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NCT Number: NCT07322302

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kongwa Trachoma Project, Mtwara, Tanzania

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About this study

The investigators will randomize 1000 individuals with post-operative trichiasis on a 1:1 basis to standard BLTR surgery or the recently developed Bevel-Rotate Advancement Procedure (B-RAP). Participants will receive trichiasis surgery and will be followed at 1 day, 2 weeks and 3, 6, 9 12, 18 and 24 months after surgery. The primary outcome is development of repeat post-operative trachomatous trichiasis (rPTT) within 12 months after surgery. Logistic regression analyses will be performed to compare the rates of PTT between the two procedures, controlling for demographic characteristics and pre-operative trichiasis severity.

Secondary outcomes include pyogenic granuloma formation and eyelid contour abnormalities as well as patient-reported outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • All eyes with previously operated trichiasis that are phthisical

Treatment and study plan

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.

Primary outcomes

  1. 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

    Presence of post-operative trichiasis defined as at least one trichiatic eyelash or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze. The outcome will be assessed at 3, 6, 9 and 12 months. If the eyelid has trichiasis at 2 weeks, but not at any future visit, the eyelid will not be considered to have rPTT.

Secondary outcomes

  1. Number of eyelids with moderate/severe eyelid contour abnormalities (ECA)

    Time frame: Assessed at last study visit (max: 2 years)

    The grader will assess for eyelid contour abnormalities (ECA) and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. Results will be based on photograph grades.

    Category definitions are: 1) Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length. 2) Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length 3) Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length

  2. Number of eyelids with clinically significant rPTT by twelve months

    Time frame: >2 weeks and up to 12 months after surgery

    Presence of clinically significant rPTT is defined as evidence of entropion AND either 1) >2 lashes touching the eye peripherally (Not touching the cornea in primary gaze) or 2) at least one eyelash emanating from the central portion of the eyelid, touching the cornea in primary gaze. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze. The outcome will be assessed at 3, 6, 9 and 12 months. If the eyelid has trichiasis at 2 weeks, but not at any future visit, the eyelid will not be considered to have rPTT.

  3. Number of eyelids with rPTT by 24 months

    Time frame: Between two weeks and twenty four months after surgery

    Presence of repeat post-operative trichiasis defined as at least one trichiatic eyelash or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze. The outcome will be assessed at 3, 6, 9, 12, 18 and 24 months. If the eyelid has trichiasis at 2 weeks, but not at any future visit, the eyelid will not be considered to have rPTT.

  4. Number of eyelids with each level of rPTT Severity

    Time frame: At first visit where rPTT is detected (up to 2 years after surgery)

    Severity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated.

    Trichiasis severity will be defined using the following categories:

    • i. Mild: 1-4 eyelashes touching globe and no epilation OR <1/3 eyelashes epilated and no eyelashes touching the globe
    • ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and <1/3 eyelashes epilated
    • iii. Severe: 5-9 eyelashes touching globe and <1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR ≥1/3 eyelashes epilated (regardless of eyelashes touching globe)
  5. Cumulative number of eyelids with pyogenic granuloma

    Time frame: Any time between surgery and 24 months after surgery

    Pyogenic granulomas occasionally develop after trichiasis surgery. It is thought that this is a response to a foreign material, such as a sutures or an incision edge. All granulomas will be noted regardless of size. The investigators will count granulomas observed at the 3, 6, 9, 12, 18 and 24 month visit s(including participants where the granuloma was removed)

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Gower, PhD

CONTACT

[email protected]

919 966 1420

Jerusha Weaver, MPH

CONTACT

[email protected]

919 966 3527

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Kongwa Trachoma Project
  • National Eye Institute (NEI)
  • University of Pennsylvania
  • University of Virginia

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 7, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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