Clinical Investigation of the Safety and Effectiveness of Monofocal PODEYE TORIC Intraocular Lens (IOL)
Conditions: Eye Diseases, Postcataract Aphakia, Cataract, Lens Opacities, Astigmatism
Sponsor: Beaver-Visitec International, Inc.

 
Clinical Investigation of the Safety and Effectiveness of Monofocal 
PODEYE TORIC Intraocular Lens (IOL) 
 
Protocol Number:  PHY2302 
IDE Sponsor: Beaver-Visitec International, Inc 
Version Number:  v.2.0 
 
03 May 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 

Clinical Trial Protocol: PHY2302 
Version 1.0 
  
 
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Summary of changes 
Document 
Affected Sections(s) 
Summary of Revisions made 
Version 1.1 
Original 
- 
Version 2.0 
8.7.7 Anticipated Adverse 
Events 
Added- “Best-corrected 
distance visual acuity loss of 2 
lines (10 letters) or more since 
the prior visit” to the list of 
Postoperative Adverse Events. 
 
 
 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 5 
1 
PROTOCOL SUMMARY ............................................................................................................................... 5 
1.2 
Schema ................................................................................................................................................. 9 
1.3 
Schedule of Activities (SoA) ............................................................................................................. 10 
1.4 
Abbreviations ...................................................................................................................................... 11 
2 
INTRODUCTION .......................................................................................................................................... 12 
2.1 
Study Rationale .................................................................................................................................. 12 
2.2 
Background......................................................................................................................................... 12 
2.3 
Risk/Benefit Assessment .................................................................................................................. 12 
2.3.1 
Known Potential Risks ................................................................................................... 12 
2.3.2 
Potential Benefits ........................................................................................................... 13 
2.3.3 
Assessment of Potential Risks and Benefits .............................................................. 13 
3 
OBJECTIVES AND endpoints .................................................................................................................... 13 
3.1 
Primary Objectives ............................................................................................................................ 13 
4 
STUDY DESIGN ........................................................................................................................................... 14 
4.1 
Overall Design .................................................................................................................................... 14 
4.2 
Scientific Rationale for Study Design.............................................................................................. 15 
4.3 
End of Study Definition ..................................................................................................................... 15 
5 
STUDY POPULATION ................................................................................................................................ 15 
5.1 
Inclusion Criteria ................................................................................................................................ 15 
5.2 
Exclusion Criteria ............................................................................................................................... 16 
5.3 
Reasons Not to Implant a Study IOL .............................................................................................. 17 
5.4 
Screen Failures .................................................................................................................................. 18 

 
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5.5 
Strategies for Recruitment and Retention ...................................................................................... 18 
6 
STUDY INTERVENTION ............................................................................................................................ 18 
6.1 
Study Devices .................................................................................................................................... 18 
6.1.1 
Investigational Device Description............................................................................... 18 
6.1.2 
Control Device Description ........................................................................................... 20 
6.2 
Device Accountability and Storage ................................................................................................. 20 
6.2.1 
Acquisition and Accountability ...................................................................................... 20 
6.2.2 
Packaging and Labeling ................................................................................................ 20 
6.2.3 
Product Storage and Stability ....................................................................................... 21 
6.3 
Measures to Minimize Bias: Randomization and Masking .......................................................... 21 
7 
PARTICIPANT DISCONTINUATION/ WITHDRAWAL ........................................................................... 21 
7.1 
Participant Discontinuation/ Withdrawal from the Study .............................................................. 21 
7.2 
Lost to Follow-Up ............................................................................................................................... 22 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 22 
8.1 
Preoperative Visit (Day -90 to Day -1) ............................................................................................ 22 
8.2 
Operative Visit (Day 0):  Form 0 ...................................................................................................... 24 
8.3 
Postoperative Visits:  Form 1 through Form 4 ............................................................................... 24 
8.4 
Unscheduled Visits ............................................................................................................................ 25 
8.5 
Concomitant Medication ................................................................................................................... 26 
8.6 
Secondary Surgical Intervention (SSI) ........................................................................................... 26 
8.6.1 
IOL Exchange ................................................................................................................. 27 
8.6.2 
IOL Repositioning ........................................................................................................... 27 
8.6.3 
IOL Explantation and Replacement ............................................................................. 27 
8.7 
Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and Device 
Deficiencies ............................................................................................................................................................ 27 
8.7.1 
Definition of Adverse Events ........................................................................................ 27 
8.7.2 
Definition of Serious Adverse Events .......................................................................... 27 
8.7.3 
Definition of adverse device effects and unanticipated adverse device effects .... 28 
8.7.4 
Classification of an Adverse Event .............................................................................. 29 
8.7.5 
Adverse Event Reporting .............................................................................................. 29 
8.7.6 
Expedited Adverse Event Reporting ........................................................................... 30 
8.7.7 
Anticipated Adverse Events .......................................................................................... 30 
8.7.8 
Device Deficiencies ....................................................................................................... 32 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 33 
9.1 
General ................................................................................................................................................ 33 
9.2 
Analysis Populations ......................................................................................................................... 33 
9.3 
Analysis Subsets ............................................................................................................................... 34 
9.4 
Hypotheses ......................................................................................................................................... 34 
9.5 
Power and Sample size .................................................................................................................... 36 
9.6 
Multiplicity ........................................................................................................................................... 36 
9.7 
Missing data and Imputation ............................................................................................................ 36 
9.8 
Statistical testing of Effectiveness endpoints................................................................................. 37 
9.9 
Statistical testing of safety endpoints.............................................................................................. 37 
9.10 
Poolability ............................................................................................................................................ 38 
9.11 
Additional Endpoints and Associated Analyses ............................................................................ 38 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 39 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 39 

 
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10.1.1 
Informed Consent Process ........................................................................................... 39 
10.1.2 
Study Discontinuation and Closure ............................................................................. 40 
10.1.3 
Confidentiality and Privacy ........................................................................................... 40 
10.1.4 
Document Retention ...................................................................................................... 40 
10.1.5 
Medical Monitor .............................................................................................................. 41 
10.1.6 
Institutional Review Board Approval ........................................................................... 41 
10.1.7 
Clinical Monitoring .......................................................................................................... 41 
10.1.8 
Compliance with Protocol ............................................................................................. 41 
10.1.9 
Data Handling and Record Keeping ............................................................................ 42 
10.1.10 
Protocol Deviations ........................................................................................................ 43 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 43 
10.2 
Protocol Amendment History ........................................................................................................... 43 
11 
REFERENCES ............................................................................................................................................. 44 
12 
Appendix A: Sponsor And TrueNorth Approvals ..................................................................................... 44 
 

 
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STATEMENT 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 Monofocal 
PODEYE TORIC Intraocular Lens (IOL) 
 
Study Description 
This study is a prospective, multicenter, randomized, double masked trial 
comparing an investigational Monofocal Toric intraocular lens (IOL) 
(PODEYE TORIC CYL 1.5 D) and a commercially available non-toric 
monofocal IOL (Alcon AcrySof SA60AT). 
Study Objective 
The purpose of this clinical trial is to evaluate the safety and effectiveness 
of Monofocal PODEYE TORIC Intraocular Lens (IOL) 
 
Endpoints 
Co-Primary Effectiveness Endpoints  
1. Residual manifest cylinder (both IOL arms) at Form 4. 
2. IOL axis misalignment < 10° from intended IOL axis of orientation 
(toric IOL arm only) at Form 4 (4-6 Months postoperative).  
3. IOL axis misalignment < 20° from intended IOL axis of orientation 
(toric IOL arm only) at Form 4.  
4. Stability of the toric IOL axis orientation (toric IOL arm only) from 
Form 3 to Form 4 of ≤ 5° change in orientation. 
Co-Primary Effectiveness Endpoint Targets 
1. Statistically significant smaller residual manifest cylinder in toric 
arm than in control arm. 
2. 90% of eyes at target. 
3. 95% of eyes at target. 
4. 90% of eyes at target per the ANSI Z80.30 rotation criteria. 
Co-Primary Safety Endpoints 
 
1. Cumulative rate of secondary surgical interventions (SSIs) related 
to the optical properties of the IOL at Form 4, including IOL 
rotation SSIs for misalignment. 
2. Rates of cumulative and persistent AEs at Form 4 via comparison 
to the ISO Safety and Performance Endpoint (SPE) rates as 
described in ISO 11979-7.  
3. BCDVA logMAR of 0.3 or better is not less than ISO 11979-
7:2018 tables E.3 and E4 (toric IOL arm only) at Form 4.  

 
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Statistical Analysis and 
Sample Size Calculation 
Hypothesis tests for co-primary effectiveness endpoints 1 through 4 
must reject their associated null hypotheses in order to claim the 
effectiveness of the PODEYE TORIC IOL.  No multiplicity adjustment 
of the significance level (i.e., Type I error probability) is performed. 
Co-primary endpoint 1, the superiority of the toric lens to reduce 
residual astigmatism, will be tested using a Wilcoxon rank-sum test 
with a one-sided p-value of 0.025. 
Binary co-primary endpoints 2-4 will be tested using a Clopper-
Pearson 95% boundary of the confidence interval (i.e., the upper one-
sided 5%), as described for testing if rate threshold is met per SPE 
(ISO-11979-7) and ANSI Z80.30 criteria. 
Based on individual power calculations for each co-primary endpoints 
1 through 4, up to 300 eyes enrolled, with 230 eyes randomized to the 
two IOL groups using a randomization ratio of 1:1 is sufficient for the 
four hypotheses associated with co-primary endpoints to reject their 
respective null hypotheses. 
 
Study Population 
The subject population will consist of subjects with cataract and pre-
existing corneal astigmatism in at least one eye with no other ocular 
comorbidity and planned for routine cataract surgery.   
Phase 
Pivotal 
 
Description of 
Sites/Facilities Enrolling 
Participants 
Subjects will be enrolled at up to approximately 10 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 unilaterally via 
routine small incision cataract surgery. Subject eyes in the test arm will 
be implanted with an investigational Toric Monofocal IOL with 
toricity of 1.5 D (in the IOL plane), while the eyes in the control arm 
will be implanted with a commercially available monofocal non-toric 
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 20 months based on 
an estimated enrollment period of 8 months, subject participation 
period of 9 months (calculated as the maximum difference between the 
time of the Preoperative Visit to completion of Form 4), and 3 months 
for study close-out, database-lock and Investigative report. 

 
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Participant Duration 
It is estimated that the duration of each subject’s participation in the 
study will be approximately 9 months (calculated as the difference 
between the time of the Preoperative Visit to completion of Form 4). 
Inclusion Criteria 
• 
Male or female adults, age 22 years or older at the Preoperative 
Visit.  
• 
Clinically significant cataract in the study eye eligible for standard 
phacoemulsification cataract surgery.    
• 
Eligible for receipt of an IOL power within the range of the 
investigational IOL in the study eye. (The Investigational IOL is 
available in powers from +15 D to +30 D Spherical Equivalent) 
• 
Pre-operative corneal astigmatism in the range: ≥0.75 D and ≤1.50 
D in the study eye 
• 
Anticipated residual astigmatism of ≤0.3 D in the study eye as 
determined by the Toric Calculator. 
• 
Clear intraocular media other than cataract in the study eye. 
• 
Best corrected visual acuity equal to or worse than 0.3 logMAR, 
with or without a glare source in the study eye. 
• 
Ability to dilate pupil sufficiently (greater than or equal to 6.0 mm) 
to allow visualization of Toric IOL axis markings post-
implantation in the study eye. 
• 
Projected BCDVA of 0.2 logMAR (20/32 Snellen) or better in the 
study eye after cataract surgery/IOL implantation, as determined 
by the medical judgment of the Investigator. 
• 
Contact lens users must be willing to discontinue wear of their 
lenses in the study eye in accordance with the following 
requirements:  
• 
Rigid gas permeable and toric lenses for ≥ 7 days 
prior to the Preoperative Visit  
• 
Soft non-toric contact lenses for ≥ 3 days prior to 
the Preoperative Visit 
• 
All contact lens wearers must demonstrate a stable 
refraction within ± 0.50 D MRSE and 15 degrees 
astigmatic axis, on two consecutive examinations 
at least 1 week apart in an eye to be treated.  
• 
Provide signed written consent prior to participation in any study-
related procedures.  
• 
Ability, comprehension, and willingness to follow study 
instructions, and to complete all study visits.  
• 
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. 

 
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Exclusion criteria 
• 
Subjects with irregular corneal astigmatism in the study eye (Note: 
corneal incisions intended to reduce astigmatism are not permitted)  
• 
Subjects with clinically significant corneal pathology potentially 
affecting corneal topography in the study eye. 
• 
Subjects with a traumatic cataract in the study eye. 
• 
Subjects with uncontrolled glaucoma in the study eye. 
• 
Subjects with diagnosed degenerative visual disorders (e.g., 
macular degeneration or other retinal disorders) that are predicted 
to cause future acuity losses to a level of 0.2 logMAR or worse in 
the study eye. 
• 
Subjects with conditions associated with increased risk of zonular 
rupture during the cataract extraction procedure which may affect 
the postoperative centration or tilt of the lens in the study eye. 
• 
Significant anterior segment pathology that might increase 
intraoperative 
risk 
or 
compromise 
IOL 
stability 
(e.g., 
pseudoexfoliation syndrome) in the study eye. 
• 
Reasonably expected to require secondary ocular surgical 
intervention or laser treatment other than YAG capsulotomy in 
study eye during the study participation period.  
• 
Presence of one or more clinically significant corneal 
abnormalities in study eye, including corneal dystrophy, 
irregularity, or edema. 
• 
Previous intraocular, corneal, or retinal detachment surgery, 
including corneal transplant, LASIK, astigmatic keratotomy and 
limbal relaxing incisions in the study eye. 
• 
Clinically significant ocular inflammation or infection present ≤ 30 
days in either eye prior to the Preoperative Visit. 
• 
Subjects with potential BCDVA of 20/200 or worse in the fellow 
eye.  
• 
Subjects with a difference of greater than 0.50 D of corneal 
astigmatism as measured with the IOL master/Lenstar/Argos and 
the topographer in the study eye using vector analysis. 
• 
Presence or history of one or more severe/serious ocular conditions 
(e.g., glaucoma, uveitis, ocular infection, severe dry eye) in the 
study 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. 
• 
Use of medications known to interfere with visual performance, 
pupil dilation, or iris structure ≤ 30 days prior to the Preoperative 
Visit.  
• 
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.  
• 
Pregnant or nursing females.  

 
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1.2 
SCHEMA  
 
 
 
 

 
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1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
Examination 
Pre-
operative/Screening 
Visit 
Form 
0 
Form 1 
Form 2 
Form 3 
Form 4 
USV1 
Informed Consent and 
HIPAA 
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Inclusion & Exclusion 
Criteria Evaluation 
X 
 
 
 
 
 
 
Inclusion & Exclusion 
Criteria Review 
 
X 
 
 
 
 
 
Ocular and non-ocular 
Medical History 
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 
PhysIOL Toric Calculator 
X 
 
 
 
 
 
 
Corneal Topography 
X 
 
 
 
 
 
 
Manifest Refraction 
(ETDRS)-4 meters 
X 
 
 
X 
X 
X 
X 
Randomization 
X 
 
 
 
 
 
 
Operative Procedures 
 
X 
 
 
 
 
 
Intraocular Pressure 
X 
 
X 
X 
X 
X 
X 
Slit Lamp Examination 
X 
 
X 
X 
X 
X 
X 
IOL Tilt and Decentration 
Grading 
 
 
X 
X 
X 
X 
X 
IOL Axis Orientation 2 
 
X 
X 
X 
X 
X 
X 
Dilated pupil size 
X 
 
 
 
 
 
 
Dilated Fundus Examination 
X 
 
 
 
X 
X 
X 
IOL Observations 
 
 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
Device Deficiencies 
 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
Exit from Study 
 
 
 
 
 
X 
 
Visual 
Acuity 
UCDVA 
X 
 
X 
X 
X 
X 
X 
BCDVA 
X 
 
 
X 
X 
X 
X 
1USV- Unscheduled Visit; specific assessments to be completed may be determined by the investigator as appropriate based on the subject’s 
condition. Recommended assessments for Investigator consideration are denoted in the table. 
2Subjects must be dilated for IOL axis of orientation assessment. 

 
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1.4 
ABBREVIATIONS 
 
ADE 
Adverse device effect 
AE 
Adverse event 
ANSI 
American National Standards Institute 
BCDVA 
Best corrected distance visual acuity 
CFR 
Code of Federal Regulations 
CME 
Cystoid macular edema 
CRF 
Case report form 
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 
ITT 
Intent to Treat 
logMAR 
Logarithm of the Minimum Angle of Resolution 
MOP 
Manual of procedures 
OCT 
Optical coherence tomography 
PCO 
Posterior capsule opacification 
PP 
Per Protocol 
RD 
Retinal detachment 
SA 
Spherical Aberration 
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 
UCDVA 
Uncorrected distance 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 PODEYE TORIC IOL. 
2.2 
BACKGROUND 
Cataract is 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. Some of 
the cataract patients may have pre-existing corneal astigmatism which contributes to blurred vision. 
Monofocal non-toric IOLs provide adequate distance vision but do not address astigmatism which can 
adversely affect the quality of vision. The PODEYE TORIC IOL is designed to optically correct corneal 
astigmatism and restore distance vision after cataract surgery. 
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 contraction syndrome (ACCS) (phimosis) 
4. Corneal edema 
5. Corneal endothelial damage 
6. Cystoid macular edema (CME) 
7. Secondary surgical intervention (including, but 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 
18. Iris or pupil damage 
19. Posterior capsular rupture 
20. Vitreous loss 
21. Wound leak (positive Seidel) 

 
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In addition to these risks associated with cataract surgery and IOLs in general, misalignment of the axis of 
toric IOLs may compromise its astigmatic correction. Such misalignment can result from inaccurate 
keratometry or marking of the cornea, inaccurate placement of the toric IOL axis during surgery, an 
unanticipated surgically induced change in the cornea, or physical rotation of the toric IOL after 
implantation. 
2.3.2 POTENTIAL BENEFITS  
The possible benefits associated with this study are: 
• 
Improvement in visual acuity  
• 
Astigmatism reduction 
• 
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 
vision outweigh the risks of cataract surgery and implantation of a Toric IOL. 
3 
OBJECTIVES AND ENDPOINTS 
3.1 
PRIMARY OBJECTIVES 
The objectives are based on ANSI Z80.30 (2018) and ISO 11979-7 (2018). 
Co-Primary Effectiveness Endpoints  
1. Residual manifest cylinder (both IOL arms) at Form 4, as measured by the mean. 
2. IOL axis misalignment < 10° from the intended IOL axis of orientation (toric IOL arm only) at   Form 
4 (4-6 Months postoperative). 
3. IOL axis misalignment < 20° from the intended IOL axis of orientation (toric IOL arm only) at Form 
4 (4-6 Months postoperative). 
4. Stability of the toric IOL axis orientation (toric IOL arm only) from Form 3 to Form 4 of ≤ 5° change 
in orientation. 
With performance goals of: 
1. Statistically significant smaller residual manifest cylinder, of 0.4D or greater, in toric arm than in 
control arm. 
2. 90% of eyes at target  
3. 95% of eyes at target  
4. 90% of eyes at target  
Co-primary Safety Endpoints 
1. Characterize the cumulative rate of SSIs related to the optical properties of the IOL at Form 4, 
including IOL rotation SSIs for misalignment. 
2. Rates of cumulative and persistent AEs at Form 4 via comparison to the ISO Safety and 
Performance Endpoint (SPE) rates as described in ISO 11979-7. 
3. BCVA logMAR of 0.3 or better at Form 4 for all-implanted and best-case test eyes. 

 
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Additional Safety endpoints 
The incidence of all adverse events other than those listed in ISO 11979-7 (2018) tables E.3 and E.4. 
 
4 
STUDY DESIGN  
4.1 
OVERALL DESIGN 
This study is a prospective, multicenter, randomized, active controlled, double masked pivotal study to 
demonstrate the effectiveness and safety of a monofocal toric IOL, PODEYE TORIC. The control IOL 
will be a commercially available monofocal non-toric IOL, AcrySof SA60AT (Alcon). The study will 
include adult subjects with operable cataract in at least one eye along with pre-existing corneal 
astigmatism 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, 
except that assessments which are part of the Investigator’s routine standard of care for cataract patients 
may be performed prior to obtaining informed consent. Only one eye per patient will be included in the 
study. In cases where a subject has significant cataracts and plans to undergo cataract surgery in both 
eyes, it is recommended that cataract surgery is performed in one eye prior to the subject being enrolled in 
the study. Once a subject has been enrolled, it is recommended that the fellow eye does not undergo 
cataract surgery (except for a YAG capsulotomy) throughout the duration of the study. At screening, if 
both eyes qualify for the study, the eye to undergo cataract surgery and IOL implantation should be the 
eye with worse pre-operative BCDVA. If pre-operative BCDVA is the same for each eye, the right eye 
will be the study eye. Subjects who meet all protocol-specified eligibility criteria will be randomized at a 
1:1 ratio to receive either the PODEYE TORIC CYL 1.5 D IOL (test) or the AcrySof SA60AT IOL 
(control) in the study eye. Only unilateral implantation of either Test or Control IOL will be performed. 
Subjects will attend regular visits where they will undergo ophthalmic examinations over a period of 
approximately 6 months. 
No interim analysis of data is planned. 
Up to 300 subjects shall be screened and approximately 230 subjects will be randomized and implanted, 
allowing 23% Screen Failure rate. A drop-out rate of 13% is expected after the subjects have been 
implanted with the test/control IOL. 
Standard clinical trial methods will be used to minimize bias, including the use of masked vision 
assessors, masking of subjects, use of standardized test procedures, common investigator training, and 
common inclusion and exclusion criteria. 

 
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4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
The purpose of this clinical study is to compare the visual outcomes and safety of the PODEYE TORIC 
IOL to that of the AcrySof monofocal non-toric IOL Model SA60AT.  The study is designed to meet the 
requirements specified for Toric IOLs in ANSI Z80.30: 2018 standard. 
4.3 
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, IOL rotation, and safety assessments at the 6-month study visit (Form 4). 
5 
STUDY POPULATION 
The study population consists of subjects with a diagnosis of cataract with pre-existing corneal 
astigmatism, eligible for phacoemulsification surgery followed by IOL implantation.   
Subjects will be enrolled at up to 10 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 and an even distribution across all sites. 
5.1 
INCLUSION CRITERIA 
Eligible subjects must meet all the following inclusion criteria to be eligible for study participation: 
1. Male or female adults, age 22 years or older at the Preoperative Visit.  
2. Clinically significant cataract in the study eye eligible for standard phacoemulsification cataract 
surgery.    
3. Eligible for receipt of an IOL power within the range of the investigational IOL in the study eye. 
(The Investigational IOL is available in powers from +15 D to +30 D Spherical Equivalent) 
4. Pre-operative corneal astigmatism in the range: ≥0.75 D and ≤1.50 D in the study eye 
5. Anticipated residual astigmatism of ≤0.3 D in the study eye as determined by the Toric Calculator. 
6. Clear intraocular media other than cataract in the study eye. 
7. Best corrected visual acuity equal to or worse than 0.3 logMAR, with or without a glare source in 
the study eye. 
8. Ability to dilate pupil sufficiently (greater than or equal to 6.0 mm) to allow visualization of Toric 
IOL axis markings post-implantation in the study eye. 
9. Projected BCDVA of 0.2 logMAR (20/32 Snellen) or better in the study eye after cataract 
surgery/IOL implantation, as determined by the medical judgment of the Investigator. 

 
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13. 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.   
1. Subjects with irregular corneal astigmatism in the study eye (Note: corneal incisions intended to 
reduce astigmatism are not permitted)  
2. Subjects with clinically significant corneal pathology potentially affecting corneal topography in 
the study eye. 
3. Subjects with a traumatic cataract in the study eye. 
4. Subjects with uncontrolled glaucoma in the study eye. 
5. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal 
disorders) that are predicted to cause future acuity losses to a level of 0.2 logMAR or worse in the 
study eye. 
6. Subjects with conditions associated with increased risk of zonular rupture during the cataract 
extraction procedure which may affect the postoperative centration or tilt of the lens in the study 
eye. 
7. Significant anterior segment pathology that might increase intraoperative risk or compromise IOL 
stability (e.g., pseudoexfoliation syndrome) in the study eye. 
8. Reasonably expected to require secondary ocular surgical intervention or laser treatment other than 
YAG capsulotomy in study eye during the study participation period.  
9. Presence of one or more clinically significant corneal abnormalities in study eye, including corneal 
dystrophy, irregularity, or edema. 
10. Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, 
astigmatic keratotomy and limbal relaxing incisions in the study eye. 
11. Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the 
Preoperative Visit. 
12. Subjects with potential BCDVA of 20/200 or worse in the fellow eye.  
10. Contact lens users must be willing to discontinue wear of their lenses in the study eye in accordance 
with the following requirements:  
i. Rigid gas permeable and toric lenses for ≥ 7 days prior to the Preoperative Visit  
ii. Soft non-toric contact lenses for ≥ 3 days prior to the Preoperative Visit  
iii. All contact lens wearers must demonstrate a stable refraction within ± 0.50 D 
MRSE and 15 degrees astigmatic axis on two consecutive examinations at least 1 
week apart in an eye to be treated. 
11. Provide signed written consent prior to participation in any study-related procedures.  
12. Ability, comprehension, and willingness to follow study instructions, and to complete all study 
visits.  

 
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13. Subjects with a difference of greater than 0.50 D of corneal astigmatism as measured with the IOL 
master/Lenstar/Argos and the topographer in the study eye using vector analysis. 
14. Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, ocular 
infection, severe dry eye) in the study 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. 
15. Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 
30 days prior to the Preoperative Visit.  
17. Pregnant or nursing females. 
5.3 
REASONS NOT TO IMPLANT A STUDY IOL 
At the time of cataract surgery, but prior to IOL implantation there are intraoperative adverse events that 
may prevent implantation of the designated IOLs for this clinical study. These criteria include, but are not 
limited to: 
1) 
Intraoperative complications during phacoemulsification that require any other additional 
procedures or further intervention, e.g., vitrectomy. 
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 curvilinear 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 and the IOL did not touch 
the eye, the subject should be implanted with an approved non-study IOL instead and followed until 
resolution or stability of that adverse event before discontinuation from the study. Later, the subject 
should be followed under the Investigator’s normal standard of care. 
If an operative adverse event prevents implantation of the investigational IOL and the IOL touched the 
eye, the subject should be implanted with an approved non-study IOL (if applicable). The Investigator 
should follow the subject through resolution of any adverse events (AEs) and then discontinue the 
16. 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.  

 
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subject, followed under the Investigator’s normal standard of care. In this case, the subject will be 
included in the Safety population. 
5.4 
SCREEN FAILURES 
An enrolled subject who fails to meet eligibility criteria and/or discontinues from the study before the 
randomization will be considered a screen failure and exited from the study.    
A subject who has failed screening will not be allowed to be rescreened. 
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). 
• 
Schedule subject follow-up visits early in the visit window to facilitate rescheduling within the 
window, if necessary. 
• 
Follow-up on subjects who do not return for scheduled examinations. 
6 
STUDY INTERVENTION 
6.1 
STUDY DEVICES 
6.1.1 INVESTIGATIONAL DEVICE DESCRIPTION 
PODEYE TORIC IOL is a posterior chamber intraocular lens intended for primary implantation in the 
capsular bag of the eye for visual correction of aphakia after removal of a cataractous lens in adult 
patients with pre-existing corneal astigmatism. The refractive power of the lens has a spherical and a 
cylindrical component to allow for the compensation of pre-existing corneal astigmatism. The single-
piece IOL has a double-C-loop haptic design with ridge technology on the haptics to prevent sticking of 
the haptics to the optic. A sketch of the IOL is depicted in Figure 1 and the main specifications are 
summarized in Table 1. 

 
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Figure 1:  PODEYE TORIC IOL 
 
Table 1: PODEYE TORIC specifications 
Designation 
Technical Specifications 
Material 
Hydrophobic acrylic  
Optical diameter 
6.00 mm 
Total diameter 
11.40 mm 
Optic 
Biconvex aspheric aberration-correcting  
(-0.11μ SA) 
Haptic design 
Double C-loop 
Filtration 
UV & Blue light 
Refractive index 
1.53 
Abbe number 
42 
Angulation 
5° 
Spherical power 
From +15.0 D to +30.0 D in 0.50 D steps 
Cylindrical power (IOL 
plane) 
1.5 D 
Cylindrical power (Corneal 
plane) 
1.03 D 
Recommended corneal 
astigmatism correction range 
(based on pre-operative 
Keratometry values 
excluding SIA) 
0.75-1.50 D 

 
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Optical Design  
PODEYE TORIC IOL is an aspheric monofocal toric IOL which provides patients with distance vision 
and corneal astigmatism correction. The front surface is aspherical to yield an optic with a spherical 
aberration of -0.11 micrometers at 5.0 mm aperture to partially compensate the positive spherical 
aberration of the cornea and to achieve a high contrast sensitivity of the pseudophakic eye. The cylinder 
correction is located on the posterior surface. The IOL displays 2 series of three physical indicators (dots, 
see Figure 1) visible to the surgeon during implantation, which align with the meridian of lowest dioptric 
power (flattest meridian).  
The injector to be used for PODEYE TORIC IOL over the course of the study is the INJ100 (Bausch & 
Lomb).  
6.1.2 CONTROL DEVICE DESCRIPTION 
AcrySof SA60AT Monofocal IOL from Alcon (Fort Worth, TX) is a non toric, 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 +15.0 D to +30.0 D in 0.50 D increments. 
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), PODEYE TORIC IOL, 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) 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. 
The control IOLs (AcrySof SA60AT) shall be procured by the Investigator from the corresponding 
manufacturer (Alcon). 
6.2.2 PACKAGING AND LABELING 
The PODEYE TORIC 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.' 

 
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The AcrySof SA60AT Monofocal IOL 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 PODEYE TORIC CYL 1.5D IOL 
or the AcrySof monofocal non-toric IOL in the study eye according to the randomization schedule (1:1 
ratio) provided.  The randomization schedule will be computer-generated and programmed by an 
independent statistician who is not involved in the day-to-day conduct of the study. Randomization is to 
occur following the completion of informed consent and screening procedures. Randomization will be 
stratified by site. 
To minimize bias, site personnel performing postoperative study assessments of visual performance, 
including manifest refraction and visual acuity, 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) will 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 randomization 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 
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• 
Investigator’s request (medical decision to ensure patient safety) 
• 
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).  
Randomized subjects who do not receive a study IOL or 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.  The subjects who qualify for further study 
participation will be randomized to receive the assigned study IOL, and the cataract surgery/IOL 
implantation will be scheduled to occur between 1 and 90 days after the Preoperative visit.  The subjects 
will be scheduled to return for follow-up visits and examinations at the Day 1-2, Week 1-2, Month 1-2, 
and Month 4-6 time periods, consistent with study visits described in ISO 11979-7 (Form 0 through Form 
4). Data collected from each visit, including any abnormal findings, will be documented in the source 
records and recorded on study eCRFs.   
The timing and type of assessments/procedures to be performed at each visit is outlined in the SOA. 
Methods for study examinations is presented in the Manual of Procedures.  
8.1 
PREOPERATIVE VISIT (DAY -90 TO DAY -1) 
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 5-digit screening 
number, where the first two digits correspond to the site number.  
At this visit, the following activities will be performed:  
1. 
Biometrya 
o Keratometry* 
o Target refraction* 
o IOL power calculation* 
o Axial length* 
o Anterior chamber depth* 
o Toric Power calculation 
2. 
Corneal Topography* 
3. 
Inclusion/Exclusion Criteria Evaluation 
4. 
Demographics 
5. 
Concomitant Medications 
6. 
Ocular and Significant Non-ocular Medical History* 
7. 
Urine Pregnancy Test (if applicable) 
8. 
Manifest Refraction (ETDRS) – 4 m*  
9. 
BCDVA - Photopic, Monocular (ETDRS) – 4 m* 
10. 
UCDVA - Photopic, Monocular (ETDRS) – 4 m* 
11. 
Projected Visual Acuity*  
12. 
Slit lamp Examination* 
13. 
Intraocular Pressure* 
14. 
Dilated pupil size* 
15. 
Dilated Fundus Exam* 
16. 
Randomization 
17. 
Adverse Events 
* 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). 
a Biometry (if not done during routine standard of care exams), to be done before inclusion/exclusion 
criteria evaluation. 
Subjects must be targeted as closely as possible to emmetropia. For PODEYE TORIC IOL, SRK/T 
formula and A-constant 119.4 should be used to determine IOL power. Surgeons may use their 
personalized A-constant for model SA60AT. 
The SIA value an investigator will use in this study must be a predetermined single value (each 
investigator may use their own personal SIA value) that is reported to the sponsor at the beginning of the 
study and consistently used for all subjects treated by the investigator. 
The subjects will be randomized in 1:1 ratio to either Study arm or control arm, as per the randomization 
schedule. 

 
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8.2 
OPERATIVE VISIT (DAY 0):  FORM 0 
At the Operative Visit, prior to surgery, subjects will be assessed to reconfirm eligibility and any changes 
in concomitant medications and 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.  
All cataract surgical procedures will be performed by a qualified Investigator according to the 
Investigator’s usual standard of care, using a phacoemulsification system adjusted according to the 
Investigator's customary settings. Surgery may be performed under either local or topical anesthesia, with 
or without intracameral ophthalmic anesthesia. Subjects must be targeted as closely as possible for 
emmetropia.  Surgeons may use their personalized A-constant for model SA60AT.  For PODEYE 
TORIC, surgeons must use the SRK/T formula and an A-constant of 119.4. The Investigator must also 
reference the Directions for Use for the PODEYE TORIC IOL and AcrySof SA60AT Monofocal IOL. 
The Bausch & Lomb INJ100 injector must be used to implant the PODEYE TORIC in accordance with 
the Bausch & Lomb Directions for Use. A qualified delivery system should be used for the AcrySof 
SA60AT IOL, in accordance with the Alcon Directions for Use. 
A temporal clear corneal main incision with a size approximately 2.4 mm will be constructed for delivery 
of the IOL.  
No additional refractive procedures are to be performed during the operative procedure or throughout the 
postoperative study period. Femtosecond laser-assisted cataract surgery (FLACS) must not be performed 
to create corneal incisions, to adjust astigmatism during the study period, or for any other reason. (Note: 
Corneal incisions intended to reduce corneal astigmatism (e.g., Limbal relaxing incisions and astigmatic 
keratotomy are not permitted)  
If operative complications prevent implantation of the investigational Study IOL (PODEYE TORIC or 
Control 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.  
The Investigator should refer to the Manual of Procedures for more detailed guidance on PODEYE 
TORIC and AcrySof SA60AT implantation. 
After the operative procedure but at the same visit, IOL axis orientation retro-illuminated slit lamp images 
must be taken for the subjects implanted with PODEYE TORIC IOL. Refer to the Manual of Procedures 
for more guidance. 
8.3 
POSTOPERATIVE VISITS:  FORM 1 THROUGH FORM 4  
Postoperative visits should be scheduled according to the following visit window schedule: 
Form 1: 1-2 days after surgery on the study eye 
Form 2: 7-14 days after surgery on the study eye 
Form 3: 30-60 days after surgery on the study eye 
Form 4: 120-180 days after surgery on the study eye 

 
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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.   
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.  Recommended assessments include:  
• 
Concomitant medication 
• 
Manifest refraction 
• 
BCDVA at 4 m- Photopic, Monocular (ETDRS) for study eye 
• 
UCDVA at 4 m- Photopic, Monocular (ETDRS) for study eye 
• 
Keratometry 
• 
Slit lamp exam 
• 
IOL observations 
• 
IOL tilt and decentration grading 
• 
Intraocular pressure (IOP) 
• 
IOL Axis Orientation (retro-illuminated slit lamp photo in a dilated eye, only for subjects 
implanted with PODEYE TORIC IOL)  
• 
Dilated Fundus Exam 
• 
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. For more details on these medications, refer to the MOP. 
8.6 
SECONDARY SURGICAL INTERVENTION (SSI) 
The study Investigator must assess 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, subject’s feedback related to visual symptoms, and any other applicable reasons. 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, i.e., rotation of a toric 
IOL. 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 
• 
Surgical complications noted at the operative visit that may reasonably be expected to affect 
postoperative outcomes 
Subjects that have a secondary surgery that is targeted to correct for postoperative toric IOL rotation shall 
have their clinical results prior to that surgical intervention carried forward as the final results for that 
subject. In cases where axis misalignment measured at follow up visits after a secondary surgical 
intervention (SSI) is greater than the axis misalignment prior to SSI, the greater misalignment error shall 
be considered final. 
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. 
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 

 
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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.   
An SSI must be reported to the sponsor or designee within 7 days of the date of SSI. 
8.6.1  IOL EXCHANGE 
An IOL exchange, where the IOL is replaced with the same lens model, is only allowed at the Operative 
visit (Form 0). If the IOL needs to be replaced sometime later after the operative visit, the replacement 
IOL cannot be the investigational IOL model. 
8.6.2 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 where IOL rotation, 
tilt, or decentration is such that repositioning is necessary to improve the visual outcomes of the subject or 
prevent damage to the eye.  
8.6.3 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. 
The Investigator should consult with the Medical Monitor and carefully consider the potential risks and 
benefits of the SSI.   
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.  
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: 
• 
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; 

 
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• 
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 
treated with 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 
• 
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 
• 
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. 

 
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8.7.4 CLASSIFICATION OF AN ADVERSE EVENT 
8.7.4.1 SEVERITY OF EVENT 
The investigator must determine the intensity of the event. 
 
 
 
 
 
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.  
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 
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 

 
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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.  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 
As per ISO 11979-7 (2018) and The American Academy of Ophthalmology Task Force Consensus 
Statement on Adverse Events with Intraocular Lenses3, the anticipated AEs associated with cataract 

 
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surgery and/or Toric 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 
• 
Vitreous prolapse 
• 
Wound leak (positive Seidel) 
• 
Posterior capsular rupture 
• 
Choroidal detachment/hemorrhage 
• 
Zonular dialysis 
• 
Thermal injury (phaco burn) 
• 
Iris or pupil damage 
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 (using the Standardization of Uveitis Nomenclature [SUN] criteria) 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.] Note that any iritis present at the final visit is considered significant and should 
be counted as a ‘persistent ISO SPE event’. 
• 
Visually significant corneal edema [corneal swelling (stromal or epithelial) resulting in BCDVA of 
0.3 logMAR or worse at Form 3 or later]. Note that any corneal stromal edema present at the 
final visit is considered significant and should be counted as a ‘persistent ISO SPE event’.  
• 
Clinically significant cystoid macular edema (CME) diagnosed by clinical exam and adjunct 
testing (e.g., OCT or other method), resulting in BCDVA of ≤ 0.3 logMAR at Form 3 or later  
• 
Endophthalmitis (intraocular inflammation leading to diagnostic vitreous tap and use of 
intraocular antibiotics) 
• 
Flat anterior chamber with lens/cornea touch or a shallow chamber with iridocorneal apposition 
without lens/cornea touch  
• 
Anterior Capsular Contraction Syndrome (ACCS, Phimosis) 
• 
Hypopyon 
• 
Corneal endothelial damage 
• 
Incorrect IOL power resulting in secondary surgical intervention 
• 
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 

 
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• 
IOL dislocation, tilt, decentration, luxation, rotation resulting in secondary surgical intervention 
• 
Best-corrected distance visual acuity loss of 2 lines (10 letters) or more on the ETDRS chart 
measured at or after postoperative Form 4 compared to any prior postoperative visit 
• 
Best-corrected distance visual acuity loss of 2 lines (10 letters) or more since the prior 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) 
• 
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 
• 
Retained lens material 
• 
Rhegmatogenous retinal detachment (RD) (partial or complete RD associated with retinal tear) 
• 
Secondary IOL intervention (Exchange, Removal, or Reposition)  
• 
Secondary surgical intervention  (include, but are not limited to lens repositioning, lens 
replacement, vitreous aspiration, iridectomy for pupillary block, wound leak repair, and retinal 
detachment repair). It excludes posterior capsulotomies 
• 
Synechiae formation 
• 
Toxic anterior segment syndrome (TASS) (An acute, noninfectious inflammation of the anterior 
segment of the eye that starts within 24 to 48 hours after surgery, usually resulting in hypopyon 
and commonly presenting with corneal edema, and that improves with steroid treatment 
Investigators should accurately record the resolution status of all AEs, including all sequalae which could 
be on ocular structure or ocular (or visual) function. 
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 that 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 

 
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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 
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 
GENERAL 
All data analysis will be performed after the study is completed and the database has been locked. 
Statistical programming and analyses will be performed using SAS Version 9.4 or higher and R Software, 
Version 4.3.0 or higher.  Figures will be produced using R Software, version 4.3.0 or higher. All study 
data will be listed by subject, and visit, as applicable, in support of summary tables. 
For continuous or ordinal measures, descriptive summary statistics will include the number of 
observations, mean, standard deviation, median, minimum, maximum, as well as the number with results 
not reported. Minima and maxima will be reported with the same precision as the raw values; means and 
medians will be presented to 1 additional decimal place than reported in the raw values. Standard 
deviations will be presented to 2 additional decimal places than reported in the raw values. For categorical 
measures, the percentage and number of cases for each condition (e.g., subject sex, age grouping), along 
with a 95% Clopper-Pearson confidence interval, will be reported. The number of subjects without results 
will be omitted from the numerator and denominator of such calculations. All percentages will be rounded 
to 1 decimal place (i.e., XX.X%). 
9.2 
ANALYSIS POPULATIONS 
The All-enrolled population includes all subjects who sign an informed consent form. This population 
will be used for disposition summaries. 
The Safety population will include all subjects where the test or control IOL touched the eye. 
The intent to treat (ITT) population includes all randomized subjects. Missing data will be imputed.  
Subjects will be analyzed as randomized. The ITT population is the primary analysis population for 
assessing effectiveness. 

 
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The All-implanted population includes all ITT subjects who were successfully implanted with one of the 
two study IOLs and who attended at least one postoperative visit.  Missing data will be imputed. Subjects 
will be analyzed as randomized.  The All-implanted population is supportive of the ITT population for 
assessing effectiveness. 
The Per-Protocol (PP) population includes all subjects in the All-implanted population who have no 
major protocol deviations that could affect the interpretation of effectiveness.  Exclusions from PP will be 
determined prior to study unmasking. Missing data will not be imputed. Subjects will be analyzed as 
treated.  Analyses based on PP will be supportive of those based on ITT. 
The Best-Case Set will include subjects in PP 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 Form 4  
o Receipt of medication likely to interfere with visual performance at Form 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 
9.3 
ANALYSIS SUBSETS 
A best-case analysis population is defined for the testing of co-primary endpoint of BCVA logMAR of 
0.3 or better at Form 4. 
9.4 
HYPOTHESES 
Formal statements for the four effectiveness hypotheses are as follows.  
Co-primary endpoint 1 hypothesis:  Residual manifest cylinder will be less in toric arm than in control 
arm at Form 4.  
H0: μT ≥μC  
HA: μT < μC 

 
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Where μT and μC are mean residual cylinder for toric and spherical IOLs, 
respectively. 
Co-primary endpoint 2 hypothesis: IOL axis misalignment < 10° from the intended IOL axis of 
orientation, will be at least 90% on test IOLs at Form 4, follows: 
H0: 𝜋T < 90%  
HA: 𝜋T ≥90% 
Where 𝜋T is the proportion of eyes with axis misalignment < 10° from the intended IOL axis of 
orientation. 
Co-primary endpoint 3 hypothesis: IOL axis misalignment < 20° from the intended IOL axis of 
orientation, will be at least 95% on test IOLs at Form 4, follows: 
H0: 𝜋T < 95%  
HA: 𝜋T ≥95% 
Where 𝜋T is the proportion of eyes with axis misalignment < 20° from the intended IOL axis of 
orientation. 
Co-primary endpoint 4 hypothesis: Stability of the test IOL axis orientation from Form 3 to Form 4 of 
≤ 5° change in orientation, will be at least 90%: 
H0: 𝜋T < 90%  
HA: 𝜋T ≥90% 
     Where 𝜋T is the proportion of eyes with axis stability ≤ 5°. 
 
Formal statements for the two safety hypotheses addressing BCDVA follow.  
The percentage of eyes with BCDVA logMAR 0.3 or better at Form 4 is not less than 92.5% (ISO 11979-
7:2018 table E.3). 
H0: 𝜋< 92.5% 
HA: 𝜋≥92.5% 
 
Where 
π is the percentage of eyes with BCDVA of 0.3 logMAR or better at Form 4. 
The percentage of best-case eyes with BCDVA logMAR 0.3 or better at Form 4 is not less than 96.7% (ISO 
11979-7:2018 table E.4). 
H0: 𝜋< 96.7% 
HA: 𝜋≥96.7% 
 
Where 
       π is the percentage of eyes with BCDVA of 0.3 logMAR or better at Form 4. 
 
Safety will also be assessed by ensuring that the following outcomes do not exceed specified rates for: 1) 
cumulative rate of SSIs related to the optical properties of the IOL at Form 4, including IOL rotation SSIs 

 
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for misalignment and for 2) cumulative and persistent AEs at Form 4 via comparison to the ISO Safety and 
Performance Endpoint (SPE) rates as described in ISO 11979-7:2018. 
 
9.5 
POWER AND SAMPLE SIZE 
A sample size of up to 300 eyes is planned to be enrolled, where a screen failure of up to 70 eyes (23%) is 
anticipated. Approximately 230 eyes will be randomized and implanted with toric or control IOL. 
For co-primary endpoint 1, a greater reduction in residual manifest cylinder in toric vs control lenses, we 
assume a difference of 0.4D and a standard deviation for the toric IOL of 0.29, based on Chassain 20234, 
and a standard deviation for the control (spherical) IOL estimated of 0.73 based on the AcrySof Toric 
SSED document5. The power to show superiority of toric over control lenses with 230 eyes is 99% using 
a t-test. We reduce this by 5% to 94%, given that the less powerful Wilcoxon rank-sum test will be used.   
For co-primary endpoint 2, IOL axis misalignment < 10° from intended IOL axis of orientation at Form 4, 
we assume a success rate of 90.36% in toric lenses. Given a target of 90% and using the testing method 
employed with SPE endpoints (ISO 11979-7(2018)), we have 99% power to show that the upper 95% 
boundary of a Clopper-Pearson confidence interval of the achieved success rate incudes the threshold rate 
of 90%. 
For co-primary endpoint 3, IOL axis misalignment < 20° from intended IOL axis of orientation at Form 4, 
we assume a success rate of 99.0% % in toric lenses. Given a target of 95%, and using the testing method 
employed with SPE endpoints, we have 99% power to show that the upper 95% boundary of a Clopper-
Pearson confidence interval of the achieved success rate includes the threshold rate of 95%. 
For co-primary endpoint 4, Stability of the toric IOL axis orientation (toric IOL arm only) from Form 3 to 
Form 4 of ≤ 5° change in orientation, we assume a success rate of 91.46% in toric lenses.  Given a target 
of 90%, and using the testing method employed with SPE endpoints, we have 99% power to show that the 
upper 95% boundary of a Clopper-Pearson confidence interval of the achieved success rate includes the 
threshold rate of 90%. 
Given that all four co-primary endpoints must be met for study success, the worst-case study power, 
assuming independence among all tests, is 0.94 x 0.99 x 0.99 x 0.99= 91%.  However, given any positive 
correlation among the endpoints, power will exceed 91%. 
9.6 
MULTIPLICITY 
All co-primary endpoints must be met for the study to be declared a success.  Consequently, no 
adjustment in alpha is necessary.  
9.7 
MISSING DATA AND IMPUTATION 
Missing Form 4 effectiveness endpoint data will be imputed for All-implanted and ITT analyses.   
For ITT, All-implanted, and PP analyses, per ANSI Z80.30-2018, eyes that have a secondary surgery that 
is targeted to correct for postoperative toric IOL rotation shall have their clinical results prior to that 
surgical intervention carried forward as the final results for analysis. Further, in cases where axis 
misalignment measured at follow up visits after an SSI is greater than the axis misalignment prior to SSI, 

 
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the greater misalignment error shall be considered as the final result for analysis. Repositioning of toric 
IOLs will result in imputation of worst observed value or assignment failure for the co-primary endpoints 
at Form 4 analysis, as appropriate. Imputation methods described below will retain these worst-value or 
failure assignments and will not overwrite them with imputed values. 
The primary imputation method for all co-primary endpoints will be by multiple imputation where details 
of initial seed, predictors and methods will be fully described in the Statistical Analysis Plan. Co-primary 
endpoint 1, will use 50 imputed datasets for analysis; all other endpoints, being binary and tested by exact 
methods, are not amenable to combining multiple imputations, so only the first imputed dataset will be 
used.  
In addition, for co-primary endpoint 1, where two arms are involved, a tipping point sensitivity analysis 
will involve initially setting all control-lens eyes with missing data to the best observed outcome 
(presumably, 0.0 residual cylinder) and setting all toric-lens eyes with missing data to the worst observed 
outcome.  The best and worst values will be incremented/decremented by 0.125 D until control eyes have 
the worst and toric have the best value imputed. The point at which, if any, where the results of the 
hypothesis test changes its results regarding rejection of the null hypothesis will be reported.  
For all other co-primary endpoints, the tipping-point sensitivity analysis will be performed in which 
missing data are initially assumed to be failures. Then, one of the imputed failures will be imputed as a 
success. Then, a second failure will be assigned to a success. This process will be repeated until all 
missing data are imputed as successes.  The point at which, if any, where the results of the hypothesis test 
changes its results regarding rejection of the null hypothesis will be reported.   
Missing data will not be imputed for PP analyses. 
9.8 
STATISTICAL TESTING OF EFFECTIVENESS ENDPOINTS 
For co-primary endpoint 1, the test of superiority of the toric lens over the control lens to result in less 
residual cylinder, a Wilcoxon rank-sum test will be performed, given that the distribution of residual 
cylinder will be discrete and likely skewed, the t-test is used only as a preliminary estimate of the needed 
sample size. Given the loss of power due to the use of a non-parametric test, an assumed loss of power of 
5% has been made to accommodate lower power of the Wilcoxon test.  The point estimate of the 
difference and a 95% confidence interval of the treatment effect will be provided based on the mean 
difference and its standard error.  
For co-primary endpoints, where axis stability is examined, the upper 95% boundary of a Clopper-
Pearson confidence interval will be used to test if the null hypothesis can be rejected.  Number and 
percentage of eyes achieving various levels of stability will be summarized. 
9.9 
STATISTICAL TESTING OF SAFETY ENDPOINTS 
Cumulative and persistent adverse events from ISO 11979-7 (2018) 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. Summaries will be provided for both spherical and toric 
lenses. 

 
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The other safety outcomes, listed in Section 3.1, will be summarized by count and percentage for each 
IOL type. Adverse events will be tabulated by type (e.g., all, serious, anticipated, unanticipated) and 
classification by IOL. 
For achievement of 0.3 logMAR BCDVA at Form 4, where a success proportions are compared with a 
target value based on the analysis population being examined (all eyes or best-case eyes), a Clopper-
Pearson upper 95% boundary of the confidence interval (i.e., the upper one-sided 5%) will be compared 
with the target to ensure that it equals or exceeds that target value. 
9.10 POOLABILITY 
Poolability of results will be assessed by site.  The binary co-primary effectiveness endpoints addressing 
performance of the toric IOL will be tabulated by site to determine if success rates indicate a difference in 
effectiveness.  Similarly, the degree of superiority of the toric arm in reducing residual cylinder, 
compared with the control arm, will be tested. Cross-tabulations of site by binary endpoints will be 
analyzed with a Fisher’s exact test and the comparison of residual cylinder between treatment arms will 
be analyzed with an analysis of variance model with an interaction term for site by treatment.  In both 
cases, a p-value of 0.15 will indicate that potential site differences exist and will require investigation as 
to the possible causes.  
9.11 ADDITIONAL ENDPOINTS AND ASSOCIATED ANALYSES 
The following are not subject to hypothesis testing. 
1) Achievement of ≤0.50 D reduction in cylindrical power of the eye as a binary endpoint. Analysis will 
summarize the overall percentage of eyes meting endpoint 1 as well as by each 0.25 D step of 
preoperative keratometric cylinder.  Tabulation will be by both arms at Form 4. 
2) Reduction in cylindrical power of the eye at Form 4.  Analysis will include summary statistics of 
reduction in cylinder power of the eye overall and by each 0.25 D step of preoperative keratometric 
cylinder. Summary statistics will be provided for both treatment arms, with the addition of a 95% 
confidence interval of the mean for each arm. Number and percentage with an absolute reduction of 
≤0.5D will be provided for each arm. 
3) Relationship between reduction in cylindrical power of the eye at the corneal plane and preoperative 
keratometric cylinder at Form 4. The association will be shown using a scatterplot with a linear regression 
line for each treatment arm. Intercept and slope, with associated p-values, will be provided. If the scatter 
of the data do not appear to be linear, a LOESS curve will be added for each arm.  
4) The surgically induced change in corneal cylinder is calculated by analysis of the preoperative and 
postoperative keratometric readings (power and axis of meridians of highest and lowest power), converted 
to components in dioptric space. Change is defined as postoperative component values minus 
preoperative component values. Change and percentage change from baseline at Form 4 will be 
summarized with descriptive statistics for each treatment arm, overall, and by preoperative keratometric 
cylinder categories.  Analyses will include:  
a) Analysis of the error in the predicted magnitude of postoperative astigmatism, including the bias, 
standard deviation, and mean absolute error, and a similar analysis of error in the predicted axis;  

 
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b) Bar plot of the absolute error in predicted keratometric axis as a function of preoperative corneal 
astigmatism, and tabulation of the proportion of eyes with absolute error in axis by 5° wide bins (e.g., 0° 
to 5°, >5° to 10°). 
5) Achievement of UCDVA of 0.0 logMAR or better, 0.2 logMAR or better, and of 0.3 logMAR or better 
at Form 4. Results will be tabulated for each treatment arm by N and percentage. 
6) UCDVA at Form 4. UCDVA will be summarized with summary statistics, overall and by each 0.25 D 
step of preoperative keratometric cylinder categories. Both treatment arms will be summarized. 
7) Manifest cylinder at Form 4.  Analysis will include summary statistics of manifest cylinder. Summary 
statistics will be provided for both treatment arms. Results will be summarized overall as well as stratified 
by each 0.25 D of preoperative keratometric cylinder. 
8) Achieving accuracy of cylinder to target at Form 4 within 0.25 D, 0.50 D, and 0.75 D.  Results will be 
tabulated for each treatment arm by N and percentage. 
9) Achieving accuracy of MRSE to target at Form 4 within 0.25 D, 0.50 D, and 0.75 D. Results will be 
tabulated for each treatment arm by N and percentage. 
10) Axis misalignment compared to target within specified accuracy at Form 4.  Results will be tabulated 
for the toric lens only, reporting the number and percentage with axis deviation greater than 30° of target.  
11) Axis misalignment at Form 4. Results for absolute and signed values will be summarized for the toric 
lens only, with summary statistics of deviation from target. A two-sided tolerance interval around the 
mean of the signed value, which contains at least 90% of the population (with 95% probability), will be 
provided. 
 
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) 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 

 
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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 to 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 of 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). 
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 
the 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 

 
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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.  
10.1.5 MEDICAL MONITOR 
Medical Monitor 
Mark Packer, MD, FACS, CPI 
Packer Research Associates, Inc.  
924 W. Mountain Ave., Fort 
Collins CO 80521 
541-915-0291 
mark@markpackerconsulting.com 
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 the designee will perform periodic monitoring visits to study sites as per 
the Clinical Monitoring Plan. 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). 
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.  

 
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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 Harmonization 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 people 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 to prior review of any publication or presentation of information 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 PROTOCOL AMENDMENT HISTORY 
 
Version 
Section 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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11 REFERENCES  
1 ANSI Z80.30: 2018; American National Standard for Ophthalmics - Toric Intraocular Lenses 
2 ISO 11979-7: 2018 Ophthalmic implants – intraocular lenses – part 7:  clinical investigations of 
intraocular lenses for the correction of aphakia 
3 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):  42-144. 
4 Chassain C, Hallak MK, Lesaffre M. Rotational stability and clinical outcomes after implantation of a 
new monofocal toric intraocular lens with double C-loop design. J Fr Ophtalmol. 2023 Jun;46(6):571-
580. doi: 10.1016/j.jfo.2022.07.005. Epub 2023 May 11. PMID: 37179129. 
5 ACRYSOF® Single-Piece Posterior Chamber Intraocular Lenses with Toric Optic- Summary of Safety 
and Effectiveness Data- Premarket Approval Application (PMA) Number: P930014/S15 
12 APPENDIX A: Sponsor And TrueNorth Approvals 
Protocol Title: Clinical Investigation of the Safety and Effectiveness of PODEYE TORIC Monofocal 
IOL 
Study number: PHY2302 
Protocol Date: 26 Oct 2023 
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. 

 
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Mattia Ronchetti 
 
Senior Director Global Clinical & Regulatory Affairs 
BVI Medical 
 
 
 
…………………………….. 
 
 
 
 
Rebecca McQuaid PhD 
 
Associate Director Global Clinical Operations 
BVI Medical 
 
 
 
 
…………………………….. 
 
 
 
 
Sonal Shekhawat MD 
 
U.S. Clinical Operations Lead 
BVI Medical 
 
 
 
 
…………………………….. 
 
 
 
 
 
Lavanya Gunasekaran 
 
Regulatory Development Manager 
BVI Medical 
 
 
 
 
…………………………….. 
 
 
 
 
Keeley Puls-Boever 
 
Executive Director of Clinical Operations 
TrueNorth 
 
 
 
…………………………….. 
 
 
 
 
Gerard Smits, PhD 
 
Biostatistician 
 
 
 
……………………………..