The FLuorometholone as Adjunctive MEdical Therapy for Trachomatous Trichiasis Surgery (FLAME) Trial: Study Design.

Abstract

To report the design of FL uorometholone as A djunctive ME dical Therapy for TT Surgery (FLAME) Trial. Parallel design, double-masked, placebo-controlled clinical trial with 1:1 randomization to fluorometholone 0.1% eyedrops twice daily or placebo twice daily for four weeks in eyes undergoing trachomatous trichiasis (TT) surgery; assessing the efficacy, safety, and cost-effectiveness of fluorometholone 0.1% in preventing recurrent postoperative trichiasis. Up to 2500 eligible persons with trachomatous trichiasis (TT) undergoing lid rotation surgery will be enrolled in Jimma zone, Ethiopia. Participants, surgeons, study field staff, and study supervisors leading operational aspects of the trial are masked to treatment assignment. Randomization is stratified by surgeon, which simultaneously stratifies by the district. The study visits are at baseline/enrollment, at four-week post-enrollment, six months, and one year (study exit). The primary outcome is cumulative one-year postoperative TT (PTT) incidence, defined as: ≥1 lashes touching the globe, evidence of epilation, and/or repeat TT surgery. Secondary postoperative outcomes include number of trichiatic lashes, location thereof (touching the cornea or not), evidence of post-operative epilation, entropion, changes in corneal opacity, IOP elevation, need for cataract surgery, visual acuity change from baseline, eyelid contour abnormality, granuloma, eyelid closure defect, and occurrence of adverse events. Health economic analyses center on calculating the incremental cost per case of PTT avoided by fluorometholone treatment. The FLAME Trial is designed to provide evidence of the efficacy, safety, and cost-effectiveness of adjunctive topical peri-/postoperative fluorometholone 0.1% therapy with trichiasis surgery, which is hypothesized to reduce the risk of recurrent trichiasis while being acceptably safe. Trial Registration: ClinicalTrials.gov # NCT04149210.