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Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium

Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05835141
Enrollment
100
Registered
2023-04-28
Start date
2023-05-01
Completion date
2024-05-31
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Endothelium

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.

Interventions

Each participant will receive imaging of the inferior sectors of the iridocorneal angle at 150°, and 180°, and 210° with the swept-source ANTERION AS-OCT system under standardized light and dark lighting conditions by a trained research technician

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome 24-6 MonthsCharacterize the variability in distance (mean and standard deviation) between the angle recess and Schwalbe's line
Primary Outcome 14-6 MonthsPredict contact between simulated OTX-TIC implant and corneal endothelium imaged using the ANTERION AS-OCT system.
Primary Outcome 34-6 MonthsCalculate the proportion of eyes with predicted contact between the simulated implant and corneal endothelium.
Primary Outcome 44-6 MonthsDevelop logistic regression models to identify demographic, clinical, and biometric risk factors for predicted contact.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026