Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:25 AM
Study NCT ID:
NCT07468058
Status:
RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetic Retinopathy Prevalence And Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of diabetic retinopathy (any stage)', 'timeFrame': 'At baseline (data collected at the time of retinal examination during the study period, January-September 2025)', 'description': 'To determine the prevalence of diabetic retinopathy among patients with diabetes mellitus.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy (DR)']}, 'descriptionModule': {'briefSummary': 'The goal of this retrospective observational study is to evaluate the prevalence and severity of diabetic retinopathy (DR) and to identify associated risk factors among patients with diabetes mellitus at Gia Dinh Family Hospital in Da Nang, Vietnam.\n\nThe main questions it aims to answer are:\n\n1. What is the prevalence and distribution of different stages of diabetic retinopathy among diabetic patients at this hospital?\n2. Which clinical and laboratory factors are associated with the presence of diabetic retinopathy?', 'detailedDescription': 'Diabetic retinopathy (DR) is a leading cause of preventable visual impairment worldwide. Global estimates suggest that approximately 22-26% of people with diabetes have some degree of DR, with about 6% experiencing vision-threatening disease. The burden is expected to increase substantially, particularly in low- and middle-income countries.\n\nVietnam is experiencing a rapid rise in diabetes prevalence, however, data from Central Vietnam, particularly from multidisciplinary general hospitals, remain limited.\n\nThis study aims to evalutate the local prevalence, severity distribution, and associated risk factors of DR in a general hospital in Da Nang which is essential to inform screening strategies, optimize management, and reduce preventable vision loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This hospital-based retrospective cohort study included adult patients with diabetes mellitus who attended the Endocrinology-Diabetes Center and underwent ophthalmologic evaluation at the Eye Clinic of Family General Hospital, Da Nang, Vietnam, between January 2025 and September 2025.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed diabetes mellitus (type 1 or type 2) according to ADA criteria\n* Underwent ophthalmic examination including dilated fundus examination and OCT\n* Available electronic medical records with key clinical and laboratory data\n\nExclusion Criteria:\n\n* Gestational diabetes mellitus\n* Media opacity precluding fundus examination (advanced cataract, corneal opacity, dense vitreous hemorrhage)\n* Other retinal diseases (e.g., hypertensive retinopathy, retinal vein occlusion)\n* History of ocular trauma or intraocular surgery within 6 months'}, 'identificationModule': {'nctId': 'NCT07468058', 'acronym': 'DR-CENTRAL', 'briefTitle': 'Diabetic Retinopathy Prevalence And Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Da Nang Family General Hospital'}, 'officialTitle': 'Diabetic Retinopathy Prevalence And Risk Factors From A Hospital - Based Cohort In Central Vietnam', 'orgStudyIdInfo': {'id': '2025/BVGĐ -HĐĐĐ'}}, 'armsInterventionsModule': {'interventions': [{'name': 'fundus examination and optical coherence tomography (OCT)', 'type': 'OTHER', 'description': 'Patients will be identified through the Ehealth program at the Family Hospital, Da Nang.\n\nAll diabetic patients who visited the Center of Endocrinology and Diabetes and had ophthalmologic examination, including fundus examination and optical coherence tomography (OCT), during the study period will be screened for eligibility'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50000', 'city': 'Da Nang', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Thao Nguyen Ngoc', 'role': 'CONTACT', 'email': 'ngocthao090897@gmail.com', 'phone': '84335393897'}], 'facility': 'Department of Endocrinology and Diabetes', 'geoPoint': {'lat': 16.06778, 'lon': 108.22083}}], 'centralContacts': [{'name': 'Thảo Nguyễn, MD', 'role': 'CONTACT', 'email': 'ngocthao090897@gmail.com', 'phone': '84335393897'}], 'overallOfficials': [{'name': 'Thao Nguyen Ngoc, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Family Hospital, Da Nang, Vietnam'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Da Nang Family General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}