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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

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 more

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

0 / 1Eligibility criteria met

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

1,341 Previous Clinical Trials

715,611 Total Patients Enrolled

W Steigleman, MDPrincipal InvestigatorUniversity of Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to be included as a participant in this clinical trial?

"Patients meeting the inclusion criteria must exhibit myopia and fall within the age range of 18 to 65 years. A total of 35 participants will be enrolled in this study."

Answered by AI

What is the upper limit for patient enrollment in this medical study?

"Indeed, information available on clinicaltrials.gov confirms the current enrollment of participants for this research. Initially shared on February 1st, 2024 and most recently revised on February 19th, 2024, this trial aims to enroll a total of 35 patients from one designated site."

Answered by AI

Is the age limit for participating in this medical study set at 40 years or above?

"To be eligible for participation in this study, individuals must meet the age requirement of being at least 18 years old but not more than 65 years old."

Answered by AI

Is this clinical trial currently seeking and enrolling participants?

"Affirmative. The records on clinicaltrials.gov highlight that this medical research initiative is presently in search of suitable candidates. Initially disclosed on February 1st, 2024, the trial's most recent revision was made on February 19th, 2024. This investigation aims to enroll a total of 35 participants from one site."

Answered by AI

Has the Food and Drug Administration sanctioned oral cannabinoid for use?

"According to our team at Power, the safety rating for Oral cannabinoid is 2 on a scale of 1 to 3. This assessment is due to the ongoing Phase 2 trial which has provided some evidence regarding safety but not yet concerning efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control

2024. "Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05477875.

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