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NCT06060041Recruiting

IC-8 Apthera IOL New Enrollment Post Approval Study

Bausch & Lomb Incorporated

Start Date

9/8/2023

Completion Date

9/30/2027

Summary

The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.

Detailed Description

Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.

Eligibility Criteria

Age Range: 22 years to No maximum

Inclusion Criteria: * 22 years of age or older, any race and any gender; * Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye * Able to comprehend and have signed a statement of informed consent; * Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits; * Clear intraocular media in both eyes; * Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation; * Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the other eye in accordance with the directions for use (DFU) for each IOL. Exclusion Criteria: * Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye; * Irregular astigmatism in either eye; * History of retinal disease; * Active or recurrent anterior segment pathology; * Presence of ocular abnormalities; * Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment; * Previous corneal or intraocular surgery, except cataract surgery; * History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention; * Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study; * Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye; * Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study. * Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits

Interested in This Trial?

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Conditions

CataractPresbyopiaPosterior Capsule Opacification

Locations

Trinity Research Group, LLC

Dothan, Alabama 36301

United States

Feinerman Vision Center

Newport Beach, California 92663

United States

Argus Research Center

Cape Coral, Florida 33909

United States

Stephenson Eye Associates

Venice, Florida 34285

United States

Virdi Eye Clinic and Laser Vision Center

Rock Island, Illinois 61201

United States

Price Vision Group

Indianapolis, Indiana 46260

United States

Grene Vision Group

Wichita, Kansas 67206

United States

Oakland Eye

Birmingham, Michigan 48009

United States

Vance Thompson Vision - Omaha

Omaha, Nebraska 68137

United States

Eye Associates of New Jersey

Dover, New Jersey 07801

United States

Northern New Jersey Eye Institute

South Orange, New Jersey 07079

United States

Ophthalmic Partners, PC

Bala-Cynwyd, Pennsylvania 19004

United States

Berkeley Eye Center

Sugar Land, Texas 77478

United States

Utah Eye Centers

Bountiful, Utah 84010

United States