Clinical Investigation of the Visual Outcomes and Safety After Bilateral Implantation of a Trifocal Presbyopia Correcting IOL in a Korean Population
Phase: NA
Conditions: Cataract, Presbyopia
Sponsor: Alcon Research

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Title 
 
Clinical Investigation of the Visual Outcomes and Safety after Bilateral 
Implantation of a Trifocal Presbyopia Correcting IOL in A Korean 
Population 
 
 
Protocol Number: 
Development Stage of 
Project: 
Sponsor Name and 
Address: 
 
 
 
 
 
 
Test Product: 
Investigator Agreement: 
 
 
 
 
 
 
Principal Investigator: 
ILH297-P004 / NCT03268746 
Product Support 
 
Alcon Research, Ltd. and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
Alcon Korea Ltd. 
6F Glasstower, Teheran-ro 534 
Gangnam-gu, Seoul 
06181, Korea 
The ACRYSOF® IQ PanOptix™ Presbyopia Correcting 
intraocular lens (IOL), Model TFNT00 
I have read the clinical study described herein, and recognize its 
confidentiality. I agree to conduct this study in accordance with 
the ethical principles contained within the Declaration of 
Helsinki, and the described study in compliance with the 
protocol, Good Clinical Practice (GCP), ISO 14155, and all 
applicable regulatory requirements. Additionally, I will comply 
with all procedures for data recording and reporting, will permit 
monitoring, auditing, and inspection of my research center, and 
will retain all records until notified by the Study Sponsor. 
 
 
 
 
 
Name and professional 
position: 
Address: 
Signature 
Date 
 
Template version 1.0, approved 09 JUNE 2017 

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Table of Contents 
Table of Contents ....................................................................................................................... 2 
List of Tables......................................................................................................................................... 5 
List of Figures ............................................................................................................................ 5 
1 
GLOSSARY OF TERMS .................................................................................................... 6 
2 
LIST OF ACRONYMS AND ABBREVIATIONS .............................................................. 10 
3 
PROTOCOL SUMMARY ................................................................................................. 11 
4 
PROTOCOL AMENDMENTS ......................................................................................... 24 
4.1 
Amendments 1 ................................................................................................... 24 
5 
INTRODUCTION ............................................................................................................. 26 
5.1 
Rationale and Background ................................................................................. 26 
5.2 
Purpose of the Study .......................................................................................... 28 
5.3 
Risks and Benefits ............................................................................................. 28 
6 
STUDY OBJECTIVES ...................................................................................................... 30 
6.1 
Primary Objective(s) .......................................................................................... 30 
6.2 
Secondary Objective(s) ...................................................................................... 30 
31 
6.4 
Safety Objective(s) ............................................................................................ 31 
7 
INVESTIGATIONAL PLAN ............................................................................................ 32 
7.1 
Study Design...................................................................................................... 32 
7.2 
Rationale for Study Design................................................................................ 33 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations ........................................................................................ 34 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 34 
7.4 
Rationale for Choice of Control Product ........................................................... 34 
7.5 
Data Monitoring Committee .............................................................................. 34 
8 
STUDY POPULATION ............................................................................................................. 34 
8.1 
Inclusion Criteria ............................................................................................... 34 
8.2 
Exclusion Criteria .............................................................................................. 35 
8.3 
Rescreening of Subjects ..................................................................................... 37 
9 
TREATMENTS ADMINISTERED ................................................................................... 37 

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9.1 
Investigational Product(s) .................................................................................. 37 
9.2 
Other Medical Device or Medication Specified for Use during the Study ........ 40 
9.3 
Treatment Assignment / Randomization ........................................................... 40 
9.4 
Treatment masking ............................................................................................ 41 
9.5 
Accountability Procedures ................................................................................. 41 
9.6 
Changes to concomitant medications, treatments/ procedures .......................... 41 
10 STUDY PROCEDURES AND ASSESSMENTS ........................................................... 42 
10.1 Informed Consent and Screening ...................................................................... 42 
10.2 Description of Study Procedures and Assessments ........................................... 42 
10.2.1 
Demographics .................................................................................... 43 
10.2.2 
Medical History ................................................................................. 43 
10.2.3 
Concomitant Medication ................................................................... 44 
10.2.4 
Inclusion/Exclusion Criteria .............................................................. 44 
10.2.5 
Investigational Product compliance................................................... 44 
10.2.6 
Urine Pregnancy Test ............................................................................... 44 
44 
44 
10.2.9 
Visual Acuity: Effectiveness Assessment .......................................... 44 
10.2.10 Binocular Defocus Curve: Effectiveness Assessment ....................... 45 
45 
10.2.12 Photopic Best Corrected Contrast Sensitivity: Effectiveness 
Assessment ........................................................................................ 45 
10.2.13 Subjective symptoms: Effectiveness Assessment .............................. 45 
10.2.14 Adverse Events including Secondary Surgical Interventions: Safety 
Assessment ........................................................................................ 45 
10.2.15 Device Deficiencies: Safety Assessment ........................................... 46 
10.2.16 Slit-Lamp Examination: Safety Assessment ...................................... 46 
10.2.17 Fundus examination and Fundus Visualization: Safety Assessment .46 
10.2.18 Subjective PCO including Posterior Capsulotomy: Safety Assessment 
46 
10.2.19 IOL Position Change: Safety Assessment.......................................... 47 
10.2.20 Other Surgical Procedures: Safety Assessment ................................. 47 
10.2.21 Problems during Surgery: Safety Assessment ................................... 47 
10.2.22 Surgical Report: Safety Assessment .................................................. 47 
10.2.23 Lens Information: Safety Assessment................................................ 47 
10.2.24 Intraocular Pressure: Safety Assessment ........................................... 47 

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10.3 Unscheduled Visits ................................................................................................ 47 
10.4 Directions Related to Secondary Surgical Intervention ..................................... 48 
10.5 Discontinued Subjects ....................................................................................... 49 
10.5.1 
Screen Failures .................................................................................. 49 
10.5.2 
Discontinuations ................................................................................ 50 
10.5.3 
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product ............................................................. 50 
10.6 Clinical Study Termination ................................................................................ 54 
10.6.1 
Follow-up of subjects after study participation has ended ................ 54 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES .................................................. 54 
11.1 General Information .......................................................................................... 54 
11.2 Monitoring for Adverse Events ......................................................................... 57 
11.3 Procedures for Recording and Reporting .......................................................... 57 
11.4 Return product analysis ..................................................................................... 60 
11.5 Unmasking of the Study Treatment ................................................................... 60 
11.6 Follow-Up of Subjects with Adverse Events ..................................................... 60 
11.7 Pregnancy in the Clinical Study ........................................................................ 61 
12 ANALYSIS PLAN........................................................................................................... 61 
12.1 Subject Evaluability........................................................................................... 61 
12.2 Analysis Sets ..................................................................................................... 61 
12.3 Demographic and Baseline Characteristics ....................................................... 61 
12.4 Effectiveness Analyses ...................................................................................... 62 
12.4.1 
Analysis of Primary Effectiveness Endpoint ..................................... 62 
12.4.1.1 
Statistical Hypotheses ........................................................ 62 
12.4.1.2 
Analysis Methods .............................................................. 62 
12.4.2 
Analysis of Secondary Effectiveness Endpoints................................ 62 
12.4.2.1 
Statistical Hypotheses ........................................................ 63 
12.4.2.2 
Analysis Methods .............................................................. 63 
64 
64 
64 
12.5 Handling of Missing Data ................................................................................. 64 
12.6 Safety Analyses ................................................................................................. 64 
12.7 Interim Analyses and Reporting ........................................................................ 66 
12.8 Sample Size Justification ................................................................................... 66 

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13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 66 
13.1 Subject Confidentiality ...................................................................................... 66 
13.2 Completion of Source Documents and Case Report Forms .............................. 67 
13.3 Data Review and Clarifications ......................................................................... 68 
13.4 Sponsor and Monitoring Responsibilities ......................................................... 68 
13.5 Regulatory Documentation and Records Retention .......................................... 69 
13.6 Quality Assurance and Quality Control ............................................................. 69 
14 ETHICS ............................................................................................................................. 69 
15 REFERENCES .................................................................................................................. 71 
15.1 References applicable for all clinical studies .................................................... 71 
15.1.1 
US references applicable for clinical studies ..................................... 71 
15.2 References for this clinical study ...................................................................... 71 
 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ............................ 10 
 
Table 3–1 
Schedule of Study Procedures and Assessments .............................................. 20 
Table 6–1 
Primary Objective(s) ........................................................................................ 30 
Table 6–2 
Secondary Objective(s) .................................................................................... 30 
31 
Table 6–4 
Safety Objective(s) ........................................................................................... 31 
Table 9–1 
Test Product...................................................................................................... 38 
List of Figures 
Figure 7-1 
Study Design .................................................................................................... 33 
Figure 11–1 
Categorization of All Adverse Events .............................................................. 55 
Figure 11–2 
Categorization of All Serious Adverse Events ................................................. 55 

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1 GLOSSARY OF TERMS 
 
Names of test product(s) 
Throughout this document, the test product(s) will be 
referred to as “The ACRYSOF IQ PanOptix Presbyopia 
Correcting intraocular lens (IOL), Model TFNT00.” 
Name of Control Product(s) N/A 
Adverse Device Effect 
Adverse event related to the use of an investigational 
medical device (test product) or control product. 
Note: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation; any malfunction; 
and use error or intentional misuse of the test product or 
control product. 
Adverse Event 
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device 
(test product). 
Note: For subjects, this definition includes events related to 
the test product, the control product, or the procedures 
involved. For users or other persons, this definition is 
restricted to events related to the test product. 
Requirements for reporting Adverse Events in the study can 
be found in Section 11. 
Device Deficiency 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance. 
Note: This definition includes malfunctions, use errors, and 
inadequate labeling. 
Requirements for reporting Device Deficiencies in the study 
can be found in Section 11. 

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Enrolled Subject 
Any subject who signs an informed consent form for 
participation in the study. 
Interventional Clinical Trial A research trial that prospectively assigns, whether 
randomly or not, human participants or groups of humans to 
one or more health-related interventions to evaluate the 
effects on health outcomes, and/or a research trial in which 
diagnostic or monitoring procedures beyond standard of care 
are conducted and generate outcomes for use in analysis of 
data. 
Investigational Product 
Is defined as a preventative (vaccine), a therapeutic (drug or 
biologic), device, diagnostic, or palliative used as a test or 
control product in a clinical trial, including a product with a 
marketing authorization when used or assembled 
(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form. 
Malfunction 
Failure of a medical device to meet its performance 
specifications or otherwise perform as intended. 
Performance specifications include all claims made in the 
labeling of the device. The intended performance of the 
device refers to the intended use for which the device is 
labeled or marketed. 
Non-serious Adverse Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 
Postmarketing/Post- 
authorization study 
Any study conducted within the conditions laid down in 
product labelling and other conditions laid down for the 
marketing of the product or under normal conditions of use. 
A postmarketing study falls either within the definitions of 
an interventional or a non-interventional study and may also 
fall within the definition of a post-approval study. 

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Produ ct Complaint s 
Any oral, electronic, or written communication that alleges 
deficiencies related to the identity (labeling), quality, 
durability, reliability, safety, effectiveness, or perfo1mance 
of a marketed product, including failure of the product, 
labeling or packaging to meet specifications, whetheror not 
the product is related to or caused the alleged deficiency. A 
complaint may allege that an adverse event or medical 
device malfunction has occuffed. 
Serious Adverse Device 
Effect (SADE) 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Serious Adverse Event 
(SAE) 
Adverse event that led to any of the following: 
• Death. 
• A serious deterioration in the health of the subject that 
either resulted in: 
a. A life-threatening illness or injmy. 
Note: Life-threatening means that the 
individual was at immediate risk of death from 
the event as it occurred, ie, it does not include 
an event which hypothetically might have 
caused death had it occurred in a more severe 
form. 
b. Any potentially sight-threatening event or 
pe1manent impai1ment to a body strncture or a 
body function. 
C. fu -patient hospi ta lizatio n or prolonged 
hospitalization. 
Note: Planned hospitalizatoi n for a pre- 
existing condition, without serious 
deterioration in health, is not considered a 
serious adverse event. In general, 
hospitalization signifies that the individual 
remained at the hospital or emergency ward 

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for observat ion and/or treatment (usually 
involving an overnight stay) that would not 
have been appropriate in the physician's office 
or an out-patient setting. Complications that 
occur during hospitalization are adverse 
events. If a complication prolongs 
hospitalization orfulfills any other serious 
criteria, the event is serious. When in doubt as 
to whether " hospitalization" occurred, the 
event should be considered serious. 
d. A medical or surgical intervention to prevent 
a) or b). Or any ocular seconda1y surgical 
inte1vention excluding posterior capsulotomy. 
e. Any indirect harm as a consequence of 
incon ect diagnostic test results when used 
within manufacturer 's instructio ns for use. 
• Fetal distress, fetal death, or a congenital abn01ma1ity or 
biith defect. 
Refer to Section 11 for additional SAEs. 
Use En or 
Act or omission of an act that results in a different medical 
device response than intended by manufacturer or expected 
by user. 
Note: This definition includes slips, lapses, and mistakes. An 
unexpected physiological response of the subject does not in 
itself constitute a use error. 

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2 LIST OF ACRONYMS AND ABBREVIATIONS 
 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol 
 
Abbreviation 
Definition 
AAS 
All-implanted analysis set 
ACD 
Anterior chamber depth 
ADE 
Adverse device effect 
AE 
Adverse event 
AL-8739 
N-2-[3-(2-Methylphenylazo)-4-hydroxyphenyl]ethyl metharcylamide 
BCVA 
Best corrected visual acuity 
BCDVA 
Best corrected distance visual acuity 
BDDA 
1,4-Butanediol diacrylate 
BSS 
Balanced salt solution 
°C 
Degrees Celsuis 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CRF 
Case report form 
cm 
Centimeter 
CM 
Clinical manager 
D 
Diopter 
DEP 
Deviations and Evaluability Plan 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
EU 
European Union 
FAS 
Full Analysis Set 
FDA 
US Food and Drug Administration 
GCP 
Good Clinical Practice 
I/A 
Irrigation/aspiration 
IEC 
Independent ethics committee 
ICF 
Informed consent form 
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
IOL 
Intraocular lens 
IOP 
Intraocular pressure 
IP 
Investigational product 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
LASIK 
Laser assisted in situ keratomileusis 
LogMAR 
Logarithm of the minimum angle of resolution 
MedDRA 
Medical Dictionary for Regulatory Activities 
MFDS 
Ministry of Food and Drug Safety 
m 
Meter 
mm 
Millimeter 

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Abbreviation 
Definition 
mmHg 
Millimeters of mercury 
MOP 
Manual of procedures 
N/A 
Not applicable 
OD 
Right eye 
oMTP 
o-Methallyl Tinuvin P 
OVD 
Ophthalmic viscosurgical device 
PC 
Posterior capsulotomy 
PCO 
Posterior capsular opacification 
PEA 
2-Phenylethyl acrylate 
PEMA 
2-Phenylethyl methacrylate 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SLE 
Slit-lamp exam 
SOP 
Standard operating procedures 
SSI 
Secondary surgical intervention 
UCDVA 
Uncorrected distance visual acuity 
UCIVA 
Uncorrected intermediate visual acuity 
UCNVA 
Uncorrected near visual acuity 
US 
United States 
VA 
Visual acuity 
WHO 
World Health Organization 
YAG 
Yttrium aluminium garnet 
 
 
3 PROTOCOL SUMMARY 
 
Investigational 
product type 
Device 
Study type 
Interventional 
Investigational 
products 
Test Product: The ACRYSOF IQ PanOptix Presbyopia Correcting 
IOL, Model TFNT00 is a single-piece ultraviolet and blue light 
filtering foldable multifocal IOL. The biconvex optic is 6.0 mm in 
diameter and the lens has an overall diameter of 13.0 mm. The 
multifocal optic diffractive structure is in the central 4.5 mm portion 
of the anterior surface of the optical zone and divides the incoming 
light to create a +2.17 D intermediate and a +3.25 D near add power 
(IOL plane). The anterior surface is designed with 0.1 microns of 
negative spherical aberration to compensate for the positive spherical 
aberration of the average human cornea. This product is a multifocal 
IOL that corrects aphakia, a condition that prevents patients from 

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seeing things at near and/or at distance, by replacing the cataractous 
lens after cataract surgery in an adult patient. It is inserted into the 
capsular bag and has near vision and intermediate add power (3.25 D, 
2.17 D). 
Purpose and 
rationale 
The ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model 
TFNT00 has a multifocal design and provides a near focal point at 40 
cm and distance vision similar to a traditional multifocal IOL, but 
with the additional benefit to patients of an intermediate focal point 
at 60 cm. 
The present study (ILH297- P004) is intended to confirm the 
effectiveness of the investigational lens in a Korean population, 
especially for visual performance, quality of vision, and subject 
satisfaction with the visual outcome, as well as the safety of the lens. 
Objective(s) 
Primary effectiveness objectives: 
Describe binocular defocus curve at 3 months (Visit 4A) post 
bilateral implantation of the ACRYSOF IQ PanOptix Presbyopia 
Correcting IOL, Model TFNT00 in a Korean population. 
Secondary effectiveness objectives: 
1. 
Describe binocular defocus curve at 1 month (Visit 3A) post 
bilateral implantation. 
2. 
Describe binocular BCVA at 4 m at 1 and 3 months (Visit 3A and 
Visit 4A) post bilateral implantation. 
3. 
Describe both uncorrected binocular and monocular mean VA at 
1 and 3 months (Visit 3A and Visit 4A) post bilateral 
implantation. 
4. 
Describe photopic contrast sensitivity at 3 months (Visit 4A) 
post bilateral implantation. 
5. 
Describe subjective symptom questions outcome at 3 months 
(Visit 4A) post bilateral implantation. 

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Safety objectives: 
Assess safety during the study up to 3 months (Visit 4A) post 
bilateral implantation of the ACRYSOF IQ PanOptix Presbyopia 
Con ecting IOL, Model TFNTOO in a Ko rean pop ul ation. 
Endpoin t(s) 
Prima 1y Effectiveness: 
• 
Binocular defocus curve at 3 months (Visit 4A) post bilateral 
implantation 
Seconda1y  Effectiveness: 
• 
Binocular defocus curve at 1 month (Visit 3A) post bilateral 
implantation 
• 
Best conected binocular visual acuity at distance (4 m) at 1 and 3 
months (Visit 3A and Visit 4A) post bilateral implantation. 
• 
Mean visual acuity at 1 and 3 months (Visit 3A and Visit 4A) post 
bilateral implantation. 
o Monocular UCDVA (4 m) 
o Monocular UCIVA (60 cm) 
o Monocular UCNVA(40 cm) 
o BinocularUCDVA(4m) 
o Binocular UCIVA (60 cm) 
o Binocular UCNVA (40 cm) 
• 
Photopic best conected binocular contrast sensitivity with and 
without glare at 3 months (Visit 4A) post bilateral implantation. 
• 
Subjective symptoms questions at preoperatively and 3 months 
(Visit 4A) post bilateral implantation. 

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Safety: 
• 
All adverse events (ocular and nonocular, serious and non- 
serious) including seconda1y surgical interventions (SSis) related 
to the optical prope1iies of the IOL for either eye. 
• 
Device deficiencies 
• 
Posterior capsule opacification 
• 
Posterior capsulotomy 
• 
IOL position change (tilt and decentration) 
• 
Intraocular pressure 
• 
Surgical problems 
Assessment(s) 
Effectiveness: 
All the effectiveness assessments will be conducted in photopic 
lighting conditions except the subjective symptoms assessment. 
• 
Distance VA(4 m), 
o Monocular (1st and/or 2nd eye) UCDVA 
o Binocular UCDVA 
o Binocular BCDVA 
• 
Inte1mediate VA (60 cm) 
o Monocular (1st and/or 2nd eye) UCIVA 
o Binocular UCIVA 
• 
Near VA (40 cm) 
o Monocular (1st and/or 2nd eye) UCNVA 
o Binocular UCNVA 
• 
Binoc ular defocus curve 
• 
• 
• 
Best conected binocular contrast sensitivity with & without glare 
• 
Subjective symptoms 

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Safety: 
• Adverse DeviceEvents including Seconda1y Surgical 
Interventions (SSis) related to the optical prope1iies of the IOL 
• Device deficiencies 
• Fundus examination and fundus visualization 
• Intraocular pressure 
• Slit-lamp examination 
• IOL observations 
• Surgical problems 
• Subjective posterior capsule opacification 
• Posterior capsulotomy 
• Lens decentration and tilt 
Study Design 
This is a prospective, single aim, unmasked, non-randomized, multi- 
center study. Study subjects will be followed for 90-120 days. 
Subject 
population 
The study population consists of adult Korean males and females, at 
least 20 years of age or older at the time of screening, with no ocular 
pathology that could confound study outcomes, who require cataract 
extraction in both eyes and desire an IOL that provides the potential 
for near, inte1mediate, and distance vision. 
Key inclusion 
criteria 
(See Section 8.1 
for a complete list 
of inclusion 
criteria) 
• 
Adults, at least 20 years of age or older at the time of screening, 
of either gender in Korea, who require cataract extraction in both 
eyes. 
• 
Clear intraocular media other than cataract in both eyes. 
• Calculated lens power between+16.0 and +24.0 D. 
• 
Preoperative OR expected postoperative regular corneal 
astigmatism of < 1.00 D. 
Key exclusion 
criteria 
(See Section 8.2 
for a complete list 
• Pregnancy or lactation 
• 
Clinically significant corneal abn01malities including corneal 
dystrophy (eg, epithelial, stromal or endothelial dystrophy), 
inflammation or edema per the Investigator's expe1i medical 

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of exclusion 
critelia) 
op1mon. 
Note: Conditions including, but not limited to: keratitis, 
keratoconjunctivititis, keratouveitis, keratopathy, or keratectasia 
should be excluded. 
• 
Previous corneal transplant. 
• 
Ocular trauma, previous refractive surgery , or refractive 
procedures throughout the entire duration of the subjects' 
participation in the clinical study (including, but not limited to 
LASIK, astigmatic keratotomy, and limbal relaxing incision). 
• 
Hist01y of or conc un ent retinal conditions or predisposition to 
retinal conditions, previous histo1y of, or a pred isposit ion to, 
retinal detachment or presence of diabetic retinopathy that the 
Investigator judges could confound outcomes. 
Note: Including but not limited to background diabetic 
retinopathy, diabetic macular edema, or proliferative diabetic 
retinopathy, macular degeneration. 
• 
Amblyopia. 
• 
Rubella, congenital, traumatic, or complicated cataract. 
• 
Extremely shallow anterior chambe r (:S 2.5 mm), not due to 
swollen cataract. 
• 
Any cmTent ante rior or posterior segment inflammation of any 
etiology, and/or histo1y of any disease producing an intraocular 
inflammat01y reaction . 
• 
Iris neovascularization. 
• 
Optic nerve atrophy. 
• 
Subjects with diagnosed degenerative eye disorder (eg, macular 
degeneration or other retinal disorders). 
• 
Known color vision deficiencies. 
• 
Subjects who may reasonably be expected to require an ocular 
surgical treatment at any time dming the surge1y (other than 
YAG capsulotomy). 

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Status: Ef f e c t i v e 
Version: 2. o; Mos t - Re c e n t ; Effective; CURRENT 
Page 17 of 71 
 
 
 
• 
Situations where the need for a large capsulotomy can be 
anticipated (eg, diabetics, retinal detachment in the fellow eye, 
peripheral retinal pathology). 
• 
Subjects who are expected to require retinal laser treatment. 
• 
Any subjects cun ently paiticipating in another investigational 
mug or device study that may confound the results of this 
investigation. 
• 
Any other conditions that may not be appropriate to this study, as 
per the Investigator's expert medical opinion. (In the expert 
opinion of the Investigator, any condition that would be expected 
to reduce the potential postoperative BCDVA to a level worse 
than 0.30 logMAR.) 
Data analysis and 
All patients with attempted IOL implantation (successful or aborted 
sample size 
after contact with the eye) are considered evaluable for the safety 
justification 
analysis. All patients with successful bilateral IOL implantation and 
have the bilateral measmements for defocus curve are considered 
evaluable for Full analysis set with effectiveness analysis. 
Effectiveness Analysis 
No formal statistical hypothesis testing is planned for the 
effectiveness endpoints. The data will be summarizedusing 
descriptive statistics. All continuous variables will be presented with 
the following summary statistics: mean, standard deviation, median, 
minimum, and maximum. Categorical variables will be summarized 
by count and percentage. The con esponding two-sided 90% 
confidence intervals will be presented for the effectiveness variables 
if deemed appropriate. 
Prima1y Effectiveness 
Binocular defocus will be summarized, and a plot will be generated 
for the defocus curve with amount of defocus along the x-axis and 
logMAR visual acuity at each defocus along the y-axis for the 
Month 3 visit. 
Seconda1y 
For both seconda1y 
effectiveness variables, the data 

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Page 18 of 71 
 
 
 
will be summarized descriptively. 
Binocular defocus curve will be summarized, and a plot will be 
generated for the defocus curve with amount of defocus along the 
x-axis and logMAR visual acuity at each defocus along the y-axis for 
the Month 1 visit. 
Binocular BCVA at distance, and monocular and binocular UCVA at 
near, intermediate, and distance will be summarized by visit with 
descriptive statistics. Binocular contrast sensitivity with/without glare 
will be summarized descriptively at the Month 3 visit. Subjective 
symptoms outcome will be summarized per symptom with frequency 
and percentage presented for each modality of responses. 
 
Safety 
Rate of SSIs related to the optical properties of the IOL for either eye 
during the study will be summarized by eye. All AEs will be coded 
using the Medical Dictionary for Regulatory Activities (MedDRA) 
and will be presented by severity (mild, moderate, or severe) and 
relationship to the test product. Device deficiencies, posterior capsule 
opacification, posterior capsulotomy, surgical problems, and IOL 
position change (tilt and decentration) will be summarized 
descriptively. Intraocular pressure at each visit and change from 
baseline will be summarized accordingly, 
Assuming a standard deviation of 0.17 logMAR with defocus visual 
outcomes, 40 subjects will have more than 99% probability to 
observe the half width of 90% two-sided confidence interval will be 
no more than 0.06 logMAR at each defocus. The precision of 
estimates are within ±3 letters with visual outcomes. 
Assuming a dropout rate of 10% at Month 3, approximately 
44 subjects will be bilaterally implanted to ensure that data for at 
least 40 subjects is available at Month 3. 
Clinical trial 
duration 
a. Total expected duration of the clinical investigation: 
approximately 12 months 
b. Expected duration of each subjects’ participation : 
approximately between 3 ~7 months 

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Document: TDOC-0054099 
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Effective Date: 13-Dec-2017 
Protocol - Clinical 
Version: 2.0; Most-Recent; Effective; CURRENT 
Page 19 of 71 
 
 
 
c. Planned follow-up duration: about 3 – 4 months post 2nd eye 
implantation 
d. Enrollment period : approximately 5 months (The recruit 
period can be extended if 44 bilaterally implanted subjects 
cannot achieve 40 evaluable due to unilateral implantation or 
exclusion after screening visit.). 
Key words 
Prospective, Single Arm, Unmasked, Non-Randomized, Multi-Center 
Study, Cataract, Bilateral implantation, The ACRYSOF IQ PanOptix 
Presbyopia Correcting IOL, Model TFNT00, Trifocal, Korea 
Associated 
materials 
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Page 20 of 71 
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Page 22 of 71 
 
 
1st Operative Eye 
2nd Operative Eye 
Both Eyes 
Visit 
Visit 0 
Day -60-0 Preoperative 
Visit 001 
Day 0 Operative 
Visit 1 
Day 1-2 Post Visit 00 
Visit 2 
Day 7-15 Post Visit 00 
Visit 00A2 
2-30 Days Post Visit 00 
Visit 1A 
Day 1-2 Post Visit 00A 
Visit 2A 
7-15 Days Post Visit 00A 
Visit 3A 
30-60 Days Post Visit 00A 
Visit 4A3 
90-120 Days Post Visit 00A 
Unscheduled Visit 
Fundus Visualization 
X 
X 
Intraocular Pressure 
X 
X 
X 
X 
X 
X 
X 
X7 
Surgical Procedure & Assessments 
Surgical report (including 
implanting surgeon, lens power, 
implant success, OVD and 
target refractive error5) 
X 
X 
Operative eye 
X 
X 
Surgical problems 
X 
X 
Lens Information 
X 
X 
Final Incision Size 
X 
X 
IOL damage 
X 
X 
Other Surgical Procedures 
X 
X 
Adverse Events & Device Deficiencies 
Adverse Events8 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Secondary Surgical 
Interventions 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Device Deficiencies 
X 
X 
X 
X 
X 
X 
X 
X 
X 
1. Visit 00 (1st eye surgery) must occur within 60 calendar days from Preoperative Visit (Visit 0). 
2. Visit 00A (2nd eye surgery) must occur after a minimum of 2 calendar days and a maximum of 30 calendar days after Visit 00. 
3. If necessary, Visit 4A may be completed over 2 days within a two-week period. Both days must fall within the specified visit window. 
Effective Date: 12/13/2017 11:35:45 AM 
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Document: TDOC-0054099 
Status: Effective 
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4. In women of child-bearing potential only. 
5. Data is reported in EDC at the surgical visit, but may be collected at a previous visit. 
6. Testing is conducted monocular bilaterally. 
7. 
Only measure in case considered necessary per the investigator’s medical opinion. 
8. Collected from time of consent onward. 
9. 1st operative eye. 
10. 2nd operative eye. 
Effective Date: 12/13/2017 11:35:45 AM 
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4 PROTOCOL AMENDMENTS 
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the Study Sponsor and must be 
approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions. 
 
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC. 

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5 INTRODUCTION 
5.1 Rationale and Background 
Monofocal IOLs are designed to replace the focusing power of the natural lens (typically 
after cataract surgery) by providing good visual function through a single, fixed, focal length; 
thus, generally correcting a subject’s distance vision. However, many pseudophakic subjects 

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implanted with monofocal IOLs ultimately require reading glasses to compensate for the loss 
of the ability to see clearly at intermediate or near distances. Several IOL designs for 
compensating the accommodation in pseudophakic subjects exist in modern day clinical 
practice, including multifocal IOLs. Multifocal IOLs offer subjects an opportunity to 
overcome the loss of near and intermediate vision by providing multiple focal points. The 
majority of commercially available multifocal IOLs provide two optical zones for distance 
and near vision. The ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 
uses technology similar to commercially available multifocal IOLs to create an additional 
focal point for intermediate vision. 
 
The ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 has a multifocal 
design and provides a near focal point at 40 cm and distance vision similar to a traditional 
multifocal IOL, but with the additional benefit to patients of an intermediate focal point at 60 
cm. The ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 has received 
CE Marking in European countries and is also approved in many other countries around the 
world. In Korea, a product import license was granted by the Ministry of Food and Drug 
Safety on April 12, 2017. 
 
The ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 delivers 3 focal 
points, including the intermediate range at approximately 60 cm, while competitive trifocal 
IOLs are at 80 cm. For many patients, critical work is performed at arm’s length (60 to 
70 cm). The ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 aims to 
provide greater initial acceptance and patient satisfaction by creating an intermediate focal 
point at 60 cm as opposed to 80 cm as in competitive trifocal designs. Alcon has received 
approval to market the ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 
with a CE mark in the European Union, and it is currently on the market in the EU and 
Australia. The interim, 6-month post-implantation results have been presented in ASCRS 
2017; the lens demonstrated approximate visual acuity of 20/25 or better from near (40 cm) 
through intermediate (60 cm) to distance. In Korea, Alcon has also received the approval to 
market as of April 12, 2017. So far, there were no clinical results in Korean populations for 
this lens. 
 
Similar to other Asian countries, the prevalence of myopia in South Korea is relevantly high, 
and many people need to wear glasses from childhood. Relevantly young cataract patients 
will have a strong desire for an extended range of intermediate vision for daily activities such 
as computer use, as well as near and distance vision after their cataract surgery; these patients 
are expected to have a strong desire to be spectacle independent. Additionally, the body 
height of the Korean population is shorter than the European or Australian population. 

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According to the Korea National Statistical Office, the average height of a Korean male is 
172.2 cm and the average height of a Korean female is 158.6 cm. The average arm length for 
a Korean male is 58.8 cm and the average arm length for a Korean female is 53.8 cm. 
Because the ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 is 
designed to have an intermediate focal point of about 60 cm, it is estimated that Koreans will 
have greater patient satisfaction with this new trifocal IOL; however, this claim is not 
currently supported since there are no clinical results in the Korean population. 
 
5.2 Purpose of the Study 
 
The present study (ILH297-P004) is intended to confirm the effectiveness of the 
investigational lens in a Korean population, especially for visual performance, quality of 
vision, and subject satisfaction with the visual outcome, as well as the safety of the lens. 
 
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards. 
 
Results of the study are intended for publication and all data and discoveries arising out of 
the study, patentable or non-patentable, shall be the sole property of Alcon, Inc. Alcon may 
use these data now and in the future for presentation or publication at Alcon’s discretion or 
for submission to government regulatory agencies. 
 
5.3 Risks and Benefits 
 
Complications may occur on the surgery day or throughout the postoperative period. As with 
any type of intraocular surgery, there is a possibility of complications due to anesthesia, drug 
reactions, and surgical problems. The surgical procedure can exacerbate a pre-existing ocular 
condition. Possible problems during surgery include corneal endothelial touch, detached 
Descemet’s membrane, iris damage, iris prolapse, iris trauma, iris incarceration, zonular 
rupture, vitreous loss, capsulorhexis tear, capsular rupture, uncontrollable intraocular 
pressure, hyphema, and endothelial cell loss. An IOP increase may occur from the surgical 
procedure, residual viscoelastic in the eye, or a steroid response to postoperative medications. 
 
Additionally, potential postoperative adverse events 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, irtis touch, pupil ovalization, posterior synechiae, ocular 
inflammation, and endothelial cell loss. 

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An IOL replacement or explantation may be appropriate in some cases of residual refractive 
error, ocular infection, subject dissatisfaction, or visual disturbances (eg, glare, halos, 
starbusts, hazy vision, blurred vision, double vision, visual distortions, and color distortions). 
 
A secondary surgical intervention (eg, IOL repositioning, replacement, or explantation) may 
be appropriate if the IOL position significantly differs from the intended placement. 
Alternatively, spectacles or contact lenses may be prescribed to resolve residual refractive 
error. Other secondary surgical interventions include, but are not limited to: refractive laser 
treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary 
block, wound leak repair, and retinal detachment repair. Postoperatively, the subject may 
experience ocular discomfort or pain, inflammation, decreased vision, decreased contrast 
sensitivity, decreased color perception, and visual disturbances. 
 
The ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 is a multifocal lens 
intended to provide optical performance and spectacle independence similar to the 
ACRYSOF IQ RESTOR +3.0 D Multifocal IOL (Model SN6AD1) at near (40 cm) and 
distance, with the additional benefit of intermediate vision at 60 cm. 
 
After CE mark approval in EU, a postmarket clinical investigation of the ACRYSOF IQ 
PanOptix Presbyopia Correcting IOL, Model TFNT00 was conducted at 14 clinical sites in 
regions where the ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 is 
approved for commercial distribution (Australia, Belgium, Chile, France, Germany, Italy, 
Netherlands, Spain, and the United Kingdom). This study was a prospective, single arm, 
unmasked, non-randomized, multi-center study. The objective was to describe visual 
outcomes and confirm long-term safety and performance at 12 months (330-420 days) post 
bilateral implantation of the ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model 
TFNT00. The 6-month interim analysis results showed that the ACRYSOF IQ PanOptix 
Presbyopia Correcting IOL, Model TFNT00could provide simultaneous visual performance 
for near, intermediate, and distance with a mean VA of 20/20 for distance and a mean VA of 
20/25 for intermediate and near vision. The ACRYSOF IQ PanOptix Presbyopia Correcting 
IOL, Model TFNT00 is safe when implanted according to the approved label. 
 
Based upon the formal risk assessment, the ACRYSOF IQ PanOptix Presbyopia Correcting 
IOL, Model TFNT00 demonstrates a favorable risk profile that is comparable to previously 
approved ACRYSOF multifocal IOLs. The ACRYSOF IQ PanOptix Presbyopia Correcting 
IOL, Model TFNT00 is designed to provide the benefit of increased intermediate vision 
while maintaining visual performance at near and distance. Potential risks following 
implantation of ACRYSOF IQ PanOptix Presbyopia Correcting IOL include visual 

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disturbances such as glare and halos, which are known risks for multifocal IOLs. The benefits 
of improved intermediate vision, when weighed against the risks of visual disturbances, result 
in a benefit to risk profile that is favorable for the ACRYSOF IQ PanOptix Presbyopia 
Correcting IOL, Model TFNT00. 
 
There may also be unknown risks with the use of ACRYSOF IQ PanOptix Presbyopia 
Correcting IOL, Model TFNT00. Any risk to subjects in this clinical study will be minimized 
by compliance with the eligibility criteria and study procedures, as well as clinical oversight 
and monitoring. The risk uncertainty is quite low due to the commercialization of PanOptix. 
 
Refer to the product label for additional information. 
 
6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
 
 
Describe visual outcomes (binocular 
defocus curve) at 3 months (90-120 days) 
post bilateral implantation of the ACRYSOF 
IQ PanOptix Presbyopia Correcting IOL, 
Model TFNT00 in a Korean population. 
Binocular defocus curve at 3 months post- 
implantation (Visit 4A, 90-120 days) 
 
6.2 Secondary Objective(s) 
 
Table 6–2 
Secondary Objective(s) 
Objective(s) 
Endpoint(s) 
 
 
1. Describe binocular defocus curve at 
1 month (30-60 days) post bilateral 
implantation. 
 
2. Describe BCDVA 4m at 1 and 3 months 
(Visit 3A and Visit 4A) post bilateral 
implantation. 
 
3. Describe mean UCVA at 1 and 
3 months (Visit 3A and Visit 4A) post 
1. 
Binocular defocus curve at 1 month 
post-implantation (Visit 3A, 
30-60 days) 
2. 
Best corrected binocular visual acuity 
at distance (4 m) at 1 and 3 months 
post-implantation (Visit 3A and 
Visit 4A) 
3. 
Mean visual acuity at 1 & 3 months 

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bilateral implantation. 
 
4. 
Describe contrast sensitivity at 
3 months (Visit 4A) post bilateral 
implantation. 
 
5. 
Describe subjective symptom at 
3 months (Visit 4A) post bilateral 
implantation. 
post-implantation (Visit 3A and 
Visit 4A) 
a) 
Monocular UCDVA (4 m) 
b) 
Monocular UCIVA (60 cm) 
c) 
Monocular UCNVA (40 cm) 
d) 
Binocular UCDVA (4 m) 
e) 
Binocular UCIVA (60 cm) 
f) 
Binocular UCNVA (40 cm) 
4. 
Photopic best corrected binocular 
contrast sensitivity at 3 months 
post-implantation (Visit 4A) 
5. 
Subjective symptom questions 
preoperatively and 3 months 
post-implantation (Visit 4A) 
 
 
 
 
 
6.4 Safety Objective(s) 
 
Table 6–4 
Safety Objective(s) 
Objective(s) 
Endpoint(s) 
 
 
Assess safety during the study up to 
3 months (90-120 days) post bilateral 
implantation of the ACRYSOF IQ PanOptix 
1. All adverse events (ocular and 
nonocular, serious and non-serious) 
including secondary surgical 

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Presbyopia Correcting IOL, Model TFNT00 
in a Korean population. 
interventions (SSIs) related to the 
optical properties of the IOL for either 
eye. 
2. Device deficiencies 
3. Posterior capsule opacification 
4. Posterior capsulotomy 
5. IOL position change (tilt and 
decentration) 
6. Intraocular pressure 
7. Surgical problems 
 
 
 
7 INVESTIGATIONAL PLAN 
7.1 Study Design 
This is a prospective, single-arm, unmasked, non-randomized, multi-center study of the 
ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00. 
 
Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. 
 
The first operative eye is defined as the eye with the worse BCDVA at screening visit. If 
BCDVA is the same in both eyes, identify the right eye (OD) as the first operative eye. The 
second eye implant can occur according to each participating site’s standard visit schedule; 
however, it must occur within 30 days of the first eye implant. 
 
A total of 9 scheduled visits are planned (some scheduled visits may be conducted on the 
same day due to the visit window) and subject participation is expected to last 3-7 months. 
The visits include a Screening visit (Visit 0), 2 Operative Visits (Visit 00 and Visit 00A), and 
6 postoperative visits at the following intervals: Day 1-2 (Visit 1/1A), Day 7-15 (Visit2/2A), 
Day 30-60 (Visit 3A), and Day 90-120 (Visit 4A) (See Figure 7-1 Study Design). Primary 
endpoint data will be collected at the Month 3 visit / Visit 4A (90-120 day post 2nd eye 
implantation). 
 
Note: Visit 4A may be completed over 2 days within a 2-week period. Both days must fall within the 
specified visit window. 
 
The schedule of visits is shown below: 

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Figure 7-1 
Study Design 
 
 
7.2 Rationale for Study Design 
The ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 has a multifocal 
design and provides a near focal point at 40 cm and distance vision similar to a traditional 
multifocal IOL, but with the additional benefit to patients of an intermediate focal point at 60 
cm. Since ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 was 
approved in EU countries, its safety and effectiveness has been proven through postmarketing 
clinical use and clinical trials. However, no formal clinical trial has been conducted in Korea 
to demonstrate the safety and effectiveness in the Korean patient population since its 
approval. 
 
The purpose of this clinical study is to describe the visual outcomes of this lens at near, 
intermediate, and distance, and to confirm the expected multifocal vision with this lens by 
measuring the binocular defocus curve in a Korean population. With well-established safety 
and effectiveness from EU clinical use data and an acknowledged standard of visual 
outcomes, a single arm, multi-center study was considered sufficient to describe the visual 
outcomes and safety of the ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model 
TFNT00 in a Korean population. 

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The study is also designed to assess performance and safety parameters of interest in 
compliance with guidance from ISO 11979-9:2006(E), with minor modifications reflecting 
the standard visit schedule of modern teaching university hospitals in South Korea. 
 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations 
Not applicable. 
 
7.3 Rationale for Duration of Treatment/Follow-Up 
The duration of use of the product is in accordance with product labeling. The follow-up visit 
schedule is in accordance with clinical practice, and the follow-up duration is sufficient based 
upon the well-established effectiveness and safety profile of the ACRYSOF IQ PanOptix 
Presbyopia Correcting IOL, Model TFNT00 in the EU and Australia. 
 
7.4 Rationale for Choice of Control Product 
Not applicable. 
 
7.5 Data Monitoring Committee 
Not applicable. 
 
8 STUDY POPULATION 
The study population consists of adult Korean males and females, at least 20 years of age or 
older at the time of screening, with no ocular pathology that could confound study outcomes, 
who require cataract extraction in both eyes and desire an IOL that provides the potential for 
near, intermediate, and distance vision. Bilateral cataract extraction is planned in 
approximately 44 subjects in approximately 4 sites in Korea, with a target of 5 to 15 subjects 
per site. Site-specific targets may vary based upon individual site capabilities. Estimated time 
needed to recruit subjects for the study is approximately 5 months. The recruit period can be 
extended if 44 bilaterally implanted subjects cannot achieve 40 evaluable due to unilateral 
implantation or exclusion after screening visit. Assuming a 20% screening failure rate, 
approximately 55 subjects are expected to be enrolled. 
 
8.1 Inclusion Criteria 
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study. 

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Subjects eligible for inclusion in this study must fulfill all of the following criteria (ocular 
criteria must be met in both eyes): 
 
1. 
Subject or legally authorized representative must be able to understand and sign an 
IRB/IEC approved Informed Consent form. 
2. 
Willing and able to attend all scheduled study visits as required per protocol. 
3. 
Adults, at least 20 years of age or older at the time of screening, of either gender in 
Korean, who require cataract extraction in both eyes. 
4. 
Clear intraocular media other than cataract in both eyes. 
5. 
Calculated lens power between +16.0 and +24.0 D. 
6. 
Preoperative OR expected postoperative regular corneal astigmatism of < 1.00 D. 
 
 
8.2 Exclusion Criteria 
Subjects fulfilling any of the following criteria are not eligible for participation in this study. 
Ocular criteria must not be met in either eye. 
 
1. 
Women of childbearing potential, defined as all women who are physiologically 
capable of becoming pregnant and who are not postmenopausal for at least 1 year or 
are less than 6 weeks since sterilization, are excluded from participation if any of the 
following apply: 
a. they are currently pregnant, 
b. have a positive urine pregnancy test result at Screening, 
c. intend to become pregnant during the study period, 
d. are breast-feeding. 
Subjects who become pregnant during the study will not be discontinued; however, 
data will be excluded from the effectiveness analyses because pregnancy can alter 
refraction and visual acuity results. 
2. 
Clinically significant corneal abnormalities including corneal dystrophy (eg, 
epithelial, stromal or endothelial dystrophy), inflammation, or edema per the 

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Investigator’s expert medical opinion. 
3. 
Previous corneal transplant. 
4. 
Ocular trauma, previous refractive surgery, or refractive procedures throughout the 
entire duration of the subjects’ participation in the clinical study (including, but not 
limited to LASIK, astigmatic keratotomy, and limbal relaxing incision). 
5. 
History of or concurrent retinal conditions or predisposition to retinal conditions, 
previous history of, or a predisposition to, retinal detachment or presence of diabetic 
retinopathy that the Investigator judges could confound outcomes (NOTE: Including 
but not limited to background diabetic retinopathy, diabetic macular edema or 
proliferative diabetic retinopathy, macular degeneration). 
6. 
Amblyopia. 
7. 
Rubella, congenital, traumatic or complicated cataract. 
8. 
Extremely shallow anterior chamber (≤ 2.5 mm), not due to swollen cataract. 
9. 
Any current anterior or posterior segment inflammation of any etiology, and/or 
history of any disease producing an intraocular inflammatory reaction. 
10. 
Iris neovascularization. 
11. 
Optic nerve atrophy. 
12. 
Subjects with diagnosed degenerative eye disorder. 
13. 
Known color vision deficiencies. 
14. 
Subjects who may reasonably be expected to require an ocular surgical treatment at 
any time during the surgery (other than YAG capsulotomy). 
15. 
Situations where the need for a large capsulotomy can be anticipated (eg, diabetics, 
retinal detachment in the fellow eye, peripheral retinal pathology). 
16. 
Subjects who are expected to require retinal laser treatment. 
17. 
Any other additional procedures during the phacoemulsification and IOL implant due 
to intraoperative complications that require further investigation (including but not 

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limited to posterior capsule rupture, vitreous loss, zonular dehiscence that may make 
the IOL implant less stable, etc). 
18. 
Zonular or capsule rupture. 
19. 
Excessive iris mobility. 
20. 
Significant anterior chamber bleeding. 
21. 
Uncontrolled intraocular pressure. 
22. 
Unrecognized (pre-existing but discovered during surgery ocular conditions or 
complications in which the IOL stability could be compromised, including zonular 
weakness). 
23. 
Bag-sulcus, sulcus-sulcus, or unknown placement of the haptics. 
24. 
Capsulorhexis tears or any areas of “can-opener” capsulotomy. 
25. 
Any subjects currently participating another investigational drug or device study that 
may confound the results of this investigation. 
26. 
Any other conditions that may not be appropriate to this study, as per the 
Investigator’s expert medical opinion. 
Note: When criteria 17-24 occur prior to IOL implantation, the study lens should not be implanted. This is true 
for both eyes. 
 
 
8.3 Rescreening of Subjects 
Rescreening of subjects is not allowed in this study. 
 
9 TREATMENTS ADMINISTERED 
9.1 Investigational Product(s) 
Test Product(s): 
The ACRYSOF IQ PanOptix Presbyopia Correcting 
IOL, Model TFNT00 
Control Product(s) (If applicable): Not applicable 

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Table 9-1 
TestProduct 
 
Test Product 
The ACRYSOF IQ PanOptix Presbyopia Conecting IOL, Model 
TFNT00 
Manufacturer 
License Holder: 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fo1tWo1th, Texas 76134-2099 
USA 
Manufacturer: 
Alcon Research Ltd 
6065 Kyle Lane Huntington 
West Virginia, 25702 
USA 
Indication for use 
and intended 
pmpose in the 
cun ent study 
The ACRYSOF IQ PanOptix Presbyopia Conecting IOL, Model 
TFNT00 is a multifocal IOL that conects aphakia, a condition that 
prevents patients from seeing things that are at near and/or at 
distance, by replacing the cataractous lens after cataract surge1y in 
an adult patient. It is inse1t ed into the capsular bag and has near 
vision and inte1mediate add power (3.25 D, 2.17 D). 
Product description 
and parameters 
ava ilable for this 
• Optic Type: Biconvex Aspheric Optic 
• Optics Material: Ultraviolet and blue light filtering Ac1ylate/ 
Methac1ylate Copolymer 
study 
• Optic Powers: 16.0 to 24.0 D in 0.5 D steps 
• Index of Refraction: 1.55 in air 
• Haptic Configuration: STABLEFORCE*Modified-L Haptics 
• Haptic Material: Ultraviolet and blue light filtering 
Ac1ylate/Methac1ylate Copolymer 
• Optic Diameter (mm): 6.0 
• Overall Length (mm): 13.0 
• Haptic Angle: 0° 
Formulation 
PEA, PEMA, BDDA, oMTP, AL-8739 

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Usage 
IOLs are implantable medical devices and are intended for long- 
te1m use over the lifetime of the pseudophakicsubject. 
Number/Amount of 
product to be 
provided to the 
subject 
Each subject will be bilaterally implanted with the test a1t icle. 
Packaging 
description 
Each IOL will be individually packaged and will have a unique 
serial number. The IOL package will contain the following items: 
• TheIOL 
• A subject registration card (Lens Implant Card) 
• A subject identification card 
• Adhesive labels containing the IOL inf01mation and unique 
serial number 
• A package inseit containing directions for use 
Labeling description • Prima1y: polypropylenewagon wheel case 
• Seconda1y: Polyester /Tyvek sterilization pouch / Cardboard box 
with polyprolylene film 
• Traceability shall be achieved by assignment of lot numbers, 
batch numbers or serial numbers. 
• Korean label (not applicable to English label) 
0 
Korean only, labeling components should be same as 
Korea license inf01mation approved by MFDS 
0 
Font size should be 6 or 7 point 
0 
 7 point: name of product & model, year and month of 
manufacture (use-by date) 
0 
 7 point and bold stroke/text box: warning/caution, 
"Medical Device", "Single use & prohibit re-use", "For 
clinical investigation.Exclusively for clinical 
investigation" 
0 
 6point: name & address of manufacturer & importer, 
product license number, packing unit, instmction of use, 
precautions in use, pmpose of use, storage method, year 
& month written on the Korean label 
• Lot number and expiration date: refer to the info1m ation on the 

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original package. 
Storage conditions 
< 45°C 
The IP must be stored in a safe, secure location within limited 
access separated from general stock. Transportation of product from 
one address to another must be documented and a Transportation 
Log (or similar documentation) utilized for appropriate 
accountability. 
Additional 
information 
In order to implant IOLs in study subjects, the surgeons 
participating in the study must be licensed ophthalmologists with 
cataract surgery experience and trained on the protocol. 
Subjects should be targeted for emmetropia postoperative 
refraction. The surgeon should target lens power that is expected to 
deliver the best visual outcome based on their medical judgement. 
Supply 
A designated amount of IOLs will be supplied to the site by the 
Sponsor. 
 
 
The ACRYSOF IQ PanOptix Presbyopia Correcting IOL, Model TFNT00 must be 
maintained within specified environmental conditions, per the labeling. 
 
A temperature log must be maintained documenting appropriate IP storage conditions as 
described in the MOP, and must be made available for inspection. 
 
More information on the test product can be found in the Package Insert of the ACRYSOF IQ 
PanOptix Presbyopia Correcting IOL, Model TFNT00. 
 
9.2 Other Medical Device or Medication Specified for Use during the 
Study 
No other medical devices or medications are required to be used in conjunction with the 
treatments during the clinical study. 
 
9.3 Treatment Assignment / Randomization 
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system. 

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9.4 Treatment masking 
All members associated with the study (at the site and the Study Sponsor) are unmasked to 
the assigned treatment. 
 
9.5 Accountability Procedures 
Upon receipt ofI Ps, the Investigator or delegate must conduct an invento1y of ACRYSOF IQ 
PanOptix Presbyopia Con ecting IOL, Model TFNT00 by serial number, complete 
study-specific confi1mation of receipt procedures as described in the MOP, and retain any 
required documentation in the Investigator's clinical study records. Throughout the study, the 
Investigator or delegate must maintain records of IP use and collection for each subject. This 
record must be made available to the study monitor for the purposes of verifying the 
accounting of IP supplies. Any discrepancies and/or deficiencies between the observed 
disposition and the written account must be recorded along with an explanation.All IPs sent  
to the Investigator must be accounted for by Study Sponsor personnel, and in no case be used 
in an unauthorized manner. 
 
• 
Return to the Study Sponsor investigational and control products associated with a device 
deficiency. Refer to Section 11 of this protocol for additional information on the reporting 
of device deficiencies and to the MOP for information on return of study products 
associated with these events. 
The Investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instru ctions provided in the MOP. 
 
9.6 Changes to concomitant medications, treatments/ procedures 
After the subject is enrolled into the study, the Investigator must instru ct the subject to notify 
the study site about: 
 
• 
Any new medications 
• 
Alterations in dose or dose schedules for cunent medications, 
• 
Any medical procedure or hospitalization that occuned or is planned 
• 
Any non-dtug therapies (including physical therapy and blood tr·ansfusions). 
The Investigator must document this inf01mation in the subject's case hist01y source 
document s. 

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10 STUDY PROCEDURES AND ASSESSMENTS 
10.1 Informed Consent and Screening 
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject or legally authorized representative read, sign, and date the IRB/IEC-approved 
infmmed consent document. The delegate should be a licensed medical doctor of 
ophthalmology. The subject must sign the ICF BEFORE any study-specific procedures or 
assessments can be performed, including study-specific screening procedures. Additionally, 
have the individual obtaining consent from the subject and a witness, if applicable, sign and 
date the info1med consent document. The subjects should be provided with enough time for 
his/her decision on participation on the trial, and shouldhave options to discuss with his/her 
family members or relatives about the participation to the investigation. 
 
The Investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject's chart, or provide documentation as 
required by local regulations. 
 
10.2 Description of Study Procedures and Assessments 
Effectiveness assessments: 
 
Below assessments will be conducted in the photopic lighting condition except subjective 
symptoms, 
 
• 
Distance VA (4 m), 
o Monocular (1st and/or 2nd eye) UCDVA 
o Binocular UCDVA 
o Binocular  BCDVA 
• 
Inte1mediate VA (60c m) 
o Monocular (1st and/or 2nd eye) UCIVA 
o Binocular UCIVA 
• 
Near VA (40 cm) 
o Mono cular (1st and/or 2nd eye) UCNVA 
o Binocular UCNVA 
• 
Binocular defocus curve 

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• 
• 
• 
Bestcon-ected binocular contrast sensitivity with & without glare 
• 
Subjective symptoms 
Safety assessments: 
 
• 
Adverse Device Events including Seconda1y Surgica l Intervent ions (SSls) related to the 
optical prope1ties of the IOL 
• 
Device deficiencies 
• 
Fundus examination and fundus visualization 
• 
Intraocular pressure 
• 
Slit-lamp examination 
• 
IOL obse1vations 
• 
Surgical problems 
• 
Subjective posterior capsule opacification 
• 
Posterior capsulotomy 
• 
Lens decentration and tilt 
Preoperative assessments: 
 
• 
U1ine PregnancyTest 
• 
 
Detailed descriptions of assessments and procedures are provided in the MOP. The 
Investigator is responsible for ensuring responsibilities for all procedures and assessments are 
delegated to appropriately qualified site personnel. 
 
10.2.1 Demographics 
Obtain demographic inforniation including age, race, ethnicity, height,- 
and sex. 
 
10.2.2 Medical History 
Collect medical hist01y info1m ation, incl uding info1mation on all medications used within the 
past 30 days. Include herbal therapies, vitamins, and all over-the-counter medications as well 

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as prescription medications. Throughout the subject’s participation, obtain information on 
any changes in medical health and/or the use of concomitant medications. 
 
10.2.3 Concomitant Medication 
Concomitant medications can be ocular or nonocular. Details are provided in the MOP. 
 
10.2.4 Inclusion/Exclusion Criteria 
At the conclusion of Visit 0, verify the subject meets all eligibility criteria as detailed in the 
protocol, Section 8.1 Inclusion Criteria and Section 8.2 Exclusion Criteria. 
 
10.2.5 Investigational Product compliance 
N/A 
 
10.2.6 Urine Pregnancy Test 
For women of childbearing potential, request a urine pregnancy test be taken at the 
Investigator’s office. 
 
 
 
10.2.9 Visual Acuity: Effectiveness Assessment 
ETDRS visual acuity testing for both eyes must be performed prior to any assessment 
requiring administration of eye drops to dilate the eyes, or any assessment requiring contact 

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with the eye. When assessing BCDVA, refractive correction is required. All visual acuity 
tests will be conducted in the photopic lighting conditions. Lighting measurement and 
manifest refraction details are provided in the MOP. 
 
Visual acuity must be obtained by study personnel who have been successfully trained. For 
Preoperative Visit (Visit 0), data from the Investigator’s previous routine cataract evaluation 
may be used, if the data 1) meet the requirements of this protocol and MOP, and 2) were 
collected less than 2 months before the ICF signed for the study. 
 
10.2.10 Binocular Defocus Curve: Effectiveness Assessment 
Defocus assessment requires the subject’s best distance correction be varied from +2.00 D 
to -5.00 D in 0.50 D increments. The purpose of the defocus evaluation is to compare 
binocular clinical performance to the theoretical lens design. Defocus curve is commonly 
used clinical endpoints to evaluate the effectiveness of presbyopia correcting intraocular 
lenses, as well as with visual acuity. 
 
10.2.12 Photopic Best Corrected Contrast Sensitivity: Effectiveness 
Assessment 
Photopic best corrected contrast sensitivity with and without glare test will be conducted to 
assess the effect on visual quality of the trifocal IOL at distance. 
 
10.2.13 Subjective symptoms: Effectiveness Assessment 
Provide the subject the patient satisfaction questions prior to seeing a physician or any 
clinical exam. Assess the subjective visual status/satisfaction on daily activities. 
 
10.2.14 Adverse Events including Secondary Surgical Interventions: Safety 
Assessment 
Assess and record any adverse events that are observed or reported, including those 
associated with changes in concomitant medication dosing since the previous visit. 

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10.2.15 Device Deficiencies: Safety Assessment 
Assess and record any device deficiencies that are reported or observed, including those 
associated with changes in concomitant medication dosing since the previous visit. 
Requirements for reporting device deficiencies in the study can be found in Section 11. 
 
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent, regardless of subject enrollment status (screen failure or 
included). 
 
10.2.16 Slit-Lamp Examination: Safety Assessment 
SLE of the cornea, iris/anterior chamber, and lens must be performed in both eyes before 
instillation of any diagnostic eye drops. For Preoperative Visit (Visit 0), data from the 
Investigator’s previous routine cataract evaluation may be used, if the data 1) meet the 
requirements of this protocol and MOP, and 2) were collected less than 2 months before the 
ICF signed for the study. 
 
Note: This exam must be completed by a medical doctor, or Ophthalmological technician. 
 
10.2.17 Fundus examination and Fundus Visualization: Safety Assessment 
For fundus examination, document the assessment of vitreous, retina, macula, choroid, optic 
nerve, and cup/disc ratio. 
 
For fundus visualization, document whether the lens causes any difficulty in viewing and/or 
examining the retina or posterior segment, or affects the surgeon's ability to administer 
vitreal/retinal treatments, as compared to experience with monofocal IOLs. For Preoperative 
Visit (Visit 0), data from the Investigator’s previous routine cataract evaluation may be used, 
if the data 1) meet the requirements of this protocol and MOP, and 2) were collected less than 
2 months before the ICF signed for the study. 
 
Note: This exam must be completed by a medical doctor, or Ophthalmological technician. 
 
10.2.18 Subjective PCO including Posterior Capsulotomy: Safety 
Assessment 
During the slit-lamp examination, assess the presence of PCO. For posterior capsulotomy 
assessment, indicate whether a posterior capsulotomy was performed since the last visit. 

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10.2.19 IOL Position Change: Safety Assessment 
After surge1y, examine the IOL with the slit-lamp. Indicate whether the lens has changed 
position, tilted, or decentered since the last visit. 
 
10.2.20 Other Surgical Procedures: Safety Assessment 
During cataract surge1y,  document whether any additional procedures (eg, anterior 
vitrectomy, capsular tension ring) were performed. Evaluate whether the procedure meets the 
definition of anAE and repo1taccordingly. 
 
10.2.21 Problems during Surgery: Safety Assessment 
Document whether any problems arose during surge1y. Examples of problems include 
anterior capsular tear, intraoperative loss of pupil dilation, bag-sulcus haptic placement. 
Evaluate whether the problem meets the definition of an AE and rep01t accordin gly. 
 
10.2.22 Surgical Report: Safety Assessment 
Implant the lens via clear cornea incision using the surgeon's standard operating procedures 
and in accordance with IOL directions for use. Keep an accurate and complete operative 
repo1t in the source documentation. 
 
10.2.23 Lens Information: Safety Assessment 
Post lens implantation, retain the IOL adhesive label in the subject source. 
 
10.2.24 Intraocular Pressure: Safety Assessment 
Intraocular pressure must be measured in both eyes following Investigator's standard of care. 
Within a single subject utilize the same instmment type to measure IOP during each visit. 
Record the measurement in mmHg. For Preoperative Visit (Visit 0), data from the 
Investigator's previous routine cataract evaluation may be used, if the data 1) meet the 
requirements of this protocol and MOP, and 2) were collected less than 2 months before the 
ICF signed for the study. 
 
10.3 Unscheduled Visits 
If a subject visit occurs between any regularly scheduled visits, this visit must be documented 
as an Unscheduled Visit. During all unscheduled visits, the Investigator must conduct the 
following procedures: 
 
• 
Record changes in medical condition or concomitant medication 

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• 
Collect Adverse Event inf01mation 
 
• 
Re cord  seco nda1y  surgical  inter vention s that have occuned since surge1y, if applicable. 
• 
Evaluate and record any device deficiencies. 
The Investigator may perform additional procedures for proper diagnosis and treatment of the 
subject as below. The Investigator must document this info1mation in the subject's case 
hist01y so urce document s. 
 
• 
Perform manifest refraction 
• 
Perform slit-lamp examination including IOL obse1vations (if any). 
• 
Obse1ve any IOL position changes (ie, tilt and decentration) occuning since the previous 
visit. [Both Eyes, Bilateral] 
• 
Assess subjective PCO, and record information for any PC that has occmTed since 
surgery , if applicable. [Both Eyes, Bilateral] 
• 
Perform tonometry to measure IOP. 
If during an Unscheduled Visit, the subject is discontinuing the IP or discontinuing from the 
study, the Investigator must conduct Exit procedures (refer to Visit 4A for the exit procedure) 
according to Table 3-1 Schedule of Study Procedures and Assessments and Section 10.4.3, as 
possible. 
 
10.4 Directions Related to Secondary Surgical Intervention 
This section is intended to provide guidance on the documentation and procedures related to 
SSis in this investigation. The investigator must consider subject complains and clinical 
outcome in his or her consideration of the need for a SSI, determine whether the cause of a 
needed SSI is due to optical properties of the IOL , and repo1tfindings to the Sponsor with 
defined timelines in Section in the Section 11.3 Procedure for Recording and Rep01ting. 
 
The main procedural steps in the decision process for SSis and notification to the Sponsor are 
detailed below: 
 
1. The Investigator must dete1mine whether an SSI is related to the optical properties of the 
IOL. 
 
2. Any SSI (other than posterior capsulotomy laser treatment) perf01med for any reason 
should be recorded as a serious adverse event and reported to the Sponsor within 24 hours of 
its occmTence. 

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Note: If the SSI is a lens exchange or repositioning, the subsequent study post-operative visits 
should be based on the date of its surgery. Unscheduled Visit Case Report Forms (CRFs) 
should be used for other post-operative follow-up visits, where applicable. If the study lens is 
exchanged and replaced with a non-study lens, the subject will be required to complete all 
original subsequent study lens visit through Visit 4A (3 months). 
 
Evaluation of Need for a Secondary Surgical Intervention: 
 
The Need for consideration of an SSI includes one or more of the followings: 
 
1. 
An Investigator assessment of subject’s clinical outcome 
 
2. 
A subject spontaneously complaining about visual symptoms to 
the investigational site personnel 
 
3. 
Other reason(s) for an SSI, e.g. retained lens fragments 
 
The Investigator should perform a thorough evaluation including diagnostic testing as needed 
and a subject interview to understand subject observations in detail to determine if an SSI is 
the appropriate treatment for the subject’s undesired outcome (e.g., blurred vision, visual 
disturbances/distortions, or other reasons). Case management should be based on the 
Investigator’s clinical assessment with consideration of the subject’s postoperative UCDVA, 
BCDVA, IOL stability after implantation, and any subjective complaints. Careful 
consideration of the potential risks and benefits associated with the SSI for the subject is 
required, and these should be discussed with the subject prior to reposition or explant the IOL 
or otherwise surgically intervene. 
 
10.5 Discontinued Subjects 
10.5.1 Screen Failures 
Screen failures are subjects who were excluded from the study after signing the informed 
consent and prior to administering treatment. 
 
The Investigator must document the reason for screen failure in the subject’s case history 
source documents. 
 
Subject numbers must not be re-used. 

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10.5.2 Discontinuations 
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the Investigator after informed consent is signed and before the last visit is 
completed. 
 
Subject numbers of discontinued subjects must not be re-used. 
 
Subjects may discontinue from study or study treatment at any time for any reason. Subjects 
may also be discontinued from study treatment at any time if, in the opinion of the 
Investigator, continued treatment poses a 1isk to their health. 
 
If a subject discontinues from study treatment, eve1y effo11 mu st be made to keep the subject 
in the study and to continue with the study assessments as specified in the schedule of study 
procedures and assessments until the final visit. 
 
For subjects discontinuing from the study, the Investigator must complete all Exit procedures 
according to Table 3-1 Schedule of Study Procedures and Assessments and Section 10.4.3, if 
the subject is willing and able, and if in the opinion of the Investigator it is safe for the 
subject to do so. 
 
The Investigator must document the reason for study or treatment discontinuation in the 
subject 's case hist01y so urce documents. 
 
To ensure the safety of all subjects who discontinueearly,  Investigatorsmust assess each 
subject and, if necessa1y, advise them of any therapies and/or medical procedures that may be 
needed to maintain their health. 
 
10.5.3 Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product 
In the case of subjects who discontinue IP but do not discontinue from the study, subjects 
must be assessed with below tests till the end of study, if applicable. 
 
Effectiveness assessment (photopic light conditions) 
Safety assessment 
Distance VA (4 m), 
• Monocular (1st and/or 2nd eye) UCDVA 
• 
Binocular UCDVA 
Adverse Device Events including 
Seconda1y Surgical Inte1ventions 
(SSis) related to the optical 
prope1ties of the IOL 

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• 
Binocular BCDVA 
lnte1mediate VA (60 cm) 
• 
Monocular (1st and/or n2  d eye) UCIVA 
• 
Binocular UCIVA 
Device Deficienc ies 
Near VA (40 cm) 
• 
Monocular (1st and/or 2nd eye) UCNVA 
• 
Binocular UCNVA 
Fundus Visualization 
Fundus Examination 
Photopic binocular defocus cmve 
Intraocular Pressure 
Photopic best conected binocular contrast sensitivity 
Surgical problems 
with & without glare 
Subjective symptoms 
 Subjective Posterior Capsule 
Opacification 
Posterior Capsulotomy 
Lens decentration and tilt 
 
 
Depending on the circumstance, the subject may continue in the study or may be 
discontinued as outlined as below. 
 
Eye 
Conditions 
Status/Follow-up 
1st Operative Eye 
• Exclusion during 
surge1y 
• Lens does not touch eye 
Subject discontinued 
• Exclusion during 
surge1y 
• Lens touches eye 
• Lens is not implanted 
• Subject continued 
• 1st eye: 
0 
 No effectiveness assessments 
conducted 
0 
Monocular safety 

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assessments conducted at 
postoperative visits 
• 2ndeye: Not implanted 
• Exclusion during 
surge1y 
• Lens implanted 
• Subject continued 
• 1st eye: 
0 
Monocular and binocula r 
effe ctivene ss ass ess ments 
cond ucted at pos toperati ve 
visits 
0 
Safe ty ass ess ment s 
cond ucted at pos toperati ve 
visits 
• 2ndeye: Proceed to implant study 
lens as scheduled 
2ndOpe rative 
Eye 
• Exclusion during 
surge1y 
• Lens does not touch eye 
• Subject continued 
• 1st eye: 
0 
Monocular 
effectiveness 
assessments perf01med at 
postoperative visits 
0 
Safety assessments 
perf01med at postopera tive 
visits 
• 2nd eye: 
0 
 No effectiveness 
assessments conducted 
• Rep01t AEs and Device 
Deficiencies, if any 
Eye 
Conditions 
Status 
2 nd0 per.atlve 
Eye 
• Exclu sion during 
surge1y 
• Subject continued 
• 1st eye: 

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• Lens touches eye 
• Lens not implanted 
0 
Monocular effectiveness 
assessments performed at 
postoperative visits 
0 
Monocular safety 
assessments performed at 
postoperative visits 
• 2nd eye: 
0 
 No effectiveness 
assessments conducted 
0 
Monocular safety 
assessments performed at 
postoperative visits 
• Exclusion during 
surge1y 
• Lens implanted 
• Subject continued 
• 1st eye: 
0 
Monocular and binocular 
effectiveness assessments 
conducted at postoperative 
visits 
0 
Safety assessments 
conducted at postoperative 
visits 
• 2nd eye: 
0 
Monocular and binocular 
effectiveness assessments 
conducted at postoperative 
visits 
0 
Safety assessments 
conducted at postoperative 
visits 

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10.6 Clinic al Study Termina tion 
The Study Sponsor reserves the right to close the investigational site or ternlinate the study in 
its entirety at any time. 
 
If the clinical study is prematurely terminated or suspendedby the Study Sponsor: 
 
• 
The Study Sponsor must: 
o Immediately notify the Investigator(s) and subsequently provide 
instructions for study termination. 
o Info1mthe Investigator and the regulat01y au thorities of the 
te1mination/suspension and the reason(s) for the te1mination/suspension. 
• 
The Investigator must: 
o Promptly notify the IRB/IEC of the termination or suspension and of the 
reasons. 
o Provide subjects with recommendations for post-study treatment options 
as needed. 
The Investigator may te1mi nate the site's prut icipation in the study for reasonable cause. 
 
10.6.1 Follow-up of subjects after study participation has ended 
Following this study, the subject will return to their eye care professional for their routine eye 
care. 
 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 General Information 
An AE is any untoward medical occmTence, umntended disease or injmy, or untoward 
clinical signs (including abn01mal labora t01y findin gs) in subje c ts, users, or other persons, 
whether or not related to the investigational medical device (test a1ti cle). Refer to the 
Glossaiy of Te1ms for categories of AEs and SAEs. 

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No 
Figure 11-1 
Categorization of All Adverse Events 
 
 
AIIAEs 
 
 
 
 
Meets 
seriousness 
criteria? 
No 
Devi ce / 
procedure- 
AE 
related? 
 
 
 
 
 
 
SAE 
ADE 
 
 
 
Figure 11-2 
Categorization of All Serious Adverse Events 
 
 
All SAEs 
 
 
 
 
 
Device / 
procedure 
related? 
 
SAE 
 
 
 
 
SADE 
 
 
 
In addition to rep01ting all AEs (serious and non-serious) meeting the definitions, the 
Investigator must repo1t any occunence of the following as an SAE: 
 
Cumulative Serious Adverse Events 
 
• 
Cystoid macular edema 
Yes 
Yes 
Yes 
No 

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• 
Hypopyon 
 
• 
Endophthalmitis 
 
• 
Lensdislocation 
 
• 
Pupillaiy block 
 
• 
Retinal detachment 
 
• 
Secondaiy surgical intervention (excluding posterior capsulotomy) 
PersistentSerious Adverse Events 
 
• 
Corneal strom al edema 
 
• 
Cystoid macular edema 
 
• 
Iritis 
 
• 
Raised IOP requiring treatment 
 
This list is consistent with the categories provided in EN ISO 11979-7:2014. A persistent AE 
is an AE that is present at the conclusion of a clinical investigation per EN ISO 11979- 
1:2012. Any other potentially sight-threatening event may also be considered serious based 
upon the judgment of the Investigator and should be report ed appropriately as delineated in 
Section 11.3. 
 
Device Deficiencies 
 
A device deficiency may or may not be associated with subject ha1m (ie, ADE or SADE); 
however, not all ADEs or SADEs are due to a device deficiency. The Investigator should 
determine the applicable category for the identified or suspect device deficiency and report 
any subject haim separately. 
 
• 
Failure to meet product specifications (eg, incoITect IO L power) 
 
• 
IOL defect 
 
• 
Broken IOL optic 
 
• 
Broken IOL haptic 
 
• 
Scratched IOL optic 
 
• 
Unsealed device packaging 
 
• 
Suspect product contamination (IOL) 

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11.2 Monitoring for Adverse Events 
At each visit, after the subject has had the oppo1tunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking the standard questions: 
 
• 
"Have you had any health problems since yom last study visit?" 
• 
"Have there been any changes in the medicines you take since your last study visit?" 
Changes in any protocol-specific parameters and/or questionnaires evaluated during the study 
are to be reviewed by the Investigator.Any untoward  (unfavorable  and unintended)  change in 
a protocol-specific parameter or questionnaire response that is clinically relevant, in the 
opinion of the Investigator, is to be rep01ied as an AE. These clinically relevant changes will 
be repo1ied regardless of causality. 
 
11.3 Procedures for Recording and Reporting 
AEs are collected from the time of inf01med consent. Any pre-existing medic al conditi ons or 
sign s/symptoms present in a subject prior to the sta1i of the study (ie,  before info1med 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
Hist01y sect ion of the eCRF. 
 
In addition, aqueous cells and flare, corneal edema, raised IOP, and superficial punctate 
keratitis are examples of early postoperative findings that are typically observed following 
ocular surgery. The se are not considered AEs if they can be reasonably expected to resolve 
within a week and not result in any untoward long te1m visual outcome impact. 
 
For each recorded event, the ADEs and SAEs documentation must include: date of 
occmTence, seve rity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the Investigator must document all device deficiencies reported or 
observed with test a1iiicles 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: 
 
• 
All SAEs must be repo1ied immedia tely (within 24 homs) of the Investigator's or site's 
awareness. 
• 
ADEs that do not meet seriousness criteria and device deficiencies must be reporied 
within 10 calendar days of the Investigator 's or site's awareness. 
• 
A printed copy of the completed Serious Adverse Event and Adverse Device Effect and/or 
Device Deficiency eCRF must be included with product retmns. 

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• 
Additional relevant inforrnation after initial reporting must be entered into the eCRF as 
soon as the data become available. 
• 
Document any changes to concomitant medications on the appropriate eCRF. 
• 
Document all relevant info1mation from Discharge Summa1y, Autopsy Rep01t, Ce1tificate 
of Death etc, if applicable, in nan ative section of the Adverse Device Effect (for related 
AEs) and Serious Adverse Event eCRF. 
Note: Should the EDC system become non-operational, the site must complete the 
appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device 
Deficiency F01m. The completedform is faxed or emailed to the Study Sponsor (Korean 
Nova1tis  Patient Safety Desk) at 
or is faxed at 
or 
) according to the timelines outlined above; however, the rep01ted 
inf01mation must be entered into the EDC system once it becomes operational. 
 
Any AEs and device deficiencies for non-study marketed devices/products (ie, but not limited 
to BSS, OVD, Delive1ysystems, Phacoemulsification systems, VAhandpieces) will be 
considered and processed as spontaneous (following  the  postmarket  vigilance  procedures) 
and should be communicated to the device's/product's  manufacturer as per  local 
requirements. 
 
Study Sponsor representatives may be contacted for any protocol related question and their 
contact info1mation is provided in the Manual of Procedures (MOP) that accompanies this 
protocol. 
 
Frnther, dependin g upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable p01tions of the subject's medical records. The 
Investigator must also repo1t all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulat01y authorities or IRB/IEC. 
 
Intensity and Causality Assessments 
 
Where appropriate, the Investigator must assess the intensity (severity) of the AE based upon 
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. 

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Severe: An AE is severe if the sign or symptom is incapacitating and results in the subject’s 
inability to work or engage in their usual activities. 
 
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below: 
 
Causality 
 
1. Definitely related 
Event which has definitive time relationship to the use of the device of interest, cannot 
be explained by other reasons but the device of interest, has symptom disappearance to 
discontinuation of the device of interest and reappears when the device of interest is 
rechallenged (only when rechallenge is possible to do so). 
Also event is consistent to already known information of the device of interest or other 
devices of the same class. 
2. Probably related 
Event where there is evidence that the device of interest was used, has reasonable time 
relationship to the use of device of interest, can be explained mainly by the device of 
interest rather than other reasons, and has symptom disappearance to discontinuation 
of the device of interest. 
3. Possibly related 
Event where there is evidence that the device of interest was used has plausible time 
relationship to the use of device of interest, device of interest and other reasons have 
similar chances of resulting to an event, has symptom disappearance to discontinuation 
of the device of interest. 
4. Possibly not related 
Event where there is evidence that the device of interest was used, can be reasonably 
explained by other reasons, has symptom disappearance or there is uncertainty of the 
symptom when device of interest is discontinued has no symptom reappearance or 
there is uncertainty of the symptom when device of interest is rechallenged (only when 
rechallenge is possible to do so). 
5. Definitely not related 
Event where device of interest was not used has no reasonable time relationship to the 
use of device of interest, can be explained by other reasons. 

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6. Unknown 
Cannot be judged because information is insufficient or contradictory and cannot be 
supplemented or confirmed. 
※ Assessment criteria used in reporting to Novartis Patient Safety based upon the 
6 classifications 
 
Safety 
Reporting Form 
MFDS Guideline 
Suspected 
Definitely related, Probably related, Possibly related, 
Unknown 
Not suspected 
Possibly not related, Definitely not related 
 
 
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that 
are upgraded from non-serious to serious or from unrelated to related. 
 
11.4 Return product analysis 
Study Sponsor representatives and their contact information are provided in the Manual of 
Procedures (MOP) that accompanies this protocol. 
 
Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # which will be provided by Study Sponsor after the 
case is entered in the iTrack (Sponsor’s Medical Safety Database). 
 
11.5 Unmasking of the Study Treatment 
Not applicable; this study is open-label, unmasked study. 
 
11.6 Follow-Up of Subjects with Adverse Events 
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
 
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 

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study, any additional information received at follow-up should be documented in the eCRF 
up to study completion (ie, database lock). 
 
All complaints received after this time period will be considered and processed as 
spontaneous (following the postmarket vigilance procedures) and should be communicated to 
the medical device’s manufacturer as per local requirements. 
 
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements. 
 
11.7 Pregnancy in the Clinical Study 
Pregnancy is not reportable as an AE; however, complications may be reportable and will be 
decided on a case–by-case basis. An Alcon form will be utilized to capture all pregnancy- 
related information until birth of the child. 
 
12 ANALYSIS PLAN 
12.1 Subject Evaluability 
The final subject evaluability will be determined using the Deviations and Evaluability Plan 
(DEP) prior to locking the database. 
 
12.2 Analysis Sets 
All effectiveness analyses will be based on the full analysis set (FAS). All-implanted analyses 
set (AAS) will be used only for effectiveness analyses of monocular assessments. 
 
All subjects with successful bilateral IOL implantation and have the bilateral measurements 
for defocus curve will be evaluable for the FAS. 
 
All-implanted analysis set (AAS) is defined as all subjects with successful implantation of the 
test product in at least one eye. 
 
The safety analysis set will include all patients with attempted IOL implantation (successful 
or aborted after contact with the eye). 
 
12.3 Demographic and Baseline Characteristics 
Demographics and baseline characteristics will be summarized for FAS, AAS and safety 
analysis set. Demographics include age, sex, ethnicity, height, 
and race. 

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Summaries of continuous variables will include the number of observations, mean, standard 
deviation, median, minimum, and maximum.Summaries of categorical variables will include 
count and percentage. 
 
12.4 Effectiveness Analyses 
This is a single aim descriptive study. No formal statistical hypothesis testing is planned for 
any endpoint. Rather the data will be summarized using descriptive statistics. 
 
12.4.1 Analysis of Primary Effectiveness Endpoint 
The primary effectiveness endpoint is: 
 
• 
Binocular defocus cmve at 3 months (Visit 4A) post bilateral implantation 
12.4.1.1 Statistical Hypotheses 
No hypothesis testing of the primary effectiveness endpoint is planned. 
 
12.4.1.2 Analysis Methods 
The visual acuity data in logMAR for binocular defocus cmve at Month 3 will be 
summarized with the number of observations, mean, standard deviation, median, minimum, 
and maximum, two-sided 90% CI of the mean. A plot will be generated for the defocus curv e 
with amount of defocus along the x-axis and logMAR visual acuity at each defocus along the 
y-axis. 
 
12.4.2 Analysis of Secondary Effectiveness Endpoints 
The seconda1yeffectiveness endpoints are: 
 
• 
Binocular defocus cmve at 1 month post-implantation (Visit 3A) 
• 
Best con ected binocula·i visual acuity at distance (4 m) (Visits 3A, 4A) 
• 
Unconected monocular & binocular visual acuity at 1 & 3 months post-implantation 
(Visits 3A, 4A) at 40 cm, 60 cm and 4 m 
• 
Photopic best con ected binoculai· contrast sensitivity with & without glare at 3 months 
post-implantation (Visit 4A) 

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• 
Subjective symptom questions at preoperatively and postoperatively: 3 months 
post-implantation (Visit 4A) 
12.4.2.1 Statistical Hypotheses 
No hypothesis testing of the seconda1y effectiveness endpoints is planned. 
 
12.4.2.2 Analysis Methods 
The visual acuity data in logMAR for binocular defocus curve data at Month I will be 
summarized with the number of observations, mean, standard deviation, median, minimum, 
and maximum, and two-sided 90% CI of the mean. A plot will be generated for the defocus 
curve with amount of defocus along the x-axis and logMAR visual acuity at each defocus 
along the y-axis. 
 
Best con ected binocular visual acuity at distance (Visits 3A, 4A), uncoffected binocular 
visual acuity at 40 cm, 60 cm and 4 m in logMAR (Visits 3A, 4A) will be summarized by 
visit with the number of observations, mean, median, standard deviation, minimum, 
maximum, and two-sided 90% CI of the mean. Additionally,  these visual acuity endpoints 
will also be summarizedin Snellen VA as categorical variables, by visit, with number of non- 
missing observations, cumulative frequency, and percentage in the following categories: 
 
• 
20/20 or better 
• 
20/25 or better 
• 
20/32 or better 
• 
20/40 or better 
Unc01Tected mono cular visual acuity will be summarized in the same way as the uncon ected 
binocular visual acuity. The uncon ected monocular visual at 40 cm, 60 cm and 4 m will be 
summarized by the first and second operative eye for the following visits: Weeki , Month I 
and Month 3 for the full analysis set. Besides the FAS analysis, similarly, the uncon ected 
monocular visual acuity will be summarizedfor AAS as well. 
Logarithmic contras t sensitivity for various spatial frequencies at Month 3 with and without 
glare will be summarized with the number of observations, mean, median, and standard 
deviation, minimum, maximum, and two-sided 90% CI of the mean. Plots will be generated 
separately for glare and without glare conditions with spatial frequency along the x-axis and 
mean logarithmic contrast sensitivity along the y-axis. Numberand percentage of  subjects 
who do not have a record for a spatial frequency will be presented. Descriptive tables and 

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plots will be generated based on the scoring instructions of Vector Vision, and based on the 
observed data. 
 
Subjective symptom questions will be summarized by visit (Preoperative, Month 3) per 
question with total number of non-missing observations, count in the category, and percent in 
the category. 
 
12.5 Handling of Missing Data 
No missing data will be imputed. 
 
12.6 Safety Analyses 
The safety endpoints are: 

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• 
Adverse events including secondaiy surgical interventions(SSis) related to the optical 
properties of the IOL. 
• 
Device deficiencies 
• 
Posterior capsule opacification 
• 
Posterior capsulotomy 
• 
IOL position change 
• 
Intraocular pressure 
 
• 
Surgical problems 
Safety analyses will be made based upon the safety analysis set. 
 
Rate of SSis related to the optical prope1iies of the IOL for either eye will be summai·ized by 
operative eye. All AEs will be coded using the Medical Dictiona1y for Regulato1y Activities 
(MedDRA) and will be presented by severity (mild, moderate, or severe) and relationship to 
the study product. Ocular AEs will be summarized by operative eye. Descriptive tables (count 
and percentage) and listing will be generated for AEs based upon the categories of ocular and 
nonocular AEs, serious and non-serious AEs, as appropriate. 
 
Device deficiencies will be listed. The count and percent of device deficiencies will be 
presented. 
 
Results of posterior capsule opacification will be summarized with count and percentage in 
each categ01y by operative eye. A list of eyes with posterior capsule opacification will be 
presented. 
 
Number and percentage of eyes with posterior capsulotomy will be presented by operative 
eye. A list of eyes with posterior capsulotomy will be presented. 
 
Number and percentage of eyes with an IOL position change (tilted, decentered) will be 
presented by operative eye. A listing will be presented for eyes with IOL position changes. 
 
Intraocular pressure and its change from baseline will be summarized descriptively with 
number of observations, mean, median, standard deviation, minimum, and maximum by 
operative eye. Baseline is defined as the last measurement taken prior to the IOL 
implantation. Individual listing of intraocular pressure and its change from baseline will be 
presented. 

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Count and percentage of eyes with surgical problems will be presented. Individual listings of 
surgical problems will be presented. 
 
Results of slit-lamp exams, fundus exams, and other procedures at surgery, final incision size, 
lens information, IOL damage and IOL observations will be listed. If applicable, some of the 
items will not be listed as safety endpoints, e.g., final incision size without complications. 
 
12.7 Interim Analyses and Reporting 
Not Applicable. No interim analysis is planned for this study. 
 
12.8 Sample Size Justification 
Assuming a standard deviation of 0.17 logMAR for defocus visual outcomes, a sample size 
of 40 subjects will ensure more than 99% probability to observe the half width of 90% two- 
sided confidence interval to be not larger than 0.06 logMAR at a defocus point. The precision 
of estimates are within ±3 letters with visual outcomes. 
 
Assume a dropout rate of 10% at Month 3, an approximate total of 44 subjects with intended 
bilateral IOL implantation are planned to be enrolled in the study to achieve 40 subjects with 
complete data at Month 3. 
 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS 
13.1 Subject Confidentiality 
The Investigator must ensure that the subject’s anonymity is maintained throughout the 
course of the study. In particular, the Investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. At the end of the clinical study, the Study Sponsor will collect a copy 
of the enrollment log without any identifying subject information. All documents submitted 
to the Study Sponsor will identify the subjects exclusively by number and demographic 
information. No other personally identifying information will be transmitted to the Study 
Sponsor. 
 
The Study Sponsor may release anonymized study data to external researchers for purposes 
of future research directly related to the study objectives, or future research that is beyond the 
scope of the current study objectives. The Informed Consent Form explains this to study 
subjects. Anonymization means that all identifiable information will be removed from the 
dataset and all links to the subjects in the study will be removed. Anonymization of the data 
will maintain confidentiality of the subjects who participate in the study so that they cannot 

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beidentifiedbyexternal researchers. The anonymized data set will contain records from all 
of the subjects in the cmTent study, but the anonymization process might change the data set 
in some ways, so external researchers will be infmmed that they might not be able to 
duplicate some of the results from this study. 
 
13.2 Completion of Source Documents and Case Report Forms 
The nature and location of all source documents will be identified to ensure that original data 
required to complete the CRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the que1yresolution process. Site 
monitors are appointed by the Study Sponsor and are independent of study site staff. 
 
If electronic records are maintained, the method of verification must be dete1mined in 
advance of sta1iing the study. 
 
At a minimum, source documents include the following info1mation for each subject: 
 
• 
Subject identification (name, sex, race/ethnicity) 
• 
Documentation of subject eligibility 
 
• 
Date of info1med consent 
• 
Dates of visits 
• 
Documentationthat protocol specific procedures were perfmmed 
• 
Results of study parameters , as required by the protocol 
• 
IP accountability records 
• 
Documentation of AEs and other safety parameters (if applicable) 
• 
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• 
Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an ently in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recordedon the CRF are consistent with the original source data. 
 
Only designated individuals at the site will complete the CRFs. The CRFs must be completed 
at regular intervals following the clinical study visit schedule. It is expected that all data 
repmied have con esponding entries in the source documents. The Principal Investigator is 

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responsible for reviewing and certifying that the CRFs are accurate and complete. The only 
subject identifiers recorded on the CRFs will be subject number, and subject demographic 
information. 
 
13.3 Data Review and Clarifications 
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, additional data 
clarifications and/or additions may be needed as a result of the data cleaning process. Data 
clarifications are documented and are part of each subject’s CRF. 
 
Deviations from this protocol and GCP must be recorded. A plan for data validation will be 
completed, and agreed upon by the study clinical manager (CM) and other team members. 
 
Concomitant medications entered into the database will be coded using the WHO Drug 
Reference List. Medical history and adverse events will be coded using the medical 
dictionary for regulatory activities (MedDRA) terminology. 
 
Upon completion of the study and once the database is declared completed and accurate, the 
database will be locked and data will be available for data analysis. 
 
13.4 Sponsor and Monitoring Responsibilities 
The Study Sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals according to the study monitoring plan. The clinical investigation will 
be monitored to ensure that the rights and well-being of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 
is conducted in compliance with the current approved protocol (and amendments[s], if 
applicable), with current GCP, and with applicable regulatory requirements. 
 
The site may not screen subjects or perform the informed consent process on any subject until 
it receives a notification from an appropriate Study Sponsor representative that the site may 
commence conducting study activities. Monitoring will be conducted periodically while the 
clinical study is ongoing. Monitoring methods may include site visits, telephone, written and 
fax correspondence. Close-out visits will take place after the last visit of the last subject at the 
site. 
 
A Coordinating Investigator may be identified by the Study Sponsor to review and endorse 
the final study report. In cases where a Coordinating Investigator is engaged, the Study 

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Sponsor will select the Coordinating Investigator based upon their experience, qualifications, 
active study participation , and their willingness and availability to take on this role. 
 
13.5 Regulatory Documentation and Records Retention 
The Investigator is required to maintain up-to-date, complete regulat01y documentationas 
indicated by the Study Sponsor and the Investigator's files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately. 
 
Additionally, the Investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the Study Sponsor. If the Investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the Study Sponsor must be notified and suitable au angements made for retention of 
study records and source documents needed to comply with national and international 
regulations. 
 
13.6 Quality Assurance and Quality Control 
The Study Sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and rep01t s for the purpose of monitoring 
and auditing by the Study Sponsor, and inspection by domestic and foreign regulatory 
authorities . Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed conectly. Agreements made by the Study Sponsor 
with the Investigator/Institution and any other parties involved in the clinical study will be 
provided in writing as pa1t of the protocol or as a separate agreement. 
 
14 ETHICS 
This clinical study must be conducted in accordance with the ethical principles contained 
within: 
 
• 
The Declaration of Helsinki, and in compliance with the ICH E6 GCP Consolidated 
Guideline, ISO 14155:2011, and the applicable US FDA 21 CFR Regulations. 
• 
SOPs of the Study Sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations. 
• 
Notifications and timelines for reporting protocol deviations should be based upon 
applicable Ethics Committee requirements 
The Investigatormust ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 

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experience. The Investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. Deviations from this protocol, regulatory requirements and/or 
GCP must be recorded and reported to the Sponsor prior to database lock. If needed, 
corrective and preventive action should be identified, implemented, and documented within 
the study records. Use of waivers to deviate from the clinical protocol is prohibited. 
 
Before clinical study initiation, this protocol, the informed consent form, any other written 
information given to subjects, and any advertisements planned for subject recruitment must 
be approved by an IRB/IEC. The Investigator must provide documentation of the IRB/IEC 
approval to the Study Sponsor. The approval must be dated and must identify the applicable 
protocol, amendments (if any), informed consent form, assent form (if any), all applicable 
recruiting materials, written information for subject, and subject compensation programs. The 
IRB/IEC must be provided with a copy of the Package Insert, any periodic safety updates, 
and all other information as required by local regulation and/or the IRB/IEC. At the end of 
the study, the Investigator must notify the IRB/IEC about the study’s completion. The 
IRB/IEC also must be notified if the study is terminated prematurely. Finally, the Investigator 
must report to the IRB/IEC on the progress of the study at intervals stipulated by the 
IRB/IEC. 
 
Voluntary informed consent must be obtained in writing from every subject and/or legal 
representative, as applicable and the process shall be documented before any procedure 
specific to the clinical investigation is applied to the subject. The Investigator must have a 
defined process for obtaining consent. Specifically, the Investigator, or their delegate, must 
explain the clinical study to each potential subject and the subject must indicate voluntary 
consent by signing and dating the approved informed consent form. The subject must be 
provided an opportunity to ask questions of the Investigator, and if required by local 
regulation, other qualified personnel. The Investigator must provide the subject with a copy 
of the consent form written in a language the subject understands. The consent document 
must meet all applicable local laws and provide subjects with information regarding the 
purpose, procedures, requirements, and restrictions of the study, along with any known risks 
and potential benefits associated with the IP and the study, the available compensation, and 
the established provisions for maintaining confidentiality of personal, protected health 
information. Subjects will be told about the voluntary nature of participation in the study and 
must be provided with contact information for the appropriate individuals should questions or 
concerns arise during the study. The subject also must be told that their records may be 
accessed by appropriate authorities and Sponsor-designated personnel. The Investigator must 
keep the original, signed copy of the consent (file in subject’s medical records) and must 
provide a duplicate copy to each subject according to local regulations. 

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The Study Sponsor assures that the key design elements of this protocol will be registered on 
www.clinicalt:rials.gov as req uir ed by cmTent regulations and, if applicable, other public 
databases as required by local countiy  regulations.  In addition,  results  of  this  study will be 
made  publicly  available  on  www.clinicaltrials.gov  regardless  of  outcome  as  required  by 
cmTent reg ulations and, if appli ca ble, in other public data bases as requi red by local countiy 
reg ulations. 
 
15 RE FERE NCES 
 
15.1 References applicable for all clinical studies 
• 
ASCRS 2017 American Society of Cataract and Refractive Surge1y 2017 
• 
Korea National Statistical Office 
• 
ISO l1979-9:2006(E)Ophthalmic implants - Intraocular lenses - Part 9: Multifocal 
intraocular lenses 
• 
EN ISO 11979-7:2014 Ophthalmic implants - Inti·aocular lenses - Pait 7: Clinical 
Investigations 
• 
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good 
clinical practice 
• 
EN ISO 11979-1:2012 Ophthalmic implants - Intraocular lenses - Pait 1: Vocabulaiy 
15.1.1 US references applicable for clinical studies 
• 
21 CFR Pait 11 - Electi·onic Records; Electronic Signatures 
 
• 
21 CFR Pait 50 - Protection of Human Subjects 
• 
21 CFR Pait 56 - Institutional Review Boards 
• 
21 CFR Pait 812 - Investigational Device Exemptions 
• 
21 CFR Pait 54 - Financial Disclosure by Clinical Investigators 
 
15.2 References for this clinical study 
Not applicable. 

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