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RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)

RecruitingNAAges 18 Years - anyAllUniversity of North Carolina, Chapel Hill
NCT07322302 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • B-RAP
  • BLTR
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Where

2 sites
University of North Carolina
Chapel Hill, United States
Kongwa Trachoma Project
Mtwara, Tanzania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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