NCT07322302 RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
| NCT ID | NCT07322302 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Trachoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-01-13 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2026-01-13 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this randomized clinical trial is to determine whether repeat trichiasis surgery performed with Bevel-Rotate Advancement Procedure (B-RAP) improves surgical success compared to Bilamellar Tarsal Rotation (BLTR) among a group of 8-10 TT surgeons in Tanzania. The study aims to enroll 1,000 individuals with PTT. The primary outcome is repeat PTT within one year after surgery. Additionally, the study will assess eyelid contour abnormalities and how they change over a two-year period as well as patient reported outcomes. If this project is successful in improving surgical outcomes, it could change the approach to treating PTT globally. Individuals with trichiasis have a significantly reduced quality of life; correcting their trichiasis long-term has the potential to improve their quality of life and their family members' quality of life considerably.
Eligibility Criteria
Inclusion Criteria: * One or both eyes with upper eyelid PTT, with a plan to undergo PTT surgery * Previous upper eyelid TT surgery in the study eye(s) * Collection of all baseline data prior to randomization * Signed, informed consent Exclusion Criteria: * Unable to provide informed consent * All eyes with previously operated trichiasis that are phthisical
Contact & Investigator
Emily Gower, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT07322302 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trachoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07322302 currently recruiting?
Yes, NCT07322302 is actively recruiting participants. Contact the research team at egower@unc.edu for enrollment information.
Where is the NCT07322302 trial being conducted?
This trial is being conducted at Chapel Hill, United States, Mtwara, Tanzania.
Who is sponsoring the NCT07322302 clinical trial?
NCT07322302 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Emily Gower, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 1,000 participants.