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

NCT06399211 | Completed Results

• 1 other identifier: PHY2302
• Study Type: interventional
• Target: 261
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Eye Diseases; Postcataract Aphakia; Cataract; Lens Opacities; Astigmatism

Keywords

Intraocular Lens; Monofocal; Toric; Hydrophobic

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Rate of Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL.

  Form 4 Visit (window: 120-180 days)

• Rates of Cumulative and Persistent Adverse Events.

  Form 4 Visit (window: 120-180 days)

• Number of Participants With Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better

  Form 4 Visit (window: 120-180 days)

Study Arms (2)

PODEYE TORIC IOL (1.5 D)

EXPERIMENTAL

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

Control IOL

ACTIVE COMPARATOR

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

Interventions

PODEYE TORIC Monofocal IOL DEVICE

Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.

PODEYE TORIC IOL (1.5 D)

Alcon AcrySof SA60AT Monofocal IOL DEVICE

Cataractous lens will be removed in the study eyes and the Alcon AcrySof SA60AT Monofocal IOL will be implanted in the capsular bag.

Control IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• · 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.

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

MeSH Terms

Conditions

Eye Diseases; Aphakia, Postcataract; Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Aphakia; Lens Diseases; Refractive Errors

Results Point of Contact

• Title: Rebecca McQuaid
• Organization: BVI medical

RMcQuaid@bvimedical.com

+353871212615

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In order to minimize bias, site personnel performing postoperative study assessments of visual performance will be masked to subject treatment assignment until after the final database lock ("masked assessors").
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to 300 subjects shall be screened and approximately 230 subjects will be randomized and implanted at up to 10 clinical sites in USA. 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 control IOL in the study eye.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 3, 2024
• Study Start: June 28, 2024
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share