Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 4:09 AM
Study NCT ID:
NCT05902650
Status:
UNKNOWN
Last Update Posted:
2023-06-15
First Post:
2023-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fasting blood glucose (FBG)', 'timeFrame': "the time of the patient's first 1 day visit", 'description': 'biochemical indexes'}, {'measure': 'glycosylated hemoglobin (HbAlc)', 'timeFrame': "the time of the patient's first 1 day visit", 'description': 'biochemical indexes'}, {'measure': 'OCTA data', 'timeFrame': "the time of the patient's first 1 day visit", 'description': 'An image of the 3mm×3mm and 6 mm×6 mm macular areas detected by OCTA were captured. Quantitative analysis of vascular density and perfusion density of superficial capillary plexus in the macular area were automatically calculated using built-in software on the device.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'All OCTA data and biochemical indexes of diabetic patients were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.', 'detailedDescription': 'Diabetic patients at the Department of Ophthalmology of the Seventh Affiliated Hospital of Sun Yat-sen University were selected as research participants. All OCTA data and biochemical indexes were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'diabetic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of diabetes\n\nExclusion Criteria:\n\n* various other types of retinal and choroidal disease;\n* history of any intraocular surgery or treatment (including intravitreal injection, retinal photocoagulation etc.\n* with severe refractive medium opacity that could affect fundus examination.'}, 'identificationModule': {'nctId': 'NCT05902650', 'briefTitle': 'Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'The Seventh Affiliated Hospital of Sun Yat-sen University'}, 'officialTitle': 'Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'MCao'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'diabetic patients with no diabetic retinopathy', 'interventionNames': ['Diagnostic Test: imaging']}, {'label': 'Group 2', 'description': 'diabetic patients with mild nonproliferative diabetic retinopathy', 'interventionNames': ['Diagnostic Test: imaging']}, {'label': 'Group 3', 'description': 'diabetic patients with moderate and severe nonproliferative diabetic retinopathy', 'interventionNames': ['Diagnostic Test: imaging']}, {'label': 'Group 4', 'description': 'diabetic patients with proliferative diabetic retinopathy', 'interventionNames': ['Diagnostic Test: imaging']}], 'interventions': [{'name': 'imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'imaging', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kuiqing Lu', 'role': 'CONTACT', 'email': 'lukq@mail.sysu.edu.cn', 'phone': '075581207047'}], 'facility': 'The Seventh Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Mingzhe Cao, Dr.', 'role': 'CONTACT', 'email': 'zhengz@mail.sysu.edu.cn', 'phone': '13060822790'}], 'overallOfficials': [{'name': 'Mingzhe Cao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Seventh Affiliated Hospital of Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The research has not been completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mingzhe Cao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending ophthalmologist', 'investigatorFullName': 'Mingzhe Cao', 'investigatorAffiliation': 'The Seventh Affiliated Hospital of Sun Yat-sen University'}}}}