Aims: To conduct a preliminary clinical trial assessing whether adjunctive topical corticosteroids improve outcomes in bacterial keratitis and, if no difference is found, to determine the feasibility and sample size necessary for conducting a larger trial to answer this question.
Methods: In this single center, double-masked clinical trial, 42 patients with culture-confirmed bacterial keratitis at Aravind Eye Hospital in India were randomized to receive either topical prednisolone phosphate or placebo. All patients received topical moxifloxacin. The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months, adjusting for enrollment BSCVA and arm. Other pre-specified outcomes included re-epithelialisation time, infiltrate/scar size, and adverse events.
Results: Compared to placebo, the steroid group re-epithelialised more slowly (hazard ratio 0.47, 95% CI 0.23 to 0.94). There was no significant difference in BSCVA or infiltrate/scar size at 3 weeks or 3 months. To have 80% power to detect a 2-line difference in acuity, 360 cases would be required.
Conclusions: Although corticosteroid treatment resulted in a statistically significant delay in re-epithelialisation, this did not translate to a significant difference in visual acuity, infiltrate/scar size, or adverse events. To assess the effect of steroids on acuity, a larger trial is warranted and feasible.
Registered at http://clinicaltrials.gov, Steroids for Corneal Ulcers Trial, NCT: NCT00324168
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