Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT05836194
Status:
COMPLETED
Last Update Posted:
2024-08-22
First Post:
2023-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Diabetic Retinopathy Using Ultra-Widefield Fundus Images Compared With Two-Field Fundus Images
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 769}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The International Clinical Diabetic Retinopathy Disease Severity Scale within the 2-fields fundus photography and Ultra-Wide field scanning laser ophthalmoscopy (Optomap) imaging and statistical comparison', 'timeFrame': '60 days', 'description': 'To compare nonmydriatic 2-fields fundus photographs with nonmydriatic ultra-wide field images for determining diabetic retinopathy(DR) severity. DR severity level agreement will be cross-tabulated, and Kappa value will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Number of Ungradable Images within the 2-field fundus photography and Optomap imaging', 'timeFrame': '7 day', 'description': 'The proportion and reasons of ungradable images will be documented.'}, {'measure': 'Number of predominantly peripheral lession(PPL) with Optomap imaging', 'timeFrame': '7 day', 'description': 'The proportion of PPL images will be documented'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic Retinopathy', 'Ultra wide-field imaging', 'Fundus Photography', 'Screening'], 'conditions': ['Retinal Diseases', 'Diabetic Retinopathy', 'Diabetes Complications', 'Diabetes Mellitus', 'Screening']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the accuracy of evaluating diabetic retinopathy using ultra-widefield fundus images versus two-field fundus images. The hypothesis is that screening and grading diabetic retinopathy based on ultra-widefield fundus images may yield higher accuracy compared to the use of two-field fundus images.', 'detailedDescription': 'As of 2030,9.7% (108.4 million) people in the China population have diabetes, and the total costs of diabetes in adults would reach $460.4 billion. Diabetic retinopathy (DR) and diabetic macular oedema (DME) are the principal causes of adult vision loss. Nevertheless,DR has few visual symptoms until DME occurs or the lessions located in the peripheral retina.Thus,it is crucial to early diagnosis and treatment of DR patients,which will prevent vision loss and reduce the societal buren of diabetes.\n\nThe Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30° color fundus photography is a time-consuming examination requiring pharmacological pupil dilation,experienced photographers and image montage.To simplify the operation process and improve patient compliance,2-field 45° retinal photographs (1 macular-centered field and 1 disc-centerde field) was proposed in the EURODIAB IDDM complications study and widely used in DR screening.Two-field 45° retinal photographs has been proven beneficial in reducing blindness resulting from DR,while may be neglected DR pathology in the peripheral retina.With the development of imaging technology, nonmydriatic ultra-widefield scanning laser opthoalmascopy (optomap) can obtain high-resolution,widefield images (180-200°) of the retina in only 0.25s. Optomap had good agreement with 7-field ETDRS in determining DR and DME severity and may be profitable in DR evaluation in research and clinical settings,espesially in predominantly peripheral lession(PPL).\n\nPatients with DM, with or without known DR, will be imaged using the optomap and 2-field 45° retinal photographs imaging device both for diagnosis and screening purposes at Ningbo Eye Hospital. Internal validation and continuous quality control will routinely be conducted. According to the International Clinical Diabetic Retinopathy Disease Severity Scale, the data for the ungradable image rate, distribution of DR severity levels, and PPL will be evaluated and compared. Statistics analysis will explore the agreement of DR severity levels between optomap images and 2-field photographs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients (18 and older) with diabetes presenting at the outpatient clinic of the Department of Ophthalmology, Ningbo Eye Hospital, practice for examination of diabetic retinopathy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Diagnosis of diabetes mellitus.\n\nExclusion Criteria:\n\n1. Diseases involving the posterior pole other than DR, such as age-related macular degeneration，retinal vein occlusion.\n2. History of panretinal laser photocoagulation.'}, 'identificationModule': {'nctId': 'NCT05836194', 'briefTitle': 'Evaluation of Diabetic Retinopathy Using Ultra-Widefield Fundus Images Compared With Two-Field Fundus Images', 'organization': {'class': 'OTHER', 'fullName': 'Ningbo Eye Hospital'}, 'officialTitle': 'Comparison of Ultra-Widefield Scanning Laser Ophthalmoscopy and Two-Field Fundus Photography for Evaluating Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'DRUWFVSFP20230501'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Ningbo Eye Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'overallOfficials': [{'name': 'Xiaotian Liu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ningbo Eye Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ningbo Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}