Abstract | PURPOSE: 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.
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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.)
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Copyright | Copyright © 2014 Elsevier Inc. All rights reserved. |
Chemical References |
- Anti-Bacterial Agents
- Aza Compounds
- Fluoroquinolones
- Glucocorticoids
- Ophthalmic Solutions
- Quinolines
- prednisolone phosphate
- Prednisolone
- Moxifloxacin
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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)
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