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(352) 733-0111

CBD vs Opioid for PRK Pain Control

  • Status
    Accepting Candidates
  • Age
    18 Years - 65 Years
  • Sexes
    All
  • Healthy Volunteers
    Accepts Healthy Volunteers
I'm interested
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Objective

Photorefractive Keratectomy (PRK) is a commonly performed corneal refractive surgery but has significant post-operative pain. Pain medications after PRK are typically opioid-acetaminophen combinations. Alternatives to opioid medication are worth consideration. Patients will receive PRK in each eye sequentially, using the cannabinoid or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.

Details

Full study title Randomized, Controlled Cross-over Comparison of Cannabidiol to Oral Opioid for Postoperative Photorefractive Keratectomy Pain Control
Protocol number OCR42790
ClinicalTrials.gov ID NCT05477875
Phase Phase 2

Eligibility

Inclusion Criteria:

  • Adults older than 18 years with refractive stability for 1 year electing to have PRK surgery

  • Consenting to participate

  • Not meeting exclusion criteria will be included in the study population.

Exclusion Criteria:

  • Patients not candidates for PRK will be excluded from the study.

  • Patients taking other pain medications for concomitant medical conditions including, but not limited to tricyclic antidepressants, gabapentin and tramadol will be excluded from the study.

  • Additional exclusion criteria will be known or suspected allergy or hypersensitivity to any of the routine or study medications.

  • Patients completing follow up appointments at anywhere other than UF Health Ophthalmology clinic at the Oaks will not be enrolled in the study.

  • Patients who are pregnant or nursing are not eligible for PRK, and such patients are not eligible to enroll in this study. Female patients of child-bearing age will be pregnancy tested before surgery and study enrollment.

  • Patients will be specifically counseled, and it will be noted in the written informed consent that use of the cannabinoid product may result in a positive THC urinalysis screening test so they may self-exclude if such a situation could cause social and/or employment conflict.

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

    Walter Steigleman
  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.