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Opioid
Oral cannabinoid for Farsightedness
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 18 and my vision has been stable for a year, and I choose to have PRK surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain as recorded by the FACES scale
Secondary outcome measures
Corneal Opacity
Ocular discomfort questionnaire
Subjective vision questionnaire
+1 moreTrial 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
60 Total Patients Enrolled
University of FloridaLead Sponsor
1,350 Previous Clinical Trials
719,425 Total Patients Enrolled
W Steigleman, MDPrincipal InvestigatorUniversity of Florida
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