PTT: Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Number of eyelids with post-operative trichiasis within 12 months [10-20 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 [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 [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 [10-20 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 [10-20 months]
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 [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 [10-20 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 [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 12 months.
- Number of eyelids with other abnormalities at 12 months [10-20 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 [10-20 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orbis Ethiopia | Hosa'ina | Southerns Nations, Nationalities, And Peoples' Region | Ethiopia |
Sponsors and Collaborators
- University of North Carolina, Chapel Hill
- Orbis
- National Eye Institute (NEI)
- University of Maryland, Baltimore
Investigators
- Principal Investigator: Emily Gower, PhD, University of North Carolina, Chapel Hill
Study Documents (Full-Text)
None provided.More Information
Publications
- 17-2766
- UG1EY025992-04S1