Overview

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