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OpenTrials
Completed

NCT Number: NCT04799093

Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

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.

Completed

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Key information

Conditions

Impairment Cannabis Intoxication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Integrated Medicine LLC

Westport, Connecticut, 06880, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EyeBOX

Diagnostic Test

Eye-Tracking based diagnostic

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Oculogica, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2021
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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