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

Affiliation(s): Aravind Eye Care System, Madurai, India; Department of Cornea and External Diseases, Aravind Eye Care System, Coimbatore, India (Dr Rajaraman); Department of Pediatric Ophthalmology, Aravind Eye Care System, Tirunelveli, India (Dr Ravindran); Francis I. Proctor Foundation for Research in Ophthalmology (Mss Ray and Oldenburg, Mr Hong, and Drs Lee, McLeod, Lietman, and Acharya) and Departments of Epidemiology and Biostatistics (Drs Glidden and Lietman) and Ophthalmology (Drs McLeod, Lietman, and Acharya), University of California, San Francisco; and Departments of Surgery (Ophthalmology) and Microbiology and Immunology, Dartmouth Medical School, Lebanon, New Hampshire (Dr Zegans).

Publication date & source: 2011-10-10, Arch Ophthalmol., [Epub ahead of print]

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.