Evaluating the Role of a Novel Surgical Procedure in Improving Repeat Trichiasis Surgery Success

Univ Of North Carolina Chapel Hill, Chapel Hill NC

Investigators

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Abstract

Project Summary Trichiasis, inturned eyelashes that abrade the eye, is the leading infectious cause of blindness globally, affecting over 7 million individuals. While surgery is available to correct trichiasis, more than 20% experience post-operative trichiasis needing further surgical management. Yet current management procedures for post-operative trichiasis are poor. The primary objective of this randomized clinical trial is to determine whether repeat trichiasis surgery performed with a new, novel surgical procedure, the Bevel/Rotate/Advance Procedure (BRAP) improves surgical success compared to the current procedure, Trabut. This trial will be conducted in southern Ethiopia as an additional aim to an existing, ongoing project, the Maximizing Trichiasis Surgery Success (MTSS) Trial. Pairing this study with the MTSS trial will result in significant cost and time savings while maximizing the benefits to MTSS enrollees. All MTSS participants who present with post-operative trichiasis at their 12-month visit will be invited to participate. We anticipate 700 individuals will be enrolled and randomized on a 1:1 basis to surgery with RAP versus surgery with Trabut. The primary outcome will be second post-operative trichiasis within 6 months after surgery. If this project is successful in improving surgical outcomes, it could change the approach to treating post-operative trichiasis globally. Additionally, individuals with trichiasis have a significantly reduced quality of life; correcting their trichiasis long-term has the potential to improve their quality of life and their family members? quality of life considerably.