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Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control

NCT05477875 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-08-07

Study results available
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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.

Conditions

  • Photorefractive Keratectomy
  • Myopia
  • Hyperopia

Interventions

DRUG

oral cannabinoid

dronabinol

COMBINATION_PRODUCT

oral codeine/acetaminophen

10 tablets of acetaminophen-codeine combination (300-30mg) without refills.

Sponsors & Collaborators

  • Consortium for Medical Marijuana Clinical Outcomes Research

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • W Steigleman, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-01-22
Completion
2025-01-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477875 on ClinicalTrials.gov