RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Recruiting
N/A
Interventional Study
Trachoma
Eye Diseases
Trichiasis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,000 (estimated)
- Sponsor
- University of North Carolina, Chapel Hill · Other
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About This Trial
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.…
Trial Locations
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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
* Al…
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