N/A
N=700
Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial
Trichiasis · Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03886519 ↗Enrolled (actual)
700
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Number of Eyelids With Post-operative Trichiasis Within 12 Months — 94; 120 Eyelids — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BRAP (Bevel/rotate/advance procedure) (Procedure); Trabut (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eyelids With Post-operative Trichiasis Within 12 Months |
94; 120 | 0.07 |
| SECONDARY Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months |
33; 49 | — |
| SECONDARY Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months |
284; 288; 21; 32; 7; 11 | — |
| SECONDARY Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months |
310; 281; 47; 76; 24; 23 | — |
| SECONDARY Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System |
21; 43; 6; 1; 1; 3 | — |
| SECONDARY Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months |
225; 236; 92; 101 | — |
| SECONDARY Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months |
317; 334; 82; 65 | — |
| SECONDARY Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months |
3; 10 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03886519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.