necessary in the course of the clinical study, 
those specific changes will be discussed and agreed upon by the Sponsor, its acting representative 
if appropriate, Investigator, and appropriate IRB/IEC approval obtained before the changes are 
implemented. All changes must be documented as protocol amendments. For studies conducted 
under an investigational device exemption (IDE), FDA approval and/or notification may be 
required in addition to the IRB approval. 
13 
ETHICAL CONSIDERATIONS 
This study is to be conducted according to US and international standards of GCP, including 
ISO 14155 GCPs, applicable government regulations and Institutional research policies and 
procedures. 
Although not all aspects of ISO 14155 guidelines are applicable to this study, subject safety and 
data integrity are not impacted. 
x The standard operating procedures of the study Sponsor and contract research 
organizations (CROs) participating in the conduct of the clinical study and all other 
applicable regulations shall apply.  
x Notifications and timelines for reporting protocol deviations should be based upon 
applicable Ethics Committee requirements. 
This protocol and any amendments will be submitted to a properly constituted IRB/IEC, in 
agreement with local legal regulations, for formal approval of the study conduct. The decision of 
the IRB/IEC concerning the conduct of the study will be made in writing to the Investigator and a 
copy of this decision will be provided to the Sponsor before commencement of this study. 
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 study. For this study, 
the Principal Investigators and Sub-Investigators must be health care professionals appropriately 
trained and/or licensed to perform IOL implantation after cataract surgery or to provide follow-up 
care for subjects having received an IOL during cataract surgery.  
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 but shall be documented and reported to the 

 
 
 
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Sponsor 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. 
Use of waivers to deviate from the clinical protocol is prohibited. 
Before clinical study initiation, this protocol, the ICF, 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), ICF, 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/Directions for Use, 
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. 
Voluntary informed consent must be obtained in writing from every subject or legal representative, 
as applicable, and the process shall be documented before any data are being collected for this 
clinical study. 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 ICF. 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 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 
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 (filed in subject’s medical records) 
and must provide a duplicate of the signed copy to each subject according to local regulations. 
14 
STUDY FINANCES 
14.1 
Funding Source 
This study is financed by Alcon Research LLC. The Sponsor will secure a human clinical study 
insurance certificate according to applicable country regulations, when required. 

 
 
 
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14.2 
Conflicts of Interest 
Investigators are required to provide financial disclosure information to allow the Sponsor to 
submit the complete and accurate certification or disclosure statements required under 
US FDA 21 CFR 54. In addition, the Investigator must provide to the Sponsor a commitment to 
promptly update this information if any relevant changes occur during the course of the 
investigation and for 1 year following the completion of the study. 
Potential conflicts of interest will be subject to the processes and procedures of the institutions 
where the potential conflict exists. 
15 
PUBLICATION PLAN 
Neither the complete nor any part of the results of the study carried out under this protocol, nor 
any of the information provided by the Sponsor for the purposes of performing the study, will be 
published or passed on to any third party without the consent of the study Sponsor. Any 
Investigator involved with this study is obligated to provide the Sponsor with complete test results 
and all data derived from the study. 
At the conclusion of the study, a multi-center manuscript may be prepared for publication in a 
reputable scientific journal. The publication of the principal results from any single center 
experience within the study is not allowed until the publication of the multi-center results. Any 
and all exceptions to this rule require the prior written approval of the Sponsor. Investigators may 
publish study results, provided Sponsor receives a copy of any proposed oral presentation or 
written publication at least 60 days in advance of submission for publication for review. Sponsor 
has the right to comment on the appropriateness of the data analysis and presentation and have that 
comment reflected in the presentation. Investigator will meet with Sponsor prior to submission for 
publication for the purpose of making good faith efforts to discuss and resolve any issues or 
disagreement. Upon Sponsor’s request, Investigator shall remove from any such oral presentation 
or written publication any material provided to Investigator by Sponsor or any confidential 
material. In addition, if requested in writing by Sponsor, Investigator will withhold such 
publication an additional 60 days to allow for filing a patent application or taking such other 
measures as Sponsor deems appropriate to establish and preserve its proprietary rights. 
The clinical study will be registered in a publicly accessible clinical trial registry in accordance 
with the Sponsor’s choice, and/or applicable national regulatory requirements. Clinical study 
results will be posted within the registry in accordance with registry requirements. 

 
 
 
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16 
REFERENCES 
16.1 
References Applicable to All Clinical Studies 
x ISO 11979-7:2018 Ophthalmic Implants ̽ Intraocular lenses ̽ Part 7: Clinical 
Investigations 
x ISO 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of 
the need for clinical investigation of intraocular lens design modifications 
x ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects - Good 
Clinical Practice 
16.2 
References Applicable to Clinical Studies Conducted in the United States 
x 21 CFR 11: Electronic Records; Electronic Signatures 
x 21 CFR 50: Protection of Human Subjects 
x 21 CFR 54: Financial Disclosures by Clinical Investigators 
x 21 CFR 56: Institutional Review Boards  
x 42 CFR 11: Clinical Trials Registration and Results Information Submission 
x 45 CFR 164: Security and Privacy 
16.3 
References Applicable to Clinical Studies Conducted In Canada 
x Medical Device Regulations SQR/98-282, Part 59: Mandatory Problem Reporting 
16.4 
Cited References 
1 
Literature Search Report for State of the Art: AcrySof IQ PanOptix Trifocal Intraocular 
Lenses Review Period: 01 Jan 2018 to 28 Jun 2023. Fort Worth (TX): Alcon Research, 
LLC; 2023 Sep. Document ID No.: V V-RIM-0152541, Version 1.0. 
 

 
 
 
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17 
APPENDICES AND ATTACHMENTS 
17.1 
Glossary of Terms 
Names of Test Product(s) 
Throughout this document, test product(s) will be referred to as  
AcrySof IQ PanOptix Trifocal and AcrySof IQ PanOptix Trifocal Toric 
IOLs. 
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 9.3. 
Anticipated Serious Adverse 
Device Effect (ASADE) 
An effect which, by its nature, incidence, severity, or outcome, has been 
identified in the risk assessment. 
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 labeling 
related to the investigational medical device or the comparator. 
Requirements for reporting Device Deficiencies in the study can be 
found in Section 9. 

 
 
 
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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 
investigational plan or diagnostic or monitoring procedures requested in 
the CIP are in addition to those available as normal clinical practice and 
burden the subject.  
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). 
Noninterventional Study 
Clinical investigation that draws inferences about the possible effect of 
an intervention on subjects, but the Investigator has not assigned subjects 
into intervention groups based on a protocol and has not made any 
attempts to collect data on variables beyond those available throughout 
the course of normal clinical practice and burden to the subject. 
NOTE: 
The 
term 
“noninterventional” 
is 
synonymous 
with 
“observational.” 
Nonserious Adverse Event 
Adverse event that does not meet the criteria for a serious adverse event. 
Postmarketing / 
Postauthorization 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 noninterventional study and may also 
fall within the definition of a postapproval study. 
Product Complaint 
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. 
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:  
x 
Death. 
x 
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. 

 
 
 
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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. 
x 
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 9 for additional SAEs. 
Serious Health Threat 
Signal from any adverse event or device deficiency that indicates an 
imminent risk of death, serious deterioration in state of health 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 study, 
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. 
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. 

 
 
 
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17.2 
Attachments 
Note that the attached questionnaires are proprietary and licensed to Alcon. Copies provided here 
for reference should not be used for the study. For the clinical study, please use the copies provided 
separately. 

 
 
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17.2.3 
Refraction Protocol 
Refraction Procedure 
Subjective Refraction 
Follow the steps outlined below to complete subjective refraction: 
1. Level the phoropter with the floor utilizing the bubble on top (ensure the subject does not tilt 
his/her head). 
2. Adjust the phoropter’s interpupillary distance to equal that of the subject’s interpupillary 
distance. 
3. Occlude the eye not tested. 
4. Set up the optical powers. Begin by using the subject’s data from the objective refraction 
(retinoscope). Dial in the sphere power, cylinder power, and cylinder axis. 
5. Perform the subjective refraction assessment completing the four steps outlined below. 
a. Determine the initial spherical adjustment 
b. Determine the cylinder axis 
c. Determine the cylinder power 
d. Complete the final sphere adjustment 
NOTE: These steps are further outlined in the following sub-sections. 
Spherical Adjustment 
Determine the initial spherical adjustment as described below. 
1. Direct the subject’s attention to the lowest line they can read on the visual acuity (VA) chart. 
2. Add +0.25 Diopter Sphere (DS). 
3. Ask the subject if his/her vision is: better, worse, or no different. 
a. If the subject reports that their vision is worse with the +0.25 DS lens, then do not add 
it. For example, if the subject has -1.0 DS in the phoropter and the letters look blurry with 
the addition of the +0.25 D lens, then the sphere power should remain at -1.0 DS in the 
phoropter. Go to Step 4 below in this section. 
b. If the subject reports that their vision improves or remains the same with additional plus 
power, then adjust the spherical power by +0.25 DS. For example, if the subject has -1.0 
DS in the phoropter and letters look clearer with the addition of the +0.25 DS lens, then 
the new sphere power will be set to -0.75 DS in the phoropter. 

 
 
 
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c. Using the same approach, continue adding plus lens power in +0.25 DS increments. Stop 
at the most plus lens that does not blur the subject’s VA. d. It would be a good check to 
measure the visual acuity to confirm that the above steps have not inadvertently worsened 
the visual acuity. 
4. Add -0.25 DS. 
a. If the subject reports that their vision is worse or remains the same with a -0.25 DS lens, 
then do not add it. For example, if the subject has -1.0 DS in the phoropter and letters look 
blurry or remain the same with the addition of the -0.25 DS lens, then the sphere power 
should remain at -1.00 DS in the phoropter. Proceed to Cylinder Axis Adjustment. 
b. If the subject reports that their vision improves with additional minus lens power, then 
adjust the spherical power by -0.25 DS. For example, if the subject has -1.0 DS in the 
phoropter and letters look clearer with the addition of the -0.25 D lens, then the new sphere 
power will be set to -1.25 DS in the phoropter. 
c. Using the same approach, add further minus lenses in -0.25 DS increments only as long 
as the VA improves. Stop at the least minus lens that provides the best VA. 
NOTE: It is important to avoid over-minusing the refraction. The goal is to provide the 
least amount of minus power that would result in the best VA. 
Cylinder Axis Adjustment 
1. Ensure the best sphere correction is in place based on the endpoint from the previous section. 
2. For refining cylinder axis and power a ±0.25 diopter cylinder (DC) Jackson cross cylinder is 
recommended. 
3. Direct the subject’s attention to a line of letters one or two rows above the present visual acuity 
that the subject can see with the sphere power. A letter “O” or “C” is recommended. 
4. Pivot the Jackson cross cylinder into position. 
NOTE: Where applicable (i.e., phoropter), the cross cylinder will click into place, and when the 
cylinder axis is moved, the cross cylinder will move the same amount. The cross cylinder may 
cause a slight blur or distortion of the image.  
5. Instruct the subject to look at the VA line of interest. Point to the line if necessary. 
6. Instruct the subject that you are going to show them two lenses and both may be slightly blurred. 
The subject must tell you which of the two is clearer or whether both look the same. 
7. As the cross cylinder is flipped, identify the image of the VA chart for the subject as “#1” and 
then “#2”. 
8. Change the lens as the images are identified. 

 
 
 
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9. Move slowly. Subjects are making an effort to differentiate small differences in image quality, 
and they may get frustrated if they feel rushed. 
10. Upon identification of the clear image, look for the position of the white dots, and rotate the 
axis 10° towards the white dot. This is known as, “chasing the white dots”. 
11. Continue to provide choices and chase the white dots until the axis reverses direction. 
12. After the axis reverses, chase the white dot in increments of 10°. 
13. Refine the axis using 5° increments. 
14. Continue to refine the axis until the flip of the cross cylinder results in no difference in clarity 
between the two images. 
15. If the axis moves back and forth over the same 5° or 10°, set the cross cylinder axis to the 
middle of the range and try to refine. 
NOTE: When using a minus-cylinder phoropter, the procedure for determining the axis is changed 
so that the red dots (not the white dots) are being chased. 
Cylinder Power Adjustment 
Determine the cylinder power as described below. 
1. Continue to direct the subject’s attention to the lowest line the subject can see with the sphere 
power. 
2. Rotate the cross cylinder so that the “P” is aligned with the cylinder axis arrow. 
NOTE: The cross cylinder will click into place. At this point the axis will be aligned with either 
the red or white dots. 
3. Instruct the subject that there will again be two choices and that both may be slightly blurred 
and distorted. 
4. Tell the subject he/she will be presented with two choices and that he/she is to choose the image 
that appears more clear. 
5. As the cross cylinder is flipped, identify the image for the subject as “#3” and then “#4”. 
6. Change the lens as the images are identified. 
7. Move slowly. Subjects are making an effort to differentiate small differences in image quality, 
and they may get frustrated if they feel rushed. 
8. Where the subject prefers the lens choice when the white dots are lined up on the cylinder axis, 
add +0.25 DC. Conversely if the red dots are lined up on the cylinder axis, add -0.25 DC. 
9. Define the choices to the subjects on each flip. 

 
 
 
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10. For each 0.5 DC of change in cylinder power, change the sphere power by 0.25 D in the 
opposite direction. For example, if you add -0.5 DC, then add +0.25 DS before comparing the lens 
positions. 
Final Sphere Adjustment 
1. Following cylinder testing, fog the eye by +1.00 DS and decrease the fog in 0.25 diopter steps 
(or adding -0.25 DS lenses) to achieve the endpoint of maximum plus sphere or least minus sphere 
that allows the subject to read the most letters possible on the threshold visual acuity line (ie, the 
best visual acuity). 
x 
As a guideline, once the best possible visual acuity is achieved, if a +0.25 diopter sphere is 
added to the endpoint sphere, the subject should lose the ability to read some or all of the 
letters. Be careful not to over minus the subject. 
x 
For example: If the subject states that his/her visual acuity (VA) seems better but he/she 
read fewer letters, he/she has been over-minused. Similarly, if he/she reports that the letters 
seem smaller and darker but he/she read the same letters or fewer letters, he/she has been 
over-minused. 
2. As a final check, add +1.50 DS and record the visual acuity. If visual acuity with the addition 
of +1.50 is better than 20/40 the patient may be over-minused and the above Step 1 should be 
repeated. Record the final refraction. Record refraction results with sphere, cylinder and axis 
readings. 
NOTE: If no cylinder correction is required, cylinder should be recorded as 0 and axis left blank 
in the Electronic Data Capture (EDC) system. 
Example: Recording a refraction with no cylinder -0.50 0.0 -Sphere + Cylinder x Axis. Once this 
step is completed, occlude the tested eye, and repeat the above procedure on the fellow eye. 

 
 
 
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17.2.4 
logMAR Visual Acuity 
A. 
General Instructions 
Measure VA prior to IOP measurement, the administration of eye drops to dilate or anesthetize the 
eye, or any examination requiring contact with the eye. Test VA at all distances (i.e., distance and 
intermediate) use a stringent version of the “ETDRSFast” method (Camparini 2001, Tong 2002) 
as outlined below. 
1. 
Provide vision correction as required by protocol. 
2. 
Seat subject in front of the chart ensuring he/she is in the appropriate distance from the 
chart, with eye level approximately aligned to the middle of the chart. 
3. 
Provide preliminary instructions to the subject. 
a. 
Inform the subject that his/her distance/intermediate/near vision will be assessed. 
b. 
Tell the subject that the chart has letters only, no numbers or other symbols. 
c. 
 Explain that he/she should read slowly when responding (i.e., about one letter per 
second) to achieve best identification of each letter, and that he/she should not proceed 
to the next letter until definite response has been given. 
4. 
Use an occluder as required. 
a. 
For monocular assessments, occlude the contralateral eye. Use a Sponsor provided 
ETDRS chart, alternating between charts so as to reduce memorization. 
b. 
 For binocular assessment, complete all monocular assessments prior to 
commencement, and use a Sponsor provided ETDRS chart, alternating between charts 
so as to reduce memorization. 
5. 
Identify the starting row. 
a. 
Ask subject to read the first letter of each line beginning at the top left of the chart, 
working downward toward progressively smaller letters. 
b. 
When the subject misidentifies the first letter on a line, move the subject up 1 line (ie, 
toward larger letters), and have him/her read every letter on that row. 
c. 
If 1 or more errors are made when reading the row, move the subject up one line and 
try again. 
d. 
Repeat the above process until zero errors are made on a row. 
e. 
Identify the row in which no errors were made, as the starting row of the test. 
f. 
Score the starting row as described in Section C, below. 

 
 
 
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6. 
Instructions on identifying the starting line in two unique scenarios are described below. 
a. 
All letters read: If the subject correctly identifies the first letter of every row in the 
chart, identify the second from bottom line as the starting row of the test.  
b. 
No letters read: For distance assessment, if no letters can be read, move the chart to a 
distance of 2 m, increase add to +0.50 D from the manifest refraction, and perform 
assessment at this distance (2 m). If no letters can be read at the 2 m distance, move 
the chart to a distance of 1 m and increase add to +1.00 D from the manifest refraction. 
Perform the test at this distance (1 m). If no letters can be read test subject for count 
finger (CF), hand motion (HM), light perception (LP), or no light perception (NLP), 
and document accordingly. 
For near and intermediate assessments, if no letters can be read, enter the worst 
possible logMAR value (eg, 1.4 logMAR) as the subject score. In addition, assess 
subject for count finger (CF), hand motion (HM), light perception (LP), or no light 
perception (NLP), and document accordingly. 
7. 
Proceed with the test. Score the assessment as described below in Section C below. 
a. 
Move the subject down one line from the starting row (toward the smaller letters). 
b. 
Request subject to call out each letter on the line. 
NOTE: If the subject identifies a character as one of two letters, he/she should be asked 
to choose one letter and, if necessary, to guess. If the subject reads a number, he or she 
should be reminded that the chart contains no numbers, and the examiner should then 
request a letter instead of the number. If the subject changes a response before he/she 
has read aloud the response after having read the next letter, then the change should 
not be accepted. 
c 
If the subject correctly identifies a majority of the letters on a line (ie, 3) have him/her 
should progress to the next smaller line. 
d. 
Terminate the test when the subject either misidentifies the majority of letters on one 
row (3) or progresses to the smallest row of letters. 
NOTE: All letters must be tried on each line attempted, as letter difficulties vary and 
the last letter may be the only one read correctly (ISO 8596, 2009). 
B. 
Examiner Conduct 
During the test monitor the subject for proper posture, no squinting of the eye under test, and 
continuous occlusion of the contralateral eye. Do not point to the chart or to specific letters on the 
chart. Do not comment on the correctness of an answer. Encourage the subject to make a maximum 
effort to identify each letter, encouraging the subject to guess if needed. 

 
 
 
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C. 
Scoring 
When performing a VA assessment, employ a VA scoring sheet. Begin scoring at the starting row. 
Mark the letters on the score sheet as follows: 
x Circle all letters correctly read; 
x Mark through incorrectly read letters; and 
x Leave letters not attempted unmarked. 
See examples 1 and 2 below. 
Example 1: 
An example of a completed VA score sheet is noted below. In this example, logMAR line 0.4 was 
identified as the starting row. The subject proceeded to the 0.3 logMAR line and correctly 
identified 4 of 5 letters. Since this was a majority of the letters in the row, the subject proceeded 
to the next line (0.2 logMAR). On the 0.2 logMAR line the subject missed 2 of 5 letters, and 
according to the rules proceeded once more to the 0.1 logMAR line. On the 0.1 logMAR line the 
subject missed most of the letters (3 of 5); therefore, the test was terminated. The 0.2 logMAR line 
is identified as the last line read and the 0.1 logMAR line is identified as the last line attempted. 
 

 
 
 
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                                                                       Effective Date 18 March 2025                                             Page 82 of 83 
Example 2: 
An example of a completed VA score sheet is noted below. In this example, logMAR line 0.4 was 
identified as the starting row. The subject proceeded to the 0.3 logMAR line and correctly 
identified 4 of 5 letters. Since this was a majority of the letters in the row, the subject proceeded 
to the next line (0.2 logMAR). On the 0.2 logMAR line the subject missed 2 of 5 letters, and 
according to the rules proceeded once more to the 0.1 logMAR line. On the 0.1 logMAR line the 
subject missed most of the letters (3 of 5); therefore, the test was terminated. The 0.2 logMAR line 
is identified as the last line read and the 0.1 logMAR line is identified as the last line attempted.
 
D. 
LogMAR Value Calculation 
To calculate the final logMAR acuity value, follow the below steps. 
1. 
Identify the last line attempted. 
2. 
Locate the logMAR value of the last line attempted. 
3. 
Count the total number of letters missed. 
4. 
Calculate the final logMAR score utilizing the below formula. 
 
Last Line Attempted + (0.02 * n) = Score 
Where “Last Line Attempted” is given in logMAR and “n” represents the total number of missed 
letters. 
NOTE: An adjustment must be made to the calculation when the chart is placed at a 2 m or 1 m 
distance. For a 2 m distance, add 0.30 logMAR to the score. For a 1 m distance, add 0.60 logMAR 
to the score. 

 
 
 
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Example: Calculation when the test is conducted at the standard 4 m distance. Referring to the 
previous provided Example 1 from Section C Scoring, the last line attempted is 0.1 logMAR, the 
number of letters missed (n) is 6. Plugging these values into the formula yields a final score of 
0.22 logMAR as demonstrated below. 
 
Example: Calculation when the test is conducted at a 2 m distance 
Using the same example as above, 0.30 logMAR will be added to the score to adjust for the 2 m 
assessment distance. 
 
E. 
ETDRS Charts