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

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.

• Authors: Muthiah Srinivasan, Jeena Mascarenhas, Revathi Rajaraman, Meenakshi Ravindran, Prajna Lalitha, Kieran S O'Brien, David V Glidden, Kathryn J Ray, Catherine E Oldenburg, Michael E Zegans, John P Whitcher, Stephen D McLeod, Travis C Porco, Thomas M Lietman, Nisha R Acharya, Steroids for Corneal Ulcers Trial Group
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 157 Issue 2 Pg. 327-333.e3 (Feb 2014) ISSN: 1879-1891 [Electronic] United States
• PMID: 24315294 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
• Copyright: Copyright © 2014 Elsevier Inc. All rights reserved.

Chemical References

• Anti-Bacterial Agents
• Aza Compounds
• Fluoroquinolones
• Glucocorticoids
• Ophthalmic Solutions
• Quinolines
• prednisolone phosphate
• Prednisolone
• Moxifloxacin

Topics

• Administration, Topical
• Adult
• Anti-Bacterial Agents (therapeutic use)
• Aza Compounds (therapeutic use)
• Bacteria (isolation & purification)
• Corneal Ulcer (drug therapy, microbiology)
• Double-Blind Method
• Eye Infections, Bacterial (drug therapy, microbiology)
• Female
• Fluoroquinolones
• Glucocorticoids (therapeutic use)
• Humans
• Male
• Middle Aged
• Moxifloxacin
• Nocardia (isolation & purification)
• Nocardia Infections (drug therapy, microbiology)
• Ophthalmic Solutions
• Prednisolone (analogs & derivatives, therapeutic use)
• Quinolines (therapeutic use)
• Treatment Outcome
• Visual Acuity (physiology)