Aims: The aim of the study was to conduct a preliminary clinical trial to assess whether adjunctive topical corticosteroids improve outcomes in bacterial keratitis and, if no difference was found, to determine the feasibility and sample size necessary for conducting a larger trial to answer this question.
Methods: In this single centre, double-masked clinical trial, 42 patients with culture-confirmed bacterial keratitis at Aravind Eye Hospital in India were randomised 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 enrolment BSCVA and arm. Other pre-specified outcomes included re-epithelialisation time, infiltrate/scar size and adverse events.
Results: Compared with placebo, patients in 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 two-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.
Trial registration number: NCT00324168
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Funding: Funding for this research was from That Man May See and the South Asia Research Fund. The Department of Ophthalmology at UCSF is supported by a core grant from the National Eye Institute, EY02162. N Acharya is supported by a National Eye Institute K23EY017897 grant and a Research to Prevent Blindness Career Development Award. T M Lietman is supported by a National Eye Institute grant U10-EY015114 and a Research to Prevent Blindness award. M Zegans is supported by a K08 EY13977-01 NEI grant.
Competing interests: None declared. Alcon donated moxifloxacin for the study. The sponsors had no role in the design or conduct of the study, data analysis or manuscript preparation. None of the authors have any financial disclosures related to this manuscript.
Ethics approval: Institutional Review Board approval was obtained at University of California, San Francisco (UCSF) and Aravind Eye Hospital.
Patient consent: Obtained.