Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial (PTT)
Primary Purpose
Trichiasis, Surgery
Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
BRAP (Bevel/rotate/advance procedure)
Trabut
Sponsored by
About this trial
This is an interventional treatment trial for Trichiasis
Eligibility Criteria
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
Sites / Locations
- Orbis Ethiopia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
BRAP (Bevel/rotate/advance procedure)
Trabut 3 mm
Arm Description
The BRAP procedure is a full-thickness beveled full-thickness incision
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
Change in severity of post-operative trichiasis between 3-6 months and 1 year using grading system
The investigators will examine progression of severity between 3-6 months and a year and assess predictors of change in severity. Change will be measured in terms of number of categories between 3-6 month and 1 year outcome. E.g. Mild to Severe would be a 2 category change.
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
Number of eyelids with moderate/severe eyelid contour abnormalities at 3-6 months
The eye 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
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
Cumulative number of eyelids with presence of pyogenic granulomas within 12 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 12 months.
Number of eyelids with other abnormalities at 12 months
The eye examiner will examine the eyes for other abnormalities at 12 months: gaps between eyelid and the eye, abnormally thick eyelid, overcorrected eyelids, and infections
Number of eyes with punctate epithelial erosion at 12 months
The eye examiner will assess the cornea for signs of corneal damage such as punctate epithelial erosions, using fluorescein staining and a blue light.
Full Information
NCT ID
NCT03886519
First Posted
March 20, 2019
Last Updated
September 11, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Orbis, National Eye Institute (NEI), University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT03886519
Brief Title
Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial
Acronym
PTT
Official Title
Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2019 (Actual)
Primary Completion Date
October 22, 2022 (Actual)
Study Completion Date
October 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Orbis, National Eye Institute (NEI), University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichiasis, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
886 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BRAP (Bevel/rotate/advance procedure)
Arm Type
Active Comparator
Arm Description
The BRAP procedure is a full-thickness beveled full-thickness incision
Arm Title
Trabut 3 mm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
BRAP (Bevel/rotate/advance procedure)
Other Intervention Name(s)
BRAP procedure
Intervention Description
Trichiasis surgery using the BRAP procedure
Intervention Type
Procedure
Intervention Name(s)
Trabut
Other Intervention Name(s)
Trabut procedure
Intervention Description
Trichiasis surgery using the Trabut procedure
Primary Outcome Measure Information:
Title
Number of eyelids with post-operative trichiasis within 12 months
Description
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.
Time Frame
10-20 months
Secondary Outcome Measure Information:
Title
Number of eyelids with presence of post-operative trichiasis within 3-6 months
Description
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.
Time Frame
3-6 months
Title
Number of eyelids with each of the trichiasis severity levels at 3-6 months
Description
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
Time Frame
3-6 months
Title
Number of eyelids with each of the trichiasis severity levels at 12 months
Description
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
Time Frame
10-20 months
Title
Change in severity of post-operative trichiasis between 3-6 months and 1 year using grading system
Description
The investigators will examine progression of severity between 3-6 months and a year and assess predictors of change in severity. Change will be measured in terms of number of categories between 3-6 month and 1 year outcome. E.g. Mild to Severe would be a 2 category change.
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
Time Frame
10-20 months
Title
Number of eyelids with moderate/severe eyelid contour abnormalities at 3-6 months
Description
The eye 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
Time Frame
3-6 months
Title
Number of eyelids with moderate/severe eyelid contour abnormalities at 12 months
Description
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
Time Frame
10-20 months
Title
Cumulative number of eyelids with presence of pyogenic granulomas within 12 months
Description
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 12 months.
Time Frame
10-20 months
Title
Number of eyelids with other abnormalities at 12 months
Description
The eye examiner will examine the eyes for other abnormalities at 12 months: gaps between eyelid and the eye, abnormally thick eyelid, overcorrected eyelids, and infections
Time Frame
10-20 months
Title
Number of eyes with punctate epithelial erosion at 12 months
Description
The eye examiner will assess the cornea for signs of corneal damage such as punctate epithelial erosions, using fluorescein staining and a blue light.
Time Frame
10-20 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Gower, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orbis Ethiopia
City
Hosa'ina
State/Province
Southerns Nations, Nationalities, And Peoples' Region
Country
Ethiopia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
22745845
Citation
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.
Results Reference
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Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial
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