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 range22 Years
SexALL
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Inclusion criteria
ā. Male or female adults, age 22 years or older at the Preoperative Visit.
ā. Visually significant cataracts in both eyes that are eligible for phacoemulsification cataract surgery.
ā. Willing to undergo cataract surgery in the second operative eye within 7 - 30 days after surgery in the first eye.
ā. 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
ā. 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
ā. Contact lens users must be willing to discontinue wear of their lenses in accordance with the following requirements:
ā. Provide signed written consent prior to participation in any study-related procedures.
ā. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
Exclusion criteria
ā. 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.
ā. Significant anterior segment pathology in either eye that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome)
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).
ā. Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in either eye during the study participation period.
ā. Presence of one or more clinically significant corneal abnormalities in either eye, including corneal dystrophy, irregularity, or edema per the Investigator's medical opinion.
ā. Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in either eye
ā. Rubella, congenital, traumatic or complicated cataract in either eye
ā. Preoperative keratometric astigmatism \> 1.0 D or irregular corneal astigmatism in either eye (Note: corneal incisions intended to reduce astigmatism are not permitted)
ā. Clinically significant ocular inflammation or infection present ā¤ 30 days in either eye prior to the Preoperative Visit.
Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).