Trachoma, the leading infectious cause of blindness worldwide. Trachomatous trichiasis (TT), a complication of the chronic trachoma-induced cicatrization, is a key mechanism leading to blindness from trachoma. Currently, surgery to relieve trichiasis is a key global programmatic strategy to prevent trachoma blindness. Unfortunately, an undesirably high recurrence rate (about 20-30%) following TT surgery. Inflammation due to surgery itself and/or the trachomatous pathogenic process likely contributes to TT recurrence. Our preliminary trial found that anti- inflammatory fluorometholone 0.1% eyedrops was associated with ~1/3 lower risk of one-year TT recurrence than the placebo group, and fluorometholone 0.1% had minimal side effects. The FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial is a double- masked placebo-controlled randomized clinical trial to evaluate the efficacy, safety and cost- effectiveness of fluorometholone 0.1% eyedrops as an adjunctive therapy for TT surgery in Ethiopia. The Data Center (DC) will collaborate closely with the Study Chairman's Office, the Field Coordinating Center (FCC) in Ethiopia, the Executive Committee (EC), and the Data Safety Monitoring Committee (DSMC) to ensure the success of the trial. The DC's role for this trial is to provide leadership and expertise on design of trials, implementation and maintenance of high quality data management system, statistical analysis and publication of trial findings. Results of this trial will provide Level 1 evidence as to whether fluorometholone 0.1% eyedrops should be recommended as a programmatically useful strategy for widespread adoption into trachoma blindness alleviation programs. Proof of the efficacy, safety and its cost-effectiveness of fluorometholone 0.1% eyedrops would provide an opportunity to improve the treatment of TT and reduce the visual impairment and the blindness from TT globally.
Surgery to relieve trachomatous trichiasis (TT) is a key global programmatic strategy to prevent trachoma blindness. Unfortunately, recurrence following TT surgery is high (about 20-30%), and inflammation due to surgery itself and/or the trachomatous pathogenic process likely contributes to TT recurrence. The proposal trial is designed to evaluate the efficacy, safety and cost-effectiveness of anti-inflammatory fluorometholone 0.1% eyedrops as an adjunctive therapy for trachomatous trichiasis surgery in Ethiopia.
