Phase 2
N=35
Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control
Photorefractive Keratectomy · Myopia · Hyperopia
Bottom Line
View on ClinicalTrials.gov: NCT05477875 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Pain as Recorded by the FACES Scale (Maximum) After First Surgery — 1.33; 1.27 units on a scale — p=0.538
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- oral cannabinoid (Drug); oral codeine/acetaminophen (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain as Recorded by the FACES Scale (Maximum) After First Surgery |
1.33; 1.27 | 0.538 |
| PRIMARY Pain as Recorded by the FACES Scale (Maximum) After Second Surgery |
1.46; 1.79 | 0.538 |
| SECONDARY Uncorrected Visual Acuity of First Eye Surgery |
-0.123; -0.054 | 0.516 |
| SECONDARY PROWL-SS |
58.0; 60.9; 81.6; 85.6 | <0.851 |
| SECONDARY Quality of Life Refractive Correction Survey |
37.7; 37.6; 19.2; 26.4 | <0.543 |
| SECONDARY Ocular Discomfort Questionnaire |
4.9; 4.8; 4.9; 3.9 | 0.725 |
| SECONDARY Uncorrected Visual Acuity of Second Eye Surgery |
-0.051; -0.075 | 0.516 |
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.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT05477875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.