The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial.

Author(s): Srinivasan M(1), Mascarenhas J(1), Rajaraman R(2), Ravindran M(3), Lalitha P(1), O'Brien KS(4), Glidden DV(5), Ray KJ(4), Oldenburg CE(4), Zegans ME(6), Whitcher JP(4), McLeod SD(7), Porco TC(8), Lietman TM(9), Acharya NR(10); Steroids for Corneal Ulcers Trial Group.

Affiliation(s): Author information: (1)Aravind Eye Care System, Madurai, India. (2)Aravind Eye Care System, Coimbatore, India. (3)Aravind Eye Care System, Tirunelveli, India. (4)Francis I. Proctor Foundation, University of California, San Francisco, California. (5)Department of Epidemiology and Biostatistics, University of California, San Francisco, California. (6)Departments of Surgery (Ophthalmology) and Microbiology and Immunology, Dartmouth Medical School, Lebanon, New Hampshire. (7)Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California. (8)Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, California. (9)Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California. (10)Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California. Electronic address: nisha.acharya@ucsf.edu.

Publication date & source: 2014, Am J Ophthalmol. , 157(2):327-333

PURPOSE: To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. DESIGN: Randomized, placebo-controlled, double-masked clinical trial. METHODS: This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. RESULTS: No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: -0.04 logMAR, 95% CI, -0.12 to 0.05, P = .39; scar size: 0.03 mm, 95% CI, -0.12 to 0.18, P = .69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (-0.10 logMAR, 95% CI, -0.19 to -0.02, P = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, -0.04 to 0.41, P = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P = .02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (-0.06 mm, 95% CI, -0.21 to 0.10, P = .46). CONCLUSIONS: Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species.