Reevaluating Anti-inflammatory Strategies in Trachomatous Trichiasis Surgery: Insights from the FLAME Trial

The FLAME trial found that topical fluorometholone does not reduce postoperative recurrence when used as an adjunct in trachomatous trichiasis surgery. Adding an ineffective anti-inflammatory diverts limited resources from proven surgical and programmatic interventions, prompting reevaluation of routine adjunctive strategies in trachoma surgery.

In a large, randomized, double‑blind, placebo‑controlled field trial in an endemic surgical setting, the FLAME trial enrolled more than 2,400 participants undergoing trachiasis surgery and compared topical fluorometholone with placebo alongside standard perioperative care. The primary outcome showed no statistically significant reduction in recurrence and no improvement in the prespecified surgical endpoint with fluorometholone. These randomized data do not support fluorometholone as a surgical adjunct to reduce recurrence.

Safety data were reassuring: fluorometholone was well tolerated and the study identified no new safety signals in the trial population. However, tolerability cannot substitute for absent efficacy when the outcome of interest is reduced postoperative recurrence; safety alone does not justify routine adjunctive use.

Given the null efficacy result, perioperative priorities should refocus on surgical quality, technique, and structured follow-up rather than routine anti-inflammatory adjuncts. Teams may emphasize preoperative screening, standardized surgical technique and training, intraoperative checklists to confirm key steps, and structured postoperative follow-up with outcome tracking. Strengthening surgical delivery and follow-up is likely a higher-yield route to lowering recurrence than adding topical anti-inflammatory agents.

Key Takeaways:

• FLAME provides large-scale randomized data showing no efficacy of topical fluorometholone as a surgical adjunct for trachomatous trichiasis.
• Fluorometholone was well tolerated but did not reduce recurrence; safety does not imply therapeutic value for this outcome.
• Programs may achieve greater gains by investing in surgical technique, training, and structured follow-up rather than routine anti-inflammatory adjuncts.