Evaluating the Role of Incision Height in Improving Trichiasis Surgery Outcomes

 描述（由申请人提供）：这项随机临床试验的主要目的是确定倒睫手术期间切口的高度是否影响手术后12个月内测量的手术结果。该试验将在埃塞俄比亚南部进行，那里沙眼倒睫是地方病。将入组约2，400例成人受试者。他们将以1：1的比例随机接受手术，切口高度为3 mm或5 mm。手术后2周拆除缝线，并在术后6周和12个月再次对受试者进行检查。主要结局是术后倒睫的存在，倒睫定义为一根或多根睫毛接触眼睛或确认的脱毛证据。次要结局是存在中度或重度眼睑轮廓异常。近8百万人需要倒睫手术。如果这项试验成功地将术后倒睫率降低25%，估计将有30万人免于术后倒睫，这将允许重新分配重复手术的资源，为数十万需要初次倒睫手术的人提供服务。

 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.