Evaluating the Role of Incision Height in Improving Trichiasis Surgery Outcomes

点击翻译按钮获取中文摘要

 DESCRIPTION (provided by applicant): The primary objective of this randomized clinical trial is to determine whether the height of the incision made during trichiasis surgery affects surgical outcomes as measured within 12 months after surgery. The trial will be conducted in southern Ethiopia, where trachomatous trichiasis is endemic. Approximately 2,400 adult subjects will be enrolled. They will be randomized on a 1:1 basis to surgery with an incision height of 3 mm or 5 mm. Sutures will be removed 2 weeks after surgery and participants will be examined again at 6 weeks and 12 months after surgery. The primary outcome is presence of post-operative trichiasis, defined as one or more lashes touching the eye or confirmed evidence of epilation. The secondary outcome is presence of a moderate or severe eyelid contour abnormality. Nearly 8 million individuals are in need of trichiasis surgery. If this trial is successful in reducing th rate of post-operative trichiasis by 25%, an estimated 300,000 individuals will be spared from post-operative trichiasis, which will allow reallocation of resources from repeat surgery to provide services to hundreds of thousands of individuals needing initial trichiasis surgery.