Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

NCT ID: NCT04799093

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-09-07

Brief Summary

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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.

Detailed Description

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Conditions

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Impairment Cannabis Intoxication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cannabis users

EyeBOX

Intervention Type DIAGNOSTIC_TEST

Eye-Tracking based diagnostic

Normals

EyeBOX

Intervention Type DIAGNOSTIC_TEST

Eye-Tracking based diagnostic

Interventions

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EyeBOX

Eye-Tracking based diagnostic

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Provide written informed consent.
2. 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.
3. Be at least 18 years old.

Exclusion Criteria

1. Be blind (no light perception), have missing or non-functional eyes.
2. Be unable to open their eyes.
3. Have a history of unresolved strabismus, diplopia, amblyopia.
4. Have a history of unresolved cranial nerve III, IV, or VI palsy.
5. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
6. 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.
7. Have a prior history of unresolved ocular-motor dysfunctions.
8. Have used cannabis, alcohol etc. 24 hours before study commences.
9. Be 100% naïve to cannabis usage.
10. Be pregnant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oculogica, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosina Samadani, Ph.D.

Role: STUDY_DIRECTOR

Oculogica, Inc.

Locations

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Integrated Medicine LLC

Westport, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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CAN-B

Identifier Type: -

Identifier Source: org_study_id

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