Two approaches to repeat eyelid surgery for post-operative trichiasis
Official title: Repeat Eyelid Surgery for Trichiasis: Optimizing Results in East Africa (RESTORE): A Randomized Controlled Trial Comparing Two Surgical Techniques for Repeat Trichiasis Surgery Performed by Integrated Eye Care Workers
Run by University of North Carolina, Chapel Hill · NCT07322302 · Data updated 2026-11-12
This project will try whether the newer Bevel-Rotate Advancement Procedure (B-RAP) or the standard Bilamellar Tarsal Rotation (BLTR) gives better results for people in Tanzania who need repeat surgery for post-operative trachomatous trichiasis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Status | Recruiting |
| Started | January 13, 2026 |
| Main results expected | August 31, 2029 |
| Study ends | August 31, 2029 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07322302 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with one or both upper eyelids showing post-operative trachomatous trichiasis who previously had upper eyelid TT surgery, can provide informed consent, and can attend scheduled follow-up visits are ideal candidates.
✕Probably not a fit
People without prior TT surgery, those with phthisical previously operated eyes, or those unable to provide informed consent or attend follow-up visits are unlikely to receive benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a randomized 1:1 design, 1,000 people with post-operative trachomatous trichiasis (PTT) will be assigned to receive either B-RAP or BLTR performed by 8–10 integrated eye care workers. Participants will be followed at 1 day, 2 weeks, and 3, 6, 9, 12, 18, and 24 months to monitor repeat trichiasis, eyelid contour changes, pyogenic granuloma formation, and patient-reported outcomes. The primary outcome is repeat PTT within 12 months, and logistic regression will compare rates between procedures while controlling for demographic factors and pre-operative severity. The trial is led by the University of North Carolina in collaboration with regional partners including the Kongwa Trachoma Project in Tanzania.
Why it matters
Potential benefit: If B-RAP lowers the rate of repeat trichiasis compared with BLTR, it could reduce reoperations and improve long-term eyelid position and quality of life for patients globally.
How similar studies have gone: BLTR is the established standard procedure and B-RAP is a recently developed technique with limited prior data, so a randomized comparison represents novel evidence.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of North Carolina
Chapel Hill, North Carolina, United States Recruiting -
Kongwa Trachoma Project
Mtwara, Tanzania Recruiting
Study contacts
- Principal investigator: Emily Gower, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Emily Gower, PhD
- Email: egower@unc.edu
- Phone: 919 966 1420
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.