Cannabidiol vs Opioid for Photorefractive Keratectomy Pain Control

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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 CBD chemovar or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Collaborator: Consortium for Medical Marijuana Clinical Outcomes Research
• Treatments: Acetaminophen; Codeine

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.