In this study, researchers assessed the safety and efficacy of fluorometholone 0.1% eye drops as an adjunctive therapy for trachomatous trichiasis (TT) surgery.
Study design
This was a randomized, placebo-controlled, double-masked, parallel dose-ranging clinical trial that recruited patients undergoing upper lid TT surgery in Ethiopia between 2013 and 2015. Patients were randomized to receive fluorometholone 0.1% twice daily for 4 weeks (n=39), 4 times daily for 4 weeks (n=39), 4 times daily for 8 weeks (n=38), or matching frequency placebo (n=13 each). Researchers assessed safety outcomes and postoperative TT incidence over 1 year.
Outcomes
At 1 year, postoperative TT occurred more frequently in placebo-treated eyes (29%) compared with eyes that received fluorometholone twice daily or 4 times daily for 4 or 8 weeks (17.7%, 19.6% and 23.3%, respectively).
There were no immediate surgical or tolerability problems reported. Among patients who received 4 daily doses, there was 1 case of elevated IOP and 1 allergic reaction, but both resolved with drug cessation.
Limitations
This is a well-designed study, but larger numbers are needed to confirm results.
Clinical significance
Trachomatous trichiasis surgery has a discouragingly high recurrence rate. Lowering this recurrence rate may require evaluating other surgeries that may be more effective. This study attempted to control postoperative inflammation using a topical steroid, thus potentially decreasing scar and cicatrization. The results show potential for lowering recurrence with the use of fluorometholone drops twice a day, for 4 weeks.