Status:
COMPLETED
Mycotic Ulcer Treatment Trial I
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Aravind Eye Hospitals, India
Dartmouth-Hitchcock Medical Center
Conditions:
Corneal Ulcer
Eye Infections, Fungal
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if natamycin or voriconazole results in better visual outcomes in fungal corneal ulcers, especially visual acuity.
Detailed Description
Fungal corneal ulcers tend to have very poor outcomes with commonly used treatments. There has only been a single randomized trial of anti-fungal therapy for mycotic keratitis, and no new ocular anti-...
Eligibility Criteria
Inclusion
- Presence of a corneal ulcer at presentation
- Evidence of filamentous fungus on smear (KOH wet mount, Giemsa, or Gram stain)
- Visual acuity between 6/12 (20/40, logMAR 0.3) and 6/120 (20/400, logMAR 1.3)
- 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 follow-up visits.
- Willingness to be treated as an inpatient or to be treated as an outpatient and return every 3 days +/- 1 day until re-epithelialization and every week to receive fresh medication for 3 weeks
- Appropriate consent
Exclusion
- Impending perforation
- Evidence of bacteria on Gram stain at the time of enrollment
- Evidence of acanthamoeba by stain
- Evidence of herpetic keratitis by history or exam
- Corneal scar not easily distinguishable from current ulcer
- Age less than 16 years (before 16th birthday)
- Bilateral ulcers
- Previous penetrating keratoplasty in the affected eye
- Pregnancy (by history or urine test) or breast feeding (by history)
- Acuity worse than 6/60 (2/200) in the fellow eye (note that any acuity, uncorrected, corrected, pinhole, or BSCVA 6/60 or better qualifies for enrollment)
- Acuity worse than 6/120 (20/400) or better than 6/12 (20/40) in the study eye (note that any acuity, uncorrected, corrected, pinhole, or BSCVA can be used for enrollment)
- Known allergy to study medications (antifungal or preservative)
- No light perception in the affected eye
- Not willing to participate
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT00996736
Start Date
April 1 2010
End Date
July 1 2012
Last Update
August 1 2018
Active Locations (3)
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1
Proctor Foundation, UCSF
San Francisco, California, United States, 94143
2
Aravind Eye Hospitals
Madurai, Tamil Nadu, India
3
Aravind Eye Hospital
Pondicherry, Tamil Nadu, India