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PUTT

  • Status
    Accepting Candidates
  • Age
    8 Years - N/A
  • Sexes
    All
  • 网红黑料y Volunteers
    No
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Objective

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

Details

Full study title Parasitic Ulcer Treatment Trial
Protocol number OCR45326
ClinicalTrials.gov ID NCT06213649
Phase Phase 3

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

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.