Status:
ACTIVE_NOT_RECRUITING
Parasitic Ulcer Treatment Trial Pilot
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Research to Prevent Blindness
Conditions:
Acanthamoeba Keratitis
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
This is a study of optimal treatments for acanthamoeba keratitis. In the first part of the study, participants will be randomized to chlorhexidine monotherapy or chlorhexidine plus povidone iodine. Af...
Detailed Description
Acanthamoeba keratitis is a rare eye infection that is difficult to treat. The mainstay of therapy is a biguanide agent such as chlorhexidine, though recent studies have found povidone iodine to be ef...
Eligibility Criteria
Inclusion
- Trial 1
- Smear or culture positive for acanthamoeba
- Age 13 years or greater
- Trial 1
Exclusion
- Interstitial or viral keratitis on history or examination
- Corneal perforation
- Therapeutic keratoplasty for acanthamoeba keratitis
- Unwillingness or inability to follow-up (e.g., living too far from hospital)
- Trial 2 Inclusion Criteria
- Smear or culture positive for acanthamoeba, with 4 weeks of anti-amoebic treatment
- Age 13 years or greater
- Willing to participate in study
- Trial 2 Exclusion Criteria
- Interstitial or viral keratitis on history or examination
- Fungus identified on culture and smear after 2 weeks of anti-amoebic treatment
- Corneal perforation
- Therapeutic keratoplasty for acanthamoeba keratitis
- Unwillingness or inability to follow-up (e.g., living too far from hospital)
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03484507
Start Date
January 1 2018
End Date
December 31 2024
Last Update
February 6 2024
Active Locations (2)
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1
Aravind Eye Hospital
Coimbatore, Tamil Nadu, India
2
Aravind Eye Hospital
Madurai, Tamil Nadu, India