Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

Impairment Clinical Trial

Official title:

Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04799093
• Other study ID #: CAN-B
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: September 7, 2021

Study information

• Verified date: September 2021
• Source: Oculogica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: September 7, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Intoxication
• Impairment
• Marijuana Abuse

Intervention

Diagnostic Test:
• EyeBOX
Eye-Tracking based diagnostic

Locations

Country	Name	City	State
United States	Integrated Medicine LLC	Westport	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Oculogica, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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