Steroids for Corneal Ulcers Trial

Completed · Phase 4 · Has a placebo group

Conditions studied: Corneal Ulcer, Eye Infections, Bacterial

In brief

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

Key facts

Study ID

NCT00324168

Run by

Thomas M. Lietman

People needed

500

Starts

2006-09-01

Expected to finish

2012-12-01

Last updated by the study team

2018-08-01

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Proctor Foundation, UCSF — San Francisco, California, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Aravind Eye Hospital — Coimbatore, Tamil Nadu, India
• Aravind Eye Hospital — Madurai, Tamil Nadu, India
• Aravind Eye Hospital — Tirunelveli, Tamil Nadu, India

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.