ImpairmentNCT04799093
Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
An observational study of Impairment and Cannabis Intoxication, run by Oculogica, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impairment, Cannabis Intoxication
- What is being tested?
- EyeBOX
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 7 Sep 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy habitual cannabis-smoking subjects, i.e., smoke or consume cannabis at least three times a week, and healthy occasional cannabis-smoking subjects, i.e., smoke or consume once a week will be recruited from the local area.
Who may be able to join
- Provide written informed consent.
- Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking.
- Be at least 18 years old.
Who cannot join
- Be blind (no light perception), have missing or non-functional eyes.
- Be unable to open their eyes.
- Have a history of unresolved strabismus, diplopia, amblyopia.
- Have a history of unresolved cranial nerve III, IV, or VI palsy.
- Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
- Have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions) or scarring.
Show all 10Show fewer
- Have a prior history of unresolved ocular-motor dysfunctions.
- Have used cannabis, alcohol etc. 24 hours before study commences.
- Be 100% naïve to cannabis usage.
- Be pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrated Medicine LLC
Westport, Connecticut, 06880
About this study
The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment.
- Conditions
- Impairment, Cannabis Intoxication
- Being tested
- EyeBOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeBOXDiagnostic test
Eye-Tracking based diagnostic
| Study group | Role | What they receive |
|---|---|---|
| Cannabis users | Not described Receives: Diagnostic Test: EyeBOX | |
| Normals | Not described Receives: Diagnostic Test: EyeBOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairment assessment correlation with EyeBOX assessment
A correlation between impairment as assessed by standard impairment tests and the EyeBOX assessment of impairment as determined by an algorithm.
Measured: Within an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Feb 2021
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpairmentStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oculogica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosina Samadani, Ph.D., Study director, Oculogica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799093
- Sponsor's protocol ID
- CAN-B
- Status last verified
- Sep 2021
- First submitted
- 11 Mar 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
- ClinicalTrials.gov ID
- NCT04799093
- Acronym / sponsor ID
- CAN-B
- Conditions
- Impairment, Cannabis Intoxication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Oculogica, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 16 Mar 2021 (actual)
- 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.
The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis users | – | Diagnostic Test: EyeBOX |
| Normals | – | Diagnostic Test: EyeBOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy habitual cannabis-smoking subjects, i.e., smoke or consume cannabis at least three times a week, and healthy occasional cannabis-smoking subjects, i.e., smoke or consume once a week will be recruited from the local area.
Key inclusion criteria (3 listed)
- Provide written informed consent.
- Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking.
- Be at least 18 years old.
Key exclusion criteria (10 listed)
- Be blind (no light perception), have missing or non-functional eyes.
- Be unable to open their eyes.
- Have a history of unresolved strabismus, diplopia, amblyopia.
- Have a history of unresolved cranial nerve III, IV, or VI palsy.
- Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EyeBOXEye-Tracking based diagnostic | Diagnostic test | Cannabis users, Normals |
Primary outcome
Impairment assessment correlation with EyeBOX assessment
Time frame: Within an hour
A correlation between impairment as assessed by standard impairment tests and the EyeBOX assessment of impairment as determined by an algorithm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Rosina Samadani, Ph.D. study director
Oculogica, Inc.
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 Impairment and Cannabis Intoxication, run by Oculogica, Inc. at 1 site in United States.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 13 Sep 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impairment assessment correlation with EyeBOX assessment (time frame: Within an hour). 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 13 Sep 2021.