Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-10 @ 10:53 AM
Study NCT ID:
NCT04994457
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2021-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2021-07-29', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of VRVF compared to SAP', 'timeFrame': 'Day 1', 'description': 'Sensitivity of VRVF will be determined by comparing Hodapp Anderson Parrish (HAP) Scores, which assess the severity of visual field defects, to those of SAP'}, {'measure': 'Specificity of VRVF compared to SAP', 'timeFrame': 'Day 1', 'description': 'Specificity of VRVF will be determined by comparing Hodapp Anderson Parrish (HAP) Scores, which assess the severity of visual field defects, to those of SAP'}], 'secondaryOutcomes': [{'measure': 'Variability of Mean Deviation', 'timeFrame': 'Day 1', 'description': 'Variability of the mean deviation scores obtained from VRVF and SAP'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Visual Field', 'Virtual Reality'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '37647317', 'type': 'DERIVED', 'citation': "McLaughlin DE, Savatovsky EJ, O'Brien RC, Vanner EA, Munshi HK, Pham AH, Grajewski AL. Reliability of Visual Field Testing in a Telehealth Setting Using a Head-Mounted Device: A Pilot Study. J Glaucoma. 2024 Jan 1;33(1):15-23. doi: 10.1097/IJG.0000000000002290. Epub 2023 Aug 14."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who are glaucoma or glaucoma suspect who are being seen at Bascom Palmer Eye Institute and/or healthy individuals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion:\n\n* Any individual who is physically able to take a virtual reality visual field test\n* Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma, or have other visual field defects, and normal individual\n* Age: Individuals who are old enough to comprehend the instructions and procedures (1-90)\n\nExclusion:\n\n* Adults unable to consent, prisoners\n* Participants who are too tired to take a visual field test\n* Participants who refuse to consent\n* Individuals who are functionally unable to use VRVF'}, 'identificationModule': {'nctId': 'NCT04994457', 'briefTitle': 'Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care', 'orgStudyIdInfo': {'id': '20210472'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with Glaucoma or Suspected Glaucoma', 'description': 'Adults with Glaucoma or Suspected Glaucoma, who have previously had standard automated perimetry (SAP) and will receive virtual reality visual field (VRVF) as part of the standard of care', 'interventionNames': ['Device: Virtual Reality Visual Field']}, {'label': 'Visual Field Naive Adults', 'description': 'Visual Field Naive Adults will receive SAP and VRVF', 'interventionNames': ['Device: Virtual Reality Visual Field', 'Diagnostic Test: Standard Automated Perimetry']}, {'label': 'Children with Glaucoma or Suspected Glaucoma', 'description': 'Children with Glaucoma or Suspected Glaucoma, who have previously had SAP and will receive VRVF as part of the standard of care', 'interventionNames': ['Device: Virtual Reality Visual Field']}, {'label': 'Visual Field Naive Children', 'description': 'Visual Field Naive Children will receive SAP and VRVF', 'interventionNames': ['Device: Virtual Reality Visual Field', 'Diagnostic Test: Standard Automated Perimetry']}, {'label': 'Remote Care Arm', 'description': 'Glaucoma or Suspected Glaucoma participants, who have previously had SAP and will receive VRVF at their home', 'interventionNames': ['Device: Virtual Reality Visual Field']}, {'label': 'Ptosis Arm', 'description': 'Patients diagnosed with Ptosis, brow ptosis, or dermatochalasis, will receive a specialized version of VRVF and SAP, specifically to detect ptosis', 'interventionNames': ['Device: Virtual Reality Visual Field', 'Diagnostic Test: Standard Automated Perimetry']}], 'interventions': [{'name': 'Virtual Reality Visual Field', 'type': 'DEVICE', 'description': 'A head-mounted perimeter with a wireless remote connected to a laptop that monitors responses', 'armGroupLabels': ['Adults with Glaucoma or Suspected Glaucoma', 'Children with Glaucoma or Suspected Glaucoma', 'Ptosis Arm', 'Remote Care Arm', 'Visual Field Naive Adults', 'Visual Field Naive Children']}, {'name': 'Standard Automated Perimetry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard of care perimeter', 'armGroupLabels': ['Ptosis Arm', 'Visual Field Naive Adults', 'Visual Field Naive Children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Elena Bitrian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical', 'investigatorFullName': 'Elena Bitrian', 'investigatorAffiliation': 'University of Miami'}}}}