Acanthamoeba Keratitis Clinical Trial
— PUTTOfficial title:
Parasitic Ulcer Treatment Trial
The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups: - Group 1: Topical corticosteroid - Group 2: Topical placebo
Status | Not yet recruiting |
Enrollment | 232 |
Est. completion date | April 2028 |
Est. primary completion date | April 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years and older |
Eligibility | Inclusion Criteria: - AK on at least one of the following: culture, smear, PCR, shotgun sequencing, biopsy, or confocal microscopy - Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation Exclusion Criteria: - Evidence or history of interstitial keratitis - Known herpetic keratitis, as determined from history, exam, or microbiological testing - Known fungal keratitis, as demonstrated from corneal scrapings - Corneal perforation or impending corneal perforation - Prior therapeutic keratoplasty for acanthamoeba keratitis - Unwillingness or inability to follow-up - No light perception in the affected eye - Known hypertensive response to steroids - Corticosteroid allergy - Concurrent treatment with systemic corticosteroids - Concurrent granulomatous amoebic encephalitis |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of São Paulo | São Paulo | |
India | Aravind Eye Hospitals | Madurai | Tamil Nadu |
United Kingdom | Moorfields Eye Hospital | London | |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | University of Illinois, Chicago | Chicago | Illinois |
United States | University of Florida | Gainesville | Florida |
United States | University of Iowa | Iowa City | Iowa |
United States | University of California, Los Angeles | Los Angeles | California |
United States | University of Miami | Miami | Florida |
United States | Columbia University | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Oregon Health and Science University | Portland | Oregon |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Jeremy Keenan, MD, MPH | Aravind Eye Care System, Columbia University, Federal University of São Paulo, Johns Hopkins University, Moorfields Eye Hospital NHS Foundation Trust, National Eye Institute (NEI), Oregon Health and Science University, University of California, Los Angeles, University of Florida, University of Illinois at Chicago, University of Iowa, University of Miami, University of Michigan, University of Pennsylvania |
United States, Brazil, India, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vision | Best corrected visual acuity | 6 Months | |
Secondary | Self-reported eye pain | Pain visual analog scale (Likert scale from 0 to 10; 0=no pain, 10=worst pain) | 2 months | |
Secondary | Clinical Resolution | Time until clinical resolution (i.e., healed ocular surface and absence of inflammation) | 12 months | |
Secondary | Multivariate Analysis | The multivariate analysis will include the following outcomes measured at 6 months: best corrected visual acuity, corneal thinning on optical coherence tomography (OCT), scar density on Scheimpflug imaging, irregular astigmatism, glare, microbial clearance on confocal microscopy, pain score, time until clinical resolution | 6 Months |
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