Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-31 @ 6:06 PM
Study NCT ID:
NCT04799093
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2021-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impairment assessment correlation with EyeBOX assessment', 'timeFrame': 'Within an hour', 'description': 'A correlation between impairment as assessed by standard impairment tests and the EyeBOX assessment of impairment as determined by an algorithm.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Impairment', 'Cannabis Intoxication']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide written informed consent.\n2. 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.\n3. Be at least 18 years old.\n\nExclusion Criteria:\n\n1. Be blind (no light perception), have missing or non-functional eyes.\n2. Be unable to open their eyes.\n3. Have a history of unresolved strabismus, diplopia, amblyopia.\n4. Have a history of unresolved cranial nerve III, IV, or VI palsy.\n5. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.\n6. 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.\n7. Have a prior history of unresolved ocular-motor dysfunctions.\n8. Have used cannabis, alcohol etc. 24 hours before study commences.\n9. Be 100% naïve to cannabis usage.\n10. Be pregnant.'}, 'identificationModule': {'nctId': 'NCT04799093', 'briefTitle': 'Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oculogica, Inc.'}, 'officialTitle': 'Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication', 'orgStudyIdInfo': {'id': 'CAN-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cannabis users', 'interventionNames': ['Diagnostic Test: EyeBOX']}, {'label': 'Normals', 'interventionNames': ['Diagnostic Test: EyeBOX']}], 'interventions': [{'name': 'EyeBOX', 'type': 'DIAGNOSTIC_TEST', 'description': 'Eye-Tracking based diagnostic', 'armGroupLabels': ['Cannabis users', 'Normals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06880', 'city': 'Westport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Integrated Medicine LLC', 'geoPoint': {'lat': 41.14149, 'lon': -73.3579}}], 'overallOfficials': [{'name': 'Rosina Samadani, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oculogica, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oculogica, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}