Intra Ocular PressureNCT02080676
Effects of Marihuana Use on Optic Nerve Parameters and Ocular Blood Flow
An observational study of Intra Ocular Pressure, run by Carmel Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intra Ocular Pressure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age over 18
- Treated with medical cannabis for approved medical indications
Who cannot join
- Known ocular pathology
- Topical or systemic treatment for intra ocular pressure
- Previous topical, intra ocular or systemic steroid treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa
Nurit Mathalone, MD, 97248250477, Nurit.Mathalone@clalit.org.il
Orna Geyer, MD
About this study
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.
Read the 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.
- Conditions
- Intra Ocular Pressure
- Keywords
- Cannabis, Intra ocular pressure, Ocular perfusion, Blood pressure
- Medical subject headings
- Marijuana Abuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra ocular pressure
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra Ocular PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orna Geyer, Carmel Medical Center
- Investigators
- Orna Geyer, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080676
- Sponsor's protocol ID
- CMC-14-0001-CTIL
- Status last verified
- Oct 2015
- First submitted
- 5 Mar 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Marihuana Use on Optic Nerve Parameters and Ocular Blood Flow
- ClinicalTrials.gov ID
- NCT02080676
- Acronym / sponsor ID
- CMC-14-0001-CTIL
- Conditions
- Intra Ocular Pressure
- Keywords
- Cannabis, Intra ocular pressure, Ocular perfusion, Blood pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age over 18
- Treated with medical cannabis for approved medical indications
Key exclusion criteria (3 listed)
- Known ocular pathology
- Topical or systemic treatment for intra ocular pressure
- Previous topical, intra ocular or systemic steroid treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intra ocular pressure
Time frame: 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orna Geyer, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra Ocular Pressure, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orna Geyer, MD (97248250926, orna_geyer@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra ocular pressure (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.