Trachomatous trichiasis remains the most vision-threatening consequence of trachoma – and a stubborn challenge for public health programs. Even after corrective eyelid surgery, relapse rates can be high enough to undermine both outcomes and patient confidence. Against that backdrop, the FLAME trial – led by John Kempen, Director of Epidemiology for Ophthalmology at Mass Eye and Ear and Harvard Medical School – set out to answer a pragmatic question: could a short course of low-potency topical steroid reduce postoperative trachomatous trichiasis (PTT) in a real-world, programmatic setting?
In this large, double-blind, randomized controlled field trial in Ethiopia’s Jimma zone, investigators evaluated fluorometholone 0.1% suspension eye drops as adjunctive therapy following trachomatous trichiasis surgery. The rationale was clear. Persistent conjunctival inflammation is common in endemic settings and is associated with progressive scarring – yet it is often not driven by active Chlamydia trachomatis infection. A low-dose steroid, therefore, might plausibly reduce inflammatory drive and lessen recurrence.
Between August 2021 and November 2024, 2,410 participants (3,235 eyes) aged 15 years and older were enrolled, with around 70 percent of participants self-reporting as female. Participants were randomised 1:1 to fluorometholone twice daily for 28 days (beginning perioperatively) or placebo (artificial tears). Randomization was stratified by surgeons, and masking extended to participants, surgeons, and outcome assessors. Follow-up rates were impressively high: approximately 98 percent of participants were evaluated at 12 months.
The results were unequivocal. At 12 months, cumulative PTT incidence was identical in both arms: 13.4 percent (218/1625 eyes placebo vs 213/1593 eyes fluorometholone). Safety, however, was reassuring. Steroid-class concerns – particularly IOP rise and cataract progression – were not borne out, and patient satisfaction with surgery was strikingly high (>99% were “satisfied” or “very satisfied”).
The takeaway for ophthalmologists working in trachoma-endemic settings is straightforward: fluorometholone twice daily for four weeks is safe, but it does not reduce relapse and is not cost-effective for program use. For now, improving surgical outcomes will likely depend less on postoperative drops – and more on surgical technique, training, and supervision.
