Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

NCT04799093 | Completed FDA Device

• 1 other identifier: CAN-B
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Impairment; Cannabis Intoxication

Outcome Measures

Primary Outcomes (1)

• 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.

  Within an hour

Study Arms (2)

Cannabis users

Diagnostic Test: EyeBOX

Normals

Diagnostic Test: EyeBOX

Interventions

EyeBOX DIAGNOSTIC_TEST

Eye-Tracking based diagnostic

Cannabis users; Normals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Oculogica, Inc.: lead

Study Sites (1)

Integrated Medicine LLC

Westport, Connecticut, 06880, United States

Location

Study Officials

• Rosina Samadani, Ph.D.

  Oculogica, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: February 1, 2021
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)