Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-03 @ 7:55 PM
Study NCT ID:
NCT03374020
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2017-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Imaging Using NOTAL-OCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-11', 'studyFirstSubmitDate': '2017-09-11', 'studyFirstSubmitQcDate': '2017-12-13', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula.', 'timeFrame': '1 year', 'description': 'OCT B-scans from both devices will be graded for fluid by an eye care professional and results per macula will be analyzed. A binary decision "there is fluid" or "there is no fluid" will be given to each macula (10 central degrees). Then agreement between decisions, commercial and Notal OCT, will be compared'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration', 'Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. AMD population - intermediate and advanced AMD (with active and non-active CNV)\n2. DR population. Patient with and without DME', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability and agreement to give informed consent (IC)\n2. Diagnosis of AMD or DR in SE by OCT\n3. Ability to undergo OCT scans\n4. VA of 20/160 or better in SE\n\nExclusion Criteria:\n\n1. AMD and DR in the same SE\n2. Evidence of macular disease other than AMD or DME in SE'}, 'identificationModule': {'nctId': 'NCT03374020', 'briefTitle': 'Retinal Imaging Using NOTAL-OCT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Notal Vision Inc.'}, 'officialTitle': 'Retinal Imaging Using NOTAL-OCT', 'orgStudyIdInfo': {'id': 'BNZ-0077-017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intermediate AMD', 'interventionNames': ['Device: Notal OCT']}, {'label': 'Advanced AMD', 'interventionNames': ['Device: Notal OCT']}, {'label': 'DR without macular edema', 'interventionNames': ['Device: Notal OCT']}, {'label': 'DR with macular edema', 'interventionNames': ['Device: Notal OCT']}], 'interventions': [{'name': 'Notal OCT', 'type': 'DEVICE', 'description': 'Imaging using Notal OCT', 'armGroupLabels': ['Advanced AMD', 'DR with macular edema', 'DR without macular edema', 'Intermediate AMD']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Notal Vision Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}