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OpenTrials
Completed

NCT Number: NCT05835141

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

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.

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Key information

Conditions

Corneal Endothelium

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

USC Roski Eye Institute

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCT Imaging

Other

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

Primary outcomes

  1. Primary Outcome 1

    Time frame: 4-6 Months

    Predict contact between simulated OTX-TIC implant and corneal endothelium imaged using the ANTERION AS-OCT system.

  2. Primary Outcome 2

    Time frame: 4-6 Months

    Characterize the variability in distance (mean and standard deviation) between the angle recess and Schwalbe's line

  3. Primary Outcome 3

    Time frame: 4-6 Months

    Calculate the proportion of eyes with predicted contact between the simulated implant and corneal endothelium.

  4. Primary Outcome 4

    Time frame: 4-6 Months

    Develop logistic regression models to identify demographic, clinical, and biometric risk factors for predicted contact.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2023
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.