Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT00324168
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00324168
Study Brief:
Protocol Section:
NCT00324168