Steroids for Corneal Ulcers Trial

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas M. Lietman
• Collaborators: Aravind Eye Hospitals, India; Dartmouth-Hitchcock Medical Center; National Eye Institute (NEI)
• Treatments: Anti-Bacterial Agents

Criteria

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 allergy to study medications (steroid or preservative)

• No light perception in the affected eye

• Not willing to come to follow-up visits

• Not willing to participate