NCT05835141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

April 17, 2023

Last Update Submit

September 26, 2025

Conditions

Corneal Endothelium

Outcome Measures

Primary Outcomes (4)

  • Primary Outcome 1

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

    4-6 Months

  • Primary Outcome 2

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

    4-6 Months

  • Primary Outcome 3

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

    4-6 Months

  • Primary Outcome 4

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

    4-6 Months

Interventions

OCT ImagingOTHER

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study aims to enroll 100 patients undergoing routine evaluation with Dr. Benjamin Xu at the USC Roski Eye Institute.

You may qualify if:

  • Age over 40 years
  • No history of ocular surgery other than cataract surgery

You may not qualify if:

  • \- Media opacities that preclude OCT imaging of the anterior segment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Roski Eye Institute

Los Angeles, California, 90033, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 17, 2023

First Posted

April 28, 2023

Study Start

May 1, 2023

Primary Completion

January 30, 2024

Study Completion

May 31, 2024

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)