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Corticosteroids for bacterial keratitis: the Steroids for Corneal Ulcers Trial (SCUT).

Author(s): Srinivasan M, Mascarenhas J, Rajaraman R, Ravindran M, Lalitha P, Glidden DV, Ray KJ, Hong KC, Oldenburg CE, Lee SM, Zegans ME, McLeod SD, Lietman TM, Acharya NR; Steroids for Corneal Ulcers Trial Group.

Collaborators: Srinivasan M, Lalitha P, Mascarenhas J, Prajna NV, Chandravathi TS, Saravanan RS, Karpagam R, Rajkumar M, Mahalakshmi R, Ravindran M, Bharathi MJ, Raj L, Meena M, Rajaraman R, Raghavan A, Manikandan P, Zegans ME, Toutain-Kidd C, Miller D, Lietman TM, Acharya NR, McLeod SD, Whitcher JP, Lee SM, Cevallos V, Oldenburg CE, Hong KC, Costanza S, Fisher M, Aldave A, Everett D, Glover J, Kannan KA, Kymes S, Murthy GV, Schwab I, Lietman TM, Acharya NR, Glidden DV, McLeod SD, Whitcher JP, Lee SM, Ray KJ, Cevallos V, Oldenburg CE, Hong KC, Costanza S, Everett DF, Zegans ME, Kidd CM.

Affiliation(s): Departments of Cornea and External Diseases, Aravind Eye Care System, Madurai, India.

Publication date & source: 2012, Arch Ophthalmol. , 130(2):143-50

OBJECTIVE: To determine whether there is a benefit in clinical outcomes with the use of topical corticosteroids as adjunctive therapy in the treatment of bacterial corneal ulcers. METHODS: Randomized, placebo-controlled, double-masked, multicenter clinical trial comparing prednisolone sodium phosphate, 1.0%, to placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and received topical moxifloxacin for at least 48 hours before randomization. MAIN OUTCOME MEASURES: The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months from enrollment. Secondary outcomes included infiltrate/scar size, reepithelialization, and corneal perforation. RESULTS: Between September 1, 2006, and February 22, 2010, 1769 patients were screened for the trial and 500 patients were enrolled. No significant difference was observed in the 3-month BSCVA (-0.009 logarithm of the minimum angle of resolution [logMAR]; 95% CI, -0.085 to 0.068; P = .82), infiltrate/scar size (P = .40), time to reepithelialization (P = .44), or corneal perforation (P > .99). A significant effect of corticosteroids was observed in subgroups of baseline BSCVA (P = .03) and ulcer location (P = .04). At 3 months, patients with vision of counting fingers or worse at baseline had 0.17 logMAR better visual acuity with corticosteroids (95% CI, -0.31 to -0.02; P = .03) compared with placebo, and patients with ulcers that were completely central at baseline had 0.20 logMAR better visual acuity with corticosteroids (-0.37 to -0.04; P = .02). CONCLUSIONS: We found no overall difference in 3-month BSCVA and no safety concerns with adjunctive corticosteroid therapy for bacterial corneal ulcers. APPLICATION TO CLINICAL PRACTICE: Adjunctive topical corticosteroid use does not improve 3-month vision in patients with bacterial corneal ulcers. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00324168.

Page last updated: 2013-02-10

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