Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-02 @ 1:46 AM
Study NCT ID:
NCT00927303
Status:
COMPLETED
Last Update Posted:
2010-06-09
First Post:
2009-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Spectralis-Cirrus Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'male or femal persons age over 50 years with exudative age-related macular degeneration'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-08', 'studyFirstSubmitDate': '2009-06-23', 'studyFirstSubmitQcDate': '2009-06-23', 'lastUpdatePostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of examinations with correctly set threshold algorithm lines', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Differences of mean retinal thickness in the central region', 'timeFrame': '1 day'}, {'measure': 'Differences of retinal volume', 'timeFrame': '1 day'}, {'measure': 'Distance acuity', 'timeFrame': '1 day'}, {'measure': 'Age', 'timeFrame': '1 day'}, {'measure': 'Classification of the lesion', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['retinal thickness', 'threshold algorithm', 'optical coherence tomography'], 'conditions': ['Exudative Age Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '21791591', 'type': 'DERIVED', 'citation': 'Krebs I, Smretschnig E, Moussa S, Brannath W, Womastek I, Binder S. Quality and reproducibility of retinal thickness measurements in two spectral-domain optical coherence tomography machines. Invest Ophthalmol Vis Sci. 2011 Sep 1;52(9):6925-33. doi: 10.1167/iovs.10-6612.'}]}, 'descriptionModule': {'briefSummary': 'Retinal thickness measurement is one of the most important examinations in the follow up of exudative age-related macular degeneration. Prior studies have shown that there are a series of algorithm line failures in OCT examinations. This study is conducted to compare the quality of the examinations of to different spectral domain OCT machines concerning the positioning of algorithm lines. Furthermore the reproducibility of the examinations id tested, both machines provide different techniques to guarantee that in repeated examinations the same location is examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'male or female persons aged more than 50 years with exudative age related macular degeneration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Exudative age related macular degeneration\n\nExclusion Criteria:\n\n* Macular pathologies other than age related macular degeneration (diabetic maculopathy, macular pucker, macular hole,\n* Visualization of the macula not possible (dens cataract, vitreous haemorrhage)\n* Not consented patients'}, 'identificationModule': {'nctId': 'NCT00927303', 'briefTitle': 'The Spectralis-Cirrus Study', 'organization': {'class': 'OTHER', 'fullName': 'The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery'}, 'officialTitle': 'Comparison of Quality and Reproducibility of Retinal Thickness Measurements in Two Spectral Domain OCT- Machines', 'orgStudyIdInfo': {'id': '09-086-0609'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Intervention 1 Sequence of observers: observer1, observer 2, observer 1, observer 2', 'interventionNames': ['Device: Cirrus-Spectralis']}, {'label': 'group 2', 'description': 'intervention 1 sequence of observers: observer 2, observer 1, observer 2, observer 1', 'interventionNames': ['Device: Cirrus-Spectralis']}, {'label': 'group 3', 'description': 'intervention 2 sequence of observers: 1,2,1,2', 'interventionNames': ['Device: Spectralis-Cirrus']}, {'label': 'group 4', 'description': 'intervention 2 sequence of observers: 2,1,2,1', 'interventionNames': ['Device: Spectralis-Cirrus']}, {'label': 'group 5', 'description': 'intervention 1 sequence of observers 1,1,2,2', 'interventionNames': ['Device: Cirrus-Spectralis']}, {'label': 'group 6', 'description': 'intervention 1 sequence of observers 2,2,1,1', 'interventionNames': ['Device: Cirrus-Spectralis']}, {'label': 'group 7', 'description': 'intervention 2 sequence of observers: 1,1,2,2', 'interventionNames': ['Device: Spectralis-Cirrus']}, {'label': 'group 8', 'description': 'intervention 2 sequence of observers: 2,2,1,1', 'interventionNames': ['Device: Spectralis-Cirrus']}], 'interventions': [{'name': 'Cirrus-Spectralis', 'type': 'DEVICE', 'description': '512x128 cúbe program of Cirrus OCT first retinal volume 121 line of Spectralis OCT thereafter', 'armGroupLabels': ['Group 1', 'group 2', 'group 5', 'group 6']}, {'name': 'Spectralis-Cirrus', 'type': 'DEVICE', 'description': 'retinal volume program 121 lines Spectralis OCT first 512x128 program Cirrus OCT thereafter', 'armGroupLabels': ['group 3', 'group 4', 'group 7', 'group 8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1030', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Susanne Binder, MD, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ilse Krebs, MD', 'oldOrganization': 'The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery'}}}}