Safety assessment of the IC-8 Apthera IOL after cataract treatment

IC-8 Apthera IOL New Enrollment Post Approval Study

This study is testing the safety of the IC-8 Apthera eye lens in people who have had cataract surgery and need treatment for a common complication called posterior capsule opacification.

Quick facts

• Study type: Observational
• Enrollment: 435 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Bausch & Lomb Incorporated (Industry-sponsored)
• Locations: 14 sites (Dothan, Alabama and 13 other locations)
• Trial ID: NCT06060041 on ClinicalTrials.gov

What this trial studies

This observational study aims to verify the post-market safety of the IC-8 Apthera intraocular lens (IOL) following treatment for posterior capsule opacification (PCO) using Nd:YAG laser capsulotomy. It is a prospective, multi-center, single-group study where participants who have previously received the IC-8 Apthera IOL and developed PCO will be monitored over 24 months. Participants will undergo approximately six study visits to assess their safety and outcomes after the treatment. The study follows a standardized technique for Nd:YAG laser capsulotomy, ensuring that all surgeons are adequately trained.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 22 years or older who have received the IC-8 Apthera IOL and developed PCO requiring treatment.

Not a fit: Patients with irregular astigmatism, history of retinal disease, or other ocular abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable safety data that may enhance the clinical use of the IC-8 Apthera IOL in cataract surgery.

How similar studies have performed: While this study focuses on post-market safety, similar studies assessing IOLs have shown promising results in ensuring patient safety and efficacy.

Eligibility criteria

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

Where this trial is running

Dothan, Alabama and 13 other locations

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

Study contacts

• Study coordinator: Jennifer Laskowski

Conditions Cataract; Presbyopia; Posterior Capsule Opacification