Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-28 @ 12:47 PM
Study NCT ID:
NCT01131650
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2010-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D012164', 'term': 'Retinal Diseases'}], 'ancestors': [{'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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 710}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-26', 'studyFirstSubmitDate': '2010-05-26', 'studyFirstSubmitQcDate': '2010-05-26', 'lastUpdatePostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of diabetic retinopathy'}], 'secondaryOutcomes': [{'measure': 'associated risk factors of diabetic retinopathy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prevalence of diabetic retinopathy', 'Diabetes', 'Retinopathy', 'Prevalence', 'Population'], 'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil\n\nAbstract\n\nObjective: To determine the prevalence and characteristics of diabetic retinopathy (DR) among patients from São José do Rio Preto-SP-Brazil .\n\nLocal: Departamento de Retina e Vítreo do Hospital do Olho de Rio Preto (HORP)\n\nMethods: Design: population-based cross-sectional study. The study sample, of 710 patients was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program) of São José do Rio Preto . All patients , known to have diabetes , underwent an eye examination by biomicroscope and indirect ophthalmoscope to check for any signs of DR through dilated pupils. Participants were also interviewed and examined to determine their demographic characteristics, medical conditions and the realization of previous fundoscopic eye examination. Statistical studies were done with t -Student test , Fisher test or chi-square test.', 'detailedDescription': 'Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil\n\nAbstract\n\nObjective: To determine the prevalence and characteristics of diabetic retinopathy (DR) among patients from São José do Rio Preto-SP-Brazil .\n\nLocal: Departamento de Retina e Vítreo do Hospital do Olho de Rio Preto (HORP)\n\nMethods: Design: population-based cross-sectional study. The study sample, of 710 patients was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program) of São José do Rio Preto . All patients , known to have diabetes , underwent an eye examination by biomicroscope and indirect ophthalmoscope to check for any signs of DR through dilated pupils. Participants were also interviewed and examined to determine their demographic characteristics, medical conditions and the realization of previous fundoscopic eye examination. Statistical studies were done with t -Student test , Fisher test or chi-square test.\n\nResults: Among 710 screened patients 112 had some degree of diabetic retinopathy and the overall standardized prevalence of any retinopathy was 16,3%., including 90 (80,4%) with non-proliferative and (22) 19,6 % with proliferative diabetic retinopathy. Only 143 patients (68,7%) had a history of previous fundoscopic eye examination.\n\nConclusion: This study demonstrated that DM and their complications are a important public health problem. The duration of DM and glicemic control is strongly associated with DR . Prevention programs with periodic fundoscopic exams shows to diminished the prevalence of this ocular disease.\n\nKeywords: Diabetes, Retinopathy, Prevalence, Population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study sample, of 710 patients was derived from the HIPERDIA (Diabetes and High-blood pressure social health care program) of São José do Rio Preto', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Diabetes Melittus\n\nExclusion Criteria:\n\n* Patients without Diabetes Melittus'}, 'identificationModule': {'nctId': 'NCT01131650', 'briefTitle': 'Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Olho Rio Preto'}, 'officialTitle': 'Prevalence of Diabetic Retinopathy in São José do Rio Preto-SP-Brazil', 'orgStudyIdInfo': {'id': 'mc201106'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diabetic retinopathy'}, {'label': 'diabetica retinopathy prevalence'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15090500', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Carlos Eduardo Cury Junior', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Olho Rio Preto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Faculty of Medicine of Ribeirão Preto (FMRP-USP)', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'CARLOS EDUARDO CURY JUNIOR'}}}}