Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-06 @ 5:21 AM
Study NCT ID:
NCT02959593
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2016-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Visior on Ocular Hemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-11', 'studyFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retinal capillary blood flow', 'timeFrame': '1 day', 'description': 'retinal capillary blood flow in arbitrary units'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Primary open-angle glaucoma', 'retinal capillary blood flow', 'visual stimulation'], 'conditions': ['Primary Open Angle Glaucoma']}, 'referencesModule': {'references': [{'pmid': '30602450', 'type': 'DERIVED', 'citation': 'Siesky B, Harris A, Gross J, Sechrist E, Camp D, Cardenas A, Patel P, Hasnain F, Kawiecki R, Shah A, Verticchio Vercellin AC. Effects of image brightness and contrast dynamic altering stimuli (DAS) when viewing video content on ocular blood flow. Br J Ophthalmol. 2019 Oct;103(10):1511-1517. doi: 10.1136/bjophthalmol-2018-312561. Epub 2019 Jan 2.'}]}, 'descriptionModule': {'briefSummary': 'To determine the relationship between the affects of viewing commercially available content through the VISIOR video goggles and ocular blood flow in glaucoma patients and healthy subjects.', 'detailedDescription': 'To determine if glaucoma patients and healthy subject experience any alteration in localized retinal blood flow after retinal stimulation by viewing commercially available content through the VISIOR video goggles.\n\nBoth groups will undergo measurements of arterial blood pressure, cardiac pulse (heart rate), intraocular pressure, and retinal blood flow using Heidelberg retinal flowmetry (Heidelberg Engineering, Heidelberg, Germany) at baseline and then ten minutes, thirty minutes, and sixty minutes after viewing commercially available content through the VISIOR video goggles for thirty minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with open-angle glaucoma 30 years or older, free from other ophthalmic disease, free from diabetes, beta agonists and uncontrolled blood pressure.\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating or who plan to become pregnant (self reporting); smoker during last ten years (self reporting); systemic diseases that may interfere with blood flow measurements or wearing the goggles.\n* In addition, 10 healthy subjects, age 18 or older, free from eye disease will be enrolled. Identical exclusion criteria apply to this healthy group. Identical procedures apply to this group, which only differs by ocular health status.'}, 'identificationModule': {'nctId': 'NCT02959593', 'briefTitle': 'The Effects of Visior on Ocular Hemodynamics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Visior Technologies Ltd.'}, 'officialTitle': 'The Effects of Visior on Ocular Hemodynamics', 'orgStudyIdInfo': {'id': '1602760177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glaucoma patients', 'description': 'To view commercially available content through the VISIOR video goggles for thirty minutes', 'interventionNames': ['Device: VISIOR video goggles']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy subjects', 'description': 'To view commercially available content through the VISIOR video goggles for thirty minutes.', 'interventionNames': ['Device: VISIOR video goggles']}], 'interventions': [{'name': 'VISIOR video goggles', 'type': 'DEVICE', 'description': 'View commercially available content through the VISIOR video goggles continuously for thirty minutes.', 'armGroupLabels': ['Glaucoma patients', 'Healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Eugene and Marilyn Glick Eye Institute, Department of Ophthalmology, Indiana School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Alon Harris, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Visior Technologies Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Indiana University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}