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| Name | Class |
|---|---|
| Hebrew University of Jerusalem | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy | Experimental | 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. |
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| Retinitis Pigmentosa | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cannabis | Drug | single dose sublingual cannabis (THC:CBD 1:1, THC:CBD 1:40) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response | microvolt | 3 hours |
| Electroretinogram (ERG) - acivity of the neural retina cone flicker latency | milliseconds | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | LogMAR ETDRS | 3 hours |
| Titmus stereo eye movements | seconds of arc | 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadas Mechoulam, MD | Contact | 9293077002 | hadasm@gmail.com | |
| Hadas Lemberg, PhD | Contact | 00 972 2 6777572 | lhadas@hadassah.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Hadas Mechoulam, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Recruiting | Jerusalem | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24495949 | Background | Lax P, Esquiva G, Altavilla C, Cuenca N. Neuroprotective effects of the cannabinoid agonist HU210 on retinal degeneration. Exp Eye Res. 2014 Mar;120:175-85. doi: 10.1016/j.exer.2014.01.019. Epub 2014 Feb 1. | |
| 15182912 | Background | Russo EB, Merzouki A, Mesa JM, Frey KA, Bach PJ. Cannabis improves night vision: a case study of dark adaptometry and scotopic sensitivity in kif smokers of the Rif mountains of northern Morocco. J Ethnopharmacol. 2004 Jul;93(1):99-104. doi: 10.1016/j.jep.2004.03.029. |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D012162 | Retinal Degeneration |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
| D002185 | Cannabidiol |
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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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.
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Electrophysiology will be analyzed by a blinded investigator.
| Eye movements | degrees/second | 3 hours |
| Intra ocular pressure | mmHg | 3 hours |
| Macular thickness (OCT) | micrometers | 3 hours |
| 27930772 | Background | Lyons CJ, Robson AG. Retinal Ganglion Cell Dysfunction in Regular Cannabis Users: Is the Evidence Strong Enough to Consider an Association? JAMA Ophthalmol. 2017 Jan 1;135(1):60-61. doi: 10.1001/jamaophthalmol.2016.4780. No abstract available. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |