N/A
N=4,914
Maximizing Trichiasis Surgery Success
Trichiasis · Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03100747 ↗Enrolled (actual)
4,914
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months — 347; 504; 298 eyes — p=0.039
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bilamellar 3 mm (Procedure); Bilamellar 5 mm (Procedure); Trabut 3 mm (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months |
347; 504; 298 | 0.039 sig |
| SECONDARY Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks |
47; 101; 59 | — |
| SECONDARY Severity of Post-Operative Trichiasis at 6 Weeks |
2085; 2035; 2089; 35; 79; 42 | — |
| SECONDARY Severity of Post-Operative Trichiasis at 12 Months |
1714; 1620; 1801; 267; 348; 202 | — |
| SECONDARY Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks |
1748; 1845; 1716; 384; 291; 432 | — |
| SECONDARY Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months |
2040; 2151; 2015; 217; 139; 253 | 0.094 |
| SECONDARY Severity of Eyelid Contour Abnormalities at 6 Weeks |
1465; 1652; 1361; 283; 193; 354 | — |
| SECONDARY Severity of Eyelid Contour Abnormalities at 12 Months |
1780; 1909; 1678; 90; 76; 194 | — |
| SECONDARY Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year |
183; 159; 208; 1721; 1769; 1731 | — |
| SECONDARY Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks |
142; 109; 166 | — |
| SECONDARY Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months |
147; 118; 170 | 0.24 |
| SECONDARY Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years |
451; 663; 401 | — |
Summary
The purpose of this study is to determine whether the rate of post-operative trachomatous trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision height of 3 mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut surgery.
Eligibility Criteria
Inclusion Criteria
- At least one eyelid with previously unoperated 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
- All eyes with previously unoperated trichiasis are phthisical
Data sourced from ClinicalTrials.gov (NCT03100747). 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.