Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-03-11 @ 4:02 PM
Study NCT ID:
NCT05286502
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2022-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NW500 Non-Mydriatic Retinal Camera Clinical Performance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005451', 'term': 'Fluorescein Angiography'}], 'ancestors': [{'id': 'D000792', 'term': 'Angiography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fundus photo image quality', 'timeFrame': '1 day'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Fundus Photography']}, 'descriptionModule': {'briefSummary': 'Comparison of color fundus images acquired by the Topcon NW500 non-mydriatic retinal camera (investigational device) and the Topcon TRC-NW400 (predicate device)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects 18 years old or older.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are 18 years of age or older on the date of informed consent.\n* Subjects who are able to understand the written informed consent and are willing to participate as evidenced by signing the informed consent.\n\nExclusion Criteria:\n\n* Subjects who are unable to tolerate ophthalmic imaging.\n* Subjects with poor fixation or ocular media not sufficiently clear to obtain acceptable images.\n* Subjects who cannot follow instructions to complete the required testing.'}, 'identificationModule': {'nctId': 'NCT05286502', 'briefTitle': 'NW500 Non-Mydriatic Retinal Camera Clinical Performance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Topcon Corporation'}, 'officialTitle': 'NW500 Non-Mydriatic Retinal Camera Clinical Performance Study', 'orgStudyIdInfo': {'id': 'THS-TPCN-2022-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults 18 years old or older', 'interventionNames': ['Device: fundus photography']}], 'interventions': [{'name': 'fundus photography', 'type': 'DEVICE', 'description': 'color fundus photography', 'armGroupLabels': ['Adults 18 years old or older']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07436', 'city': 'Oakland', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Topcon Healthcare Solutions', 'geoPoint': {'lat': 41.01315, 'lon': -74.26431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Topcon Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}