NCT06060041 IC-8 Apthera IOL New Enrollment Post Approval Study
| NCT ID | NCT06060041 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bausch & Lomb Incorporated |
| Condition | Cataract |
| Study Type | OBSERVATIONAL |
| Enrollment | 435 participants |
| Start Date | 2023-09-08 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 435 participants in total. It began in 2023-09-08 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06060041 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06060041 currently recruiting?
Yes, NCT06060041 is actively recruiting participants. Contact the research team at jennifer.laskowski@bausch.com for enrollment information.
Where is the NCT06060041 trial being conducted?
This trial is being conducted at Dothan, United States, Newport Beach, United States, Cape Coral, United States, Venice, United States and 10 additional locations.
Who is sponsoring the NCT06060041 clinical trial?
NCT06060041 is sponsored by Bausch & Lomb Incorporated. The trial plans to enroll 435 participants.