Investigation of the Safety and Effectiveness of Monofocal Toric Intraocular Lens (IOL)

Clinical Investigation of the Safety and Effectiveness of Monofocal PODEYE TORIC Intraocular Lens (IOL)

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.

Study Overview

• Status: Completed
• Conditions: Eye Diseases; Cataract; Astigmatism; Lens Opacities; Postcataract Aphakia
• Intervention / Treatment: Device: PODEYE TORIC Monofocal IOL; Device: Alcon AcrySof SA60AT Monofocal IOL

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 261

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

   • 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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PODEYE TORIC IOL (1.5 D); Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.	Device: PODEYE TORIC Monofocal IOL; Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.
Active Comparator: Control IOL; Cataractous lens will be removed in the study eyes and the control IOL will be implanted in the capsular bag.	Device: Alcon AcrySof SA60AT Monofocal IOL; Cataractous lens will be removed in the study eyes and the Alcon AcrySof SA60AT Monofocal IOL will be implanted in the capsular bag.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Residual Manifest Cylinder in Diopters in Toric and Control Arms.	Residual Cylinder in Diopters as measured by Manifest Refraction	Form 4 visit (window: 120-180 days)
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than 10 Degrees (Toric IOL Arm Only)	Intraocular lens (IOL) axis misalignment of less than 10 degrees at 4 to 6 months compared to the intended IOL axis of orientation at the operative visit after the surgery	Form 4 visit (window: 120-180 days)
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than 20 Degrees (Toric IOL Arm Only)	Intraocular lens (IOL) axis misalignment of less than 20 degrees at 4 to 6 months compared to the intended IOL axis of orientation at the operative visit after the surgery	Form 4 visit (window: 120-180 days)
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than or Equal to 5 Degrees (Toric IOL Arm Only)	Intraocular Lens (IOL) rotation of less than or equal to five degrees between Form 3 visit (window: 30-60 days) and Form 4 visit (window: 120-180 days)	Form 3 Visit (window: 30-60 days), Form 4 Visit (window: 120-180 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL.	Secondary surgical interventions (SSIs) related to the optical properties of the IOL including IOL rotation SSIs for misalignment.	Form 4 Visit (window: 120-180 days)
Rates of Cumulative and Persistent Adverse Events.	Rates of cumulative and persistent Adverse Events via comparison to the ISO Safety and Performance Endpoint (SPE) rates as described in ISO 11979-7	Form 4 Visit (window: 120-180 days)
Number of Participants With Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better	Proportion of eyes achieving best-corrected distance visual acuity (BCDVA) of 0.30 logMAR or better at Form 4. BCDVA was measured at 4 meters using an ETDRS chart under photopic conditions. A logMAR value of 0.3 or better (lower logMAR = better vision) corresponds to approximately 20/40 Snellen acuity. The performance goal was at least 92.5% per ISO 11979-7:2018 Table E.3 for All-Implanted eyes and 96.7% per Table E.4 for Best-Case eyes.	Form 4 Visit (window: 120-180 days)

Collaborators and Investigators

• Sponsor: Beaver-Visitec International, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Actual): November 6, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Toric; Intraocular Lens; Monofocal; Hydrophobic
• Additional Relevant MeSH Terms: Refractive Errors; Lens Diseases; Aphakia; Eye Diseases; Cataract; Astigmatism; Aphakia, Postcataract
• Other Study ID Numbers: PHY2302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO