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Opioid

Cannabinoid vs Opioid for PRK Pain Control

Phase 2
Waitlist Available
Led By W Steigleman, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults older than 18 years with refractive stability for 1 year electing to have PRK surgery
Be older than 18 years old
Must not have
Patients not candidates for PRK
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at different pain medications used after Photorefractive Keratectomy (PRK) surgery. Normally, patients are given opioid-acetaminophen combinations for pain relief,

Who is the study for?
This trial is for adults over 18 who have stable near-sightedness or farsightedness and choose to undergo Photorefractive Keratectomy (PRK) surgery. Participants must consent to the study and can't be excluded based on other criteria not listed here.
What is being tested?
The study compares pain control methods after PRK surgery: one eye will receive an oral cannabinoid for pain, while the other eye will get a codeine/acetaminophen combination two weeks later. This allows patients to experience both treatments.
What are the potential side effects?
Cannabinoids may cause dizziness, dry mouth, or mood changes, while codeine/acetaminophen can lead to constipation, nausea, drowsiness, and potential addiction with long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and my vision has been stable for a year, and I choose to have PRK surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not a candidate for PRK eye surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain as recorded by the FACES scale
Secondary study objectives
Corneal Opacity
Ocular discomfort questionnaire
Subjective vision questionnaire
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Oral cannabinoidExperimental Treatment1 Intervention
Oral cannabinoid
Group II: Oral codeine/acetaminophenActive Control1 Intervention
Oral codeine-acetaminophen for controlling pain

Find a Location

Who is running the clinical trial?

Consortium for Medical Marijuana Clinical Outcomes ResearchOTHER
4 Previous Clinical Trials
67 Total Patients Enrolled
University of FloridaLead Sponsor
1,398 Previous Clinical Trials
767,015 Total Patients Enrolled
W Steigleman, MDPrincipal InvestigatorUniversity of Florida
~3 spots leftby Jan 2025
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