RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs) (NCT07322302)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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 can join: Review the eligibility criteria below.
Location: University of North Carolina โ Chapel Hill, North Carolina
Age range: 18 Years
๐งช Interventions in This Study
- B-RAP (PROCEDURE)
- BLTR (PROCEDURE)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- University of North Carolina โ Chapel Hill, North Carolina
- Kongwa Trachoma Project โ Mtwara,
๐ Contact the Study Coordinator
Phone: (919) 966-1420
Email: egower@unc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.