Trachoma is the world's leading cause of infectious blindness, predominantly affecting low-income individuals and women, with Ethiopia being the most affected country. The disease causes scarring on the ocular surface, including the inner eyelids, leading to eyelashes turning inward (trachomatous trichiasis or TT) that scratch the cornea, resulting in blindness and constant discomfort.
The World Health Organization (WHO) aims to eliminate blindness from trachoma, partly through surgery for TT. Improving surgical outcomes is critical due to the common failure rate of TT surgery. The FLAME Trial, supported by the National Eye Institute of the NIH, was initiated to improve the quality of surgery and prevent blindness.
The FLAME Trial, a large-scale randomized controlled clinical trial conducted in the Jimma Zone, Ethiopia, evaluated whether fluorometholone 0.1% suspension, given before and for four weeks after surgery, would reduce the risk of postoperative TT recurrence. Over 2,400 participants received either active treatment or a placebo (artificial tears). Researchers often traveled to remote sites to conduct the study.
The study found no significant difference between the active fluorometholone treatment and placebo in preventing TT recurrence, with near-identical results in both groups. Safety profiles were also similar, indicating that fluorometholone use for four weeks is generally safe. These "negative" results suggest that anti-inflammatory therapy is unlikely to improve TT surgery outcomes.
Future efforts should focus on alternative strategies to improve TT surgery outcomes. A secondary analysis from the FLAME Trial indicated that the Posterior Lamellar Tarsal Rotation (PLTR) technique reduces recurrent postoperative TT by approximately 70% compared to the Bilamellar Tarsal Rotation technique. Additionally, refresher training in a structured supportive mentorship context has been shown to substantially reduce the risk of postoperative TT. Prioritizing quality assurance for TT surgery, alongside general preventive measures such as antibiotics, face washing, and environmental improvement, is considered key to achieving the most favorable outcomes.