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.

Study Overview

• Status: Completed
• Conditions: Impairment; Cannabis Intoxication
• Intervention / Treatment: Diagnostic test: EyeBOX

• Study Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Westport, Connecticut, United States, 06880
      • Integrated Medicine LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cannabis users	Diagnostic test: EyeBOX; Eye-Tracking based diagnostic
Normals	Diagnostic test: EyeBOX; Eye-Tracking based diagnostic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oculogica, Inc.
• Investigators: Study Director: Rosina Samadani, Ph.D., Oculogica, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): September 7, 2021
• Study Completion (Actual): September 7, 2021

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: CAN-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes