Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-06 @ 5:03 AM
Study NCT ID:
NCT00839150
Status:
COMPLETED
Last Update Posted:
2011-09-19
First Post:
2009-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Function in Diabetic Patients Without Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-16', 'studyFirstSubmitDate': '2009-02-06', 'studyFirstSubmitQcDate': '2009-02-06', 'lastUpdatePostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetic retinopathy', 'Color vision', 'Contrast sensitivity', 'Electroretinogram', 'Flicker-induced vasodilatation', 'Dynamic Vessel Analyzer'], 'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '21282578', 'type': 'DERIVED', 'citation': 'Lecleire-Collet A, Audo I, Aout M, Girmens JF, Sofroni R, Erginay A, Le Gargasson JF, Mohand-Said S, Meas T, Guillausseau PJ, Vicaut E, Paques M, Massin P. Evaluation of retinal function and flicker light-induced retinal vascular response in normotensive patients with diabetes without retinopathy. Invest Ophthalmol Vis Sci. 2011 May 2;52(6):2861-7. doi: 10.1167/iovs.10-5960.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose was to assess, in diabetic patients without diabetic retinopathy and control subjects, color vision, contrast sensitivity, electroretinography, and flicker-induced vasodilatation using the Dynamic Vessel Analyzer, in order to specify the earliest impaired retinal cells in diabetes, and gain more insight into diabetic retinopathy pathogenesis.', 'detailedDescription': 'Type 1 and type 2 diabetic patients with no diabetic retinopathy and no hypertension were compared with sex and age-matched control subjects. Color vision was tested with the desaturated LANTHONY 15-Hue test. Contrast sensitivity was assessed with the Pelli-Robson contrast sensitivity test. Pattern-electroretinogram, Ganzfeld full-field electroretinogram and multifocal electroretinogram were recorded according to the International Society for Clinical Electrophysiology of Vision (ISCEV). Flicker-induced vasodilatation in retinal arteries and veins was assessed using the Dynamic Vessel Analyzer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For diabetic patients :\n\nage between 20 and 55 type 1 or type 2 diabetes mellitus diabetes duration of more than 5 years no diabetic retinopathy on fundus examination or fundus photographs\n\nFor control subjects :\n\nsex and age matching with the diabetic patients no diabetes, no familial or personal history of elevated blood sugar', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For diabetic patients :\n\n * age between 20 and 55\n * type 1 or type 2 diabetes mellitus\n * diabetes duration of more than 5 years\n * no diabetic retinopathy on fundus examination or fundus photographs\n* For control subjects :\n\n * sex and age matching with the diabetic patients\n * no diabetes, no familial or personal history of elevated blood sugar\n\nExclusion Criteria:\n\n\\*For both diabetic patients and control subjects :\n\n* presence of cataract or history of cataract surgery\n* intraocular pressure of more than 21 mmHg\n* abnormal score on the Ishihara test\n* other ocular disease\n* ametropia more than 3 diopters, anisometropia more than 1 diopter, astigmatism more than 1 diopter\n* systemic hypertension (defined as systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg)\n* treatment with vasoactive drugs\n* tobacco consumption of more than 20 cigarettes a day'}, 'identificationModule': {'nctId': 'NCT00839150', 'acronym': 'NEURODIAB', 'briefTitle': 'Retinal Function in Diabetic Patients Without Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Assessment of Retinal Functional Abnormalities in Diabetic Patients Without Retinopathy', 'orgStudyIdInfo': {'id': 'P041009'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Diabetic patients without diabetic retinopathy : No intervention'}, {'label': '2', 'description': 'Sex and age-matched control subjects : No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Lariboisiere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Pascale Massin, MD,Pr;PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}