Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2026-01-01 @ 6:52 AM
Study NCT ID:
NCT05527535
Status:
UNKNOWN
Last Update Posted:
2022-09-02
First Post:
2022-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand
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': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of AI in diabetic retinopathy screening', 'timeFrame': 'Throughout the whole period of screening, approximately 6 months', 'description': 'Referral adherance of patients in AI group in percentage'}, {'measure': 'Efficiency of AI in diabetic retinopathy screening', 'timeFrame': 'Throughout the whole period of screening, approximately 6 months', 'description': 'Down time and failure rate of AI system'}, {'measure': 'Efficiency of AI in diabetic retinopathy screening', 'timeFrame': 'Throughout the whole period of screening, approximately 6 months', 'description': 'Cost in development and implement of AI system in Thai baht unit'}], 'secondaryOutcomes': [{'measure': 'Satisfaction of patients and health care personnel in AI-based screening', 'timeFrame': 'At the end of the screening, approximately at Month 6', 'description': "Measurement of health care personnel's satisfaction by well-developed questionnaire"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic Retinopathy, Screening, Deep Learning Algorithm, Human Grader'], 'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': "Efficiency and effectiveness of real-world diabetic retinopathy screening by artificial intelligent (AI) are limited. Investigators will implement AI for diabetic retinopathy screening in 13 health districts in Thailand and investigate the efficiency, effectiveness as well as patients and health care personnel's satisfaction by an implementation research."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All diabetes mellitus patients who visit for diabetic retinopathy screening at selected primary care units and hospitals in 13 health districts in Thailand', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Type 1 or 2 diabetes mellitus patients whose name are in primary hospital record\n2. No full-time ophthalmologists in those primary hospital\n3. Age more than or equal to 18 years\n4. Eligible for fundus photo imaging at least 1 eye\n\nExclusion Criteria:\n\n1. Type 1 or 2 diabetes mellitus patients whose name are in primary hospital record that have full-time ophthalmologists\n2. Patients who previously diagnosed with other causes of macular edema, for example, Age-related Macular Degeneration, Radiation Retinopathy, Retinal Vein Occlusion etc.\n3. History of retinal laser or surgery\n4. Other ocular diseases that require referral to ophthalmologists\n5. Not eligible for fundus photo imaging for both eyes (any causes)'}, 'identificationModule': {'nctId': 'NCT05527535', 'briefTitle': 'Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Expansion of Integrated AI Solution for Diabetic Retinopathy Screening in Thailand: An Implementation Research', 'orgStudyIdInfo': {'id': '65057'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AI screening group', 'description': 'Diabetes mellitus patients undergo diabetic retinopathy screening by AI', 'interventionNames': ['Diagnostic Test: Diabetic retinopathy screening by artificial intelligence']}, {'label': 'Manual screening group', 'description': 'Diabetes mellitus patients undergo diabetic retinopathy screening by health care personnel', 'interventionNames': ['Diagnostic Test: Diabetic retinopathy screening by healthcare personnel']}], 'interventions': [{'name': 'Diabetic retinopathy screening by artificial intelligence', 'type': 'DIAGNOSTIC_TEST', 'description': "Screening diabetic patients' eyes with AI through digital health platform", 'armGroupLabels': ['AI screening group']}, {'name': 'Diabetic retinopathy screening by healthcare personnel', 'type': 'DIAGNOSTIC_TEST', 'description': "Screening diabetic patients' eyes by conventional method (healthcare personnel)", 'armGroupLabels': ['Manual screening group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Paisan Ruamviboonsuk, Dr.', 'role': 'CONTACT', 'email': 'paisan.trs@gmail.com', 'phone': '+6622062900', 'phoneExt': '30731'}, {'name': 'Methaphon Chainakul, Dr.', 'role': 'CONTACT', 'email': 'methaphonc1995@gmail.com', 'phone': '+6622062900', 'phoneExt': '30731'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Fear of inappropriate use of data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Health Systems Research Institute,Thailand', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}