NOTE: The project dates for this administrative supplement are March 1, 2020 ? February 28, 2021. Project Abstract 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 5,000 adult subjects will be enrolled. They will be randomized on a 1:1:1 basis to bilamellar surgery with an incision height of 3 mm, bilamellar surgery with incision targeted at 5 mm or Trabut. Sutures will be removed 2 weeks after surgery and participants will be examined again at 6 weeks, 12 months and 3 years after surgery (extended follow up due to covid-related shutdowns). 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 the 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.
The World Health Organization has set a target of eliminating blinding trachoma, the leading infectious cause of blindness, by 2020, and reaching this target will require trichiasis surgery for nearly 8 million individuals worldwide. The goal of this trial is to try to improve surgery outcomes by altering the way that surgery is performed. This information will help National Trachoma Control programs worldwide to develop better surgical training guidelines by informing them of the importance (or lack thereof) of the incision height for the remaining several million trichiasis surgeries that must be done to tackle the backlog.
