Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT03578302
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2018-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Heidelberg Engineering BI US Evaluation 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_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2018-06-21', 'studyFirstSubmitQcDate': '2018-07-03', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of successfully scanned biometry images of the eye', 'timeFrame': '1 day', 'description': 'Percentage of successfully scanned biometry images of the eyes per scan mode. Success is defined as agreement of the subjective assessment of the operator and the auto assessment of the device.'}, {'measure': 'Repeatabiltiy of specific parameters of the biometry images of the eye', 'timeFrame': '1 day', 'description': 'Repeatability of specific parameters stratified by different eye pathologies'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Normal Eyes', 'Eye Abnormalities']}, 'descriptionModule': {'briefSummary': 'Evaluation of defined parameters measured in pathological and non-pathological eyes with the Heidelberg BI', 'detailedDescription': 'The primary objectives of this study are to assess the feasibility to acquire acceptable images and to assess repeatability'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with:\n\n1. Eyes with Normal Anterior Segment or\n2. Eyes with Abnormal Anterior Segment, including Eyes with Cataract Eyes without a Crystalline Lens Eyes with Corneal Abnormality Eyes with Anterior Segment Pathology', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older\n2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions\n\n At least one of the following:\n3. Eyes with Normal Anterior Segment\n4. Eyes with Cataract\n5. Eyes without a Crystalline Lens\n6. Eyes with Corneal Abnormality\n7. Eyes with Anterior Segment Pathology\n\nExclusion Criteria:\n\n1. Subjects unable to read or write\n2. Active infection or inflammation in one or both eyes\n3. Insufficient tear film or corneal reflex\n4. Physical inability to be properly positioned at the study devices or eye exam equipment\n5. Inability to fixate\n6. Rigid contact lens wear during past 2 weeks\n7. Soft lenses, in the study eye, if worn, should be removed at least one hour prior to the measurements \\*Note: Eyes with risk for acute angle closure glaucoma are excluded from the dilated portion of the study'}, 'identificationModule': {'nctId': 'NCT03578302', 'briefTitle': 'The Heidelberg Engineering BI US Evaluation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heidelberg Engineering GmbH'}, 'officialTitle': 'The Heidelberg Engineering BI US Evaluation Study', 'orgStudyIdInfo': {'id': 'B-2018-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anterior Segment Pathology', 'description': 'single measurement Anterior Segment Pathology', 'interventionNames': ['Device: BI Anterior Segment Mode']}, {'label': 'All except Anterior Segment Pathology', 'description': '3 repeat measurements with and without dilation for all eyes except Anterior Segment Pathology', 'interventionNames': ['Device: BI Anterior Segment and IOL Biometry Mode']}], 'interventions': [{'name': 'BI Anterior Segment Mode', 'type': 'DEVICE', 'description': 'Single eye measurement in Anterior Segment Mode', 'armGroupLabels': ['Anterior Segment Pathology']}, {'name': 'BI Anterior Segment and IOL Biometry Mode', 'type': 'DEVICE', 'description': 'Eye measurement 3 times with and without dilation in IOL biometry and Anterior Segment mode', 'armGroupLabels': ['All except Anterior Segment Pathology']}]}, '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, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York College of Optometry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg Engineering GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}