BLTR vs B-RAP for Trichiasis
What You Need to Know Before You Apply
What is the purpose of 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. 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.
Who Is on the Research Team?
Emily Gower, PhD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for individuals in Tanzania who have had previous upper eyelid surgery for trichiasis and are planning to undergo another one. They must have collected all baseline data and signed an informed consent form.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo trichiasis surgery using either the B-RAP or BLTR procedure
Follow-up
Participants are monitored for repeat post-operative trachomatous trichiasis (rPTT) and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- BLTR
- B-RAP
Trial Overview
The RESTORE trial is comparing two surgical techniques, B-RAP and BLTR, to see which is more successful at treating repeat trichiasis. The goal is to determine if one method can prevent the condition from returning within a year after surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Trichiasis surgery using the B-RAP procedure.
Trichiasis surgery using the BLTR procedure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
University of Virginia
Collaborator
Kongwa Trachoma Project
Collaborator
National Eye Institute (NEI)
Collaborator
University of Pennsylvania
Collaborator
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