Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control

Randomized, Controlled Cross-over Comparison of Cannabinoid to Oral Opioid for Postoperative Photorefractive Keratectomy Pain Control

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia; Hyperopia; Photorefractive Keratectomy
• Intervention / Treatment: Combination product: oral codeine/acetaminophen; Drug: oral cannabinoid

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shannon Hampton; Phone Number: 352-294-5016; Email: sthistle@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32605
      • Recruiting
      • University of Florida Oaks Eye Center
      • Contact: Walter Steigleman, md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral codeine/acetaminophen; Oral codeine-acetaminophen for controlling pain	Combination product: oral codeine/acetaminophen; 10 tablets of acetaminophen-codeine combination (300-30mg) without refills.
Experimental: Oral cannabinoid	Drug: oral cannabinoid; dronabinol; Other Names: dronabinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected visual acuity	Uncorrected visual acuity as measured by Snellen Chart, as well as change in uncorrected visual acuity.	1 week
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.	1 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.	1 week
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.	1 week

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Consortium for Medical Marijuana Clinical Outcomes Research
• Investigators: Principal Investigator: W Steigleman, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Respiratory System Agents; Antitussive Agents; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Acetaminophen; Dronabinol; Codeine
• Other Study ID Numbers: IRB202201660 -A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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