Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-02 @ 12:48 AM
Study NCT ID:
NCT01084850
Status:
UNKNOWN
Last Update Posted:
2010-03-11
First Post:
2010-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-10', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2010-03-10', 'lastUpdatePostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal endothelium cell number', 'timeFrame': '1 year', 'description': 'The study is a cross-sectional study. We compare a cohort of patients with DM to a cohort with no DM. We examine each patient and control once. We call time of appointment or examination for "at entry to study".'}], 'secondaryOutcomes': [{'measure': 'Corneal endothelium morphology', 'timeFrame': '1 year', 'description': 'The size and hexagonality of the cells are analysed automaticly by computer recognizion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Corneal endothelium', 'diabetes mellitus', 'corneal thickness'], 'conditions': ['Corneal Dystrophy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with special reference to glycemic status.', 'detailedDescription': 'Diabetes might influence the health of the corneal endothelium. Older studies have presented different results and the glycemic status of the patients have not been reported. In this study we examine the corneal endothelium morphology and central thickness in type II Diabetes Mellitus and normal subjects with modern specular microscopy. Each patient and control is examined once ("entry to study").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients visiting Frederiksberg hospital for any reason', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type II diabetes (diagnose confirmed by general practitioner)\n* Controls with no diabetes (confirmed by blood testing).\n\nExclusion Criteria:\n\n* Glaucoma\n* Uveitis (current or previous)\n* Corneal scaring\n* Previous eye surgery'}, 'identificationModule': {'nctId': 'NCT01084850', 'briefTitle': 'Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Frederiksberg University Hospital'}, 'officialTitle': 'Corneal Endothelium Morphology and Central Thickness in Type II Diabetes Mellitus and Normal Subjects', 'orgStudyIdInfo': {'id': 'FH5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes Type II', 'description': 'Patients with type 2 Diabetes Mellitus'}, {'label': 'Control', 'description': 'Patients with no diabetes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Frederiksberg', 'state': 'Frederiksberg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Allan Storr-Paulsen, MD', 'role': 'CONTACT', 'email': 'allanstorr@dadlnet.dk', 'phone': '+4538163646'}], 'facility': 'Frederiksberg University Eye Clinque', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'centralContacts': [{'name': 'Allan Storr-Paulsen, MD', 'role': 'CONTACT', 'email': 'allanstorr@dadlnet.dk', 'phone': '+4538163646'}], 'overallOfficials': [{'name': 'Jens C Norregaard, MD, phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Frederiksberg University Hospital, Eye Clinque'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frederiksberg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jens christian Norregaard/Head of Department', 'oldOrganization': 'Frederiksberg Hospital'}}}}