Steroids for Corneal Ulcers Trial (NCT00324168) | Clinical Trial Compass
CompletedPhase 4
Steroids for Corneal Ulcers Trial
United States, India500 participantsStarted 2006-09
Plain-language summary
The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
At Presentation:
* Presence of a corneal ulcer at presentation
At Enrollment:
* Presence of bacteria on blood or chocolate agar culture
* Antibiotic given for \> 48 hours
* The patient must be able to verbalize a basic understanding of the study after it is explained to the patient, as determined by physician examiner. This understanding must include a commitment to return for f/u visits.
* Appropriate consent
Exclusion Criteria
At Presentation:
* Overlying epithelial defect \< 0.75 mm at its greatest width at presentation
* Corneal perforation or impending perforation
* Evidence of fungus on KOH, Giemsa at time of presentation
* Evidence of acanthamoeba by stain
* Evidence of herpetic keratitis by history or exam
* Corneal scar not easily distinguishable from current ulcer
* Use of a topical steroid in the affected eye during the course of the present ulcer, including use after the symptoms of the ulcer started but before presentation
* Use of systemic prednisolone during the course of the present ulcer
* Age less than 16 years (before 16th birthday)
* Bilateral ulcers
* Previous penetrating keratoplasty
* Pregnancy (by history or urine test)
* Immediate steroid use necessary due to surgery or other condition
At Enrollment:
* Evidence of fungus on culture at time of enrollment
* Absence of bacteria on blood or chocolate agar culture
* Best spectacle-corrected vision worse than 6/60 in the fellow eye
* Corneal perforation or descemetocele
* Known a…
What they're measuring
1
Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 3 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate