In a significant development in the fight against trachoma, a debilitating eye disease, a recent study led by Dr. John Kempen from Mass Eye and Ear and Harvard Medical School has cast doubt on the effectiveness of a promising treatment. The study, published in The Lancet Global Health, evaluated the use of fluorometholone as an adjunctive therapy for trachomatous trichiasis surgery in Ethiopia’s Jimma Zone.
Trachoma remains the leading cause of infectious blindness globally, disproportionately affecting low-income populations and women. The disease is most prevalent in Africa, with Ethiopia bearing the highest burden. Trachoma leads to scarring on the inner eyelids, causing the eyelashes to turn inward and scratch the cornea, resulting in blindness if untreated.
Understanding Trachoma and Its Impact
The World Health Organization (WHO) has long targeted trachoma for eradication, emphasizing surgical interventions for trachomatous trichiasis (TT), where the eyelashes turn inward. However, the surgery’s success is not guaranteed, with failures being difficult to rectify. The FLAME Trial aimed to enhance surgical outcomes, potentially reducing blindness and improving life quality for those affected.
Dr. Kempen’s study, a large-scale field trial, sought to validate earlier promising results of fluorometholone, a low-risk anti-inflammatory treatment, in reducing postoperative TT. However, the trial’s findings did not confirm these initial results, suggesting that anti-inflammatory therapy might not significantly advance treatment outcomes.
The FLAME Trial: Methodology and Findings
Supported by the National Eye Institute of the NIH, the FLAME Trial was a randomized controlled clinical study involving over 2,400 participants. It compared the effects of fluorometholone to a placebo in preventing TT recurrence post-surgery. Researchers often traveled to remote areas, sometimes on motorcycles or on foot, to conduct surgeries and provide free treatment to nearly 3,000 individuals.
The trial’s results were clear: there was no significant difference in outcomes between the treatment and placebo groups, with both showing similar safety profiles. This finding is crucial for the broader use of fluorometholone in treating other conditions, but it suggests limited benefit in TT surgery.
“Our results convincingly showed no difference between the active fluorometholone treatment and placebo, with near-identical results between groups,” stated Dr. Kempen.
Implications and Future Directions
The FLAME Trial’s findings, alongside other studies, indicate that anti-inflammatory therapy may not enhance TT surgery outcomes. However, the rich dataset from the trial opens avenues for secondary analyses. One promising area is the refinement of surgical techniques.
Notably, a secondary analysis from the FLAME Trial highlighted the effectiveness of the “Posterior Lamellar Tarsal Rotation” (PLTR) technique, which showed a 70% reduction in recurrent TT compared to the “Bilamellar Tarsal Rotation” method. This aligns with previous research indicating a 50% reduction with PLTR.
“Focusing on quality assurance for TT surgery seems to be the key concept to make outcomes as favorable as possible,” Dr. Kempen emphasized.
Broader Context and Next Steps
As the global health community continues to battle trachoma, the emphasis may shift toward enhancing surgical quality and preventive measures. This includes refresher training for surgeons and broader public health initiatives such as antibiotic distribution, face washing, and environmental improvements.
The FLAME Trial was a collaborative effort, with contributions from researchers at Mass General Brigham and the University of Pennsylvania. It was funded by the National Eye Institute, Mass Eye and Ear Global Surgery Program, and other organizations, with fluorometholone provided by Allergan.
As new strategies are explored, the fight against trachoma remains a priority for global health, with ongoing research and innovation critical to eradicating this preventable cause of blindness.
