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The Steroids for Corneal Ulcers Trial (SCUT): Secondary 12-Month Clinical Outcomes of a Randomized Controlled Trial

Authors
  • Srinivasan, Muthiah
  • Mascarenhas, Jeena
  • Rajaraman, Revathi
  • Ravindran, Meenakshi
  • Lalitha, Prajna
  • O'Brien, Kieran S.
  • Glidden, David V.
  • Ray, Kathryn J.
  • Oldenburg, Catherine E.
  • Zegans, Michael E.
  • Whitcher, John P.
  • McLeod, Stephen D.
  • Porco, Travis C.
  • Lietman, Thomas M.
  • Acharya, Nisha R.1, 1, 1, 2, 3, 4, 3, 5, 6, 7, 3
  • 1 Aravind Eye Care System
  • 2 Francis I. Proctor Foundation
  • 3 University of California
  • 4 Department of Epidemiology and Biostatistics
  • 5 Departments of Surgery (Ophthalmology) and Microbiology and Immunology
  • 6 Dartmouth Medical School
  • 7 Department of Ophthalmology
Type
Published Article
Journal
American Journal of Ophthalmology
Publisher
Elsevier
Publication Date
Jan 01, 2014
Accepted Date
Sep 24, 2013
Volume
157
Issue
2
Pages
327–333
Identifiers
DOI: 10.1016/j.ajo.2013.09.025
Source
Elsevier
License
Unknown

Abstract

PurposeTo determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. DesignRandomized, placebo-controlled, double-masked clinical trial. MethodsThis 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. ResultsNo 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). ConclusionsAdjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species.

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