Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-29 @ 2:29 AM
Study NCT ID:
NCT06150495
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Control and Retinal Microvascular Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D009410', 'term': 'Nerve Degeneration'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-11-12', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The foveal avascular zone (FAZ) area (mm^2)', 'timeFrame': 'Upon initial registration and through study completion, an average of 1 year', 'description': 'FAZ was defined as the avascular area in the foveal center.'}, {'measure': 'central foveal retinal thickness (um) and macular ganglion cell-inner plexiform layer (GC-IPL) thickness (um)', 'timeFrame': 'Upon initial registration and through study completion, an average of 1 year', 'description': 'Retinal layer thickness were calculated automatically using the bundled software'}, {'measure': 'Retinal vessel density (VD, %)', 'timeFrame': 'Upon initial registration and through study completion, an average of 1 year', 'description': 'The VD (%) was calculated using the following formula: VD (%) = vascular area (pixel) / (total area - FAZ area) (pixel) × 100.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy', 'Neurodegeneration', 'Blood Sugar; High']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective, observational study is to compare in the association of glycemic control and retinal microvascular changes in patients with type 2 diabetes mellitus (T2DM) without diabetic retinopathy (DR).\n\nThe main question it aims to answer are:\n\n• Do degenerative changes in retinal microvasculature or nerves depend on glycemic control even before diabetic retinopathy is detected?\n\nParticipants will receive an annual routine comprehensive examination including ultra-widefield fundus photography, spectral domain optical coherence tomography (OCT), and swept-source optical coherence tomography angiography (OCTA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included 30-70-year-old patients with T2DM without known DR at baseline who underwent regular screening for DR at the department of ophthalmology. The controls included patients without DM who presented for regular ophthalmic examination. One eye each of DM patients and controls was included in the study. The eye without significant ocular disease was selected from both eyes; if both eyes were eligible, the right eye was selected. The participants underwent comprehensive ophthalmic examination, including best-corrected visual acuity assessment using the Snellen chart, slit-lamp biomicroscopy, dilated fundus examination, ultra-widefield fundus photography, spectrum-domain OCT, and SS-OCTA. Patients with T2DM were included in the study after a retinal specialist confirmed absence of signs of DR on clinical examination and ultra-wide fundus photography.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The study included 30-70-year-old patients with T2DM without known DR at baseline who underwent regular screening for DR at the department of ophthalmology.\n* Who underwent regular checkups for DR between January 2019 and August 2022 at Dongguk University Ilsan Hospital.\n* The controls included patients without DM who presented for regular ophthalmic examination.\n\nExclusion Criteria:\n\n* patients with a history of retinal or choroidal diseases (i.e., age-related macular degeneration, retinal vein occlusion, uveitis, retinal detachment, and central serous chorioretinopathy), glaucoma, or optic neuropathy\n* patients with neurodegenerative diseases, such as Parkinson's disease and dementia."}, 'identificationModule': {'nctId': 'NCT06150495', 'briefTitle': 'Glycemic Control and Retinal Microvascular Changes', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Glycemic Control and Retinal Microvascular Changes in Type 2 Diabetes Mellitus Patients Without Clinical Retinopathy', 'orgStudyIdInfo': {'id': 'IRB no. 2021-06-029'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy control', 'description': 'The controls included patients without DM who presented for regular ophthalmic examination.'}, {'label': 'intensive control (IC) group', 'description': 'The mean HbA1c level was calculated during the 12 months prior to the OCT and OCTA. Based on the mean HbA1c level, T2DM patients were divided into intensive control (IC; mean HbA1c ≤ 7.0%) and moderate control (MC; mean HbA1c \\> 7.0%) groups'}, {'label': 'moderate control (MC) group', 'description': 'The mean HbA1c level was calculated during the 12 months prior to the OCT and OCTA. Based on the mean HbA1c level, T2DM patients were divided into intensive control (IC; mean HbA1c ≤ 7.0%) and moderate control (MC; mean HbA1c \\> 7.0%) groups'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10324', 'city': 'Goyang-si', 'state': 'Republic of Korea', 'country': 'South Korea', 'facility': 'Dongguk University Ilsan Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}