Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT05223556
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2022-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self-testing Diagnosis Imaging Model 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2022-01-22', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy in the diagnosis of referral retinal lesions', 'timeFrame': '1 week', 'description': 'Accuracy in the diagnosis of referral retinal lesions using the self-testing diagnosis imaging'}], 'secondaryOutcomes': [{'measure': 'The agreement between the two modalities', 'timeFrame': '1 week', 'description': 'kappa value to assess the agreement between the two modalities in the diagnosis of referral retinal lesions'}, {'measure': 'Feasibility of self-testing diagnosis imaging model', 'timeFrame': '1 week', 'description': 'Feasibility is measured by examination completion rate'}, {'measure': 'Feasibility of self-testing diagnosis imaging model', 'timeFrame': '1 week', 'description': 'Feasibility is measured by interpretable image rate'}, {'measure': 'Satisfaction of participants as measured by questionnaire', 'timeFrame': '1 week', 'description': 'Satisfaction is measured by a questionnaire between the two modalities'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'This is a prospective clinical study. At the Shaoguan Diabetic Eye Screening Programme, patients ages 30-80 will undergo the two diagnostic models: (1) in a remote diagnostic clinic site, patients undergo a self-testing device that provides both color retinal photography (CRP) and optical coherence tomography (OCT) imaging of nondilated pupils, and receive an online consultation provided by a retinal specialist; (2) on a separate day, patients visit the tertiary hospital, undergo traditional imaging of dilated pupils acquired by a non-expert imager using a traditional CRP imaging device at the point of care, and receive a face-to-face consultation provided by a retinal specialist.\n\nWithin one week of receiving both diagnostic imaging services, patient preferences are assessed and they decide which diagnostic imaging model is preferred.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants from Shaoguan diabetic cohort', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. who are enrolled in the Shaoguan Diabetic Eye Screening Programme for their eye check-up\n2. who are diagnosed with diabetes and aged between 30 years and 80 years\n3. be able to sit for an imaging device for image acquisition\n4. be capable of giving their own consent\n\nExclusion Criteria:\n\n1\\. who are pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT05223556', 'briefTitle': 'Self-testing Diagnosis Imaging Model for Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': 'Investigation of the Accuracy of a Self-testing Diagnosis Imaging Model for Diabetic Retinopathy', 'orgStudyIdInfo': {'id': '2020KYPJ201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Shaoguan Diabetic cohort', 'description': 'Patients with diabetes ages 30-80 were enrolled in Shaoguan Diabetic Eye Screening Programme, who will receive diabetic retinopathy screening both in a remote diagnostic imaging site and in a tertiary hospital', 'interventionNames': ['Device: Full Self-Diagnostic device in a remote diagnostic imaging site', 'Device: Human imager operated diagnostic device in the hospital']}], 'interventions': [{'name': 'Full Self-Diagnostic device in a remote diagnostic imaging site', 'type': 'DEVICE', 'description': 'Full Self-Diagnostic CRP+OCT imaging, followed by online consultation', 'armGroupLabels': ['Shaoguan Diabetic cohort']}, {'name': 'Human imager operated diagnostic device in the hospital', 'type': 'DEVICE', 'description': 'Human imager operated CRP imaging with dilated pupils, followed by face-to-face consultation', 'armGroupLabels': ['Shaoguan Diabetic cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}