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
About this trial
This is an interventional treatment trial for Photorefractive Keratectomy
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 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
NCT ID
NCT05477875
First Posted
July 21, 2022
Last Updated
June 7, 2023
Sponsor
University of Florida
Collaborators
Consortium for Medical Marijuana Clinical Outcomes Research
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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