Corticosteroids for bacterial corneal ulcers

Abstract

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 reepithelialisation, 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.

New Insights Into Infectious Keratitis

“…Results from these studies indicated that steroid use in bacterial ulcers lead to similar visual outcome, [20][21][22] complication rates, 20 and infiltrate/scar size 21 as compared with antibiotic use alone. Although 1 author noticed no difference in epithelial healing rates between the 2 groups during 18 months of followup, 5 others concluded that the steroid with antibiotic group healed slower than the antibiotic only group.…”

“…Although 1 author noticed no difference in epithelial healing rates between the 2 groups during 18 months of followup, 5 others concluded that the steroid with antibiotic group healed slower than the antibiotic only group. 21,22 Very recently, a large randomized, double-masked multicenter clinical trial has been performed as the Steroids for Corneal Ulcers Trial. 23 In this trial, 500 patients with culturepositive bacterial corneal ulcer received either prednisolone sodium phosphate 1.0% or placebo after being treated with topical moxifloxacin for at least 48 hours before randomization.…”

Levofloxacin and Tobramycin for Severe Bacterial Keratouveitis

“…Many clinical trials have studied the benefit of early addition of corticosteroids to antibiotics in decreasing scarring and improving visual acuity, but the results are still controversial. 42,43 Corneal perforation, increased intraocular pressure, and delayed corneal healing are potential adverse events associated with corticosteroid therapy, particularly in P. aeruginosa infections, which are known to be more invasive and to cause rapid tissue destruction. 44 Sy et al observed that Pseudomonas aeruginosa corneal ulcers have a more severe presentation but they show a better response to antibiotic treatment than other bacterial ulcers, without any significant benefits in visual outcome, infiltrate/scar size, and incidence of adverse events related to a treatment with topical steroids.…”

Corticosteroids as a therapy for bacterial keratitis: an evidence-based review of ‘who, when and why’

“…A pilot study for the Steroids for Corneal Ulcers Trial (SCUT), published by Srinivasan et al, 43 included 42 participants. Both SCUT studies compared the effect of 1% topical prednisolone with a placebo (0.9% sodium chloride), with therapy initiated after receiving moxifloxacin for at least 48 h before randomisation.…”