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Am J Ophthalmol. 2014 Feb;157(2):327-333.e3. doi: 10.1016/j.ajo.2013.09.025. Epub 2013 Oct 1.

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

Author information

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

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00324168.

PMID:
24315294
PMCID:
PMC3946996
DOI:
10.1016/j.ajo.2013.09.025
[PubMed - indexed for MEDLINE]
Free PMC Article
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