Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT00347594
Status:
COMPLETED
Last Update Posted:
2014-01-17
First Post:
2006-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-15', 'studyFirstSubmitDate': '2006-06-30', 'studyFirstSubmitQcDate': '2006-06-30', 'lastUpdatePostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of aberrations with the NGDI and the Zywave II.', 'timeFrame': 'Single visit'}], 'secondaryOutcomes': [{'measure': 'Measurement of corneal topography and pachymetry with the NGDI and the Orbscan IIz.', 'timeFrame': 'Single visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Corneal surface topography', 'Ocular aberrations'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the aberrations, corneal surface topography and pachymetry of normal human eyes with the NGDI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* +10.00D to -20.00D of absolute spherical ametropia\n* Must be part of the Bausch \\& Lomb research clinic\n* Snellen visual acuity must be correctable to 20/25\n\nExclusion Criteria:\n\n* No more than -6.00D of refractive astigmatism'}, 'identificationModule': {'nctId': 'NCT00347594', 'briefTitle': 'A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)', 'orgStudyIdInfo': {'id': 'GVC2-03-052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Next Generation Diagnostic Instrument', 'description': 'Next Generation Diagnostic Instrument (NGDI)', 'interventionNames': ['Device: Next Generation Diagnostic Instrument (NGDI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zyoptix Diagnostic Workstation', 'description': 'Zyoptix Diagnostic Workstation (ZDW)', 'interventionNames': ['Device: Zyoptix Diagnostic Workstation (ZDW)']}], 'interventions': [{'name': 'Next Generation Diagnostic Instrument (NGDI)', 'type': 'DEVICE', 'description': 'Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes', 'armGroupLabels': ['Next Generation Diagnostic Instrument']}, {'name': 'Zyoptix Diagnostic Workstation (ZDW)', 'type': 'DEVICE', 'description': 'Measurement of the aberrations, corneal surface topography, and pachymetry of normal human eyes', 'armGroupLabels': ['Zyoptix Diagnostic Workstation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch & Lomb', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Michele Lagana', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}