Parasitic Ulcer Treatment Trial

Description

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

Conditions

Acanthamoeba Keratitis

Talk to us

Study Overview

On this page

Study Details

Study overview

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

Parasitic Ulcer Treatment Trial

Parasitic Ulcer Treatment Trial

Condition
Acanthamoeba Keratitis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94158

Gainesville

University of Florida, Gainesville, Florida, United States, 32605

Miami

University of Miami, Miami, Florida, United States, 33136

Chicago

University of Illinois, Chicago, Chicago, Illinois, United States, 60612

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

New York

Columbia University, New York, New York, United States, 10032

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

8 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jeremy Keenan, MD, MPH,

Jeremy Keenan, MD, MPH, PRINCIPAL_INVESTIGATOR, Proctor Foundation, UCSF

Study Record Dates

2028-07