Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium
Sponsor
University of Southern California (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05835141
Collaborator
(none)
100
8
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium
Anticipated Study Start Date
:
May 1, 2023
Anticipated Primary Completion Date
:
Sep 30, 2023
Anticipated Study Completion Date
:
Dec 31, 2023
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Southern California
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Benjamin Xu,
Assistant Professor,
University of Southern California
ClinicalTrials.gov Identifier:
NCT05835141
Other Study ID Numbers:
- The XU Study
First Posted:
Apr 28, 2023
Last Update Posted:
Apr 28, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No