Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT02311504
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2014-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eye Screening in German Secondary Diabetes Care Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 831}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-27', 'studyFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2014-12-04', 'lastUpdatePostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of diabetic retinopathy', 'timeFrame': 'day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '27701169', 'type': 'DERIVED', 'citation': "Marahrens L, Ziemssen F, Fritsche A, Ziemssen T, Kern R, Martus P, Roeck D. Limited Time from the Diabetes Patients' Perspective: Need for Conversation with the Eye Specialist. Ophthalmologica. 2016;236(3):154-158. doi: 10.1159/000450708. Epub 2016 Oct 5."}]}, 'descriptionModule': {'briefSummary': 'In patients with confirmed diagnosis of diabetes, an eye examination and a comprehensive survey are conducted after recruitment in secondary diabetes care centers. All patients undergo a comprehensive eye examination including wide-angle fundus photograph and ocular cohaerence tomography. A questionnaire assesses the characteristics (history: diabetes duration, type of treatment), knowledge and personal attitudes of the persons affected. The relevant lab findings were collected from the electronic files.\n\nMain focus of the study is the concordance to the national screening recommendations (last eye exam, presence of retinopathy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with diabetes in secondary care diabetes centers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- diabetes\n\nExclusion Criteria:\n\n* mental handicap\n* in the case of blindness absence of a caregiver'}, 'identificationModule': {'nctId': 'NCT02311504', 'acronym': 'DiabCheckophta', 'briefTitle': 'Eye Screening in German Secondary Diabetes Care Centers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'OCT Screening of Diabetes Patients: Health Care Research in Secondary Diabetes Care Centers', 'orgStudyIdInfo': {'id': 'DCophtaOCTplus14_C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DiabCheck ophta OCTplus', 'description': 'persons with diabetes undergoing OCT examination', 'interventionNames': ['Device: OCT examination']}], 'interventions': [{'name': 'OCT examination', 'type': 'DEVICE', 'armGroupLabels': ['DiabCheck ophta OCTplus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Eye Hospital', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}