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

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ClinicalTrials.gov Identifier: NCT02080676
Recruitment Status : Unknown
Verified October 2015 by Orna Geyer, Carmel Medical Center.
Recruitment status was:  Recruiting
First Posted : March 6, 2014
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Orna Geyer, Carmel Medical Center

Tracking Information
First Submitted Date March 5, 2014
First Posted Date March 6, 2014
Last Update Posted Date October 14, 2015
Study Start Date March 2014
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2014)
Intra ocular pressure [ Time Frame: 5 hours ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02080676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Marihuana Use on Optic Nerve Parameters and Ocular Blood Flow
Official Title Effects of Marihuana Use on Optic Nerve Parameters and Ocular Blood Flow
Brief 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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients over the age of 18, with no ocular pathology that are being treated in the neurology or pain clinics with medical cannabis for different indications.
Condition Intra Ocular Pressure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 5, 2014)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2016
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT02080676
Other Study ID Numbers CMC-14-0001-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Orna Geyer, Carmel Medical Center
Study Sponsor Carmel Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Orna Geyer, MD Carmel Medical Center
PRS Account Carmel Medical Center
Verification Date October 2015