TrachomaNCT07322302
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
A study testing B-RAP and BLTR in people with Trachoma and Eye Diseases, run by University of North Carolina, Chapel Hill at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trachoma, Eye Diseases, Trichiasis
- What is being tested?
- B-RAP and BLTR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Jan 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
- All eyes with previously operated trichiasis that are phthisical
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Emily Gower, PhD, 443-690-7653, egower@unc.edu
Emily Gower, PhD
Tanzania1 site, 1 recruiting
- Recruiting
Kongwa Trachoma Project
Mtwara
Harran Mkocha, MS, 255784313890, hmkocha@yahoo.com
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Trachoma, Eye Diseases, Trichiasis
- Being tested
- B-RAP, BLTR
- Keywords
- Surgery, Oculoplastics, trichiasis, trachoma
- Medical subject headings
- Trachoma, Eye Diseases, Trichiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-RAPProcedure or surgery
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.
BLTRProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Bevel/rotate/advance procedure (B-RAP) | Experimental | Trichiasis surgery using the B-RAP procedure. Receives: Procedure: B-RAP |
| Bilamellar tarsal rotation (BLTR) | Active comparator | Trichiasis surgery using the BLTR procedure. Receives: Procedure: BLTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eyelids with repeat postoperative trachomatous trichiasis (rPTT) within 12 months 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.
Measured: >2 weeks after surgery to one year after surgery
Secondary outcomes (5)
Number of eyelids with moderate/severe eyelid contour abnormalities (ECA)
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
Measured: Assessed at last study visit (max: 2 years)
Number of eyelids with clinically significant rPTT by twelve months
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.
Measured: >2 weeks and up to 12 months after surgery
Number of eyelids with rPTT by 24 months
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.
Measured: Between two weeks and twenty four months after surgery
Number of eyelids with each level of rPTT Severity
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)
Measured: At first visit where rPTT is detected (up to 2 years after surgery)
Cumulative number of eyelids with pyogenic granuloma
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)
Measured: Any time between surgery and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start13 Jan 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for TrachomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization at the person level, stratified by surgeon and baseline PTT severity (mild vs severe)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, University of Pennsylvania, Kongwa Trachoma Project, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Emily Gower, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322302
- Sponsor's protocol ID
- 24-2957
- Other IDs
- 1UG1EY036891
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made available at the time of publication of the primary and pre-planned secondary results papers.
Publications
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.
PubMed 29653629Habtamu 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.
PubMed 26774708Burton 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.
PubMed 16170117Rajak 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.
PubMed 22180732West 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.
PubMed 16534049Gower 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.
PubMed 23494035Khandekar 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.
PubMed 11471085Khandekar 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.
PubMed 20927208Gower 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.
PubMed 39226693Courtright 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.
PubMed 34570049Gower 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.
PubMed 22745845Kamuyu 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.
PubMed 38048374
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07322302
- Acronym / sponsor ID
- 24-2957
- Conditions
- Trachoma, Eye Diseases, Trichiasis
- Keywords
- Surgery, Oculoplastics, trichiasis, trachoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Virginia, University of Pennsylvania, Kongwa Trachoma Project, National Eye Institute (NEI)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization at the person level, stratified by surgeon and baseline PTT severity (mild vs severe)
| Arm | Type | Receives |
|---|---|---|
| Bevel/rotate/advance procedure (B-RAP) | Experimental | Procedure: B-RAPTrichiasis surgery using the B-RAP procedure. |
| Bilamellar tarsal rotation (BLTR) | Active comparator | Procedure: BLTRTrichiasis surgery using the BLTR procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- All eyes with previously operated trichiasis that are phthisical
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-RAPB-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. | Procedure or surgery | Bevel/rotate/advance procedure (B-RAP) |
| BLTRA 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. | Procedure or surgery | Bilamellar tarsal rotation (BLTR) |
Primary outcome
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.
5 secondary outcomes
Number of eyelids with moderate/severe eyelid contour abnormalities (ECA)
Time frame: Assessed at last study visit (max: 2 years)
Number of eyelids with clinically significant rPTT by twelve months
Time frame: >2 weeks and up to 12 months after surgery
Number of eyelids with rPTT by 24 months
Time frame: Between two weeks and twenty four months after surgery
Number of eyelids with each level of rPTT Severity
Time frame: At first visit where rPTT is detected (up to 2 years after surgery)
Cumulative number of eyelids with pyogenic granuloma
Time frame: Any time between surgery and 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- BackgroundKello AB, Merbs SL, Resnikoff S, West S, Mariotti SP, Solomon A. Trichiasis Surgery for Trachoma. 3rd ed. World Health Organization; 2024:80.
- Background: PubMed 29653629Habtamu 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.
- Background: PubMed 26774708Habtamu 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.
- Background: PubMed 16170117Burton 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.
- Background: PubMed 22180732Rajak 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.
- Background: PubMed 16534049West 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.
- Background: PubMed 23494035Gower 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.
- Background: PubMed 11471085Khandekar 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.
- Background: PubMed 20927208Khandekar 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.
- Background: PubMed 39226693Gower 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.
- BackgroundCourtright 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.
- Background: PubMed 34570049Merbs 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.
- Individual participant dataSharing planned: Yes. Deidentified data will be made available at the time of publication of the primary and pre-planned secondary results papers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Gower, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-RAP and BLTR in people with Trachoma and Eye Diseases, run by University of North Carolina, Chapel Hill at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Gower, PhD (919 966 1420, egower@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07322302, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.