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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07322302
Status
Recruiting
Apply to this trial

Conditions

  • Eye Diseases
  • Trachoma
  • Trichiasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • B-RAP — PROCEDURE
    B-RAP uses an incision beveled toward the eyelashes to thin the distal fragment and allow access to and removal of scarring from previous surgery. The distal fragment is rotated and the tarsus and conjunctiva are advanced downward to further correct the PTT.
  • BLTR — PROCEDURE
    A full-thickness incision is made through the anterior and posterior lamellae, parallel to and 3mm above the lid margin. Three sutures are placed externally to rotate and fix the eyelid.

Study Details

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.

Key Dates

Start date
Jan 13, 2026
Status verified
Dec 2025
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number of eyelids with repeat postoperative trachomatous trichiasis (rPTT) within 12 months after surgery [ Time Frame: >2 weeks after surgery to one year after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27599
Emily Gower, PhD
[email protected]
443-690-7653
Emily Gower, PhD (PRINCIPAL_INVESTIGATOR)
Shannath Merbs, MD, PhD (SUB_INVESTIGATOR)
Gui-shuang Ying, PhD (SUB_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By research site
University of North Carolina· Chapel Hill, NC

Related Studies