A recent study led by John Kempen, MD, MPH, PhD, MHS, Director of Epidemiology for Ophthalmology at Mass Eye and Ear and Harvard Medical School, has found that anti-inflammatory therapy with fluorometholone does not improve surgical outcomes in patients undergoing trachomatous trichiasis (TT) surgery. The findings were published in The Lancet Global Health.
Trachoma is the world’s leading cause of infectious blindness and disproportionately affects low-income populations and women. It is most prevalent in Africa, with Ethiopia bearing the highest burden. Trachoma leads to scarring on the eyelids which can cause eyelashes to turn inward and damage the cornea, resulting in blindness.
The World Health Organization (WHO) aims to eliminate blindness from trachoma through various strategies, including surgery for TT—an advanced stage where upper eyelashes are turned inward. However, surgical failures are common and difficult to address, making improvements in surgical outcomes a priority.
Kempen explained: "The FLAME Trial was a large-scale field trial in Ethiopia designed to confirm (or refute) the impressive results from a preliminary trial comparing three doses of a low-risk, topical anti-inflammatory treatment called fluorometholone to placebo. In this initial trial, all three groups experienced about a one-third reduction in the risk of postoperative TT."
He added: "However, as our new study reports, the FLAME trial could not confirm the promising preliminary results. Given the far larger sample size of FLAME, we are confident in its 'negative' results, and interpret them to mean that anti-inflammatory therapy is unlikely to advance this field."
The study involved more than 2,400 participants who received either fluorometholone or placebo drops before and after surgery over four weeks. Researchers often traveled by motorcycle or on foot to reach remote communities where surgeries were performed. The project also provided free care to nearly 3,000 people who sought treatment but did not enroll in the study.
"Our results convincingly showed no difference between the active fluorometholone treatment and placebo, with near-identical results between groups," Kempen said. "In terms of safety, results were similar as well, suggesting that taking fluorometholone twice daily for 4 weeks is generally safe. That is an important finding for the use of fluorometholone for other diseases."
He noted: "The results, along with negative results from a different trial, suggest that the use of anti-inflammatory therapy along with all surgeries is not likely to help improve TT surgery outcomes. However, because of the rich dataset we accumulated, we plan to conduct additional, secondary analyses."
Looking ahead at next steps for improving outcomes after TT surgery rather than focusing on adjunctive drug therapies like anti-inflammatories—the research points toward surgical technique improvements and enhanced training programs for surgeons as promising avenues.
"It will be best to shift focus to other ideas for improving TT surgery outcomes," Kempen stated. He highlighted findings from secondary analyses showing that one WHO-endorsed surgical method—Posterior Lamellar Tarsal Rotation (PLTR), also known as Trabut technique—results in significantly fewer recurrences compared with another method.
"In addition," he continued,"our group has also shown that refresher training in a structured supportive mentorship context can reduce the risk of postoperative TT substantially." Kempen concluded that quality assurance measures during surgery are key alongside preventive efforts such as antibiotic use and environmental hygiene interventions.
