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Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control

Primary Purpose

Photorefractive Keratectomy, Myopia, Hyperopia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
oral cannabinoid
oral codeine/acetaminophen
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Photorefractive Keratectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 CBD 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Oral cannabinoid

    Oral codeine/acetaminophen

    Arm Description

    Oral cannabinoid

    Oral codeine-acetaminophen for controlling pain

    Outcomes

    Primary Outcome Measures

    Pain as recorded by the FACES scale
    The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"

    Secondary Outcome Measures

    Uncorrected visual acuity
    Uncorrected visual acuity as measured by Snellen Chart, as well as change in uncorrected visual acuity.
    Subjective vision questionnaire
    An online questionnaire derived from the Ocular Surface Disease Index (OSDI) and the Patient-Reported Outcomes With LASIK (PROWL) will be given to patients after PRK. A ocular discomfort score will be calculated at one week.
    Corneal haze
    Corneal haze will be recorded by slit lamp exam according to the Fantes scale, which measures degree of corneal haze after surface ablation.
    Ocular discomfort questionnaire
    An online questionnaire derived from the Ocular Surface Disease Index (OSDI) and the Patient-Reported Outcomes With LASIK (PROWL) will be given to patients after PRK. A subjective vision score will be calculated at one week.

    Full Information

    First Posted
    July 21, 2022
    Last Updated
    June 7, 2023
    Sponsor
    University of Florida
    Collaborators
    Consortium for Medical Marijuana Clinical Outcomes Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05477875
    Brief Title
    Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control
    Official Title
    Randomized, Controlled Cross-over Comparison of Cannabinoid to Oral Opioid for Postoperative Photorefractive Keratectomy Pain Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    Consortium for Medical Marijuana Clinical Outcomes Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Photorefractive Keratectomy, Myopia, Hyperopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral cannabinoid
    Arm Type
    Experimental
    Arm Description
    Oral cannabinoid
    Arm Title
    Oral codeine/acetaminophen
    Arm Type
    Active Comparator
    Arm Description
    Oral codeine-acetaminophen for controlling pain
    Intervention Type
    Drug
    Intervention Name(s)
    oral cannabinoid
    Other Intervention Name(s)
    dronabinol
    Intervention Description
    dronabinol
    Intervention Type
    Combination Product
    Intervention Name(s)
    oral codeine/acetaminophen
    Intervention Description
    10 tablets of acetaminophen-codeine combination (300-30mg) without refills.
    Primary Outcome Measure Information:
    Title
    Pain as recorded by the FACES scale
    Description
    The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    Uncorrected visual acuity
    Description
    Uncorrected visual acuity as measured by Snellen Chart, as well as change in uncorrected visual acuity.
    Time Frame
    1 week
    Title
    Subjective vision questionnaire
    Description
    An online questionnaire derived from the Ocular Surface Disease Index (OSDI) and the Patient-Reported Outcomes With LASIK (PROWL) will be given to patients after PRK. A ocular discomfort score will be calculated at one week.
    Time Frame
    1 week
    Title
    Corneal haze
    Description
    Corneal haze will be recorded by slit lamp exam according to the Fantes scale, which measures degree of corneal haze after surface ablation.
    Time Frame
    1 week
    Title
    Ocular discomfort questionnaire
    Description
    An online questionnaire derived from the Ocular Surface Disease Index (OSDI) and the Patient-Reported Outcomes With LASIK (PROWL) will be given to patients after PRK. A subjective vision score will be calculated at one week.
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shannon Hampton
    Phone
    352-294-5016
    Email
    sthistle@ufl.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    W Steigleman, MD
    Organizational Affiliation
    University of Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control

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