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Randomized Controlled Trial
. 2012 Feb;130(2):151-7.
doi: 10.1001/archophthalmol.2011.303. Epub 2011 Oct 10.

The steroids for corneal ulcers trial: study design and baseline characteristics

Muthiah Srinivasan  1 , Jeena Mascarenhas, Revathi Rajaraman, Meenakshi Ravindran, Prajna Lalitha, David V Glidden, Kathryn J Ray, Kevin C Hong, Catherine E Oldenburg, Salena M Lee, Michael E Zegans, Stephen D McLeod, Thomas M Lietman, Nisha R Acharya; Steroids for Corneal Ulcers Trial Group
Collaborators, Affiliations
Randomized Controlled Trial

The steroids for corneal ulcers trial: study design and baseline characteristics

Muthiah Srinivasan et al. Arch Ophthalmol. 2012 Feb.

Abstract

Objectives: To provide comprehensive trial methods and baseline data for the Steroids for Corneal Ulcers Trial and to present epidemiological characteristics such as risk factors, causative organisms, and ulcer severity.

Methods: Baseline data from a 1:1 randomized, placebo-controlled, double-masked clinical trial comparing prednisolone phosphate, 1%, with placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and had been taking moxifloxacin for 48 hours. The primary outcome for the trial is best spectacle-corrected visual acuity at 3 months from enrollment. This report provides comprehensive baseline data, including best spectacle-corrected visual acuity, infiltrate size, microbiological results, and patient demographics, for patients enrolled in the trial.

Results: Of 500 patients enrolled, 97% were in India. Two hundred twenty patients (44%) were agricultural workers. Median baseline visual acuity was 0.84 logMAR (Snellen, 20/125) (interquartile range, 0.36-1.7; Snellen, 20/50 to counting fingers). Baseline visual acuity was not significantly different between the United States and India. Ulcers in India had larger infiltrate/scar sizes (P = .04) and deeper infiltrates (P = .04) and were more likely to be localized centrally (P = .002) than ulcers enrolled in the United States. Gram-positive bacteria were the most common organisms isolated from the ulcers (n = 366, 72%).

Conclusions: The Steroids for Corneal Ulcers Trial will compare the use of a topical corticosteroid with placebo as adjunctive therapy for bacterial corneal ulcers. Patients enrolled in this trial had diverse ulcer severity and on average significantly reduced visual acuity at presentation.

Trial registration: clinicaltrials.gov Identifier: NCT00324168.

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References

    1. Whitcher JP, Srinivasan M, Upadhyay MP. Corneal blindness: a global perspective. Bull World Health Organ. 2001;79(3):214–221. - PMC - PubMed
    1. Resnikoff S, Pascolini D, Etya'ale D, et al. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004;82(11):844–851. - PMC - PubMed
    1. Bourcier T, Thomas F, Borderie V, Chaumeil C, Laroche L. Bacterial keratitis: pre-disposing factors, clinical and microbiological review of 300 cases. Br J Ophthalmol. 2003;87(7):834–838. - PMC - PubMed
    1. Schaefer F, Bruttin O, Zografos L, Guex-Crosier Y. Bacterial keratitis: a prospective clinical and microbiological study. Br J Ophthalmol. 2001;85(7):842–847. - PMC - PubMed
    1. Srinivasan M, Gonzales CA, George C, et al. Epidemiology and aetiological diagnosis of corneal ulceration in Madurai, south India. Br J Ophthalmol. 1997;81(11):965–971. - PMC - PubMed

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