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Completed

NCT Number: NCT05477875

Cannabinoid vs Opioid for 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.

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Key information

Conditions

Photorefractive Keratectomy Eye Diseases Hyperopia Myopia Refractive Errors

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida Oaks Eye Center

Gainesville, Florida, 32605, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral cannabinoid

Drug

dronabinol

Other names: dronabinol

oral codeine/acetaminophen

Combination Product

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

Primary outcomes

  1. Pain as Recorded by the FACES Scale (Maximum) After First Surgery

    Time frame: 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"

  2. Pain as Recorded by the FACES Scale (Maximum) After Second Surgery

    Time frame: 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 outcomes

  1. Uncorrected Visual Acuity of First Eye Surgery

    Time frame: 3 months after first surgery

    Uncorrected visual acuity as measured by Snellen Chart

  2. PROWL-SS

    Time frame: 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.

  3. Quality of Life Refractive Correction Survey

    Time frame: 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.

  4. Ocular Discomfort Questionnaire

    Time frame: 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.

  5. Uncorrected Visual Acuity of Second Eye Surgery

    Time frame: 3 months after second surgery

    Uncorrected visual acuity as measured by Snellen Chart

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Consortium for Medical Marijuana Clinical Outcomes Research

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2022
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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