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W. G. Hodge, J. Blair, S. Al-Ghambdi, R. Balabanian, B. C. Lowcock, Y. I. Pan, D. Fergusson, S. Aaron, W. B. Jackson, G. Mintsioulis; Comparison of Antibiotic-Only and Antibiotic-Steroid Combination Treatment in Corneal Ulcer Patients: A Double-Blinded, Randomized Clinical Trial - Interim Report. Invest. Ophthalmol. Vis. Sci. 2007;48(13):4275.
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Standard antibiotic treatment effectively treats cornea infection, but often leaves a scar that still impairs vision. In order to reduce the size of the scar and improve vision, topical corticosteroids could be used early in treating the infection. However, topical steroids have many known side effects. Therefore, a randomized, double-blinded, controlled trial was conducted to determine the benefit of corticosteroid in addition to antibiotics for treating corneal ulcers.
Patients were recruited if they met the eligibility criteria and consented to participate. Subjects were randomized before enrollment. Primary outcome is residual ulcer size at 10 weeks compared to baseline measurement based on digital photographic documentation. Secondary outcomes are time to healing, rate of cure or treatment failure, and visual acuity. This report is the first interim analysis of the study.
All subjects demonstrated a reduction in photographic ulcer area over the study period (from baseline to 10 weeks). Individuals randomized to receive antibiotic plus steroid showed greater mean differences (-8.36 mm2 vs. -2.16mm2, p=0.4795) and mean percent differences (74% vs. 52%, p=0.3235) than individuals who received only antibiotic. Area measurements taken from the slit lamp also showed larger mean decreases in ulcer size among individuals receiving steroid (-9.82 vs. -3.99 mm2, p=0.4795). Among the secondary outcomes examined, treatment with antibiotic plus steroid was beneficial in terms of time to healing (3.5 vs. 6.33 weeks, p=0.3624) and ETDRS visual acuity (mean improvements of 0.27 vs. 0.04, p=0.1428). Two participants from different treatment groups have experienced a total of three adverse events.
None of the observed differences between treatment regimes reached the level of statistical significance in this interim analysis. We do, however, find it encouraging that the residual ulcer size decreased for all study participants following the treatment course, and that the secondary outcomes also favored the treatment group.
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