Antimicrobial treatment of a bacterial corneal ulcer is generally effective in eradicating infection. However, """"""""successful"""""""" treatment is not always associated with a good visual outcome. The scarring that accompanies the resolution of infection leaves many eyes blind. Some corneal specialists advocate the use of topical corticosteroids along with antibiotics in an effort to reduce immune mediated tissue damage, and thus scarring. Others fear that using steroids to reduce the cornea's immune response will prolong or even exacerbate infection. Evidence from animal and human reports is mixed. No single referral center in the United States has the volume necessary to support an adequate trial. We propose to perform a clinical trial evaluating the efficacy of steroids at the Aravind Eye Hospital in Madurai, India. This center receives 3-7 bacterial cornea ulcers per day and has the administrative, medical, and microbiological facilities necessary to perform the study. Since the bacterial pathogens seen in corneal ulcer patients at Aravind are similar to those seen in the United States, we believe that Aravind is a logical and cost-effective site to study the role of steroids in the treatment of bacterial keratitis, and will provide results relevant to the treatment of patients in both India and the United States. At the advice of reviewers, two parallel sites in the U.S. (the Proctor Foundation and Dartmouth Medical School) will be added to provide confirmatory data, and to highlight the differences in American and South Indian ulcers. Long-term goal: Can immunosuppressive agents improve outcomes in infectious corneal ulcers? The Specific Aims (and short-term goals), a randomized, placebo-controlled clinical trial: 1) To determine whether the addition of topical steroids to the treatment of a bacterial corneal ulcer improves post-treatment visual acuity. 2) To determine whether the addition of topical steroids results in a higher frequency of adverse outcomes. 3) To determine whether outcomes depend on the organism. ? ?
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