NCT02080676

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

March 5, 2014

Last Update Submit

October 13, 2015

Conditions

Intra Ocular Pressure

Keywords

CannabisIntra ocular pressureOcular perfusionBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Intra ocular pressure

    5 hours

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Age over 18
  • Treated with medical cannabis for approved medical indications

You may not qualify if:

  • Known ocular pathology
  • Topical or systemic treatment for intra ocular pressure
  • Previous topical, intra ocular or systemic steroid treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Orna Geyer, MD

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Orna Geyer, MD

CONTACT

97248250926orna_geyer@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 6, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

IL(1)