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N. Acharya, M. Srinivasan, R. Mahalakshmi, D. Jayashree, L. Prajna, J. House, S. Mcleod, J. Whitcher, M. Zegans, T. Lietman; Steroids for Corneal Ulcers Treatment – SCUT Pilot Study Results . Invest. Ophthalmol. Vis. Sci. 2006;47(13):4752.
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Antimicrobial treatment of a bacterial corneal ulcer is generally effective in eradicating infection, but the scarring that accompanies the resolution of infection leaves many eyes blind. Some advocate the use of topical corticosteroids along with antibiotics in an effort to reduce immune–mediated tissue damage and scarring. Others fear using steroids to reduce the cornea's immune response will prolong or even exacerbate infection. The Steroids for Corneal Ulcers Trial (SCUT) is a multicenter, randomized controlled trial with the main objective of evaluating whether topical steroid use can improve the outcome of bacterial corneal ulcers. We now present the results of the pilot study for the SCUT trial. This is the largest study to date to address this research question.
After identification of the etiologic organism and 48 hours of antibiotic treatment, 42 patients presenting to the cornea clinic at Aravind Eye Hospital with a bacterial corneal ulcer were randomized to either topical prednisolone phosphate or placebo in addition to topical moxifloxacin. The primary outcome was best spectacle–corrected visual acuity three months after the resolution of the overlying epithelial defect.
Baseline characteristics, including baseline visual acuity, infiltrate size, and frequency of pseudomonas ulcers were not significantly different between the 2 arms. A multivariate model using treatment arm and enrollment acuity as covariates revealed that steroid treatment was associated with a 0.089 decreased LogMAR acuity at 3 weeks (P=0.70), and a 0.074 increased LogMAR acuity at 3 months (P=0.76). A second model using enrollment infiltrate size and treatment arm as covariates found that steroid treatment was associated with a 0.30 mm decrease in average infiltrate/scar diameter at 3 weeks (P=0.47) and 0.1 mm decrease at 3 months (P=0.77). Time to re–epithelialization was slightly longer (8.6 vs 6.3 days) in the steroid treated group compared to placebo (P=0.05). There was no statistical difference in adverse events between the 2 arms.
Steroid use was associated with approximately a 1 line improvement in vision at 3 weeks, although this difference had disappeared by 3 months. Steroid use was also associated with a decrease in infiltrate/scar size at 3 weeks and 3 months, but not significantly. Re–epithelialization time was significantly longer in the steroid treated patients. A larger study is being set up to further address these questions.
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