Investigation of the Safety and Effectiveness of a Trifocal IOL

Completed · Not applicable

Conditions studied: Eye Diseases, Postcataract Aphakia, Cataract, Lens Opacities

In brief

This study is a prospective, multicenter, randomized, double masked confirmatory trial comparing an investigational trifocal intraocular lens (IOL) and a commercially available monofocal IOL.

Key facts

Study ID: NCT04176965
Run by: Beaver-Visitec International, Inc.
People needed: 539
Starts: 2022-04-28
Expected to finish: 2024-05-13
Last updated by the study team: 2025-01-29

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Rigid gas permeable lenses for ≥ 7 days prior to the Preoperative Visit
Soft contact lenses for ≥ 3 days prior to the Preoperative Visit Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in each eye, as determined by manifest refraction on two consecutive examination dates at least one week apart after discontinuation of contact lens wear.
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.
Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.

You may not qualify if…

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.
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.
Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, ocular infection, severe dry eye) in either 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.
Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.
Pregnant or nursing females.

Where it is running

Mitchell C Shultz MD/Shultz Chang Vision — Northridge, California, United States
Coastal Vision Medical Group — Orange, California, United States
Arbor Centers for Eye Care — Orland Park, Illinois, United States
Michael Washburn Center for Ophthalmic Research — Indianapolis, Indiana, United States
Vance Thompson Vision, MN Site — Alexandria, Minnesota, United States
Chu Vision Institute — Bloomington, Minnesota, United States
Ophthalmology Consultants, Ltd — St Louis, Missouri, United States
Vance Thompson Vision, MT Site — Bozeman, Montana, United States
Vance Thompson Vision NE Site — Omaha, Nebraska, United States
Center For Sight — Las Vegas, Nevada, United States
Eye Associates & SurgiCenter — Vineland, New Jersey, United States
Vance Thompson Vision ND Site — West Fargo, North Dakota, United States
Cleveland Eye Clinic — Brecksville, Ohio, United States
Associates in Ophthalmology Ltd — West Mifflin, Pennsylvania, United States
Vance Thompson Vision. SD Site — Sioux Falls, South Dakota, United States
Key-Whitman Eye Center — Dallas, Texas, United States
Lehmann Eye Center — Nacogdoches, Texas, United States
Parkhurst Nuvision — San Antonio, Texas, United States
The Eye Institute of Utah — Salt Lake City, Utah, United States
Piedmont Eye Center — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.