RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
NCT ID: NCT07322302
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1000 participants
INTERVENTIONAL
2026-01-15
2029-08-31
Brief Summary
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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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Detailed Description
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Secondary outcomes include pyogenic granuloma formation and eyelid contour abnormalities as well as patient-reported outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bevel/rotate/advance procedure (B-RAP)
Trichiasis surgery using the B-RAP procedure.
B-RAP
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.
Bilamellar tarsal rotation (BLTR)
Trichiasis surgery using the BLTR procedure.
BLTR
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.
Interventions
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B-RAP
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
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.
Eligibility Criteria
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Inclusion Criteria
* Previous upper eyelid TT surgery in the study eye(s)
* Collection of all baseline data prior to randomization
* Signed, informed consent
Exclusion Criteria
* All eyes with previously operated trichiasis that are phthisical
18 Years
ALL
No
Sponsors
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University of Virginia
OTHER
University of Pennsylvania
OTHER
Kongwa Trachoma Project
UNKNOWN
National Eye Institute (NEI)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Emily Gower, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina
Chapel Hill, North Carolina, United States
Kongwa Trachoma Project
Mtwara, , Tanzania
Countries
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Central Contacts
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Facility Contacts
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References
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Kello AB, Merbs SL, Resnikoff S, West S, Mariotti SP, Solomon A. Trichiasis Surgery for Trachoma. 3rd ed. World Health Organization; 2024:80.
Habtamu E, Wondie T, Aweke S, Tadesse Z, Zerihun M, Gashaw B, Roberts CH, Kello AB, Mabey DCW, Rajak SN, Callahan EK, Macleod D, Weiss HA, Burton MJ. Oral doxycycline for the prevention of postoperative trachomatous trichiasis in Ethiopia: a randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2018 May;6(5):e579-e592. doi: 10.1016/S2214-109X(18)30111-6.
Habtamu E, Wondie T, Aweke S, Tadesse Z, Zerihun M, Zewudie Z, Kello AB, Roberts CH, Emerson PM, Bailey RL, Mabey DC, Rajak SN, Callahan K, Weiss HA, Burton MJ. Posterior lamellar versus bilamellar tarsal rotation surgery for trachomatous trichiasis in Ethiopia: a randomised controlled trial. Lancet Glob Health. 2016 Mar;4(3):e175-84. doi: 10.1016/S2214-109X(15)00299-5. Epub 2016 Jan 14.
Burton MJ, Kinteh F, Jallow O, Sillah A, Bah M, Faye M, Aryee EA, Ikumapayi UN, Alexander ND, Adegbola RA, Faal H, Mabey DC, Foster A, Johnson GJ, Bailey RL. A randomised controlled trial of azithromycin following surgery for trachomatous trichiasis in the Gambia. Br J Ophthalmol. 2005 Oct;89(10):1282-8. doi: 10.1136/bjo.2004.062489.
Rajak SN, Habtamu E, Weiss HA, Kello AB, Gebre T, Genet A, Bailey RL, Mabey DC, Khaw PT, Gilbert CE, Emerson PM, Burton MJ. Absorbable versus silk sutures for surgical treatment of trachomatous trichiasis in Ethiopia: a randomised controlled trial. PLoS Med. 2011 Dec;8(12):e1001137. doi: 10.1371/journal.pmed.1001137. Epub 2011 Dec 13.
West SK, West ES, Alemayehu W, Melese M, Munoz B, Imeru A, Worku A, Gaydos C, Meinert CL, Quinn T. Single-dose azithromycin prevents trichiasis recurrence following surgery: randomized trial in Ethiopia. Arch Ophthalmol. 2006 Mar;124(3):309-14. doi: 10.1001/archopht.124.3.309.
Gower EW, West SK, Harding JC, Cassard SD, Munoz BE, Othman MS, Kello AB, Merbs SL. Trachomatous trichiasis clamp vs standard bilamellar tarsal rotation instrumentation for trichiasis surgery: results of a randomized clinical trial. JAMA Ophthalmol. 2013 Mar;131(3):294-301. doi: 10.1001/jamaophthalmol.2013.910.
Khandekar R, Mohammed AJ, Courtright P. Recurrence of trichiasis: a long-term follow-up study in the Sultanate of Oman. Ophthalmic Epidemiol. 2001 Jul;8(2-3):155-61. doi: 10.1076/opep.8.2.155.4165.
Khandekar R, Thanh TT, Luong VQ. The determinants of trichiasis recurrence differ at one and two years following lid surgery in Vietnam: A community-based intervention study. Oman J Ophthalmol. 2009 Sep;2(3):119-25. doi: 10.4103/0974-620X.57311.
Gower EW, Sisay A, Bayissasse B, Seyum D, Weaver J, Munoz B, Keil AP, Bankoski A, Sullivan KM, Kana H, Admassu F, Tadesse D, Merbs SL. The impact of modified incision height and surgical procedure on trichiasis surgery outcomes: Results of the maximizing trichiasis surgery success (MTSS) randomized trial. PLoS Negl Trop Dis. 2024 Sep 3;18(9):e0012034. doi: 10.1371/journal.pntd.0012034. eCollection 2024 Sep.
Courtright P, Gower EW, Kello AB, Solomon AW. Second Global Scientific Meeting on Trachomatous Trichiasis, Cape Town 4-6 November 2015. (Solomon A, ed.). World Health Organization; 2016.
Merbs SL, Talero SL, Tadesse D, Sisay A, Bayissasse B, Weaver JU, Gower EW. A New Surgical Technique for Postoperative Trachomatous Trichiasis. Ophthalmic Plast Reconstr Surg. 2021 Nov-Dec 01;37(6):595-598. doi: 10.1097/IOP.0000000000002055.
Gower EW, West SK, Cassard SD, Munoz BE, Harding JC, Merbs SL. Definitions and standardization of a new grading scheme for eyelid contour abnormalities after trichiasis surgery. PLoS Negl Trop Dis. 2012;6(6):e1713. doi: 10.1371/journal.pntd.0001713. Epub 2012 Jun 26.
Kamuyu MK, Kelly M, Somerville S. A secondary analysis to determine countries and districts eligible for documented full geographic coverage for trichiasis case finding and outreaches. Int Health. 2023 Dec 4;15(15 Suppl 2):ii53-ii57. doi: 10.1093/inthealth/ihad075.
Other Identifiers
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24-2957
Identifier Type: -
Identifier Source: org_study_id
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