Actively Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-13
1000
Participants Needed
2
Research Sites
189 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
U
University of Virginia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- One or both eyes with upper eyelid post-operative trachomatous trichiasis (PTT), with a plan to undergo PTT surgery
- Previous upper eyelid trichiasis surgery in the study eye(s)
- Collection of all baseline data prior to randomization
- Signed, informed consent
You will not qualify if you...
- Unable to provide informed consent
- All eyes with previously operated trichiasis that are phthisical
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
2
Kongwa Trachoma Project
Mtwara, Tanzania
Actively Recruiting
Research Team
E
Emily Gower, PhD
CONTACT
J
Jerusha Weaver, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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