Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control

Phase 2

Completed

• Conditions: Photorefractive Keratectomy; Hyperopia; Myopia
• Interventions: Combination Product: oral codeine/acetaminophen; Drug: oral cannabinoid

• Registration Number: NCT05477875
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-28
• Study Start: 2024-02-01
• Primary Completion: 2025-01-22
• Study Completion: 2025-01-22
• Results First Submitted: 2025-05-19
• Status Verified: 2025-06
• Results First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Results First Posted: 2025-08-07
• Last Update Posted: 2025-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral codeine/acetaminophen	oral codeine/acetaminophen	Oral codeine-acetaminophen for controlling pain
Oral cannabinoid	oral cannabinoid	Oral cannabinoid

Primary Outcome Measures

Name	Time	Method
Pain as Recorded by the FACES Scale (Maximum) After First Surgery	1 week after first surgery	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"
Pain as Recorded by the FACES Scale (Maximum) After Second Surgery	1 week after second surgery	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

Name	Time	Method
Uncorrected Visual Acuity of First Eye Surgery	3 months after first surgery	Uncorrected visual acuity as measured by Snellen Chart
PROWL-SS	3 month	An online questionnaire derived from the Patient-Reported Outcomes With LASIK (PROWL) will be given to patients after PRK at 3 months. It ranges from 0-100, where 100 indicates best possible vision and satisfaction, while 0 indicates worst possible vision and satisfaction.
Quality of Life Refractive Correction Survey	3 months	The QIRC measures quality of life associated with vision and eyewear problems, measured at 3 months. It ranges from 0-100, where 0 indicates best possible vision and quality of life and 100 indicates worst possible vision and quality of life.
Ocular Discomfort Questionnaire	3 months	An online questionnaire derived from the Ocular Surface Disease Index (OSDI) at 3 months. It ranges from 0-48, where 0 indicates no eye discomfort and 48 indicates constant, debilitating, worst-possible eye discomfort or pain.
Uncorrected Visual Acuity of Second Eye Surgery	3 months after second surgery	Uncorrected visual acuity as measured by Snellen Chart

Trial Locations

Locations (1)

University of Florida Oaks Eye Center; 🇺🇸 Gainesville, Florida, United States