Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium
Recruiting
- Conditions
- Corneal Endothelium
- Registration Number
- NCT05835141
- Lead Sponsor
- University of Southern California
- Brief Summary
To determine what proportion of patients have inferior angle recess dimensions that could accommodate the OTX-TIC, and what are risk factors for implant contact with the corneal endothelium.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome 1 4-6 Months Predict contact between simulated OTX-TIC implant and corneal endothelium imaged using the ANTERION AS-OCT system.
Primary Outcome 2 4-6 Months Characterize the variability in distance (mean and standard deviation) between the angle recess and Schwalbe's line
Primary Outcome 3 4-6 Months Calculate the proportion of eyes with predicted contact between the simulated implant and corneal endothelium.
Primary Outcome 4 4-6 Months Develop logistic regression models to identify demographic, clinical, and biometric risk factors for predicted contact.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
USC Roski Eye Institute
🇺🇸Los Angeles, California, United States