Acanthamoeba Keratitis
Conditions
Keywords
corneal ulcer, steroids
Brief summary
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
Interventions
DRUGPolyhexamethylene biguanide (PHMB)
PHMB is a cationic antiseptic agent used for topical treatment of acanthamoeba keratitis (AK). Both treatment groups will take PHMB at least 4 times daily while on the allocated study drug.
Dexamethasone sodium phosphate, 0.1% ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks.
OTHERTopical placebo
An artificial tear ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks.
Sponsors
Jeremy Keenan, MD, MPH
Johns Hopkins University
Oregon Health and Science University
University of Illinois at Chicago
University of California, Los Angeles
University of Pittsburgh
University of Pennsylvania
Columbia University
University of Iowa
University of Florida
Aravind Eye Care System
Moorfields Eye Hospital NHS Foundation Trust
Federal University of São Paulo
National Eye Institute (NEI)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vision | 6 Months | Best corrected visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported eye pain | 2 months | Pain scale (Likert 11-point ordinal scale from 0 to 10; 0=no pain, 10=worst pain) |
| Clinical Resolution | 12 months | Time until clinical resolution (i.e., healed ocular surface and absence of inflammation) |
| Multivariate Analysis | 6 Months | 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 |
Countries
Brazil, India, United Kingdom, United States
Contacts
CONTACTJeremy Keenan, MD, MPH
CONTACTKrisi Aromin
PRINCIPAL_INVESTIGATORJeremy Keenan, MD, MPH
Proctor Foundation, UCSF
PRINCIPAL_INVESTIGATORGerami Seitzman, MD
Proctor Foundation, UCSF
Outcome results
None listed