Clinical Investigation of the Safety and Effectiveness of FINEVISION HP Trifocal IOL
Phase: NA
Conditions: Eye Diseases, Postcataract Aphakia, Cataract, Lens Opacities
Sponsor: Beaver-Visitec International, Inc.

 
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Protocol PHY1903 
09 Feb 2024 
Clinical Investigation of the Safety and Effectiveness of 
FINEVISION HP Trifocal IOL 
 
Protocol Number:  PHY1903 
Sponsor: Beaver-Visitec International, Inc 
Version Number:  v.1.7 
09 Feb 2024 
 
 
Investigator Agreement: 
I have read the clinical study described herein, recognize its 
confidentiality and agree to conduct the described study in 
compliance with Good Clinical Practices, the ethical principles 
contained within the Declaration of Helsinki, this protocol and all 
applicable regulatory requirements. 
 
Investigator 
 
___________________________________________ 
___________________ 
 
 
 
Signature 
 
 
 
 
 
Date 
 
Investigator Name 
_________________________________________________________________ 
 
Investigator Address 
_________________________________________________________________ 
 
 
 
 
_________________________________________________________________ 
 
 
CONFIDENTIAL – Property of Beaver-Visitec International, Inc 
 

 
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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 5 
1 
PROTOCOL SUMMARY ............................................................................................................................... 5 
1.1 
Synopsis ................................................................................................................................................ 5 
1.2 
Schema ................................................................................................................................................. 7 
1.3 
Schedule of Activities (SoA) ............................................................................................................... 8 
1.4 
Abbreviations ...................................................................................................................................... 12 
2 
INTRODUCTION .......................................................................................................................................... 14 
2.1 
Study Rationale .................................................................................................................................. 14 
2.2 
Background......................................................................................................................................... 14 
2.3 
Risk/Benefit Assessment .................................................................................................................. 14 
2.3.1 
Known Potential Risks ................................................................................................... 14 
2.3.2 
Potential Benefits ........................................................................................................... 15 
2.3.3 
Assessment of Potential Risks and Benefits .............................................................. 15 
3 
OBJECTIVES ................................................................................................................................................ 15 
3.1 
Primary Objectives ............................................................................................................................ 15 
3.2 
Secondary Objectives ....................................................................................................................... 16 
3.3 
Additional Objectives ......................................................................................................................... 16 
4 
STUDY DESIGN ........................................................................................................................................... 18 
4.1 
Overall Design .................................................................................................................................... 18 
4.2 
 
4.3 
Scientific Rationale for Study Design.............................................................................................. 18 
4.4 
End of Study Definition ..................................................................................................................... 19 
5 
STUDY POPULATION ................................................................................................................................ 19 
5.1 
Inclusion Criteria ................................................................................................................................ 19 
5.2 
Exclusion Criteria ............................................................................................................................... 20 
5.3 
Reasons Not to Implant a Study IOL .............................................................................................. 21 
5.4 
Screen Failures .................................................................................................................................. 21 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 22 
6 
STUDY INTERVENTION ............................................................................................................................ 22 
6.1 
Study Devices .................................................................................................................................... 22 
6.1.1 
Investigational Device Description............................................................................... 22 
6.1.2 
Control Device Description ........................................................................................... 23 
6.2 
Device Accountability and Storage ................................................................................................. 24 
6.2.1 
Acquisition and Accountability ...................................................................................... 24 
6.2.2 
Packaging and Labeling ................................................................................................ 24 
6.2.3 
Product Storage and Stability ....................................................................................... 24 
6.3 
Measures to Minimize Bias: Randomization and Masking .......................................................... 24 
7 
PARTICIPANT DISCONTINUATION/ WITHDRAWAL ........................................................................... 25 
7.1 
Participant Discontinuation/ Withdrawal from the Study .............................................................. 25 
7.2 
Lost to Follow-Up ............................................................................................................................... 26 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 26 
8.1 
Preoperative Visit (Day -90 to Day -1):  Visit 0 .............................................................................. 26 
8.2 
Operative Visit (Day 0):  Visit 00 A/B .............................................................................................. 27 
8.3 
Postoperative Visits:  Visit 1 thru Visit 5 ......................................................................................... 28 
8.4 
Unscheduled Visits ............................................................................................................................ 28 
8.5 
Concomitant Medication ................................................................................................................... 30 

 
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8.6 
Secondary Surgical Intervention (SSI) ........................................................................................... 30 
8.6.1 
IOL Repositioning ........................................................................................................... 31 
8.6.2 
IOL Explantation and Replacement ............................................................................. 31 
8.7 
Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and Device 
Deficiencies ............................................................................................................................................................ 31 
8.7.1 
Definition of Adverse Events ........................................................................................ 31 
8.7.2 
Definition of Serious Adverse Events .......................................................................... 32 
8.7.3 
Definition of adverse device effects and unanticipated adverse device effects .... 33 
8.7.4 
Classification of an Adverse Event .............................................................................. 33 
8.7.5 
Adverse Event Reporting .............................................................................................. 34 
8.7.6 
Expedited Adverse Event Reporting ........................................................................... 35 
8.7.7 
Anticipated Adverse Events .......................................................................................... 35 
8.7.8 
Device Deficiencies ....................................................................................................... 37 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 38 
9.1 
Statistical Hypotheses ....................................................................................................................... 38 
9.2 
Sample Size Determination .............................................................................................................. 39 
9.3 
Populations for Analyses .................................................................................................................. 40 
9.4 
Statistical Analyses............................................................................................................................ 41 
9.4.1 
General Approach .......................................................................................................... 41 
9.4.2 
Handling of Missing Data .............................................................................................. 41 
9.4.3 
Analysis of Primary Effectiveness Endpoints ............................................................. 42 
9.4.4 
Analysis of Secondary effectiveness Endpoints ........................................................ 42 
9.4.5 
Multiplicity Considerations ............................................................................................ 43 
9.4.6 
Safety Analyses .............................................................................................................. 43 
9.4.7 
Poolability Analysis ........................................................................................................ 45 
9.4.8 
Baseline Descriptive Statistics ..................................................................................... 46 
9.4.9 
 
9.4.10 
Sub-Group Analyses ..................................................................................................... 48 
9.4.11 
Additional Effectiveness Analyses ............................................................................... 48 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 50 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 50 
10.1.1 
Informed Consent Process ........................................................................................... 50 
10.1.2 
Study Discontinuation and Closure ............................................................................. 50 
10.1.3 
Confidentiality and Privacy ........................................................................................... 51 
10.1.4 
Document Retention ...................................................................................................... 51 
10.1.5 
Medical Monitor .............................................................................................................. 52 
10.1.6 
Institutional Review Board Approval ........................................................................... 52 
10.1.7 
Clinical Monitoring .......................................................................................................... 52 
10.1.8 
Compliance with Protocol ............................................................................................. 52 
10.1.9 
Data Handling and Record Keeping ............................................................................ 53 
10.1.10 
Protocol Deviations ........................................................................................................ 54 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 54 
10.2 
 
11 
REFERENCES ............................................................................................................................................. 55 
12 
Appendix A: 
 
 

 
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SSTATEMENT OF COMPLIANCE 
This study will be conducted in compliance with the protocol, IRB requirements, FDA Title 21 CFR 812, FDA/ICH GCP, 
and consistent with the Declaration of Helsinki. 
In addition, all applicable local, state, and federal requirements relevant to the use of study devices in the US will be 
adhered to. 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Clinical investigation of the safety and effectiveness of FINEVISION HP 
Trifocal IOL 
Study Description: 
This study is a prospective, multicenter, randomized, double masked 
confirmatory trial comparing an investigational trifocal intraocular lens 
(IOL) and a commercially available monofocal IOL. 
Objectives: 
 
Co-primary effectiveness objectives are to: 
• 
Demonstrate non-inferiority of FINEVISION HP trifocal IOL to the 
control in mean photopic monocular BCDVA (best corrected 
distance visual acuity) for the first operative eye at Month 6 (Visit 
4). 
• 
Demonstrate superiority of FINEVISION HP trifocal IOL to the 
control in mean photopic monocular DCNVA (distance corrected 
near visual acuity) for the first operative eye at Month 6 (Visit 4) 
Co-primary safety objectives are to: 
• 
Estimate the cumulative rate of SSIs related to the optical 
properties of the IOL for the first operative eye up to Month 12 
(Visit 5) 
• 
Evaluate the mean monocular contrast sensitivity for the first 
operative eye, with and without glare for mesopic conditions and 
photopic conditions, at Month 12 (Visit 5) 
The secondary effectiveness objective is to: 
• 
Demonstrate superiority of FINEVISION HP trifocal IOL to the 
control in mean photopic monocular DCVA at intermediate (66 cm) 
for the first operative eye at Month 6 (Visit 4) 
The secondary safety objectives are to evaluate: 
• 
Rates of cumulative and persistent adverse events in first operative 
eyes at Month 12 (Visit 5) in comparison to the ISO Safety and 
Performance Endpoint (SPE) rates as described in ISO 11979-7 

 
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• 
Visual disturbances using the Quality of Vision (QoV) questionnaire 
and QoV Supplemental Questions at Month 12 (Visit 5) 
Study Population: 
The subject population will consist of subjects with operable bilateral 
cataracts in each eye.  Up to 539 subjects are to be enrolled, with 501 
subjects planned to undergo phacoemulsification cataract surgery with IOL 
implantation in both eyes.  Prior to cataract surgery in the first operative 
eye, subjects will be randomly assigned at a 2:1 ratio to receive either the 
investigational FINEVISION HP or the control IOL, Alcon AcrySof 
SN60AT
 IOL.  The second operative eye will undergo cataract 
surgery 7 – 30 days afterwards, with the same model IOL implanted.  
Phase: 
Pivotal 
Description of 
Sites/Facilities Enrolling 
Participants: 
Subjects will be enrolled at up to 24 study sites and surgeries will be 
performed in ambulatory surgery centers or hospitals.  All study sites and 
surgery centers will be located in the United States.  Each site will be 
encouraged to randomize a minimum of 20 subjects, and no site will 
randomize more than 25% of the total number of randomized subjects.  
Description of Study 
Intervention: 
The study intervention is an IOL to be implanted via routine small incision 
cataract surgery.  Subject eyes in the test arm will be implanted with an 
investigational trifocal IOL, while the eyes in the control arm will be 
implanted with a commercially available monofocal IOL.  IOLs are 
implantable medical devices intended for long term use over the lifetime 
of the subject. 
Study Duration: 
Study duration is estimated to be approximately 24 months based on an 
estimated enrollment period of 10 months and subject participation 
period of 14 months (calculated as the difference between the time of the 
Preoperative Visit to completion of 12-month follow-up on the second 
operative eye) 
Participant Duration: 
It is estimated that the duration of each subject’s participation in the study 
will be approximately 14 months (calculated as the difference between the 
time of the Preoperative Visit to completion of 12-month follow-up on the 
second operative eye). 

 
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1.2 
SCHEMA  
 
 
 
Note:  For study visits designated A or B, ‘A’ represents the first eye implanted (Eye A), and ‘B’ represents the second eye implanted 
(Eye B).  Monocular assessments will be performed at Visits 00 A/B, 1 A/B, 2 A/B, and 3 A/B for only Eye A or only Eye B, 
respectively, unless binocular assessments are specified (See Schedule of Activities, Section 1.3).  At Visits 4 and 5, monocular 
assessments and binocular assessments will be completed for both eyes.   
 
 

 
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1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
Visit 0 
Visit 00 A 
Visit 00 B  
Visit 1 
A/B 
Visit 2 
A/B 
Visit 3 
A/B 
Visit 4 
Visit 5 
USV2 
Examination 
Light 
Condition 
Monocular / 
Binocular 
Pre-Op 
/ 
Screen 
D -90 to 
-1 
Implant A1 
D 0 
 
 
Implant B1 
(D 7 to D 30 
after Visit 00 
A) 
Post-Op 
D 1-2  
Post-Op 
D 7-14 
Post-Op 
D 30-60 
Post-Op 
D 150-180 
(from 1st 
eye) 
Post-Op 
D 360-420 
(from 1st 
eye) 
N/A 
Informed Consent and HIPAA 
X 
  
 
 
 
 
 
 
 
Demographics 
X 
  
 
 
 
 
 
 
 
Inclusion & Exclusion Criteria Evaluation 
X 
  
 
 
 
 
 
 
 
Inclusion & Exclusion Criteria Review 
  
X 
 
 
 
 
 
 
 
Ocular and non-ocular Medical History 
X 
 X 
X 
X 
X 
X 
X 
X 
X 
Urine Pregnancy Test (if applicable)  
X 
 
 
 
 
 
 
 
 
Projected Visual Acuity 
X 
  
 
 
 
 
 
 
 
Target Refraction 
X 
  
 
 
 
 
 
 
 
IOL Power Calculation 
X 
  
 
 
 
 
 
 
 
Axial Length and Anterior Chamber Depth  
X 
  
 
 
 
 
 
 
 
Keratometry Measurement 
X 
  
 
 
 
X 
X 
X 
X 
Corneal Topography 
X 
 
 
 
 
 
 
 
 
Manifest Refraction (ETDRS) – 4 meters 
X 
  
 
 
X 
X 
X 
X 
X 
Randomization 
X 
 
 
 
 
 
 
 
 
Operative Procedures 
  
X 
X 
 
 
 
 
 
 
Patient Reported Outcome Questionnaires3 
X 
  
 
 
 
 
X 
X 
X 
Pupil Size Measurements4 
Photopic 
Monocular 
X 
  
 
 
 
 
X 
X 
 
Mesopic 
X 
  
 
 
 
 
X 
X  
 
Intraocular Pressure 
X 
  
 
X 
X 
X 
X 
X 
X 
Slit Lamp Examination 
X 
  
 
X 
X 
X 
X 
X 
X 
IOL Tilt and Decentration Grading 
  
  
 
X 
X 
X 
X 
X 
X 

 
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Visit 0 
Visit 00 A 
Visit 00 B  
Visit 1 
A/B 
Visit 2 
A/B 
Visit 3 
A/B 
Visit 4 
Visit 5 
USV2 
Examination 
Light 
Condition 
Monocular / 
Binocular 
Pre-Op 
/ 
Screen 
D -90 to 
-1 
Implant A1 
D 0 
 
 
Implant B1 
(D 7 to D 30 
after Visit 00 
A) 
Post-Op 
D 1-2  
Post-Op 
D 7-14 
Post-Op 
D 30-60 
Post-Op 
D 150-180 
(from 1st 
eye) 
Post-Op 
D 360-420 
(from 1st 
eye) 
N/A 
 
 
 
 
 
 
 
 
 
 
Dilated Fundus Examination  
X 
  
 
 
 
X 
X 
X 
X 
Posterior Capsule Assessment (PCO grade assessment) 
  
  
 
X 
X 
X 
X 
X 
X 
IOL Observations 
 
 
 
X 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Device Deficiencies 
 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Exit from Study 
  
  
 
 
 
 
 
X 
 
Visual Acuity 
UCDVA  
(4 meters) 
Photopic 
Monocular 
X 
  
 
X 
X 
X 
X 
X 
X 
Binocular 
  
  
 
 
X 
X 
X 
X 
X 
BCDVA  
(4 meters) 
Photopic 
Monocular 
X 
  
 
 
X 
X 
X 
X 
X 
Binocular 
  
  
 
 
X 
X 
X 
X 
X 
UCNVA  
(40 cm) 
Photopic 
Monocular 
  
  
 
 
 
X 
X 
X 
 
Binocular 
  
  
 
 
 
X 
X 
X 
 
BCNVA 
(40 cm) 
Photopic 
Monocular 
 
 
 
 
 
X 
X 
X 
 
Binocular 
 
 
 
 
 
X 
X 
X 
 
DCNVA  
(40 cm) 
Photopic 
Monocular 
  
  
 
 
 
X 
X 
X 
 
Binocular 
  
  
 
 
 
X 
X 
X 
 
Mesopic 
Monocular 
  
  
 
 
 
X 
X 
X 
 
Binocular 
  
  
 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
UCIVA  
(66 cm) 
Photopic 
Monocular 
  
  
 
 
 
X 
X 
X 
 
Binocular 
  
  
 
 
 
 
X 
X 
 

 
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Visit 0 
Visit 00 A 
Visit 00 B  
Visit 1 
A/B 
Visit 2 
A/B 
Visit 3 
A/B 
Visit 4 
Visit 5 
USV2 
Examination 
Light 
Condition 
Monocular / 
Binocular 
Pre-Op 
/ 
Screen 
D -90 to 
-1 
Implant A1 
D 0 
 
 
Implant B1 
(D 7 to D 30 
after Visit 00 
A) 
Post-Op 
D 1-2  
Post-Op 
D 7-14 
Post-Op 
D 30-60 
Post-Op 
D 150-180 
(from 1st 
eye) 
Post-Op 
D 360-420 
(from 1st 
eye) 
N/A 
DCIVA  
(66 cm) 
Photopic 
Monocular 
  
  
 
 
 
X 
X 
X 
 
Binocular 
  
  
 
 
 
 
X 
X 
 
Mesopic 
Monocular 
  
  
 
 
 
X 
X 
X 
 
Binocular 
  
  
 
 
 
 
X 
X 
 
  
 
 
 
  
  
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
  
 
 
 
  
  
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
Contrast Sensitivity with Glare 
– 2.5 meters 
Photopic 
Monocular 
  
  
 
 
 
 
X 
X 
 
Contrast Sensitivity without 
Glare – 2.5 meters 
 
 
 
 
 
 
X 
X 
 
Contrast Sensitivity with Glare 
– 2.5 meters 
Mesopic 
Monocular 
  
  
 
 
 
 
X 
X 
 
Contrast Sensitivity without 
Glare – 2.5 meters 
  
  
 
 
 
 
X 
X 
 
Defocus Curve (Best Distance Corrected) –  
4 meters6 
Monocular 
  
  
 
 
 
 
X 
X 
 
Binocular 
 
 
 
 
 
 
X 
X 
 
1 A – First Operative Eye, B – Second Operative Eye 
2 USV – Unscheduled Visit; for unscheduled visits, mandatory assessments to be completed are defined in the table.  Additional assessments may be performed as 
appropriate, based on the subject’s condition. 
3 Patient Reported Outcome Questionnaires include the PRSIQ, QoV and QoV Supplemental Questions 
 

 
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Visit 0 
Visit 00 A 
Visit 00 B  
Visit 1 
A/B 
Visit 2 
A/B 
Visit 3 
A/B 
Visit 4 
Visit 5 
USV2 
Examination 
Light 
Condition 
Monocular / 
Binocular 
Pre-Op 
/ 
Screen 
D -90 to 
-1 
Implant A1 
D 0 
 
 
Implant B1 
(D 7 to D 30 
after Visit 00 
A) 
Post-Op 
D 1-2  
Post-Op 
D 7-14 
Post-Op 
D 30-60 
Post-Op 
D 150-180 
(from 1st 
eye) 
Post-Op 
D 360-420 
(from 1st 
eye) 
N/A 
4 Pupil size measurements in mesopic and photopic lighting conditions must be taken right before contrast sensitivity testing (see instructions for Pupil Size 
Measurements in Manual of Procedures) 
 
 
 
 
 
 

 
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1.4 
ABBREVIATIONS 
 
ADE 
Adverse device effect 
AE 
Adverse event 
ANSI 
American National Standards Institute 
BAT 
Brightness acuity meter 
BCDVA 
Best corrected distance visual acuity 
BCIVA 
Best corrected intermediate visual acuity 
BCNVA 
Best corrected near visual acuity 
CFR 
Code of Federal Regulations 
CME 
Cystoid macular edema 
cpd 
Cycles per degree 
CRF 
Case report form 
DCIVA 
Distance corrected intermediate visual acuity 
DCNVA 
Distance corrected near visual acuity 
DFU 
Directions for Use 
eCRF 
Electronic case report form 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
FDA 
Food and Drug Administration 
FLACS 
Femto Laser-Assisted Cataract Surgery 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed consent form 
ICH 
International Conference on Harmonization 
IOL 
Intraocular lens 
IOP 
Intraocular pressure 
IP 
Investigational Product 
IRB 
Institutional/Independent Review Board 
ISO 
International Organization for Standardization 
logMAR 
Logarithm of the Minimum Angle of Resolution 
MCMC 
Markov Chain Monte Carlo 
MOP 
Manual of procedures 
OCT 
Optical coherence tomography 
PCO 
Posterior capsule opacification 
PRSIQ 
Patient-Reported Spectacle Independence Questionnaire 
QoV 
Quality of Vision questionnaire 
 
 
RD 
Retinal detachment 
SAE 
Serious adverse event 
SOA 
Schedule of activities 
SPE 
Safety and Performance Endpoints 
SSI 
Secondary surgical intervention 
TASS 
Toxic anterior segment syndrome 
UADE 
Unanticipated Adverse Device Effect 

 
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UCDVA 
Uncorrected distance visual acuity 
UCIVA 
Uncorrected intermediate visual acuity 
UCNVA 
Uncorrected near visual acuity 
USV 
Unscheduled visit 
VA 
Visual Acuity 
 
 
 

 
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2 
 
INTRODUCTION 
2.1 
STUDY RATIONALE  
The purpose of this clinical study is to evaluate the safety and effectiveness of the FINEVISION HP 
Trifocal IOL. 
2.2 
BACKGROUND 
Cataracts are a common condition in adults over 40 years of age, and surgical replacement of the 
cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision to cataract 
patients. Monofocal IOLs provide adequate distance vision but require spectacle use for activities 
requiring near or intermediate vision. Multifocal IOLs, including bifocal and trifocal IOLs, have been 
successfully developed to improve near and intermediate distance vision and increase spectacle 
independence following cataract surgery. The FINEVISION HP Trifocal IOL is designed to provide distance 
vision similar to a monofocal IOL, but with improved intermediate and near vision. 
 
2.3 
RISK/BENEFIT ASSESSMENT   
2.3.1 KNOWN POTENTIAL RISKS  
Potential complications accompanying cataract or IOL implant surgery may include the following: 
1. Ocular infection (endophthalmitis, microbial keratitis) 
2. Inflammatory reaction [e.g. uveitis, Toxic anterior segment syndrome (TASS), hypopyon] 
3. Anterior capsular phimosis 
4. Corneal edema 
5. Corneal endothelial damage 
6. Cystoïd macular edema (CME) 
7. Secondary surgical intervention (including, but are not limited to: lens repositioning, lens 
replacement, vitreous aspiration, iridectomy for pupillary block, wound leak repair, and retinal 
detachment repair) 
8. IOL dislocation, tilt, decentration, luxation, rotation 
9. Elevated intraocular pressure 
10. Pupillary block  
11. Posterior capsular opacification (PCO) 
12. Chromatic aberrations 
13. Dysphotopsia 
14. Loss of visual acuity 
15. Deviation from target refraction 
16. Hyphema 
17. Retinal detachment 

 
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18. Iris or pupil damage 
19. Posterior capsular rupture 
20. Vitreous loss 
21. Wound leak (positive Seidel) 
 
In addition to these risks associated with cataract surgery and IOLs in general, multifocal IOLs in 
particular have been associated with an increased risk of reduced contrast sensitivity and also 
dysphotopias such as halos and glare, potentially leading to secondary surgical interventions. 
 
2.3.2 POTENTIAL BENEFITS  
The possible benefits associated with this study are: 
• 
Improved vision at near, intermediate, and distance  
• 
Furthering the understanding of vision care 
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
Based on a formal risk assessment, the benefit to risk profile is favorable as the benefits of improved 
intermediate and near vision are compared against the risks of reduced contrast sensitivity and visual 
disturbances, a known risk associated with multifocal IOLs. 
 
3 
OBJECTIVES  
3.1 
PRIMARY OBJECTIVES 
Co-primary effectiveness objectives are to: 
• 
Demonstrate non-inferiority of FINEVISION HP trifocal IOL to the control in mean photopic 
monocular BCDVA (best corrected distance visual acuity) for the first operative eye at Month 6 
(Visit 4) 
• 
Demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic 
monocular DCNVA (distance corrected near visual acuity) for the first operative eye at Month 6 
(Visit 4) 
Co-primary safety objectives are to: 
• 
Estimate the cumulative rate of SSIs related to the optical properties of the IOL for the first 
operative eye up to Month 12 (Visit 5) 
• 
Evaluate the mean monocular contrast sensitivity for the first operative eye, with and without 
glare for mesopic conditions and photopic conditions, at Month 12 (Visit 5) 

 
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Primary Effectiveness Variables 
• 
Photopic monocular logMAR best corrected distance visual acuity (BCDVA) in first operative 
eyes at Month 6 (Visit 4)  
 
• 
Photopic monocular logMAR near (40 cm) visual acuity with distance correction (DCNVA) in 
first operative eyes at Month 6 (Visit 4) 
Primary Safety Variables 
• Cumulative rate of secondary surgical interventions (SSIs) related to the optical properties of the 
IOL in first operative eyes through Month 12 (Visit 5) 
 
• Mean monocular distance contrast sensitivity (mesopic with and without glare at 1.5, 3, 6, and 
12 cpd measured at 2.5 m, and photopic with and without glare at 3, 6, 12, and 18 cpd, 
measured at 2.5 m) in first operative eyes at Month 12 (Visit 5) 
 
3.2 
SECONDARY OBJECTIVES 
The secondary effectiveness objective is to: 
• 
Demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic 
monocular DCVA at intermediate (66 cm) for the first operative eye at Month 6 (Visit 4) 
The secondary safety objectives are to evaluate: 
• 
Rates of cumulative and persistent adverse events in first operative eyes at Month 12 (Visit 5) in 
comparison to the ISO Safety and Performance Endpoint (SPE) rates as described in ISO 11979-7 
• 
Visual disturbances using the Quality of Vision (QoV) questionnaire and QoV Supplemental 
Questions at Month 12 (Visit 5) 
Secondary Effectiveness Variables 
• 
Photopic monocular logMAR intermediate (66 cm) visual acuity with distance correction 
(DCIVA) in first operative eyes at Month 6 (Visit 4)  
Secondary Safety Variables 
• 
Rates of cumulative and persistent adverse events in first operative eyes through Month 12 
(Visit 5), compared to the ISO SPE rates as described in ISO 11979-7 
• 
Visual disturbances using the Quality of Vision (QoV) questionnaire and QoV Supplemental 
Questions at Month 12 (Visit 5) 
 
3.3 
ADDITIONAL OBJECTIVES 
 

 
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• 
 
  
 
 
 
  
 
 
 
 
 
 
Additional effectiveness objectives are to: 
• 
Characterize all visual acuity measurements at Months 6 and 12 (Visits 4 and 5) 
• 
Characterize monocular and binocular defocus curves at Month 6 (Visit 4) 
• 
Evaluate spectacle independence using the Patient-Reported Spectacle Independence 
Questionnaire (PRSIQ) at Month 6 (Visit 4) 
 
 
 
 
Additional Effectiveness Variables 
• 
Photopic monocular logMAR BCDVA, 
, DCIVA (66 cm), and DCNVA in first 
operative eyes at Month 6 (Visit 4) and Month 12 (Visit 5) 
• 
Mesopic monocular logMAR 
, DCIVA (66 cm), and DCNVA in first operative eyes at 
Month 6 (Visit 4) and Month 12 (Visit 5) 
• 
Photopic binocular logMAR BCDVA, 
 DCIVA (66 cm), and DCNVA at Month 6 (Visit 
4) and Month 12 (Visit 5) 
• 
Mesopic binocular logMAR 
, DCIVA (66 cm), and DCNVA at Month 6 (Visit 4) and 
Month 12 (Visit 5) 
• 
Photopic monocular logMAR UCDVA, 
 UCIVA (66 cm), and UCNVA in first 
operative eyes at Month 6 (Visit 4) and Month 12 (Visit 5) 
• 
Photopic binocular logMAR UCDVA, 
, UCIVA (66 cm), and UCNVA at Month 6 (Visit 
4) and Month 12 (Visit 5) 
• 
Photopic monocular logMAR 
 and BCNVA in first operative eyes at Month 6 (Visit 
4) and Month 12 (Visit 5) 
• 
Photopic binocular logMAR 
 and BCNVA at Month 6 (Visit 4) and Month 12 
(Visit 5) 
• 
Monocular and binocular defocus curves at Month 6 (Visit 4) 
• 
Spectacle Independence using the Patient-Reported Spectacle Independence Questionnaire 
(PRSIQ) at Month 6 (Visit 4) 
 

 
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4 
STUDY DESIGN  
4.1 
OVERALL DESIGN 
This study is a prospective, multicenter, randomized, active controlled, double masked pivotal study.  It 
compares an investigational trifocal IOL, FINEVISION HP Trifocal IOL, and a commercially available 
monofocal IOL, AcrySof SN60AT
 Monofocal IOL Model SN60AT
 (Alcon). The study will 
include adult subjects with operable cataracts in both eyes who are eligible for phacoemulsification 
cataract surgery followed by IOL implantation.  Potential subjects, after signature of the study informed 
consent document, will be screened for eligibility.  Subjects who meet all protocol-specified eligibility 
criteria   will be randomized at a 2:1 ratio to receive either the FINEVISION HP Trifocal IOL (test) or the 
AcrySof SN60AT
 Monofocal IOL (control) in both eyes.  The first eye undergoing cataract 
surgery/IOL implantation will be the eye with the worse preoperative BCDVA.  If BCDVA of both eyes is 
the same, the first operative eye will be the right eye.  Subjects will undergo cataract surgery/IOL 
implantation in the second operative eye 7 – 30 days subsequent to primary eye surgery.  Subjects will 
attend regular visits where they will undergo ophthalmic examinations over a period of approximately 
12 months. 
Standard clinical trial methods will be used to minimize bias, such as the use of a masked vision assessor 
as well as masking of subjects, standardized test procedures, common investigator training and common 
inclusion and exclusion criteria.  
 
 
 
4.2 
 
 
 
 
 
 
 
 
 
   
4.3 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
The purpose of this clinical study is to compare the visual outcomes and safety of the FINEVISION HP 
Trifocal IOL to that of the AcrySof Monofocal IOL Model SN60AT
  Visual outcomes evaluated 
will include distance, intermediate and near visual acuity.  The study is designed to meet the 
requirements specified for multifocal IOLs in the ISO 11979-7, ISO 11979-9, and ANSI Z80.12 standards.  
 

 
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4.4 
END OF STUDY DEFINITION 
The end of the study is defined as completion of the last procedure specified for the last visit as shown 
in the Schedule of Activities (SoA), Section 1.3, by all subjects who did not terminate study participation 
early. 
Subjects will be considered to have completed the study if they did not terminate study participation 
prior to completion of visual acuity and safety assessments at the 12-month study visit (Visit 5). 
 
5 
STUDY POPULATION 
The study population consists of subjects with a diagnosis of bilateral cataracts, eligible for 
phacoemulsification surgery followed by IOL implantation.   
Subjects will be enrolled at up to 24 investigational sites.  Investigators will be encouraged to perform 
cataract surgery/IOL implant for at least 20 subjects per site; no Investigator may implant more than 
25% of the total number of subjects planned.  Site enrollment will be closely monitored to facilitate 
achievement of the stated enrollment goals in order to achieve an even distribution across all sites. 
 
5.1 
INCLUSION CRITERIA 
Eligible subjects must meet all the following inclusion criteria in order to be eligible for study 
participation.  Ocular criteria must be met for both eyes: 
1) 
Male or female adults, age 22 years or older at the Preoperative Visit. 
2) 
Visually significant cataracts in both eyes that are eligible for phacoemulsification cataract 
surgery.   
3) 
Willing to undergo cataract surgery in the second operative eye within 7 – 30 days after 
surgery in the first eye.  
4) 
Projected BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye after cataract 
surgery/IOL implantation, as determined by the medical judgement of the Investigator 
5) 
Eligible for receipt of an IOL power within the range of the investigational IOL (+10.0 D to 
+30.0 D, in 0.50 D increments) in each eye 
6) 
Contact lens users must be willing to discontinue wear of their lenses in accordance with the 
following requirements: 
• 
Rigid gas permeable lenses for ≥ 7 days prior to the Preoperative Visit 
• 
Soft contact lenses for ≥ 3 days prior to the Preoperative Visit  
Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere 
and cylinder) in each eye, as determined by manifest refraction on two consecutive 
examination dates at least one week apart after discontinuation of contact lens wear. 
7) 
Provide signed written consent prior to participation in any study-related procedures. 

 
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8) 
Ability, comprehension, and willingness to follow study instructions, and likely to complete 
all study visits. 
9) 
Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing 
potential, have a negative urine pregnancy test at the Preoperative Visit.  Women of 
childbearing potential must use an acceptable form of contraception throughout the study.  
Acceptable methods include at least one of the following:  intrauterine (intrauterine device), 
hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, 
diaphragm), or abstinence. 
5.2 
EXCLUSION CRITERIA 
Subjects with any of the following diseases, surgeries or conditions are ineligible for study participation.  
Subjects may not participate if either eye meets any of the ocular exclusion criteria: 
 
1) 
History or presence of, or predisposition to, degenerative visual disorders (e.g., macular 
degeneration, retinal detachment, proliferative diabetic retinopathy, or other retinal 
disorders) predicted to result in BCDVA worse than 0.2 LogMAR (20/32 Snellen) in either eye 
during the study participation period. 
2) 
Significant anterior segment pathology in either eye that might increase intraoperative risk 
or compromise IOL stability (e.g., pseudoexfoliation syndrome)  
3) 
Reasonably expected to require secondary ocular surgical intervention or laser treatment 
other than YAG capsulotomy in either eye during the study participation period. 
4) 
Presence of one or more clinically significant corneal abnormalities in either eye, including 
corneal dystrophy, irregularity, or edema per the Investigator’s medical opinion. 
5) 
Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, 
LASIK, astigmatic keratotomy and limbal relaxing incisions in either eye 
6) 
Rubella, congenital, traumatic or complicated cataract in either eye 
7) 
Preoperative keratometric astigmatism > 1.0 D or irregular corneal astigmatism in either eye 
(Note:  corneal incisions intended to reduce astigmatism are not permitted) 
8) 
Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to 
the Preoperative Visit. 
9) 
Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, 
ocular infection, severe dry eye) in either eye, or any other unstable medical condition (e.g., 
uncontrolled diabetes) that in the opinion of the Investigator would put the subject’s health 
at risk, confound the results of the study and/or prevent the subject from completing all 
study visits. 
10) 
Use of medications known to interfere with visual performance, pupil dilation, or iris 
structure ≤ 30 days prior to the Preoperative Visit. 
11) 
Participation in any study of an investigational, interventional product within 30 days prior 
to the Preoperative Visit or at any time during the study period. 
12) 
Pregnant or nursing females. 

 
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5.3 
REASONS NOT TO IMPLANT A STUDY IOL 
At the time of cataract surgery, but prior to IOL implantation there are operative adverse events that may 
prevent implantation of the designated IOLs for this clinical study.  There criteria include, but are not 
limited to: 
1) 
Intraoperative complications during the phacoemulsification and IOL implant that require 
any other additional procedures or further intervention 
2) 
Significant detachment of Descemet’s membrane 
3) 
Significant corneal endothelial damage 
4) 
Wound burn 
5) 
Capsular tear, iris incarceration or damage, posterior capsular rupture, vitreous loss or 
prolapse, or zonular weakness, dehiscence or rupture 
6) 
Significant anterior chamber bleeding 
7) 
Excessive iris mobility or need for iris manipulation 
8) 
Mechanical or surgical manipulation required to enlarge the pupil prior to or at IOL 
implantation 
9) 
Other ocular conditions or complications that could compromise IOL stability 
10) 
Bag sulcus, sulcus-sulcus or unknown placement of haptics 
11) 
Any method of anterior capsulotomy other than circular continuous capsulorhexis (e.g., 
anterior capsular tears or any areas of ‘can-opener’ capsulotomy or FLACS) 
12) 
Capsular fibrosis or other opacity 
13) 
Optic and/or haptic damage/amputation  
14) 
Inability to fixate IOL in desired position 
If an operative adverse event prevents implantation of the investigational IOL in the first eye and the IOL 
did not touch the eye, the subject should be implanted with a non-study IOL instead and discontinued 
from the study, followed under the Investigator’s normal standard of care.   
If an operative adverse event prevents implantation of the investigational IOL in the first eye and the IOL 
touched the eye, the Investigator should follow the subject through resolution of any adverse events 
(AEs) and then discontinue the subject. If an operative AE prevents implantation of the investigational 
IOL in the second operative eye, the Investigator should follow the subject through resolution of any AEs 
for the second operative eye and the subject should remain in the study and attend all study visits for 
the first operative eye. 
 
5.4 
SCREEN FAILURES 
An enrolled subject who fails to meet eligibility criteria and/or discontinues from the study before the 
first eye is implanted will be considered a screen failure and exited from the study.    
 

 
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5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Study participants will be recruited from the investigator’s patient population, referrals, or other 
outreach methods.  Written recruitment materials directed to potential study participants must be 
approved by the overseeing IRB.   
Where possible, candidate participants may be pre-screened via review of their medical charts to 
evaluate potential eligibility based on study inclusion/exclusion criteria.  During the informed consent 
discussion, the potential participant’s willingness and ability to meet the follow-up requirements will be 
evaluated.  Those who elect to sign the study informed consent form (ICF) will be considered enrolled in 
the study and given a study identification code.  At/after the time of enrollment, the subject will be 
evaluated at the Preoperative Visit for study eligibility based on inclusion/exclusion requirements.   
Study site personnel should take the following steps to minimize the likelihood of early termination 
during the study: 
• 
During the Preoperative Visit, emphasize the importance of returning for all study follow-up 
visits and thoroughly evaluate the study subject for potential health or motivational issues or 
other life circumstances that may negatively affect compliance with the study follow-up visit 
schedule. 
• 
Evaluate research staff flexibility to work around personal difficulties encountered by the 
subject related to protocol compliance (e.g., appointment times). 
• 
Attempt to schedule subject follow-up visits early in the visit window to facilitate rescheduling 
within the window, if necessary. 
• 
Attempt to follow-up on subjects who do not return for scheduled examinations. 
6 
STUDY INTERVENTION 
6.1 
STUDY DEVICES 
6.1.1 INVESTIGATIONAL DEVICE DESCRIPTION 
The FINEVISION HP Trifocal IOL, shown in Figure 1, is a diffractive IOL designed to provide recipients with 
intermediate, near and distance vision. These lenses provide three focal points by combining two 
superimposed diffractive profiles, one with a +1.75 D addition at the IOL plane for intermediate vision, 
and the other with a +3.50 D addition for near vision. The light-energy distribution sends the greatest 
amount of light to distance, then near, and the least to intermediate. 

 
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Figure 1:  FINEVISION HP Trifocal IOL 
The FINEVISION HP Trifocal IOL is available in powers from +10.0 D to +30.0 D in 0.50 D steps.  The 
single-piece IOL has a double-C-loop haptic design and 5° vault. The 4 haptics are of 0.34 mm thickness. 
The optic portion diameter is 6.0 mm and the IOL total diameter is 11.4 mm. The device has a square 
edge of 360° aiming at optimal lens-tissue contact.  The IOL has a biconvex aspheric optic (-0.11 microns 
of spherical aberration at 5 mm pupil) to adjust for the positive spherical aberration of the cornea.  
 
  
 
The IOL is made with the proprietary medical quality hydrophobic acrylic (GFY) (meth) acrylic material. 
The material includes an UV blocker and a blue light filtering chromophore. 
  
 
6.1.2 CONTROL DEVICE DESCRIPTION 
AcrySof SN60AT
 Monofocal IOL Model SN60AT
 from Alcon (Fort Worth, TX) is a 
hydrophobic, ultraviolet filtering, foldable monofocal IOL with biconvex single-piece design comprised of 
a central optic and 2 open-loop haptics.  The optic is 6.0 mm in diameter and the lens has a total 
diameter of 13.0mm.  The lenses will be available in powers +10.0 D to +30.0 D in 0.50 D increments. 
 
 T
 
 

 
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6.2 
DEVICE ACCOUNTABILITY AND STORAGE 
6.2.1 ACQUISITION AND ACCOUNTABILITY 
Throughout the clinical study, the Investigator will be responsible for the accounting of all test and 
control IOLs and will ensure that the investigational products are used in accordance with the 
manufacturer’s manual of procedures (MOP) and directions for use (DFU). 
Upon receipt of the investigational product (IP), shipment records will be verified by comparing the 
Shipping Receipt Confirmation to the devices actually received at the site.  If a discrepancy is noted, the 
Sponsor or designee must be notified immediately.  Accurate records of receipt and disposition 
(dispensing log) of the study devices (e.g., dates, subject number, etc.) must be maintained by the 
Investigator or authorized site representative. 
Throughout the study, the Investigator must maintain records of IP dispensed and implanted for each 
subject.  All IP sent to the Investigator must be accounted for and in no case be used in an unauthorized 
manner.   
The Investigator is responsible for proper disposition of all unused IP at the conclusion of the study, 
according to the instructions provided by the Sponsor. 
 
6.2.2 PACKAGING AND LABELING 
The FINEVISION HP investigational lenses will be provided sterile in blisters and labeled with the lens ID, 
lot number, expiry date.  Each IOL will bear a sticker with the following statement: 'CAUTION--
Investigational device. Limited by Federal (or United States) law to investigational use.' 
The AcrySof SN60AT
 Monofocal IOL Model SN60AT
 control lenses will be provided 
sterile in blisters and labeled with the lot number and expiry date along with the standard 
manufacturer’s packaging instructions. 
To maintain product sterility and integrity, the study devices will be supplied in their original packaging 
and used according to the appropriate device instructions.   
 
6.2.3 PRODUCT STORAGE AND STABILITY 
Study devices should be stored in a secure area according to the package labels. 
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND MASKING 
Subjects will be randomly assigned to receive either the investigational FINEVISION HP IOL or the 
AcrySof monofocal IOL in both eyes according to the randomization schedule (2:1 ratio) provided.  
Randomization will be stratified by site. The randomization schedule will be created using computer-
generated randomization methodology by an independent statistician who is not involved in the day-to-

 
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day conduct of the study. Randomization is to occur following the completion of informed consent and 
screening procedures. 
In order to minimize bias, site personnel performing postoperative study assessments of visual 
performance, including manifest refraction, visual acuity, defocus curve testing and contrast sensitivity 
will be masked to subject treatment assignment until after the final database lock (“masked assessors”).  
Any unmasking of the masked assessor or any study subjects must be reported to the Sponsor. Every 
attempt should be made to have the same masked assessor perform the same postoperative 
measurements for an individual subject throughout the subject’s study participation.    
Subjects will also be masked to their assigned treatment group (test or control group).  Any material that 
may indicate the subjects’ assigned treatment, e.g., packaging, documents, etc., should be removed 
from areas where subjects and/or masked personnel may see it.  Unmasked personnel should further be 
instructed to avoid conversation and communication with masked personnel, subjects and persons 
other than the study investigator regarding subjects’ assignments, outcomes, clinical courses and all 
other information potentially relevant to the study and its conduct. 
 
7 
PARTICIPANT DISCONTINUATION/ WITHDRAWAL 
7.1 
PARTICIPANT DISCONTINUATION/ WITHDRAWAL FROM THE STUDY 
Discontinued subjects are those who withdraw from the study after the study informed consent 
document is signed and before the final visit is completed.  Subjects who sign the study consent 
document but fail to meet eligibility criteria or withdraw prior to study IOL implantation in the first 
eye shall be considered discontinued due to screen failure. 
A subject may be discontinued prior to the final study visit for any of the following reasons, including but 
not limited to: 
• 
Screen failure 
• 
Adverse event(s); note that subjects should be followed within the study until adverse event 
resolution or stability 
• 
Investigator’s request (e.g. medical decision) 
• 
Voluntary withdrawal (subject’s request) 
• 
Death 
• 
Study terminated by Sponsor 
• 
Loss to follow-up 
Prior to discontinuing a subject, every effort should be made to contact the subject to schedule a final 
study visit and obtain as much follow-up data as possible. Discontinued subjects should thereafter be 
followed outside of the study protocol according to the Investigator’s normal standard of care. 
The reason for participant discontinuation or withdrawal from the study will be recorded on the Exit 
Case Report Form (CRF).  

 
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Randomized subjects who do not receive a study IOL may be replaced.  Randomized subjects who 
receive a study IOL and are discontinued or withdraw from the study afterwards will not be replaced. 
 
7.2 
LOST TO FOLLOW-UP 
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 
• 
The site will attempt to contact the participant by telephone, electronic, or regular mail to 
reschedule the missed visit. At least 3 documented attempts to contact the subject must be 
made.  If the subject does not respond to these attempts, a certified letter must be sent to the 
participant’s last known mailing address.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up.] 
These actions will be recorded in the source documents and a copy of the certified follow-up letter 
maintained in the source documents. The date of discontinuation for subjects lost to follow-up will be 7 
calendar days after the date that the unanswered certified letter was sent. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
Study participants will be evaluated at a Preoperative Visit.  For subjects who qualify for further study 
participation, the primary eye will be determined, the subject will be randomized to receive the assigned 
study IOL, and surgery will be scheduled to occur between 1 and 90 days after the Preoperative visit.  
Cataract surgery/IOL implantation will be performed for the primary eye and the subject will be 
scheduled to return for follow-up visits and examinations at the Day 1, Week 1, Month 1, Month 6, and 
Month 12 time periods, consistent with study visits described in ISO 11979-7 (Form 0 through Form 5).  
Cataract surgery/IOL implantation in the second operative eye will be scheduled 7 – 30 days after 
primary eye surgery in a manner such that follow-up examinations for the second operative eye may be 
performed when the subject returns for scheduled primary eye visits.  Data collected from each visit, 
including any abnormal findings, will be documented in the source records and recorded on study 
eCRFs.   
The timing and frequency of assessments/procedures to be performed at each visit is outlined in the 
SoA. 
Methodology for study examinations is presented in the Manual of Procedures.  
 
8.1 
PREOPERATIVE VISIT (DAY -90 TO DAY -1):  VISIT 0 
The Preoperative Visit must occur no more than 90 days and no less than 1 day prior to the Operative 
Visit.  Informed consent must be obtained prior to performing study-specific procedures not part of the 

 
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investigator’s routine standard of care.  Subjects who sign the ICF will be given a unique 4-digit screening 
number, where the first two digits corresponds to the site number.  
At this visit, the following activities will be performed:  
• 
Ocular and significant non-ocular medical history* 
• 
Projected Visual Acuity* 
• 
UCDVA* 
• 
BCDVA* 
• 
Target Refraction/IOL power calculation/Axial Length/Anterior Chamber Depth (biometry)* 
• 
Keratometry* 
• 
Corneal Topography* 
• 
Manifest Refraction (ETDRS)* 
• 
Photopic/mesopic pupil size* 
• 
Intraocular Pressure* 
• 
Slit Lamp Exam* 
• 
Dilated Fundus Exam* 
* These assessments, if performed during routine standard of care exams up to 90 days before the 
subject Preoperative Visit, may be used as qualifying preoperative assessments prior to consent. All study 
specific evaluations not included in a routine cataract evaluation must be performed in the preoperative 
time period (Day -90 to Day -1). 
For those determined to be eligible for cataract surgery/IOL implantation, the eye with the worse 
BCDVA will be scheduled for surgery first. If BCDVA is the same for both eyes, the right eye will be 
implanted first.  The randomization assignment will be determined indicating which IOL will be used, 
and the subject’s surgery will be scheduled. 
 
8.2 
OPERATIVE VISIT (DAY 0):  VISIT 00 A/B 
The Operative Visit for the first operative eye must occur on Day 0.  The Operative Visit for the second 
operative eye must be scheduled between Days 7 – 30, inclusive.   
At the Operative Visit, prior to surgery, subjects will be assessed to reconfirm eligibility and any changes 
in concomitant medications or medical/ocular conditions will be recorded on the appropriate CRF. If the 
subject is determined no longer to be eligible, he/she will be discontinued from the study prior to 
cataract surgery and considered a screen failure.   
If operative complications prevent implantation of the investigational IOL (see Section 5.3 – Reasons Not 
to Implant a Study IOL), a non-study IOL may be implanted instead.  Subjects who were not exposed to 
the study IOL will be exited from the study and followed per the investigator’s standard of care.  
No additional refractive procedures are to be performed during the operative procedure or throughout 
the postoperative study period. 

 
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The Investigator should refer to the Manual of Procedures for more detailed guidance on FINEVISION HP 
implantation and AcrySof SN60AT
 implantation.  Subjects must be targeted as closely as 
possible for emmetropia.  Surgeons may use their personalized A-constant for model SN60AT
. 
For study visits designated A or B, ‘A’ represents the first eye implanted (Eye A), and ‘B’ represents the 
second eye implanted (Eye B).  Monocular assessments will be performed at Visits 00 A/B, 1 A/B, 2 A/B, 
and 3 A/B for only Eye A or only Eye B, respectively, unless binocular assessments are specified (See 
Schedule of Activities, Section 1.3).  At Visits 4 and 5, monocular assessments and binocular assessments 
will be completed for both eyes. 
 
8.3 
POSTOPERATIVE VISITS:  VISIT 1 THRU VISIT 5  
Postoperative visits should be scheduled according to the following visit window schedule: 
• 
Visit 1 A: 1-2 days after surgery on the first eye 
• 
Visit 1 B: 1-2 days after surgery on the second eye 
 
• 
Visit 2 A: 7-14 days after surgery on the first eye 
• 
Visit 2 B: 7-14 days after surgery on the second eye 
 
• 
Visit 3 A: 30-60 days after surgery on the first eye 
• 
Visit 3 B: 30-60 days after surgery on the second eye  
 
• 
Visit 4: 150-180 days after surgery on the first eye 
• 
Visit 5: 360-420 days after surgery on the first eye 
IOL implantation in the second operative eye is to be scheduled between 7 to 30 days after IOL 
implantation in the first operative eye.  Subsequent Post-Op visits for the first and second eye are to be 
conducted as separate visits for Visits 1-3.  Visits 4 and 5 must be conducted for both eyes at the same 
time based on timing from when the first eye was implanted. 
Refer to the Schedule of Activities in Section 1.3 and the MOP for detailed procedures to be performed 
at these scheduled postoperative visits. 
 
 
8.4 
UNSCHEDULED VISITS 
Unscheduled visits are those which are not required by the study protocol, but which occur due to an 
ocular intervention or a subject complaint regarding their eye.   

 
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If a subject visit occurs between any regularly scheduled visits, this visit is to be documented as an 
Unscheduled Visit. During all unscheduled visits, the Investigator should conduct assessments as 
appropriate given the subject’s condition.  Mandatory assessments include:  
• 
Patient Reported Outcomes Questionnaires 
• 
Concomitant medication 
• 
Ocular and non-ocular medical history 
• 
Manifest refraction 
• 
BCDVA at 4 m (photopic) monocularly, binocularly for each implanted eye 
• 
UCDVA at 4 m (photopic) monocularly, binocularly for each implanted eye 
• 
Keratometry 
• 
Slit lamp exam 
• 
Posterior capsule assessment 
• 
IOL observations 
• 
IOL tilt and decentration grading 
• 
Intraocular pressure 
• 
IOL Axis Orientation (retroilluminated slit lamp photo) – selected sites only 
• 
Fundus exam with dilated pupil 
• 
Adverse events 
• 
Device deficiencies 
The Investigator may perform additional procedures for proper diagnosis and treatment of the subject 
according to SoA in Section 1.3. The Investigator must document this information in the subject’s source 
documents and record it on the USV eCRF. 
If, during an Unscheduled Visit, the subject is discontinuing from the study, the Investigator must 
complete the Exit CRF. 
Visits intended to fulfill scheduled visit requirements that fall outside the designated scheduled visit 
window are not Unscheduled Visits. In these cases, the visit data will be collected and transcribed to the 
appropriate scheduled visit CRF and a protocol deviation should be reported, if applicable. 
 

 
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8.5 
CONCOMITANT MEDICATION 
Documentation of all medications used by the subject within 30 days of the Preoperative Visit and 
during the study will be entered in the Concomitant Medication CRF. Pre-, intra-, and postoperative 
medications may be administered per the Investigator’s standard of care and documented in source 
documents only (not to be entered in CRFs). A complete list of the Investigator’s standard regimen of 
these medications will be provided to the Sponsor or its designee and approved by the Medical Monitor 
prior to initiation of the study. Medications known to interfere with visual performance, pupil dilation, 
or iris structure are prohibited for the duration of the study. 
 
8.6 
SECONDARY SURGICAL INTERVENTION (SSI) 
The study Investigator must make an assessment of the subject to determine if a secondary surgical 
intervention (SSI) is needed.  This assessment should be based on the Investigator’s assessment of the 
subject’s clinical outcome, subjects feedback related to visual symptoms, and other reasons, such as 
observed retained lens fragments.  The Investigator’s assessment of the need for SSI should be based on 
a thorough examination including diagnostic testing as appropriate.  Consideration of BCDVA, IOL 
stability and subjective complaints such as blurred vision or visual disturbances should be considered, 
with an assessment of the potential risks and benefits associated with the SSI.   
The Investigator must assess if an SSI is related to the optical properties of the IOL.  An SSI is considered 
related to the optical properties of the IOL if the SSI is due to subject intolerance of visual symptoms not 
adequately improved by spectacle correction. 
Situations requiring SSIs that are not considered related to the optical properties of the IOL include: 
• 
Posterior capsular opacification (PCO; note that YAG for PCO is not considered an SSI but an 
analysis of rates will be performed) 
• 
Macular edema confirmed by optical coherence tomography and/or fluorescein angiography 
• 
Corneal disorders (e.g., dry eye syndrome, edema, and corneal irregularities) 
• 
Pre-existing or newly developed ocular pathologies, including those related to decentration, tilt 
or rotation of the IOL requiring reoperation 
• 
Surgical complications noted at the operative visit that may reasonably be expected to affect 
postoperative outcomes 
Secondary IOL interventions should be categorized as IOL exchange (the investigational device is 
replaced with the same lens model), IOL removal (the investigational device is removed and replaced 
with a non-investigational lens or no lens is implanted), IOL repositioning (the existing IOL is surgically 
moved to another location or rotated), or other.  Indications for device exchange, removal, or 
repositioning will be recorded in the CRF. 

 
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The investigator should consult with the Medical Monitor to determine if an SSI is warranted.  If there is 
any uncertainty as to whether the SSI is related to the optical properties of the IOL or to some other 
unrelated factor, the Investigator should consult with the Medical Monitor.  The Investigator should 
determine the most suitable SSI procedure for each case.  Note that limbal relaxing incisions during 
cataract surgery and refractive procedures to address residual refractive error are disallowed by the 
protocol.   
 
8.6.1 IOL REPOSITIONING 
If IOL repositioning is required, it should be done in the early postoperative period, preferably within the 
first 30 days following surgery.  Repositioning should only be considered in cases when tilt or 
decentration is such that repositioning is necessary to improve the visual outcomes of the subject or 
prevent damage to the eye. 
 
8.6.2 IOL EXPLANTATION AND REPLACEMENT 
If IOL explantation and replacement is required, it should be done in the early postoperative period.  In 
the case of an incorrect IOL power or residual refractive error, if IOL replacement is expected to improve 
the subject’s visual outcomes, the IOL should be replaced with a new lens; however, the replacement 
IOL cannot be the investigational IOL model. 
In the case where the subject reports visual disturbances in the early postoperative period, the surgeon 
should remind the subject that these symptoms generally improve over time due to neural adaptation.  
Therefore, adequate time should be allowed for this neural adaptation to occur.  The Investigator should 
consult with the Medical Monitor and carefully consider the potential risks and benefits of the SSI.  
These should be discussed with the subject; if the subject is intolerant of persistent visual disturbances 
and the Investigator identifies the IOL properties as being the primary cause then lens replacement 
should be considered. 
 
8.7 
ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, UNANTICIPATED ADVERSE DEVICE 
EFFECTS AND DEVICE DEFICIENCIES 
8.7.1 DEFINITION OF ADVERSE EVENTS 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical sign (including an abnormal laboratory finding) or symptom in subjects whether or not related to 
an investigational device.  
 
 
 

 
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8.7.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
A serious adverse event (SAE) is defined as any untoward medical occurrence that meets any of the 
following: 
• 
Is associated with a loss of 2 or more lines of BCDVA [loss of 10 or more Early Treatment 
Diabetic Retinopathy Study (ETDRS) letters] at Visit 4 or later from any prior postoperative visit 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization; 
• 
Requires medical or surgical intervention to preclude permanent impairment of a body function 
or permanent damage to a body structure; 
• 
Is life threatening (places the subject at immediate risk of death from the event as it occurred) 
or sight threatening; 
• 
Results in permanent impairment of a body function or permanent damage to a body structure; 
• 
Results in death; 
• 
May jeopardize the subject and require medical or surgical intervention to prevent one of the 
other outcomes. 
 
8.7.2.1 CUMULATIVE ADVERSE EVENTS   
In addition, the total number of the following adverse events that have occurred at any time will be 
reported as cumulative AEs, consistent with categories provided in ISO 11979-7: 
• 
Cystoid macular edema 
• 
Hypopyon 
• 
Endophthalmitis - defined as intraocular inflammation leading to diagnostic vitreous tap and 
intraocular antibiotics 
• 
Lens dislocation from posterior chamber 
• 
Pupillary block - shallowing of anterior chamber due to obstruction of aqueous humor flow from 
the posterior to anterior chamber through the pupil by the crystalline lens, vitreous face, or 
implanted device 
• 
Retinal detachment 
• 
Secondary surgical intervention (excluding posterior capsulotomies) 
 
8.7.2.2 PERSISTENT ADVERSE EVENTS 
The total number of the following adverse events that are present at the conclusion of the clinical 
investigation will be reported as persistent AEs, consistent with categories provided in ISO 11979-7: 
• 
Corneal stromal edema  
• 
Cystoid macular edema 
• 
Iritis 

 
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• 
Raised intraocular pressure (IOP) requiring treatment 
 
8.7.3 DEFINITION OF ADVERSE DEVICE EFFECTS AND UNANTICIPATED ADVERSE DEVICE 
EFFECTS  
An Adverse Device Effect (ADE) is any adverse event related to the use of a study device. This definition 
includes any events resulting from insufficient or inadequate instructions for use, deployment, 
implantation, installation or operation, or any malfunction of the device. This definition also includes 
any event resulting from use error or from intentional misuse of a study device. 
An Unanticipated Adverse Device Effect (UADE) is any serious adverse effect on subject health or safety, 
or any life-threatening problem or death caused by or associated with the investigational device, if that 
effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the 
study protocol. 
 
8.7.4 CLASSIFICATION OF AN ADVERSE EVENT 
8.7.4.1 SEVERITY OF EVENT 
The investigator must determine the intensity of the event. 
 
Mild 
Awareness of sign or symptom, but easily tolerated 
Moderate 
Discomfort enough to cause interference with normal daily 
activities 
Severe 
Inability to perform normal daily activities 
 
8.7.4.2 RELATIONSHIP TO STUDY INTERVENTION 
All adverse events (AEs) must have their relationship to study intervention assessed by the Investigator 
based on temporal relationship and his/her clinical judgment. The degree of certainty about causality 
will be graded using the categories below.  

 
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Relationship of the AE to Study Device or Surgical Procedure: 
Definite 
A clear-cut causal relationship and no other possible cause 
Probable 
A causal relationship is likely although alternate etiologies are 
also possible 
Possible 
A causal relationship is not definite, alternate etiologies 
are also possible 
Not Related 
The AE has no causal relationship and/or there is evidence of 
alternative etiology such as concurrent medication or illness. 
 
8.7.5 ADVERSE EVENT REPORTING  
All AEs that occur during or after the Preoperative Visit through completion of study participation must 
be documented.  Adverse events are collected from time of informed consent, and may be determined 
by evaluating the following in relation to the study subject: 
• 
Observed or volunteered problems 
• 
Complaints 
• 
Physical signs and symptoms  
• 
The occurrence of a medical condition during the study, which was absent at baseline 
• 
The worsening of a baseline medical condition during the study 
Each subject eye must be examined for the presence/absence of adverse events at all visits, whether 
scheduled or not. If an AE occurs, the first concern will be the safety and welfare of the subject; 
treatment should be provided as appropriate for the event. 
AEs, regardless of causal relationship, must be assessed by the Investigator and recorded in the subject’s 
CRF. AEs should be recorded in the form of a diagnosis, rather than signs and symptoms. Each AE must 
be described as ocular or non-ocular along with the following information: date of onset, date of 
resolution, severity, nature of the event (intermittent, continuous), action taken (none, medical and/or 
surgical), relationship to study device and surgical procedure, seriousness criteria and expectedness.    
Any medication or other intervention necessary for the treatment of an AE must be recorded on the 
appropriate eCRF.  If the same type of AE occurs multiple times, each event should be recorded 
separately. 
AEs will be documented beginning at the time of onset, and documentation must continue until 
recovery is noted.  Events that are ongoing at the time of study exit should be followed until resolution 
or stabilization. 
Ocular conditions or diseases noted during the Preoperative Visit that are chronic but stable and meet 
the inclusion/exclusions criteria should be recorded as Ocular History in the subject’s case report form.  

 
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The worsening of a preoperative condition or disease will be considered an AE.  As applicable, signs and 
symptoms indicating a common underlying pathology should be noted as one comprehensive event. 
 
8.7.6 EXPEDITED ADVERSE EVENT REPORTING  
Any ocular SAE or UADE, whether the event is expected or unexpected, must be reported to the 
Sponsor, or the Sponsor’s designee, within 24 hours of the Investigator becoming aware of the event.  
Non-ocular SAEs must be reported within 7 days.   
SAEs and UADEs must be recorded in the subject’s eCRF.  Information provided on the eCRF should be 
supplemented with hospitalization records, death certificate, clinic notes from specialists evaluating the 
subject’s condition, etc. as applicable for the event.  The urgency for reporting SAEs/UADEs is 3-fold:  
• 
To facilitate discussion [and implementation, if necessary] by the Sponsor and the Investigator 
of appropriate follow-up measures;  
• 
To facilitate Investigator reporting of unanticipated problems involving risk to human subjects to 
the IRB; and  
• 
To enable the Sponsor to fulfill the reporting requirements to the appropriate regulatory 
authority. 
It is the responsibility of the Investigator to promptly notify the IRB of SAEs per the IRBs reporting 
requirements. Investigators must report the occurrence of a UADE to their reviewing IRB as soon as 
possible, but no later than 10 working days after first learning of the event. The Sponsor must report the 
results of an evaluation of an UADE to FDA and all reviewing IRBs and participating investigators within 
10 working days after the Sponsor first receives notice of the effect. 
 
8.7.7 ANTICIPATED ADVERSE EVENTS 
Anticipated AEs associated with cataract surgery and/or premium IOL implantation that might 
reasonably be expected to occur in this study are listed below and include, but are not limited to, the 
following: 
 
Intraoperative Adverse Events 
• 
Anterior capsule tear 
• 
Hyphema obscuring the surgeon’s view 
• 
Vitreous prolapse 
• 
Wound leak (positive Seidel) 
• 
Posterior capsular rupture 
• 
Choroidal detachment/hemorrhage 
• 
Zonular dialysis 
• 
Thermal injury (phaco burn) 

 
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Postoperative Adverse Events 
• 
Anterior uveitis (including iritis and iridocyclitis) 
• 
Capsular block syndrome 
• 
Choroidal detachment/hemorrhage 
• 
Chronic anterior uveitis [anterior segment inflammation characterized by grade 1+ cell or 
greater that is persistent for greater than 3 months after surgery, or relapses in less than 3 
months after discontinuation of therapy, or the subject is maintained on therapy for more than 
3 months to control inflammation.] 
• 
Corneal edema [corneal swelling (stromal or epithelial) resulting in BCDVA of 0.3 logMAR or 
worse at Visit 3 or later] 
• 
Cystoid macular edema (CME) diagnosed by clinical exam and adjunct testing (eg. OCT or other 
method), resulting in BCDVA of ≤ 0.3 logMAR at Visit 3 or later  
• 
Difficulty with tasks in dim light resulting in secondary surgical intervention 
• 
Endophthalmitis (intraocular inflammation leading to diagnostic vitreous tap and use of 
intraocular antibiotics) 
o Flat anterior chamber with lens/cornea touch or a shallow chamber with iridocorneal 
apposition without lens/cornea touch  
• 
Hypopyon 
• 
Incorrect IOL power resulting in secondary surgical intervention 
• 
Increased glare or halos 
• 
Increased IOP (elevation of IOP ≥ 10 mmHg above the IOP measured at the Preoperative Visit to 
a minimum of 25 mmHg) 
• 
Infectious keratitis 
• 
IOL damage resulting in secondary surgical intervention 
• 
IOL malposition resulting in secondary surgical intervention 
• 
Iris or pupil damage 
o Best-corrected distance visual acuity loss of 2 lines (10 letters) or more on the ETDRS chart 
measured at or after postoperative Visit 4 compared to any prior postoperative visit 
• 
Mechanical pupillary block (A shallowing of the anterior chamber due to obstruction of aqueous 
humor flow from the posterior to anterior chamber through the pupil by the crystalline lens, 
vitreous face, or implanted device) 
• 
Multiple (or “ghost”) images 
o Chronic pain in the study eye, per subjective patient reporting, graded as ≥ 4 on the 
standardized pain rating scale (from 0 to 10), present greater than 3 months postoperative 
• 
Reduced contrast sensitivity 
• 
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• 
Rhegomatogenous retinal detachment (RD) (partial or complete RD associated with retinal tear) 
• 
Secondary IOL intervention (reposition, exchange or removal) 
• 
Synechiae formation 
• 
Toxic anterior segment syndrome (TASS) (An acute, noninfectious inflammation of the anterior 
segment of the eye that develops within 24 to 48 hours after surgery, usually resulting in 
hypopyon and commonly presenting with corneal edema, and that improves with steroid 
treatment) 
• 
Undesirable severe optical phenomena resulting in secondary surgical intervention 
 
Early, low grade anterior chamber cell/flare, corneal edema, and increase in IOP can often be considered 
normal or expected after IOL surgery.  They do not need to be reported as adverse events if they occur 
prior to 1 week postoperatively if they meet the following criteria: 
• 
Anterior chamber cells or flare of grade 2 or less and requires no change in standard 
postoperative medication regimen (if it persists to 1 week or more it should be reported as an 
adverse event); 
• 
Corneal edema of grade 2 or less that does not reduce acuity to 0.3 logMAR (20/40) or worse 
and does not require any change in standard postoperative medication regiment (If it persists to 
1 week or more it should be reported as an adverse event); 
• 
Increased IOP that is <10mm Hg above baseline or is < 25mmHg and requires no change in 
standard postoperative medications regiment or any other special treatment. 
 
However, note that all secondary surgical interventions (and events that cause these interventions) and 
all events that have sequelae should be reported as adverse events, regardless of when they occur. 
Note: Posterior capsular opacification (PCO) is NOT to be reported as an AE, per ISO 11979-7.  YAG 
capsulotomies should be reported in the subject’s case report form. 
 
8.7.8 DEVICE DEFICIENCIES 
Device deficiencies related to the identity (e.g., labeling), quality, durability, reliability, safety, 
effectiveness, or performance of the study device must be reported to the Sponsor, or Sponsor’s 
designee, within 7 days of the Investigator becoming aware of the deficiency. Device deficiencies must 
be recorded in the subject’s case report form.  
Device deficiencies will be categories as one of the following:  
• 
Device failure: A device has failed if it is used according to the labeling, including without 
limitation, instructions for use, and applicable standards of medical practice but does not 
perform according to the labeling and negatively impacts the treatment. 
• 
Device malfunction: A device malfunction is a change in the function of the device that is not 

 
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described in the labeling and that may or may not affect device performance. 
• 
Device misuse: A misused device, i.e. one that is not used by the Investigator (in the study) in 
compliance with applicable standards of medical practice, including without limitation, those 
described in the instructions for use and labeling, will not be considered a malfunction.  
• 
Other: must be described by the Investigator 
 
9 
STATISTICAL CONSIDERATIONS  
9.1 
STATISTICAL HYPOTHESES 
Primary Effectiveness Hypotheses 
The null and alternative hypotheses for the first co-primary effectiveness analysis are: 
H01e: µt1e - µc1e ≥ 0.10  
H11e: µt1e - µc1e < 0.10  
Where µt1e and µc1e denote the population mean photopic monocular BCDVA (logMAR) at 4m in the first 
operative eyes at Month 6 (Visit 4) for the test and control IOLs, respectively. 
 
The null and alternative hypotheses for the second co-primary effectiveness analysis are: 
H02e: µt2e - µc2e ≥ 0  
H12e: µt2e - µc2e < 0  
Where µt2e and µc2e denote the population mean photopic monocular DCNVA (logMAR) at 40 cm in the 
first operative eyes at Month 6 (Visit 4) for the test and control IOLs, respectively. 
 
Secondary Effectiveness Hypothesis 
The null and alternative hypotheses for the secondary effective analysis are: 
H03e: µt3e - µc3e ≥ 0  
H13e: µt3e - µc3e < 0  
Where µt3e and µc3e denote the population mean photopic monocular DCIVA (logMAR) at 66 cm in the 
first operative eyes at Month 6 (Visit 4) for the test and control IOLs, respectively. 
 
Primary Safety Hypotheses 
The null and alternative hypotheses for the first co-primary safety analysis are: 
H01s: pt1s – pc1s ≥ 0.014 

 
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H11s: pt1s – pc1s < 0.014 
Where pt1s and pc1s denote the population proportion of first operative eyes at Month 12 (Visit 5) 
requiring secondary surgical intervention related to the optical properties of the IOL for the test and 
control IOLs, respectively. 
 
9.2 
SAMPLE SIZE DETERMINATION 
As specified in ANSI Z80.12:2007 (R2017) –C.4, a minimum of 300 subjects implanted with the 
investigational IOL and 150 subjects implanted with the comparator IOL must be available for analysis at 
Visit 5 (postoperative days 330-420). To consider the potential loss of subjects between the time of 
enrollment and study completion, a total of approximately 501 subjects will be randomized and undergo 
surgery in this study. It is assumed that of approximately 501 subjects who undergo surgery, 51 subjects 
(10%) will be discontinued prematurely or lost to follow-up. Subjects will be randomized to receive 
either the investigational or comparator IOL in a 2:1 ratio. Of 501 subjects who undergo surgery, 
approximately 334 subjects will receive the investigational IOL and 167 subjects will receive the 
comparator IOL. Expecting a screen failure rate of 7%, up to 539 subjects will be enrolled in the study to 
have 501 subjects randomized and scheduled for surgery. 
For effectiveness, 300 subjects (first operative eyes) randomized to FINEVISION HP IOL and 150 subjects 
(first operative eyes) randomized to AcrySof SN60AT
 IOL completing through Month 6 (Visit 4) 
yields >99% power to reject H01e in favor of H11e and conclude the FINEVISION HP IOL is non-inferior to 
the AcrySof SN60AT
 IOL in BCDVA (logMAR) at Month 6 (Visit 4), using a one-sided test with an 
alpha level of 0.05 and assuming no difference in mean BCDVA between test and control IOLs, a 
common standard deviation of 0.10 logMAR, and a non-inferiority margin of 0.10 logMAR. 
Similarly with the sample size required for safety, 300 subjects (first operative eyes) randomized to 
FINEVISION HP IOL and 150 subjects (first operative eyes) randomized to AcrySof SN60AT
 IOL 
completing through Month 6 (Visit 4) will have >99% power to demonstrate superiority of FINEVISION 
HP IOL to AcrySof SN60AT
 IOL in DCIVA (reject H03e in favor of H13e) and DCNVA (reject H02e in 
favor of H12e) using a two-sided test with an alpha level of 0.05 and assuming a true difference in means 
of -0.10 logMAR (FINEVISION HP minus AcrySof SN60AT
 with a common standard deviation of 
0.14 logMAR. 
For safety (based on ANSI Z80.12) 300 first operative eyes with FINEVISION HP IOL and 150 first 
operative eyes with AcrySof SN60AT
 IOL completing through Month 12 (Visit 5) yields 
approximately 80% power to reject H01s in favor of H11s and conclude the FINEVISION HP IOL is non-
inferior to the AcrySof SN60AT
 IOL in secondary surgical interventions related to the optical 
properties of the IOL, using a one-sided Farrington-Manning score test with an alpha level of 0.05 and 
assuming the true proportion of secondary surgical interventions related to the optical properties of the 
FINEVISION HP IOL and of the AcrySof SN60AT
 IOL is 0.001, and a non-inferiority margin of 
0.014 (1.4%). Similarly, ISO 11979-7 specifies that a minimum of 300 subjects should complete a clinical 
evaluation of an IOL to obtain appropriate specificity around adverse event and visual acuity rates.  

 
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9.3 
POPULATIONS FOR ANALYSES 
Intent-to-Treat Set 
The Intent-to-Treat (ITT) Set will include all randomized subjects (eyes). 
All-Implanted Analysis Set  
The All-Implanted Analysis Set will include all eyes with successful IOL implantation with a least 1 
postoperative visit and will be the primary analysis for all effectiveness analysis. 
Safety Set 
The Safety Set will include all subjects with at least one eye implanted with a study lens. 
Best Case Set 
The Best Case Set will include subjects with all of the following characteristics: 
• 
No major protocol deviations potentially affecting any of the primary effectiveness endpoints 
(BCDVA, DCNVA). Major protocol deviations that may potentially affect the primary effectiveness 
endpoints include, but are not limited to: 
o Inclusion of ineligible subjects 
o Implantation of incorrect IOL 
o Missed assessments for effectiveness endpoints at Month 6 (Visit 4) 
o Receipt of medication likely to interfere with visual performance at Month 6 (Visit 4) 
• 
At least one eye implanted with a study lens 
• 
No clinically significant preoperative ocular pathology in the first operative eye, including any of 
the following present prior to the operative visit 
o Pseudoexfoliation 
o Glaucoma 
o Uveitis 
o Retinal detachment 
o Diabetic retinopathy 
o Macular degeneration 
o Amblyopia 
o Other preoperative pathologies that are likely to affect central acuity 
• 
No macular degeneration detected at any time in the first operative eye 
• 
No previous surgery for the correction of refractive errors in the first operative eye 
 
 
. 

 
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9.4 
STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
Summaries for continuous variables will include the sample size, mean, standard deviation, median, 
minimum, and maximum. Summaries for discrete (categorical) variables will include the tabulation of 
frequencies and percentages. 
The unit of analysis in this study will be the first operative eye for all primary effectiveness and safety 
summaries and will be the second operative eye and all eyes for supportive safety summaries; 
 
 
 Both eyes of each 
subject will be treated during the study. For those subjects whose eyes are both determined to be 
eligible for cataract surgery/IOL implantations at Preoperative Visit 0, the eye with the worse best-
corrected distance visual acuity (BCDVA) will be scheduled for surgery first. If BCDVA is the same for 
both eyes, the right eye will be implanted first. Additionally, non-ocular AEs and medical history will be 
presented at the subject level. 
 
9.4.2 HANDLING OF MISSING DATA 
Missing data for primary and secondary efficacy analyses will be imputed under the following strategies. 
Nonmonotone missing data will be multiply-imputed using treatment-based Markov Chain Monte Carlo 
(MCMC) methods; monotone missing data will be multiply imputed using regression methods assuming 
data as either missing at random or missing not at random as described below. 
Primary Strategy 
1. Withdrawal due to investigator’s request:  missing data assumed to be missing not at random. 
Control-based multiple imputations will be completed for superiority hypotheses and 
treatment-based multiple imputations will be completed for non-inferiority hypotheses. 
[hypothetical strategy] 
2. Missing data without withdrawal or withdrawal due to reasons other than due to investigator’s 
request:  missing data assumed to be missing at random.  Treatment-based multiple 
imputations will be completed.  [hypothetical strategy] 
Secondary Strategy 
1. Withdrawal due to investigator’s request:  missing data assumed to be missing not at random. 
Control-based multiple imputations will be completed for superiority hypotheses and 
treatment-based multiple imputations, using the worst half of the subjects who have data within 
the same treatment group, will be completed for non-inferiority hypotheses. [hypothetical 
strategy] 

 
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2. Missing data without withdrawal or withdrawal due to reasons other than due to investigator’s 
request:  missing data assumed to be missing at random.  Treatment-based multiple 
imputations will be completed.  [hypothetical strategy] 
 
9.4.3 ANALYSIS OF PRIMARY EFFECTIVENESS ENDPOINTS 
The statistical analyses described in ISO 11979-7, ISO 11979-9, and ANSI Z80.12 will be performed unless 
otherwise specified in the statistical analysis plan. 
The co-primary effectiveness endpoints are: 
• 
Photopic monocular logMAR best corrected distance visual acuity (BCDVA) in first operative 
eyes at Month 6 (Visit 4)  
• 
Photopic monocular logMAR distance corrected near visual acuity (DCNVA) in first operative 
eyes at Month 6 (Visit 4)  
Primary effectiveness endpoint analyses will be based on the All-implanted Analysis Set. Imputation of 
missing data will be performed utilizing multiple imputation techniques under assumptions of missing at 
random and missing not at random following the primary strategy presented in Section 9.4.2.  As 
sensitivity analyses, the primary effectiveness analyses will be repeated using the secondary multiple 
imputation strategies presented in Section 9.4.2, as well as on the ITT and Best Case Sets using the 
primary multiple imputation strategy only. If the results of the ITT or Best Case Set robustness analyses 
materially differ from the primary analyses on the All-implanted Analysis Set then the results of 
investigations into the cause of such differences will be presented.  
Photopic monocular BCDVA in first operative eyes at Postoperative Month 6 (Visit 4) will be primarily 
summarized using continuous summary statistics by treatment group. The treatment effect [mean Test 
group IOL visual acuity (VA) minus mean Control group IOL VA] in logMAR units will be presented in 
addition to a two-sided 90% t-distribution confidence interval around the difference. If the upper 
confidence limit is less than 0.1, then H01e will be rejected in favor of H11e and the FINEVISION HP IOL will 
be considered to be statistically non-inferior to the AcrySof SN60AT
 IOL in BCDVA. 
Photopic monocular DCNVA in first operative eyes at Postoperative Month 6 (Visit 4) will be summarized 
using continuous summary statistics in logMAR units by treatment group. The FINEVISION HP IOL will be 
compared to the AcrySof SN60AT
 IOL using a two-sample t-test with a two-sided alpha of 0.05. 
If the two-sided p-value < 0.05 in favor of FINEVISION HP IOL for DCNVA, then the FINEVISION HP IOL 
will be considered to be statistically superior to the AcrySof SN60AT
 IOL in DCNVA.  
The study will be considered a success only if both primary effectiveness endpoints are met. 
 
9.4.4 ANALYSIS OF SECONDARY EFFECTIVENESS ENDPOINTS 
The secondary effectiveness endpoint is: 
• 
Photopic monocular logMAR DCIVA at 66 cm in first operative eyes at Month 6 (Visit 4) 

 
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The secondary effectiveness endpoint will be based on the All-implanted Analysis Set. Imputation of 
missing data and sensitivity analyses for the secondary effectiveness endpoint will be performed 
similarly as for the primary effectiveness endpoints. 
Photopic DCIVA (66 cm) in first operative eyes at Postoperative Month 6 (Visit 4) will be summarized 
using continuous summary statistics in logMAR units by treatment group. The FINEVISION HP IOL will be 
compared to the AcrySof SN60AT
 IOL using a two-sample t-test with a two-sided alpha of 0.05. 
If the two-sided p-value < 0.05 in favor of FINEVISION HP IOL for DCIVA, then the FINEVISION HP IOL will 
be considered to be statistically superior to the AcrySof SN60AT
 IOL in DCIVA. 
Inference will be conducted for the secondary effectiveness analysis only if all primary effectiveness 
endpoints are met. 
 
9.4.5 MULTIPLICITY CONSIDERATIONS 
The Type I error rate for the primary effectiveness hypothesis tests will be controlled by requiring all 
primary effectiveness hypothesis test results to be statistically significant to declare success for the 
study. The overall Type I error rate including the primary and secondary effectiveness hypothesis tests 
will be controlled by a hierarchical testing strategy in which statistical inference for the secondary 
effectiveness endpoint will only be performed if the primary effectiveness analyses are successful. 
 
9.4.6 SAFETY ANALYSES 
All safety analyses will be based on the Safety Set, unless otherwise specified. 
Co-primary Safety Analyses 
The co-primary safety endpoints are: 
• 
Cumulative rate of SSIs related to the optical properties of the IOL in first operative eyes through 
Month 12 (Visit 5) 
• 
Mean monocular distance contrast sensitivity (mesopic with and without glare at 1.5, 3, 6, and 
12 cpd measured at 2.5m, and photopic with and without glare at 3, 6, 12, and 18 cpd, 
measured at 2.5m) in first operative eyes at Month 12 (Visit 5) 
Descriptive statistics and analyses of co-primary safety variables will be based on first operative eyes 
and repeated as supportive analyses using second operative eyes as well as all operative eyes. 
Secondary surgical interventions related to the optical properties of the IOL will be summarized by 
descriptive statistics for each IOL group. Noninferiority of FINEVISION HP IOL compared to AcrySof 
SN60AT
 IOL in the proportions of first operative eyes with secondary surgical interventions 
related to the optical properties of the IOL will be evaluated using two-sided 90% Farrington method 
confidence intervals around the difference in proportions between the FINEVISION HP IOL and AcrySof 
SN60AT
 IOL. If the upper limit of the confidence interval is less than 0.014, then H01s will be 
rejected in favor of H11s and the FINEVISION HP IOL will be considered statistically non-inferior to the 

 
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AcrySof SN60AT
 IOL in rate of secondary surgical interventions related to optical properties of 
the IOL. 
Monocular best-corrected distance contrast sensitivity (mesopic with and without glare at 1.5, 3, 6, and 
12 cpd measured at 2.5m, and photopic with and without glare at 3, 6, 12, and 18 cpd, measured at 
2.5m) in first operative eyes based on the Best Case Set will be summarized by descriptive statistics for 
each IOL group. The treatment group difference (mean Test group contrast sensitivity minus mean 
Control group contrast sensitivity) in log units will be presented by testing condition and frequency. 
Additionally, for each testing condition and frequency, the 5th percentile for the control group log 
contrast sensitivity will be determined and the percentage of subjects in the investigational arm who 
have achieved a log contrast sensitivity lower than this value will be reported.  
Secondary Safety Analyses 
The secondary safety endpoints are: 
• 
Rates of cumulative and persistent adverse events in first operative eyes through Month 12 
(Visit 5), compared to the ISO SPE rates as described in ISO 11979-7 
• 
Visual disturbances using the QoV questionnaire and QoV Supplemental Questions at Month 12 
(Visit 5) 
Descriptive statistics and analyses of secondary safety variables will be based on first operative eyes and 
repeated as supportive analyses using second operative eyes as well as all operative eyes. 
Cumulative and persistent adverse events from ISO 11979-7 Table E.2 will be summarized using 
descriptive statistics by AE type and treatment and will be compared to the maximum number of cases 
allowed before the ISO SPE rate is exceeded. 
Visual disturbances will be assessed by the QoV questionnaire with supplemental questions at Month 12 
(Visit 5). Total QoV subscale scores (frequency, severity, bothersomeness) will be summarized using 
continuous summary statistics by treatment group. The frequencies and proportions of subjects for each 
response category for each question from the QoV Supplemental Questions will be presented by 
treatment group. 
As additional categorical analyses of the QoV questionnaire, the frequencies and proportions of subjects 
for each response category of frequency, severity, or bothersomeness (separately) at Month 12 (Visit 5) 
will be presented for each item by treatment group. Subjects’ satisfaction with the IOL at Month 12 
(Visit 5) will also be summarized by treatment group. 
 
Adverse Events 
Analyses of adverse events will be performed separately for first operative eyes, second operative eyes, 
and all operative eyes. 
The incidence of operative eyes with at least one serious adverse event will be summarized using 
categorical summary statistics by treatment received.      

 
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Cumulative and persistent adverse events from ISO 11979-7 Table E.2 will be summarized using 
descriptive statistics by AE type and treatment and will be compared to the maximum number of cases 
allowed before the ISO SPE rate is exceeded. Additionally, cumulative and persistent adverse events will 
be summarized separately by age group (< 65 years vs. ≥ 65 years) and by investigator. 
The incidence of adverse events based on consensus definitions as set forth by the American Academy 
of Ophthalmology’s Task Force (Masket et al. Ophthalmology 2017) will be summarized by treatment 
group. 
All types of adverse events will be reported and compared between arms using descriptive statistics.  
Separate analyses will be done for device-related events and events that are of moderate to severe 
severity.  All adverse events reported will be summarized and listed by subject. 
Adverse events will also be summarized for all ocular AEs and for all SAEs. All ocular AEs will also be 
summarized by maximal severity, for AEs related to the study lens, and by study day of onset. 
In addition, the following summaries will be provided: 
• 
Ocular AEs by relationship to study device/procedure as well as unrelated Ocular and Non-
ocular AEs 
• 
Ocular Serious AEs by relationship to study device/procedure as well as unrelated Ocular and 
Non-ocular Serious AEs 
• 
Ocular AEs by maximal severity 
• 
Ocular AEs by age group (< 65 years vs. ≥ 65 years) 
• 
Ocular AEs by investigator 
Other Safety Endpoints 
YAG capsulotomy procedures (number and rate) will be summarized by descriptive statistics for each IOL 
group.   
Other safety endpoints will be summarized descriptively by visit, including but not limited to IOP, slit 
lamp examination results, dilated fundus exam results, and PCO results. Changes or shifts from baseline 
will also be summarized where appropriate. In addition, the proportion of eyes with any worsening in 
BCDVA during the study of 10 letters or more (from a postoperative visit to any later postoperative visit) 
will be summarized. Reasons for VA worsening by 10 letters or more will be summarized. For 
assessments performed by eye, first operative eye and second operative eye will be summarized 
separately. 
 
9.4.7 POOLABILITY ANALYSIS 
Consistency of treatment effectiveness for primary and alpha adjusted secondary endpoints across sites 
will be evaluated through summaries by site and treatment.  Additionally, a linear model will be fit with 
explanatory variables: site, treatment, and the site by treatment interaction, including sites with 6 or 
more subjects. Sites with fewer than 6 subjects will not be arbitrarily pooled into a single larger site to 

 
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be included in this model.  If the site by treatment interaction is significant at a 2-sided alpha = 0.15, the 
cause of the significant interaction will be evaluated and presented.  
Consistency of treatment safety across sites will be evaluated through summaries by site and treatment 
of frequency and proportion of subjects with SSI’s related to the optical properties of the IOL and the 
cumulative and persistent adverse events in first operative eyes through Month 12 (Visit 5) as described 
in ISO 11979-7, ratings for each response category for each item from the QoV Supplemental Questions 
at Month 12 (Visit 5), as well as continuous descriptive statistics summarizing distance contrast 
sensitivity for each test condition at Month 12 (Visit 5) and total QoV subscale scores at Month 12 (Visit 
5) by site and treatment.  
 
9.4.8 BASELINE DESCRIPTIVE STATISTICS 
Demographic variables collected in this study, including age, sex, race, and ethnicity, and baseline 
characteristics, including mesopic and photopic pupil size, target refraction, and keratometric cylinder 
for first operative eyes, will be summarized using descriptive statistics for the All-implanted Analysis Set 
by treatment group.  
 
9.4.9 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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9.4.10 SUB-GROUP ANALYSES 
Summary statistics for primary and secondary effectiveness endpoints, as well as primary safety 
endpoints, will be presented by postoperative photopic pupil size (≤ 4mm; > 4mm). 
 
9.4.11 ADDITIONAL EFFECTIVENESS ANALYSES 
All additional effectiveness analyses will be based on the All-implanted Analysis Set population unless 
otherwise stated. 
The visual acuity exploratory endpoints are as follows: 
• 
Photopic monocular logMAR BCDVA, 
, DCIVA (66 cm), and DCNVA in first operative 
eyes at Month 6 (Visit 4) and Month 12 (Visit 5) 
• 
Mesopic monocular logMAR 
, DCIVA (66 cm), and DCNVA in first operative eyes at 
Month 6 (Visit 4) and Month 12 (Visit 5) 
• 
Photopic binocular logMAR BCDVA, 
, DCIVA (66 cm), and DCNVA at Month 6 
(Visit 4) and Month 12 (Visit 5) 
• 
Mesopic binocular logMAR 
, DCIVA (66 cm), and DCNVA at Month 6 (Visit 4) and 
Month 12 (Visit 5) 
• 
Photopic monocular logMAR UCDVA, 
, UCIVA (66 cm), and UCNVA in first 
operative eyes at Month 6 (Visit 4) and Month 12 (Visit 5) 
• 
Photopic binocular logMAR UCDVA, 
, UCIVA (66 cm), and UCNVA at Month 6 
(Visit 4) and Month 12 (Visit 5) 
• 
Photopic monocular logMAR 
 and BCNVA in first operative eyes at Month 6 
(Visit 4) and Month 12 (Visit 5) 
• 
Photopic binocular logMAR 
 and BCNVA at Month 6 (Visit 4) and Month 12 
(Visit 5) 
 
A visual acuity variable will be summarized categorically by logMAR level by presenting the sample size, 
frequency, and percentage of subjects with logMAR visual acuity within the following visual acuity 
ranges: 
• 
0.00 logMAR or better 
• 
0.10 logMAR or better 
• 
0.20 logMAR or better 
• 
0.30 logMAR or better 
• 
Worse than 0.30 logMAR 
A visual acuity variable will be summarized categorically by Snellen level by presenting the sample size, 
frequency, and percentage of subjects with Snellen visual acuity within the following visual acuity 
ranges: 

 
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• 
20/20-2 or better: ≤ 0.04 logMAR 
• 
20/25-2 or better: ≤ 0.14 logMAR 
• 
20/32-2 or better: ≤ 0.24 logMAR 
• 
20/40-2 or better: ≤ 0.34 logMAR 
• 
Worse than 20/40-2: > 0.34 logMAR 
The visual acuity exploratory endpoints will be summarized categorically by logMAR level and Snellen 
level by treatment group and will also be summarized by treatment group using continuous descriptive 
statistics. 
Additionally, photopic monocular logMAR BCDVA, DCIVA (66 cm), and DCNVA in first operative eyes at 
Month 12 (Visit 5) will be analyzed by repeating the primary and secondary effectiveness analyses at 
Month 12 (Visit 5). 
The sample size, frequency, and percentage of subjects achieving logMAR visual acuity thresholds at all 
distances for photopic binocular logMAR UCDVA, UCIVA (66 cm), and UCNVA at Month 6 (Visit 4) and 
Month 12 (Visit 5) will be presented by treatment group. Similar analyses will also be performed using 
Snellen visual acuity thresholds. 
 
 
 Monocular and binocular defocus curves from Month 6 
(Visit 4) based on the Best Case Set will be summarized utilizing continuous descriptive statistics by 
treatment group. Defocus curve summaries by treatment group will also be presented for each of the 
following postoperative photopic pupil size groups: 
• 
Small (≤ 2.5mm) 
• 
Medium (> 2.5mm and < 4mm) 
• 
Large (≥ 4mm) 
The defocus curve means will be plotted for each treatment group and pupil size group, when 
applicable, with error bars representing one standard deviation. The defocus curve analyses above will 
be repeated at Month 12 (Visit 5) as additional analyses. 
Spectacle independence as measured by the Patient-Reported Spectacle Independence Questionnaire 
(PRSIQ) at Month 6 (Visit 4) will be summarized using frequencies and percentages for each response 
category for each item and viewing distance by treatment group. 

 
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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
 
The study ICF has been developed in compliance with 21 CFR Part 50.25.  Study ICFs and any other 
subject-facing materials (e.g., recruitment materials, subject instruction sheets, etc.) must be submitted 
to and approved by the IRB prior to implementation.  Any IRB-requested modifications to the consent 
form must remain in compliance with 21 CFR Part 50.25.  Each participant must be provided with a copy 
of the IRB-approved ICF for their review, and the participants’ written approval must be provided prior 
to initiation of study procedures.   
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
The investigator or designee will explain the study purpose, procedures and responsibilities to the 
potential participant and provide sufficient opportunity to ask questions, while allowing adequate time 
for consideration of the information provided.  Documentation of written consent for study 
participation must be present prior to initiation of any study-specific procedure, and subjects will be 
considered enrolled in the study upon their signature on the ICF.   
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
The Sponsor reserves the right terminate the study at any time. If the clinical study is prematurely 
terminated or suspended, the Sponsor will inform the Investigators and the regulatory authorities and 
the reason for the termination/suspension.  The Investigator should promptly notify the IRB of the 
termination or suspension and of the reasons.  If the Sponsor terminates the study for safety reasons, it 
will promptly notify the Investigators and provide written instruction for study termination and 
applicable subject follow-up. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of insufficient effectiveness that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
If the study is suspended, it may resume once concerns about safety, protocol compliance, and data 
quality are addressed, and satisfy the Sponsor, IRB and/or Food and Drug Administration (FDA). 

 
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If, in the opinion of the investigator, the clinical observations in the study suggest that it may be unwise 
to continue, the investigator may terminate the study at his or her site after consultation with the 
Sponsor. A written statement fully documenting the reasons for such a termination will be provided to 
the Sponsor.  
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
The investigator will maintain the confidentiality of the identity of subjects enrolled in the study and the 
information contained in the study records.  The records will be made available as required for review 
by FDA and other governing regulatory authorities, as well as reviewing IRBs; however, to the extent 
possible, the subject’s identity will not be disclosed. 
 
 
 
10.1.4 DOCUMENT RETENTION 
Source documents may include a subject’s medical records, hospital charts, clinic charts, the 
investigator’s study subject files, as well as the results of diagnostic tests such as X-rays, laboratory tests, 
and electrocardiograms. The investigator’s copy of the Case Report Forms serves as the investigator’s 
record of a subject’s study-related data. 
All study related correspondence, patient records, consent forms, record of the use of the study device 
and copies of case report forms will be maintained on file for at least two years after the last approval of 
a marketing application and until there are no pending or contemplated marketing applications; or until 
at least two years have elapsed since the formal discontinuation of clinical development of the 
investigational device. These documents will be retained for a longer period if required by the applicable 
regulatory requirements or by an agreement with the Sponsor. It is the responsibility of the Sponsor to 
inform the investigator/institution as to when these documents no longer need to be retained or should 
be forwarded to the Sponsor. 
If the responsible investigator retires, relocates, or for other reasons withdraws from the responsibility 
of keeping study records, custody must be transferred to a person who will accept the responsibility. 
The Sponsor must be notified in writing of the name and address of the new custodian.  
 

 
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10.1.5 MEDICAL MONITOR 
 
 
  
 
 
 
 
 
10.1.6 INSTITUTIONAL REVIEW BOARD APPROVAL 
Before enrollment of study subjects, this protocol must be reviewed and approved by an IRB operating 
in accordance with 21 CFR Part 50 and all applicable local regulations.  Any changes to the study 
protocol or consent forms must be approved by the IRB prior to implementation.  Materials for study 
patient recruitment and study-specific written materials provided to the subject must also be approved 
by the IRB prior to use.   
Ongoing study progress reports will be submitted to the IRB at least annually, and more frequently if 
specified by the IRB.  Reports of safety events and any protocol deviations that affect the safety and 
welfare of a study subject will be submitted to the IRB in accordance with United States Food and Drug 
Administration (FDA) and IRB requirements. 
  
10.1.7 CLINICAL MONITORING 
During the study, the Sponsor or designee will perform periodic monitoring visits to study sites. During 
these visits, information recorded on the study eCRFs will be verified against source documents to 
confirm data capture completeness, accuracy and logical consistency.  Study documents will be 
reviewed to confirm protocol compliance and adherence to IRB and Sponsor-specified reporting 
requirements, and product accountability will be checked.   
 
10.1.8 COMPLIANCE WITH PROTOCOL 
The Investigator is responsible for complying with the requirements of the study protocol and any 
amendment or clarification as published by the Sponsor, or Sponsor designee.  Subject evaluations will 
be performed as described in the study protocol.  All information generated by the subject evaluation 
will be recorded using eCRFs with access provided by the Sponsor or Sponsor designee.  If applicable, 
original laboratory reports will be retained by the Investigator, but as the results become available, they 
will be entered on appropriate eCRFs.   

 
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Investigator(s) will not deviate from the study protocol without prior approval of the Sponsor, or 
Sponsor designee, unless the protection of health, safety or welfare of study subjects requires prompt 
action. 
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
Procedures for the handling and analysis of data will be conducted using good computing practices 
meeting International Conference on Harmonization (ICH) and FDA guidelines and all applicable local 
regulations for the handling and analysis of data for clinical trials. 
Data Quality Control and Reporting 
After data have been entered into the study database, a system of computerized data validation checks 
will be applied and queries pertaining to data omissions and discrepancies will be directed to study sites 
for resolution within the study database. Study staff will update the database as appropriate to resolve 
queries generated.  All changes to the study database will be documented. 
Data Archiving 
Archived versions of the database will be saved by the Sponsor or designee consistent with ICH GCP 
Guidelines, complying with whichever of the requirements is longer. The Sponsor will notify the 
investigator when documents should be returned. 
Records Retention 
The Investigator’s site will retain all records related to the study in compliance with ICH GCP Guidelines. 
Protocol Amendments 
Modifications to the approved protocol are only possible using approved protocol amendments and 
with the agreement of all responsible persons. The procedure for approval of a protocol amendment is 
identical to that for approval of the protocol. The IRB must review and approve any protocol 
amendments prior to their implementation at each study site. 
 
The Investigator may not implement any deviation from or change to the protocol, without 
discussion with, and agreement by the Sponsor and prior review and documented 
approval/favorable opinion of the amendment from the relevant IRB, except where it is necessary to 
eliminate an immediate hazard to study subjects, or where the change(s) involves only logistical or 
administrative aspects of the study (e.g., change in monitor(s), change of telephone number(s)). 
Protocol amendments will be submitted to the appropriate authority(ies) as required by the 
applicable regulatory requirement(s). 
 

 
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10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
Investigator. The Investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
Data recorded in the electronic case report form (eCRF) should be consistent with the data recorded on 
the source documents.  
Clinical data (including the measures as presented in Section 1.3 Schedule of Activities) will be entered 
into a 21 CFR Part 11-compliant data capture system that includes password protection and internal 
quality checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, or 
inaccurate.  Clinical data will be entered directly from the source documents. 
 
10.1.10 
PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol requirements or International 
Conference on Harmonisation Good Clinical Practice (ICH GCP).  
Per ICH E3, Structure and Content of Clinical Study Reports and ICH E3, Questions and Answers (R1), 
major protocol deviations are those that might significantly affect the completeness, accuracy, and/or 
reliability of study data or that might significantly affect a subject's rights, safety or well-being.  For 
example, major protocol deviations might include enrolling subjects in violation of key eligibility criteria 
designed to ensure a specific subject population, or failing to collect data necessary to interpret primary 
endpoints that may compromise the scientific value of the trial. 
The site investigator is responsible for knowing and adhering to the reviewing IRB requirements 
regarding reporting of protocol deviations. Further details about the handling of protocol deviations will 
be included in the Statistical Analysis Plan.  
 
10.1.11 
PUBLICATION AND DATA SHARING POLICY 
Any information other than that disclosed upon registration should not be discussed with persons 
outside the study. The protocol, study data, and information related to the study or to BVI’s products or 
research programs that is provided by BVI (Confidential Information) is to be kept confidential, and not 
disclosed directly or indirectly to any third party other than those involved in the study with a need to 
know.  
All data and discoveries arising out of the study, patentable or non-patentable, shall be the sole 
property of BVI.  BVI reserves the right of prior review of any publication or presentation of information 

 
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related to the study. BVI may use these data now and in the future for presentation or publication at 
BVI’s discretion or for submission to government regulatory agencies.  
 
10.2 
 
 
 
11 REFERENCES  
ANSI Z80.12: 2007 (R2017) American National Standard for Ophthalmics - Multifocal Intraocular Lenses 
 
ISO 11979-7: 2014 Ophthalmic implants – intraocular lenses – part 7:  clinical investigations  
ISO 11979-9: 2014 Ophthalmic implants – intraocular lenses – part 9:  multifocal intraocular lenses 
Masket S, Rorer E, Stark W, Holladay J, MacRae S, Tarver M, Glasser A, Calogero D, Hilmantel G, Nguyen 
T, Eydelman M. Special Report:  The American Academy of Ophthalmology Task Force Consensus 
Statement on Adverse Events with Intraocular Lenses.  Ophthalmology, Vol 124, No 1, 2017; 124 (1):  
142-144. 
 
 

 
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12 APPENDIX A: 
 
Protocol Title:  
Clinical Investigation of the Safety and Effectiveness of FINEVISION HP Trifocal IOL 
Study number: 
PHY1903 
Protocol Date:  
 
This clinical study protocol was subject to critical review and has been approved by the Sponsor. The following 
personnel contributed to writing and/or approving this protocol.