IC-8 Apthera IOL New Enrollment Post Approval Study

Launched by BAUSCH & LOMB INCORPORATED · Sep 23, 2023

Keywords

ClinConnect Summary

The IC-8 Apthera IOL New Enrollment Post Approval Study is looking at the safety of a specific type of eye implant called the IC-8 Apthera IOL after treatment for posterior capsule opacification (PCO). PCO is a common complication that can occur after cataract surgery, where the back of the lens becomes cloudy. This study is currently recruiting participants who are 22 years or older and have had PCO that needs treatment in an eye that has received the IC-8 Apthera IOL.

To be eligible for the study, participants should be able to understand the study and provide consent, have clear vision in both eyes, and meet specific eye health criteria. Participants can expect to attend several study visits to monitor their eye health and the performance of the implant. It's important to note that individuals with certain eye conditions, health issues, or who are pregnant or breastfeeding may not qualify for this study. If you’re interested in participating, it could be a valuable opportunity to help further research on this eye implant while also receiving care for your condition.

Gender

ALL

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