IC-8 Apthera IOL New Enrollment Post Approval Study

Recruiting now

Conditions studied: Cataract, Presbyopia, Posterior Capsule Opacification

In brief

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.

Key facts

Study ID

NCT06060041

Run by

Bausch & Lomb Incorporated

People needed

435

Starts

2023-09-08

Expected to finish

2027-09-30

Last updated by the study team

2026-01-12

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Trinity Research Group, LLC — Dothan, Alabama, United States (enrolling)
• Feinerman Vision Center — Newport Beach, California, United States (enrolling)
• Argus Research Center — Cape Coral, Florida, United States (enrolling)
• Stephenson Eye Associates — Venice, Florida, United States (enrolling)
• Virdi Eye Clinic and Laser Vision Center — Rock Island, Illinois, United States (enrolling)
• Price Vision Group — Indianapolis, Indiana, United States (enrolling)
• Grene Vision Group — Wichita, Kansas, United States (enrolling)
• Oakland Eye — Birmingham, Michigan, United States (enrolling)
• Vance Thompson Vision - Omaha — Omaha, Nebraska, United States (enrolling)
• Eye Associates of New Jersey — Dover, New Jersey, United States (enrolling)
• Northern New Jersey Eye Institute — South Orange, New Jersey, United States (enrolling)
• Ophthalmic Partners, PC — Bala-Cynwyd, Pennsylvania, United States (enrolling)
• Berkeley Eye Center — Sugar Land, Texas, United States (enrolling)
• Utah Eye Centers — Bountiful, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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