Investigation of the Safety and Effectiveness of Monofocal Toric Intraocular Lens (IOL) (NCT06399211) | Clinical Trial Compass
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 range
22 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Residual Manifest Cylinder in Diopters in Toric and Control Arms.
Timeframe: Form 4 visit (window: 120-180 days)
2
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)
3
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)
4
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)