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.

Public Health Relevance

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 s 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.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
1UG1EY025992-01
Application #
9000072
Study Section
Special Emphasis Panel (ZEY1)
Program Officer
Bhargava, Sangeeta
Project Start
2016-03-01
Project End
2020-02-29
Budget Start
2016-03-01
Budget End
2017-02-28
Support Year
1
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157