Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:22 AM
Study NCT ID:
NCT00873106
Status:
COMPLETED
Last Update Posted:
2012-09-06
First Post:
2009-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Thickness and Volume Estimates Given by Time Domain and Spectral Optical Coherence Tomography
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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-05', 'studyFirstSubmitDate': '2009-03-18', 'studyFirstSubmitQcDate': '2009-03-31', 'lastUpdatePostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal thickness and retinal volume from each OCT scan', 'timeFrame': 'within 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy', 'Diabetic Maculopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to determine if the retinal thickness estimates of the Stratus OCT, the 3D OCT-1000, and the CirrusHD OCT are comparable in diabetic and in healthy individuals (OCT=Optical Coherence Tomography).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A group of diabetic and healthy participants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic retinopathy in the diabetic group\n* healthy retinas in the healthy group\n\nExclusion Criteria:\n\n* not able to cooperate\n* retinal disease other than macular oedema\n* severe media opacities (e.g. cataract)\n* prior macular laser photocoagulation except for large oedemas'}, 'identificationModule': {'nctId': 'NCT00873106', 'briefTitle': 'Retinal Thickness and Volume Estimates Given by Time Domain and Spectral Optical Coherence Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Retinal Thickness and Volume Estimates Given by Time Domain and Spectral Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'OCT comparison'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Optical coherence tomography', 'type': 'DEVICE', 'description': 'Stratus OCT: fast radial lines 3D OCT-1000: radial 2048 and 3D OCT Cirrus HD OCT: 3D OCT'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2600', 'city': 'Glostrup Municipality', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Dorte Nellemann Thornit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57, DK-2600 Glostrup, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ph.d', 'investigatorFullName': 'Birgit Sander', 'investigatorAffiliation': 'Glostrup University Hospital, Copenhagen'}}}}