Corticosteroids for bacterial corneal ulcers.

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.

• Authors: M Srinivasan, 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
• Journal: The British journal of ophthalmology (Br J Ophthalmol) Vol. 93 Issue 2 Pg. 198-202 (Feb 2009) ISSN: 1468-2079 [Electronic] England
• PMID: 18829631 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Glucocorticoids
• Ophthalmic Solutions
• prednisolone phosphate
• Prednisolone

Topics

• Adult
• Aged
• Corneal Ulcer (drug therapy, microbiology, physiopathology)
• Double-Blind Method
• Epithelium, Corneal (physiology)
• Eye Infections, Bacterial (drug therapy, physiopathology)
• Feasibility Studies
• Female
• Glucocorticoids (therapeutic use)
• Humans
• Male
• Middle Aged
• Ophthalmic Solutions
• Prednisolone (analogs & derivatives, therapeutic use)
• Treatment Outcome
• Visual Acuity (drug effects)
• Wound Healing (drug effects)