Comparison of antibiotic-only and antibiotic-steroid combination treatment in corneal ulcer patients: double-blinded randomized clinical trial.

OBJECTIVE: To determine the benefit of early addition of corticosteroids to antibiotics in the treatment of corneal ulcers.
DESIGN: Randomized clinical trial. PARTICIPANTS: Thirty eyes of 30 patients, over the age of 12 years, with bacterial corneal ulcer confirmed by culture.
METHODS: Patients were randomized before enrollment; 15 were treated with gatifloxacin (Zymar) and a masked placebo and the other 15 were treated with gatifloxacin and masked dexamethasone 0.1% (Maxidex). Primary outcome was residual ulcer size at 10 weeks based on digital photographs. Secondary outcomes included residual ulcer area by clinician estimate, visual acuity, VF-14 score, and time to healing.
RESULTS: All subjects (n = 30) demonstrated a reduction in ulcer size over the study period. There was no significant difference between the 2 groups in terms of the primary outcome. There was a significant difference between the 2 groups in 1 of the secondary outcomes. The mean residual ulcer size compared with the baseline by clinician estimate (slit-lamp) was -0.789 mm2 for the antibiotic-only group and -4.206 mm2 for the antibiotic-steroid group (p = 0.05). Among the other secondary outcomes there were no significant differences between the 2 groups.
CONCLUSIONS: No benefit was demonstrated in our primary outcome for using steroids in combination with antibiotic therapy in treatment of corneal ulcers. This study suggests that the early addition of steroids to the antibiotic treatment of corneal ulcers does not seem to be harmful when employed in a closely monitored clinical setting.

RCT Entities:   Population Interventions Outcomes