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Clinical Trials/NCT04799093
NCT04799093
Completed
Not Applicable

Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

Oculogica, Inc.1 site in 1 country225 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Impairment
Sponsor
Oculogica, Inc.
Enrollment
225
Locations
1
Primary Endpoint
Impairment assessment correlation with EyeBOX assessment
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
September 7, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
  • 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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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