Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT03528720
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2018-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation System and Clinical Application for 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The earliest and most frequently occurring fundus quadrant of diabetic retinopathy in fundus fluorescein angiography.', 'timeFrame': '2 years', 'description': 'The study is to find the earliest and most frequently occurring fundus quadrant of diabetic retinopathy.Based on the the retrospective analysis results, a prospective comparative study will be conducted to build up a evaluation system and clinical application for diabetic retinopathy.We divided the FFA images into nine quadrants: posterior pole, superior, superior nasal, nasal, inferior nasal, inferior, inferior temporal, temporal, and superior temporal. The qualitative analysis of diabetic retinopathy in each quadrant was performed. The earliest and most common fundus quadrant of diabetic retinopathy was then assessed using a rank sum test, t-test, and analysis of variance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tomography, Optical Coherence', 'Fluorescein Angiography', 'Fundus photographs'], 'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '33261573', 'type': 'DERIVED', 'citation': 'Li X, Xie J, Zhang L, Cui Y, Zhang G, Wang J, Zhang A, Chen X, Huang T, Meng Q. Differential distribution of manifest lesions in diabetic retinopathy by fundus fluorescein angiography and fundus photography. BMC Ophthalmol. 2020 Dec 1;20(1):471. doi: 10.1186/s12886-020-01740-2.'}]}, 'descriptionModule': {'briefSummary': 'Diabetic retinopathy(DR) is one of the most common and serious microvascular complications of diabetes,which is the primary cause of vision loss of diabetic patients. The risk of blindness is 25 times that of healthy people.Fundus fluorescein angiography (FFA) is the gold standard for diagnosing the stage of diabetic retinopathy.However,FFA is an invasive examination which requires the patient to be in good physical condition and is not suitable for large-scale screening.Therefore, it is important to build up an evaluation system for early diagnosis of DR,which is more convenient, safer, and non-invasive.Firstly, this study will retrospectively analyze the FFA images of DR to find the earliest and most frequently occurring fundus quadrant.Secondly,based on the retrospective analysis results, a prospective comparative study will be conducted,which combines the fundus photography with optical coherence tomography angiography(angio-OCT) and physical indicators to find out whether it has consistency, sensitivity and specificity with FFA in diagnosing the stage of DR in order to build up a more effective,safer and faster evaluation system and clinical application for DR.', 'detailedDescription': 'Firstly, this study will retrospectively analyze the FFA images of DR to find the earliest and most frequently occurring fundus quadrant.Secondly,based on the retrospective analysis results, a prospective comparative study will be conducted,which combines the fundus photography with angio-OCT and physical indicators to find out whether it has consistency, sensitivity and specificity with FFA in diagnosing the stage of DR.Finally，based on all the results,to build up a more effective,safer and faster evaluation system and clinical application for DR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The retrospective study needs 150 people.The prospective comparative study needs 200 people.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with diabetic retinopathy\n\nExclusion Criteria:\n\nRefractive interstitial turbidity Cannot cooperate with examiner Retinal surgery in patients Malignant tumors Hematological diseases Immune diseases Glaucoma or other retinal diseases'}, 'identificationModule': {'nctId': 'NCT03528720', 'briefTitle': 'Evaluation System and Clinical Application for Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Evaluation System and Clinical Application for Diabetic Retinopathy', 'orgStudyIdInfo': {'id': '2018188H'}}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Qianli Meng', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}