Assessing the contact between an ocular implant and the corneal endothelium
Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium
This study is testing how well an eye implant fits in patients' eyes and if it safely stays away from the cornea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05835141 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the proportion of patients whose inferior angle recess dimensions can accommodate the OTX-TIC intracameral ocular implant. It will also identify risk factors associated with contact between the implant and the corneal endothelium. The methodology involves using OCT imaging to gather data on the anterior segment of the eye. By analyzing these factors, the study seeks to enhance the understanding of the implant's safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 40 years old with no history of ocular surgery other than cataract surgery.
Not a fit: Patients with media opacities that prevent OCT imaging of the anterior segment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety profile of the OTX-TIC implant for patients requiring ocular interventions.
How similar studies have performed: While this specific approach is observational, similar studies using OCT imaging have shown promise in assessing ocular implants and their interactions with eye structures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 40 years * No history of ocular surgery other than cataract surgery Exclusion Criteria: - Media opacities that preclude OCT imaging of the anterior segment
Where this trial is running
Los Angeles, California
- USC Roski Eye Institute — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Joseph Yim
- Email: joseph.yim@med.usc.edu
- Phone: 323-865-6823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.