Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 10:53 PM
Study NCT ID:
NCT01299233
Status:
UNKNOWN
Last Update Posted:
2015-01-06
First Post:
2011-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061766', 'term': 'Proton Therapy'}], 'ancestors': [{'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-05', 'studyFirstSubmitDate': '2011-02-16', 'studyFirstSubmitQcDate': '2011-02-17', 'lastUpdatePostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COV', 'timeFrame': 'T0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma Patients and Healthy Controls']}, 'descriptionModule': {'briefSummary': 'To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle scan-measurements.\n\n* Trial with medical device'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients and controls are selected out of our primary care clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nfor both groups (glaucoma study group and control group): men and women of at least 50 years of age\n\nfor the glaucoma study group: diagnosis of primary open angle glaucoma (POAG)\n\nExclusion criteria:\n\nfor both groups (glaucoma study group and control group):\n\n* less then 18 years of age\n* any pathology of the central retina\n* any optic nerve disorder other then glaucoma\n* retinal vascular disorder\n\nfor the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma\n\nfor the control group: any diagnosis of glaucoma'}, 'identificationModule': {'nctId': 'NCT01299233', 'briefTitle': 'Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3', 'orgStudyIdInfo': {'id': 'ART-OCT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group', 'description': 'age matched healthy controls', 'interventionNames': ['Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H']}, {'label': 'Glaucoma', 'description': 'patients with diagnosis of primary open angle glaucoma', 'interventionNames': ['Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H']}], 'interventions': [{'name': 'Spectralis® SD-OCT, Heidelberg Engineering GmbH, H', 'type': 'DEVICE', 'description': 'Measurement of the peripapillar nerve fiber layer with different settings of ART', 'armGroupLabels': ['Glaucoma', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Ophthalmic Clinic', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Jens Funk, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Ophtalmic Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}