Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT02609204
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2015-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Normative Database for Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ljkatz@willseye.org', 'phone': '215-928-3123', 'title': 'Dr. L. Jay Katz', 'organization': 'Wills Eye Hospital, Glaucoma Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'All participants came from the same location.'}}, 'adverseEventsModule': {'timeFrame': '2 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Controls', 'description': '51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.\n\nDiopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': '51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.\n\nDiopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.68', 'spread': '0.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours', 'description': 'Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) amplitude in micro volts.', 'unitOfMeasure': 'micro volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': '51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.\n\nDiopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA (Neuro Optic Vision Assessment) machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.'}], 'classes': [{'categories': [{'measurements': [{'value': '107.39', 'spread': '10.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours', 'description': 'Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) latency in milliseconds.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Controls', 'description': '51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA (Neuro Optic Vision Assessment).\n\nDiopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Controls', 'description': '51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.\n\nDiopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-07', 'studyFirstSubmitDate': '2015-08-07', 'resultsFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2015-11-17', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-21', 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude', 'timeFrame': '2 hours', 'description': 'Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) amplitude in micro volts.'}, {'measure': 'Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency', 'timeFrame': '2 hours', 'description': 'Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) latency in milliseconds.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Pattern Electroretinogram (PERG)', 'Flash Electroretinogram (FERG)'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The main goal of the study is to compile a normative database for the Neuro Optic Vision Assessment (NOVATM) Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules. This normalization intends to be included in a probabilistic analysis protocol to allow NOVATM PERG/FERG users to identify patients with results outside the normal ranges.', 'detailedDescription': "Investigators plan to enroll 50 subjects at Wills Eye Hospital without any eye diseases.\n\nParticipants will undergo a complete eye examination to determine eligibility, including visual acuity testing, intraocular pressure (IOP) in millimeters of mercury (mmHG), and visual field (VF) testing.\n\nParticipants will then be tested with Diopsys NOVA™ PERG \\& FERG systems. For both tests, two electrodes are placed on the skin underneath each eye below the eyelashes. Participants' skin will be cleaned before electrodes are placed. A small amount of gel will be placed on skin where electrodes are placed for testing. Electrical responses are recorded with electrodes in response to visual stimuli."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers age 18 years\n* older with normal eye exam\n\nExclusion Criteria:\n\n* spherical refraction outside + 5.0 Diopters and cylinder correction outside + 3.0 Diopters.\n* IOP (intraocular pressure) ≥ 22 mm Hg (millimeters of mercury)\n* history of any type of glaucoma in either eye.\n* Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment).\n* Best corrected visual acuity worse than 20/40.\n* Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo-retinal disease in either eye.\n* Evidence of optic nerve, macula and/or retinal nerve fiber layer abnormality in either eye.\n* Evidence of reproducible (false positives, fixation losses and false negatives ≤ 25% with no observable testing artifacts).\n* Standard Automatic Perimetry (SAP) abnormality in either eye, defined as Pattern Standard Deviation \\< 5% level, and/or abnormal Glaucoma Hemifield test result, and/or any other pattern of loss which is consistent with a neurologic and/or ocular disease.\n* Current or recent (within the past 30 days) use of an agent (by any administering method) known to affect visual function.\n* Inability to obtain reliable PERG/FERG (Pattern Electroretinogram/Flash Electroretinogram) results.'}, 'identificationModule': {'nctId': 'NCT02609204', 'acronym': 'DIOPSYS-ND', 'briefTitle': 'Normative Database for Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG)', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'NOVA™ PERG (Pattern Electroretinogram)and FERG (Flash Electroretinogram): Establishment of Reference Values for PERG and FERG Measurements', 'orgStudyIdInfo': {'id': '14-426E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Controls', 'description': 'Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.', 'interventionNames': ['Diagnostic Test: Diopsys NOVA']}], 'interventions': [{'name': 'Diopsys NOVA', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Diopsys-ND'], 'description': 'Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.', 'armGroupLabels': ['Healthy Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'L. Jay Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wills Eye', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Glaucoma Specialist', 'investigatorFullName': 'L. Jay Katz MD', 'investigatorAffiliation': 'Wills Eye'}}}}