A major randomised clinical trial conducted in rural Ethiopia has found that adding a specific topical anti-inflammatory therapy to standard trachomatous trichiasis (TT) surgery does not reduce the risk of postoperative recurrence, despite earlier smaller studies suggesting potential benefit. The results, published in The Lancet Global Health, have important implications for efforts to improve surgical outcomes for trachoma, the world’s leading infectious cause of blindness.

Trachoma is caused by repeated infection with Chlamydia trachomatis, leading to scarring of the inner eyelids and inward-turning eyelashes that scratch the cornea (trichiasis). Surgery to rotate the eyelids outward is a key component of the World Health Organization’s strategy to prevent vision loss. However, a sizeable proportion of patients experience recurrent trichiasis after surgery (postoperative TT), which reduces the long-term benefits of the procedure.

The FLAME trial (Fluorometholone as Adjunctive Medical Therapy for TT Surgery) tested whether perioperative and postoperative use of fluorometholone 0.1% eye drops twice daily for four weeks could safely and cost-effectively decrease the likelihood of postoperative trichiasis. The study enrolled 2,410 participants aged 15 years and older across multiple surgical sites in the Jimma Zone of Ethiopia, randomly assigning them to receive fluorometholone or placebo (artificial tears) alongside their surgery.

At one year after surgery, the cumulative incidence of postoperative TT was 13.4% in both the fluorometholone and placebo groups — with 213 of 1,593 eyes in the treatment arm and 218 of 1,625 eyes in the placebo arm showing recurrence. There were no statistically significant differences between groups in secondary efficacy outcomes, patient satisfaction, or safety measures. Rates of adverse events attributed to the study treatments were low and similar between arms.

The trial’s findings demonstrate that, although fluorometholone is safe in this context, it does not provide additional benefit in preventing recurrence of trachomatous trichiasis when used adjunctively with surgery, and therefore is not recommended for routine programmatic implementation. Cost-effectiveness analyses also did not support its use given the lack of efficacy.

These results matter for global trachoma control strategies: by ruling out this adjunctive medical therapy, resources and research can be directed toward other avenues for improving surgical outcomes. Already, secondary analyses and other research suggest that surgical technique choice and quality assurance (including training and mentorship) may have a greater impact on reducing recurrence.

Trachoma elimination programmes now continue to emphasise evidence-based improvements in surgery delivery, service quality, and community engagement, while monitoring outcomes to optimise patient benefit. The FLAME trial provides a definitive answer on fluorometholone’s role in TT surgery and underscores the importance of large, rigorous trials in guiding public health interventions in underserved populations.

Publication

Kempen JH, Abashawl A, Mohammed AA et al. Evaluation of fluorometholone as adjunctive medical therapy for trachomatous trichiasis surgery (FLAME): a parallel, double-blind, randomised controlled field trial in the Jimma Zone, Ethiopia. The Lancet Global Health. January 2026. https://doi.org/10.1016/S2214-109X(25)00493-0