Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT04068818
Status:
COMPLETED
Last Update Posted:
2022-08-04
First Post:
2019-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Heidelberg Engineering ANTERION Imaging Agreement Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005124', 'term': 'Eye Abnormalities'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality', 'timeFrame': '30 days', 'description': 'Comparison of the B-Scan image quality between the ANTERION and the reference device'}, {'measure': 'Agreement in identification of abnormality', 'timeFrame': '30 days', 'description': 'Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '1 day', 'description': 'Evaluate any adverse events found during the clinical study'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Eye Abnormalities', 'Normal Eyes']}, 'descriptionModule': {'briefSummary': 'This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess image quality of acquired biometry images of the eye', 'detailedDescription': 'The conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. Because the study is not interventional, the study is not an Applicable Clinical Trial per Clinicaltrials.gov definition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A: normal eyes B: eyes with anterior segment abnormalities', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 22 years or older\n2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions\n3. Able to fixate\n4. With eye pathology status for each of the two eye populations. A. Eye with normal anterior segment\n\nB. Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to:\n\n* glaucoma surgeries: trabeculectomy, laser peripheral iridotomy and drainage devices\n* corneal surgeries: corneal inlays and corneal transplants\n* pterygium and corneal scar\n\nExclusion Criteria:\n\n1. Subjects which were enrolled in the B-2018-1 Study\n2. Physical inability to be properly positioned at the study devices or eye exam equipment\n3. Contact lenses worn during imaging'}, 'identificationModule': {'nctId': 'NCT04068818', 'briefTitle': 'The Heidelberg Engineering ANTERION Imaging Agreement Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heidelberg Engineering GmbH'}, 'officialTitle': 'The Heidelberg Engineering ANTERION Imaging Agreement Study', 'orgStudyIdInfo': {'id': 'B-2018-4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Eyes with normal anterior segment', 'interventionNames': ['Device: ANTERION']}, {'label': 'Eyes with anterior segment abnormalities', 'interventionNames': ['Device: ANTERION']}], 'interventions': [{'name': 'ANTERION', 'type': 'DEVICE', 'description': 'Biometry images will be acquired on the ANTERION and the reference device and the image quality and the identification of abnormalities will be assessed by a reading center', 'armGroupLabels': ['Eyes with anterior segment abnormalities', 'Eyes with normal anterior segment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York College of Optometry', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mitchell Dul', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York College of Optometry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg Engineering GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}