FLAME Trial: Reevaluating Adjunctive Therapy in Trachomatous Trichiasis Surgery

The FLAME trial found that adjunctive topical fluorometholone did not reduce postoperative trachomatous trichiasis recurrence compared with placebo.

FLAME was a randomized, double‑blind, placebo‑controlled field trial in a trachoma‑endemic setting, with blinded outcome assessment and standard postoperative follow‑up.

Primary endpoints—postoperative trichiasis recurrence and prespecified surgical outcomes—showed no statistically significant or clinically meaningful benefit for adjunctive fluorometholone versus placebo. Blinded assessments reported near‑identical event rates in both arms. In short, perioperative topical fluorometholone provided no measurable advantage on surgical outcomes.

Adverse‑event rates and severity distributions were comparable between fluorometholone and placebo, with no new ocular or systemic safety signals identified—reassuring but not sufficient to offset the null efficacy finding.