Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05477875
• Other study ID #: IRB202201660 -A
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2024
• Est. completion date: September 2025

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: Shannon Hampton
• Phone: 352-294-5016
• Email: sthistle[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

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.

Related Conditions & MeSH terms

• Hyperopia
• Myopia
• Photorefractive Keratectomy

Intervention

Drug:
• oral cannabinoid
dronabinol

Combination Product:
• oral codeine/acetaminophen
10 tablets of acetaminophen-codeine combination (300-30mg) without refills.

Locations

Country	Name	City	State
United States	University of Florida Oaks Eye Center	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Consortium for Medical Marijuana Clinical Outcomes Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Uncorrected visual acuity	Uncorrected visual acuity as measured by Snellen Chart, as well as change in uncorrected visual acuity.	1 week
Secondary	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
Secondary	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
Secondary	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