Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

• Sponsor: Oculogica, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04799093
• Collaborator: (none)
• Enrollment: 225
• Location: 1
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 31.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Impairment; Cannabis Intoxication	Diagnostic Test: EyeBOX

Study Design

• Study Type: Observational
• Actual Enrollment: 225 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
• Actual Study Start Date: Feb 1, 2021
• Actual Primary Completion Date: Sep 7, 2021
• Actual Study Completion Date: Sep 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Cannabis users	Diagnostic Test: EyeBOX; Eye-Tracking based diagnostic
Normals	Diagnostic Test: EyeBOX; Eye-Tracking based diagnostic

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Integrated Medicine LLC	Westport	Connecticut	United States	06880

Sponsors and Collaborators

• Oculogica, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oculogica, Inc.
• ClinicalTrials.gov Identifier: NCT04799093
• Other Study ID Numbers: CAN-B
• First Posted: Mar 16, 2021
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Marijuana Abuse

Study Results

No Results Posted as of Sep 13, 2021