CompletedNot Applicable

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

261 participantsStarted 2024-06-28

Plain-language 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.

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mean Residual Manifest Cylinder in Diopters in Toric and Control Arms.

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: Form 3 Visit (window: 30-60 days), Form 4 Visit (window: 120-180 days)

Trial details

NCT IDNCT06399211

SponsorBeaver-Visitec International, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-06

Results submitted2026-02-27

View on ClinicalTrials.gov More Eye Diseases trials

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mean Residual Manifest Cylinder in Diopters in Toric and Control Arms.

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: Form 3 Visit (window: 30-60 days), Form 4 Visit (window: 120-180 days)