Conjunctivitis (Pink Eye) Clinical Trials

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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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Other Locations
United Republic of Tanzania
Kongwa Trachoma Project
RECRUITING
Mtwara
Contact Information
Primary
Emily Gower, PhD
egower@unc.edu
919 966 1420
Backup
Jerusha Weaver, MPH
jweave25@unc.edu
919 966 3527
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 1000
Treatments
Experimental: Bevel/rotate/advance procedure (B-RAP)
Trichiasis surgery using the B-RAP procedure.
Active_comparator: Bilamellar tarsal rotation (BLTR)
Trichiasis surgery using the BLTR procedure.
Related Therapeutic Areas
Sponsors
Collaborators: Kongwa Trachoma Project, University of Virginia, National Eye Institute (NEI), University of Pennsylvania
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov