Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-01 @ 9:42 AM
Study NCT ID:
NCT06457295
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Diabetes Mellitus on Retinal Microvasculature in Patients Without Clinical Retinopathy Using Optical Coherence Tomography Angiography
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-25', 'size': 428537, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-08T05:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-06-08', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FAZ metrics', 'timeFrame': 'baseline', 'description': 'FAZ area, FAZ perimeter \\& FAZ flow density'}, {'measure': 'Superficial Vessel Density', 'timeFrame': 'baseline', 'description': 'foveal, average parafoveal \\& average perifoveal'}, {'measure': 'Deep Vessel Density', 'timeFrame': 'baseline', 'description': 'foveal, average parafoveal, average perifoveal'}, {'measure': 'SCP thickness', 'timeFrame': 'baseline', 'description': 'foveal, average parafoveal \\& average perifoveal'}, {'measure': 'DCP thickness', 'timeFrame': 'baseline', 'description': 'foveal, average parafoveal \\& average perifoveal'}, {'measure': 'Sectoral superficial vessel density', 'timeFrame': 'baseline', 'description': 'superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal \\& temporal perifoveal'}, {'measure': 'Sectoral deep vessel density', 'timeFrame': 'baseline', 'description': 'superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal \\& temporal perifoveal'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy, DR']}, 'referencesModule': {'references': [{'pmid': '32053551', 'type': 'RESULT', 'citation': 'Rao HL, Pradhan ZS, Suh MH, Moghimi S, Mansouri K, Weinreb RN. Optical Coherence Tomography Angiography in Glaucoma. J Glaucoma. 2020 Apr;29(4):312-321. doi: 10.1097/IJG.0000000000001463.'}]}, 'descriptionModule': {'briefSummary': 'the aim of this study is to assess the impact of duration of DM on OCTA parameters in diabetic patients without clinical Diabetic retinopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients will be recruited from diabetics who will present for retinopathy screening examination at outpatient clinic of Sohag University Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Type of DM: Type 2.\n2. Fundus examination: no macular edema or other signs of clinical retinopathy\n\nExclusion Criteria:\n\n1. Ocular history : any history of significant ocular injury or disease that could affect the retinal microvasculature such as retinal vascular occlusion, glaucoma, or vitreo-macular disease, as such conditions have also been noted to show sub-clinical OCTA changes \\[13, 14\\].\n2. Fundus examination: macular edema or any other signs of clinical retinopathy'}, 'identificationModule': {'nctId': 'NCT06457295', 'briefTitle': 'Impact of Diabetes Mellitus on Retinal Microvasculature in Patients Without Clinical Retinopathy Using Optical Coherence Tomography Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Impact of Diabetes Mellitus on Retinal Microvasculature in Patients Without Clinical Retinopathy Using Optical Coherence Tomography Angiography', 'orgStudyIdInfo': {'id': 'Soh-Med-24-05-16MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-diabetic', 'description': "patients who are above 40 years old and don't have diabetes", 'interventionNames': ['Diagnostic Test: optical coherence tomography angiography']}, {'label': 'diabetic (0-5y)', 'description': 'patients who are above 40 years old and have diabetes for less than 5 years', 'interventionNames': ['Diagnostic Test: optical coherence tomography angiography']}, {'label': 'diabetics (5-10y)', 'description': 'patients who are above 40 years old and have diabetes for 5-10 years', 'interventionNames': ['Diagnostic Test: optical coherence tomography angiography']}, {'label': 'diabetics (10y < )', 'description': 'patients who are above 40 years old and have diabetes for more than 10 years', 'interventionNames': ['Diagnostic Test: optical coherence tomography angiography']}], 'interventions': [{'name': 'optical coherence tomography angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'A non-invasive eye imaging technique that creates high-resolution, 3D maps of blood flow in the retina and choroid by comparing sequential OCT scans to detect the motion of red blood cells to provide a visual contrast to the static tissue that allows the visualization the retinal microvasculature without needing an injectable dye, unlike traditional angiography.', 'armGroupLabels': ['diabetic (0-5y)', 'diabetics (10y < )', 'diabetics (5-10y)', 'non-diabetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82749', 'city': 'Sohag', 'state': 'Sohag Governorate', 'country': 'Egypt', 'facility': 'Sohag university hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mohamed Abdou Saeed', 'investigatorAffiliation': 'Sohag University'}}}}