The steroids for corneal ulcers trial: study design and baseline characteristics.
Arch Ophthalmol
; 130(2): 151-7, 2012 Feb.
Article
en En
| MEDLINE
| ID: mdl-21987581
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 11 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.
Texto completo:
1
Bases de datos:
MEDLINE
Métodos Terapéuticos y Terapias MTCI:
Terapias_biologicas
/
Aromoterapia
Asunto principal:
Quinolinas
/
Proyectos de Investigación
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Compuestos Aza
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Prednisolona
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Infecciones Bacterianas del Ojo
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Úlcera de la Córnea
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Glucocorticoides
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Antiinfecciosos
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
/
Risk_factors_studies
Idioma:
En
Revista:
Arch Ophthalmol
Año:
2012
Tipo del documento:
Article
País de afiliación:
India