The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cannabis
- Retinal Degeneration
- Retinitis Pigmentosa
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Arm 1 - healthy subjects. Arm 2 - subjects with retinitis pigmentosa All subjects will undergo a full ocular exam and visual functions will be assessed before and after the administration of a single dose of cannabis (THC:CBD 1:40). On the second study day all subjects will receive a single dose of cannabis (THC:CBD 1:1) and undergo the full ocular exam again.Masking: Single (Outcomes Assessor)Masking Description: Electrophysiology will be analyzed by a blinded investigator.Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Twenty five healthy subjects and 25 retinitis pigmentosa patients will be recruited and will sign an informed consent form. An initial eye exam will include visual acuity and stereo vision, eye movements and eye movement recording, a full slit lamp eye exam, intra-ocular pressure measurement, visual...
Twenty five healthy subjects and 25 retinitis pigmentosa patients will be recruited and will sign an informed consent form. An initial eye exam will include visual acuity and stereo vision, eye movements and eye movement recording, a full slit lamp eye exam, intra-ocular pressure measurement, visual field, OCT and electrophysiology. The subjects will receive a single sublingual dose of cannabis (THC:CBD 1:1, THC 5 mg, or THE:CBD 1:40, THC 5 mg), and will undergo the above examination again. Subjects will be monitored for 5 hours after the administration of cannabis.
Tracking Information
- NCT #
- NCT03078309
- Collaborators
- Hebrew University of Jerusalem
- Investigators
- Principal Investigator: Hadas Mechoulam, MD Hadassah Medical Organization
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