Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2026-01-26 @ 7:56 AM
Study NCT ID:
NCT03970161
Status:
UNKNOWN
Last Update Posted:
2019-05-31
First Post:
2019-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 720}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-29', 'studyFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2019-05-29', 'lastUpdatePostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripapillary RNFL thickness', 'timeFrame': '96 weeks', 'description': 'Peripapillary RNFL thickness'}, {'measure': 'GCL+ in the macular area obtained using the 3D wide mode', 'timeFrame': '96 weeks', 'description': 'GCL+ in the macular area obtained using the 3D wide mode'}, {'measure': 'Retinal thickness in all macular regions', 'timeFrame': '96 weeks', 'description': 'Retinal thickness in all macular regions'}, {'measure': 'RNFL thickness in the macular area obtained using the 3D Macula (v) mode', 'timeFrame': '96 weeks', 'description': 'RNFL thickness in the macular area obtained using the 3D Macula (v) mode'}, {'measure': 'GCL+ thickness in the macular region obtained using the 3D Macula (v) mode', 'timeFrame': '96 weeks', 'description': 'GCL+ thickness in the macular region obtained using the 3D Macula (v) mode'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Diabetic Retinopathy', 'Nerve Injury']}, 'descriptionModule': {'briefSummary': 'The object of this study is to investigate the damage to the retinal nerve fiber layer (RNFL) and ganglion cell complex layer (GCL+) in diabetic patients without retinal microangioma as detected by fundus fluorescein angiography (FFA) and to determine the kind of nerve damage more likely to indicate early injury.', 'detailedDescription': 'Patients with type 2 diabetes mellitus and healthy volunteers will be included in our study. Patients with retinal microangioma are excluded by FFA. The parameters around the optic disc and macular area of the above two groups are measured by optical coherence tomography (OCT), and the results will be analyzed using the SPSS 22.0 software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with T2DM\n2. Patients without microangioma\n\nExclusion Criteria:\n\n1. Patients with any other ocular disease that might affect retinal nerve injury\n2. Patients with optic neuropathy, age-related macular degeneration, retinal and choroidal disease, and retinal artery/vein occlusion.\n3. Patients with hypertension, hematopathy, neuropathy, and other systemic diseases causing retinal nerve changes.\n4. Patients with keratopathy, cataract, and vitreous hemorrhage were also excluded.'}, 'identificationModule': {'nctId': 'NCT03970161', 'briefTitle': 'Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Third Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'Retinal nerve injury in T2DM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T2DM Patients', 'description': 'Patients without microangioma changes undergoing FFA examination were included in the present study. All of the participants enrolled in the present study underwent a systematic ophthalmic examination.', 'interventionNames': ['Device: routine ophthalmic examination']}, {'type': 'EXPERIMENTAL', 'label': 'healthy control subjects', 'description': 'All of the participants enrolled in the present study underwent a systematic ophthalmic examination.', 'interventionNames': ['Device: routine ophthalmic examination']}], 'interventions': [{'name': 'routine ophthalmic examination', 'type': 'DEVICE', 'description': 'Routine ophthalmic examination, including slit lamp, intraocular pressure, and fundus examinations using direct or indirect ophthalmoscopy after pupil dilation and optical coherence tomography (OCT) examination. Patients with DM also underwent fundus fluorescein angiography (FFA) examination.', 'armGroupLabels': ['T2DM Patients', 'healthy control subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Zhu, Doctor', 'role': 'CONTACT', 'email': '0628zhuxiang@163.com', 'phone': '13826452564'}], 'facility': 'The third affiliated hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiang Zhu', 'role': 'CONTACT', 'email': '0628zhuxiang@163.com', 'phone': '13826452564'}], 'overallOfficials': [{'name': 'Xiang Zhu, Dorctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiang Zhu', 'investigatorAffiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}}}}