Status:
COMPLETED
Steroids for Corneal Ulcers Trial
Lead Sponsor:
Thomas M. Lietman
Collaborating Sponsors:
Aravind Eye Hospitals, India
Dartmouth-Hitchcock Medical Center
Conditions:
Corneal Ulcer
Eye Infections, Bacterial
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.
Detailed Description
Antimicrobial treatment of a bacterial corneal ulcer is generally effective in eradicating infection. However, "successful" treatment is not always associated with a good visual outcome. The scarring ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00324168
Start Date
September 1 2006
End Date
December 1 2012
Last Update
August 1 2018
Active Locations (5)
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1
Proctor Foundation, UCSF
San Francisco, California, United States, 94143
2
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
3
Aravind Eye Hospital
Coimbatore, Tamil Nadu, India
4
Aravind Eye Hospital
Madurai, Tamil Nadu, India, 625 020