Cannabis, Retinal Degeneration, Retinitis Pigmentosa
Conditions
Keywords
retinitis pigmentosa, retinal degeneration, cannabis, THC, CBD, electrophysiology, visual functions, eye, retina
Brief summary
Medical Marijuana is used widely, and its effects on the visual system and the function of the retina have not been investigated thoroughly. Some evidence suggests that cannabinoids may be beneficial in certain degenerative diseases of the retina. The purpose of the study is 1. To determine whether cannabis derivatives affect the visual functions in healthy adults 2. To examine the effect of cannabis derivatives on the retina of retinitis pigmentosa patients
Detailed 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 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.
Interventions
single dose sublingual cannabis (THC:CBD 1:1, THC:CBD 1:40)
Sponsors
Study design
Masking description
Electrophysiology will be analyzed by a blinded investigator.
Intervention 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.
Eligibility
Inclusion criteria
* consenting adults * generally healthy with or without retinitis pigmentosa
Exclusion criteria
* chronic or acute disease other than retinitis pigmentosa * use of medication * congestive heart failure * recent use of illicit drugs (past month) * history of drug dependency * history of psychiatric disorder in subject or immediate relatives * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response | 3 hours | microvolt |
| Electroretinogram (ERG) - acivity of the neural retina cone flicker latency | 3 hours | milliseconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eye movements | 3 hours | degrees/second |
| Visual acuity | 3 hours | LogMAR ETDRS |
| Macular thickness (OCT) | 3 hours | micrometers |
| Intra ocular pressure | 3 hours | mmHg |
| Titmus stereo eye movements | 3 hours | seconds of arc |
Countries
Israel