Corneal EndotheliumNCT05835141
Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium
An observational study of Corneal Endothelium, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Endothelium
- What is being tested?
- OCT Imaging
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study aims to enroll 100 patients undergoing routine evaluation with Dr. Benjamin Xu at the USC Roski Eye Institute.
Who may be able to join
- Age over 40 years
- No history of ocular surgery other than cataract surgery
Who cannot join
- Media opacities that preclude OCT imaging of the anterior segment
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Roski Eye Institute
Los Angeles, California, 90033
About this study
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.
- Conditions
- Corneal Endothelium
- Being tested
- OCT Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome 1
Predict contact between simulated OTX-TIC implant and corneal endothelium imaged using the ANTERION AS-OCT system.
Measured: 4-6 Months
Primary Outcome 2
Characterize the variability in distance (mean and standard deviation) between the angle recess and Schwalbe's line
Measured: 4-6 Months
Primary Outcome 3
Calculate the proportion of eyes with predicted contact between the simulated implant and corneal endothelium.
Measured: 4-6 Months
Primary Outcome 4
Develop logistic regression models to identify demographic, clinical, and biometric risk factors for predicted contact.
Measured: 4-6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 May 2023
- Primary completion30 Jan 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EndotheliumStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Xu, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835141
- Sponsor's protocol ID
- The XU Study
- Status last verified
- Sep 2025
- First submitted
- 17 Apr 2023
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium
- ClinicalTrials.gov ID
- NCT05835141
- Acronym / sponsor ID
- The XU Study
- Conditions
- Corneal Endothelium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study aims to enroll 100 patients undergoing routine evaluation with Dr. Benjamin Xu at the USC Roski Eye Institute.
Key inclusion criteria (2 listed)
- Age over 40 years
- No history of ocular surgery other than cataract surgery
Key exclusion criteria (1 listed)
- Media opacities that preclude OCT imaging of the anterior segment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT ImagingEach 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 | Other | – |
Primary outcome
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.
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
Primary Outcome 3
Time frame: 4-6 Months
Calculate the proportion of eyes with predicted contact between the simulated implant and corneal endothelium.
Primary Outcome 4
Time frame: 4-6 Months
Develop logistic regression models to identify demographic, clinical, and biometric risk factors for predicted contact.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Endothelium, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome 1 (time frame: 4-6 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.