Investigation of the Safety and Effectiveness of a Trifocal IOL (NCT04176965) | Clinical Trial Compass
CompletedNot Applicable
Investigation of the Safety and Effectiveness of a Trifocal IOL
United States539 participantsStarted 2022-04-28
Plain-language summary
This study is a prospective, multicenter, randomized, double masked confirmatory trial comparing an investigational trifocal intraocular lens (IOL) and a commercially available 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.
. Visually significant cataracts in both eyes that are eligible for phacoemulsification cataract surgery.
. Willing to undergo cataract surgery in the second operative eye within 7 - 30 days after surgery in the first eye.
. Projected Best Corrected Distance Visual Acuity (BCDVA) of 0.2 logMAR (20/32 Snellen) or better in each eye after cataract surgery/IOL implantation, as determined by the medical judgement of the Investigator
. Eligible for receipt of an IOL power within the range of the investigational IOL (+10.0 D to +30.0 D, in 0.50 D increments) in each eye
. Contact lens users must be willing to discontinue wear of their lenses in accordance with the following requirements:
. Provide signed written consent prior to participation in any study-related procedures.
. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
Exclusion criteria
. History or presence of, or predisposition to, degenerative visual disorders (e.g., macular degeneration, retinal detachment, proliferative diabetic retinopathy, or other retinal disorders) predicted to result in BCDVA worse than 0.2 LogMAR (20/32 Snellen) in either eye during the study participation period.
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 Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes
Timeframe: 150-180 days after surgery on the first eyes
2
Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes.
Timeframe: 150-180 days after surgery on the first eyes
3
Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5)
Timeframe: Up to Month 12 (Day 360-420), post first eye implantation
4
Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
. Significant anterior segment pathology in either eye that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome)
. Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in either eye during the study participation period.
. Presence of one or more clinically significant corneal abnormalities in either eye, including corneal dystrophy, irregularity, or edema per the Investigator's medical opinion.
. Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in either eye
. Rubella, congenital, traumatic or complicated cataract in either eye
. Preoperative keratometric astigmatism \> 1.0 D or irregular corneal astigmatism in either eye (Note: corneal incisions intended to reduce astigmatism are not permitted)
. Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit.
7
Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).