Two approaches to repeat eyelid surgery for post-operative trichiasis
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
NA · University of North Carolina, Chapel Hill · NCT07322302
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Trial ID | NCT07322302 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chapel Hill, North Carolina and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Trachoma, Eye Diseases, Trichiasis, Surgery, Oculoplastics, trichiasis, trachoma