Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial (PTT)

The objective of this study is to determine if there is a significant difference in post-operative trichiasis at 12 months comparing a new procedure, the Bevel/rotate/advance procedure (BRAP), to the Trabut procedure among repeat surgery patients.

Study Overview

• Status: Completed
• Conditions: Surgery; Trichiasis
• Intervention / Treatment: Procedure: BRAP (Bevel/rotate/advance procedure); Procedure: Trabut

Detailed Description

The investigators will randomize participants with previously operated trichiasis on a 1:1 basis to receive either the Bevel/rotate/advance procedure (BRAP) or the Trabut procedure. The participants will be followed at 1 day, 2 weeks, 3-6 months, and then 12 months following the surgery. The primary study endpoint is recurrence of post-operative trichiasis within 12 months of surgery. The investigators will conduct logistic regression analysis comparing post-operative trichiasis recurrent rates in participants receiving BRAP versus participants receiving Trabut. Adjusted analyses will account for demographic characteristics as well as trichiasis severity prior to surgery.

• Study Type: Interventional
• Enrollment (Actual): 886
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Southerns Nations, Nationalities, And Peoples' Region
    • Hosa'ina, Southerns Nations, Nationalities, And Peoples' Region, Ethiopia
      • Orbis Ethiopia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 or older
• At least one eyelid with post-operative upper eyelid trichiasis
• Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

• Inability to provide independent, informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BRAP (Bevel/rotate/advance procedure); The BRAP procedure is a full-thickness beveled full-thickness incision	Procedure: BRAP (Bevel/rotate/advance procedure); Trichiasis surgery using the BRAP procedure; Other Names: BRAP procedure
Active Comparator: Trabut 3 mm; The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.	Procedure: Trabut; Trichiasis surgery using the Trabut procedure; Other Names: Trabut procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Eyelids With Post-operative Trichiasis Within 12 Months	Presence of post-operative trichiasis defined as at least one trichiatic eyelashes or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in the primary gaze. The outcome will be assessed at 3-6 months and at 12 months. If the eyelid has trichiasis at 2 weeks, but not at 3-6 months or 12 months, the eyelid will not be considered to have post-operative trichiasis. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.	10-20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months	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.	3-6 months
Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months	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) OR entire eyelid epilated	3-6 months
Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months	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) OR entire eyelid epilated. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.	10-20 months
Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System	The change in PTT severity between 3-6 months and 12 months will be measured in eyes with PTT at 3-6 months that also were examined at the 12-month visit. Change will be measured in the difference in the number of categories between 3-6 month and 1 year outcome. For example, Mild to Severe would be a 2 category change.	10-20 months
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months	The examiner 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. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe. The definitions for the categories 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 len	3-6 months
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months	The examiner in the field will assess for eyelid contour abnormalities 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. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe. The definitions for the categories 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	10-20 months
Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months	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 month visit (including participants where the granuloma was removed) and granulomas observed at the 12 month visit. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.	10-20 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: University of Maryland, Baltimore; National Eye Institute (NEI); Orbis
• Investigators: Principal Investigator: Emily Gower, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2019
• Primary Completion (Actual): October 22, 2022
• Study Completion (Actual): October 22, 2022

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Trichiasis
• Other Study ID Numbers: 17-2766; UG1EY025992-04S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be made available at the time of publication of the primary and pre-planned secondary results papers.
• IPD Sharing Time Frame: Deidentified individual data that support the results will be shared beginning 9 to 36 months following publication.
• IPD Sharing Access Criteria: An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No