Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

Completed

• Conditions: Cannabis Intoxication; Impairment
• Interventions: Diagnostic Test: EyeBOX

• Registration Number: NCT04799093
• Lead Sponsor: Oculogica, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-16
• Status Verified: 2021-09
• Primary Completion: 2021-09-07
• Study Completion: 2021-09-07
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cannabis users	EyeBOX	-
Normals	EyeBOX	-

Primary Outcome Measures

Name	Time	Method
Impairment assessment correlation with EyeBOX assessment	Within an hour	A correlation between impairment as assessed by standard impairment tests and the EyeBOX assessment of impairment as determined by an algorithm.

Trial Locations

Locations (1)

Integrated Medicine LLC; 🇺🇸 Westport, Connecticut, United States