Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT04604002
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2020-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2020-10-20', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality score', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'Graded 0-2 (0 = poor, 1 = average, 2 = good)'}, {'measure': 'Visibility of OCTA key anatomical vascular structures quality score', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'Graded 0-2 (easy (2), difficult (1) or unable to be distinguished (0)) based on pre-specified abnormalities'}, {'measure': 'Identification of vascular abnormalities on OCTA', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'Graded Yes, No, or Unable to Grade based on pre-specified abnormalities'}, {'measure': 'Adverse Events', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'All AEs'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Retinal Vascular', 'Normal Eyes']}, 'descriptionModule': {'briefSummary': 'Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations', 'detailedDescription': 'The objectives of this study are:\n\n1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types.\n\n2\\. Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types.\n\n3\\. Assess the agreement in identification of vascular abnormalities between the predicate scan types and the corresponding investigational scan types, where agreement is assessed by the vascular abnormalities identified from the predicate scan types.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with Healthy Eyes and Adults with Eyes with retinal vascular pathology', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Populations:\n\n 1. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.\n 2. Age ≥ 22\n* Normal Population:\n\n 3\\. Subjects without uncontrolled systemic conditions, as determined by the Investigator 4. Subjects without ocular disease, as determined by the Investigator 5. Corrected visual acuity ≥ 20/40 6. No reported history of ocular surgical intervention (except for refractive or cataract surgery)\n* Pathology Population:\n\n 3\\. Subjects with vascular abnormalities such as retinal ischemia, microaneurysms, choroidal neovascularization, retinal neovascularization in at least one eye\n\nExclusion Criteria:\n\n* All Populations:\n\n 1. Subjects unable to read or write\n 2. Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging\n 3. Subjects who cannot tolerate the imaging procedures\n 4. Subjects without an accompanying structural OCT and CFP image for an acceptable OCTA image'}, 'identificationModule': {'nctId': 'NCT04604002', 'acronym': 'OCTA', 'briefTitle': 'Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heidelberg Engineering GmbH'}, 'officialTitle': 'Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types', 'orgStudyIdInfo': {'id': 'S-2020-5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with Normal Eyes', 'description': 'OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology', 'interventionNames': ['Device: OCT Angiography', 'Device: Color Fundus Photography', 'Device: Optical Coherence Tomography']}, {'label': 'Subjects with Pathology', 'description': 'OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology', 'interventionNames': ['Device: OCT Angiography', 'Device: Color Fundus Photography', 'Device: Optical Coherence Tomography']}], 'interventions': [{'name': 'OCT Angiography', 'type': 'DEVICE', 'otherNames': ['Optical Coherence Tomography Angiography', 'OCTA'], 'description': 'OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.', 'armGroupLabels': ['Subjects with Normal Eyes', 'Subjects with Pathology']}, {'name': 'Color Fundus Photography', 'type': 'DEVICE', 'otherNames': ['CFP'], 'description': 'Non-contact white light photography', 'armGroupLabels': ['Subjects with Normal Eyes', 'Subjects with Pathology']}, {'name': 'Optical Coherence Tomography', 'type': 'DEVICE', 'otherNames': ['OCT'], 'description': 'A non-contact test that uses light waves to take cross-sectional pictures of the retina', 'armGroupLabels': ['Subjects with Normal Eyes', 'Subjects with Pathology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Retina Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'overallOfficials': [{'name': 'Dennis Marcus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southeast Retina Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg Engineering GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}