LSHTM Research Online

Srinivasan, M; Lalitha, P; Mahalakshmi, R; Prajna, NV; Mascarenhas, J; Chidambaram, JD; Lee, S; Hong, KC; Zegans, M; Glidden, DV; McLeod, S; Whitcher, JP; Lietman, TM; Acharya, NR; (2009) Corticosteroids for bacterial corneal ulcers. The British journal of ophthalmology, 93 (2). pp. 198-202. ISSN 0007-1161 DOI: https://doi.org/10.1136/bjo.2008.147298

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Abstract

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.

Item Type:	Article
Faculty and Department:	Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
PubMed ID:	18829631
Web of Science ID:	262833900014
URI:	http://researchonline.lshtm.ac.uk/id/eprint/834646

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