Effects of Marihuana Use on Optic Nerve Parameters and Ocular Blood Flow

Intra Ocular Pressure Clinical Trial

Official title:

Effects of Marihuana Use on Optic Nerve Parameters and Ocular Blood Flow

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02080676
• Other study ID #: CMC-14-0001-CTIL
• Status: Recruiting
• Phase: N/A
• First received: March 5, 2014
• Last updated: October 13, 2015
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2015
• Source: Carmel Medical Center
• Contact: Orna Geyer, MD
• Phone: 97248250926
• Email: orna_geyer[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Purpose of study: to check the effect of medical cannabis given for approved medical indications on ocular parameters including intra ocular pressure, optic nerve fibers thickness and choroidal thickness.

Description:

Purpose of study: to check the effect of medical cannabis given for approved medical indications on ocular parameters including intra ocular pressure, Retinal Nerve Fiber Layer (RNFL) thickness, optic nerve fibers thickness and choroidal thickness.

Adult patients with no ocular pathology that are being treated in the neurology or pain clinics with medical cannabis for different indications, were examined in the eye clinic.

First examination took place after the patient was not smoking for 5 hours. Three more examinations took place 1 hour 3 hours and 5 hours after smoking cannabis.

The following parameters were checked: blood pressure, pulse, visual acuity, intra ocular pressure, corneal thickness, axial length, slit lamp examination of anterior segment, fundoscopy and Optical Coherence Tomography (OCT) of the retina, and optic nerve.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age over 18

• Treated with medical cannabis for approved medical indications

Exclusion Criteria:

• Known ocular pathology

• Topical or systemic treatment for intra ocular pressure

• Previous topical, intra ocular or systemic steroid treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intra Ocular Pressure

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra ocular pressure		5 hours	No