Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-27 @ 9:28 AM
Study NCT ID:
NCT05981950
Status:
RECRUITING
Last Update Posted:
2023-08-08
First Post:
2023-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world of AI in Diagnosing Retinal Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2029-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2023-08-01', 'studyFirstSubmitQcDate': '2023-08-01', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under curve', 'timeFrame': '1 month', 'description': 'We used the receiver operating characteristic (ROC) curve and area under curve to examine the ability of this artificial intelligence algorism recognition and classification of retinal diseases.'}, {'measure': 'Sensitivity and specificity', 'timeFrame': '1 month', 'description': 'We used sensitivity and specificity to examine the ability of this artificial intelligence algorism recognition and classification of retinal diseases.'}, {'measure': 'Positive predictive value, negative predictive value', 'timeFrame': '1 month', 'description': 'We used positive predictive value and negative predictive value to examine the ability of this artificial intelligence algorism recognition and classification of retinal diseases.'}, {'measure': 'F1 score', 'timeFrame': '1 month', 'description': 'We used F1 score to examine the ability of this artificial intelligence algorism recognition and classification of retinal diseases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Artificial Intelligence', 'Retinal Diseases']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to apply an artificial intelligence algorithm to diagnose multi-retinal diseases in real-world settings. The effectiveness and accuracy of this algorithm are evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.', 'detailedDescription': 'The objective of this study is to apply an artificial intelligence algorithm to diagnose referral diabetes retinopathy, referral age-related macular degeneration, referral possible glaucoma, pathological myopia, retinal vein occlusion, macular hole, macular epiretinal membrane, hypertensive retinopathy, myelinated fibers, retinitis pigmentosa and other retinal lesions from fundus photography. tic 45-degree fundus cameras, trained operators took binocular fundus photography on participants. Operators were then asked to identify gradable images and unload for algorithm diagnosis. The effectiveness and accuracy of this algorithm are evaluated by sensitivity, specificity, positive predictive value, negative predictive value, area under curve, and F1 score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is derived from an anonymous database that contains health examination results of the general population.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fundus photography around 45° field which covers optic disc and macula\n* complete identification information\n\nExclusion Criteria:\n\n* insufficient information for diagnosis'}, 'identificationModule': {'nctId': 'NCT05981950', 'briefTitle': 'Real-world of AI in Diagnosing Retinal Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'Real-world Application of Using Artificial Intelligence in Diagnosing Retinal Diseases', 'orgStudyIdInfo': {'id': 'Real-world RAIDS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retinal diseases diagnosed by artificial intelligence algorithm', 'description': 'An artificial intelligence algorithm was applied to diagnose referral diabetes retinopathy, referral age-related macular degeneration, referral possible glaucoma, pathological myopia, retinal vein occlusion, macular hole, macular epiretinal membrane, hypertensive retinopathy, myelinated fibers, retinitis pigmentosa and other retinal lesions from fundus photography.', 'interventionNames': ['Diagnostic Test: artificial intelligence algorithm']}], 'interventions': [{'name': 'artificial intelligence algorithm', 'type': 'DIAGNOSTIC_TEST', 'description': 'Retinal diseases diagnosed by artificial intelligence algorithm', 'armGroupLabels': ['Retinal diseases diagnosed by artificial intelligence algorithm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wen-Bin Wei, MD', 'role': 'CONTACT', 'email': 'weiwenbintr@163.com', 'phone': '58269516'}, {'name': 'Wen-Bin Wei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wen-Bin Wei', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wenbin Wei, MD', 'role': 'CONTACT', 'email': 'weiwenbintr@163.cim', 'phone': '58269516'}, {'name': 'Ruiheng Zhang, MD', 'role': 'CONTACT', 'email': 'zhangruihengsy@outlook.com', 'phone': '18801121782'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Wenbin Wei', 'investigatorAffiliation': 'Beijing Tongren Hospital'}}}}