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Randomized Controlled Trial
. 2009 Feb;93(2):198-202.
doi: 10.1136/bjo.2008.147298. Epub 2008 Oct 1.

Corticosteroids for bacterial corneal ulcers

M Srinivasan  1 , P Lalitha, R Mahalakshmi, N V Prajna, J Mascarenhas, J D Chidambaram, S Lee, K C Hong, M Zegans, D V Glidden, S McLeod, J P Whitcher, T M Lietman, N R Acharya
Affiliations
Randomized Controlled Trial

Corticosteroids for bacterial corneal ulcers

M Srinivasan et al. Br J Ophthalmol. 2009 Feb.

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.

Trial registration: ClinicalTrials.gov NCT00324168.

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Figures

Figure 1
Figure 1
CONSORT Flowchart: Enrollment 1/4/05 – 8/20/05
Figure 2
Figure 2
Time to Re-epithelialisation in Steroid and Placebo Groups
See this image and copyright information in PMC

References

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    1. Matoba AY, et al. Bacterial Keratitis: Preferred Practice Pattern: American Association of Ophthalmology. 2000

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