Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 7:58 PM
Study NCT ID:
NCT07404657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects whose results provided by the automatic AI-based tool match the reading center grading for the identification of referable diabetic eye disease (more than mild DR).', 'timeFrame': '1-day visit'}], 'secondaryOutcomes': [{'measure': 'percentage of eyes for which the AI-based automatic tool produced a result', 'timeFrame': '1-day visit'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy (DR)']}, 'descriptionModule': {'briefSummary': 'This study is being done to evaluate the performance of a software that uses artificial intelligence to analyze photographs of the retina to help detect diabetic retinopathy. The study will also assess the safety of the software in combination with a fundus camera already available on the market. This software analyzes retinal photographs to detect more than mild diabetic retinopathy in adults with diabetes. The results will be compared to expert human evaluations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'population attending a primary-care facility with diagnosis of diabetes mellitus and/or past diagnosis of diabetic retinopathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 22 years old or older\n* diabetes or diabetic retinopathy\n* understand the study information and able to sign a consent form\n\nExclusion Criteria:\n\n* cannot tolerate eye imaging tests\n* laser treatment or injections\n* eye surgery, except for simple cataract surgery\n* currently involved in another study\n* pregnant\n* cannot or do not want to have your eyes dilated\n* photodynamic therapy within the last 90 days'}, 'identificationModule': {'nctId': 'NCT07404657', 'briefTitle': 'Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centervue SpA'}, 'officialTitle': 'Preliminary Assessment of iCare RETCAD as an Automated Tool for Diabetic Retinopathy Screening', 'orgStudyIdInfo': {'id': 'RETCAD-PVAL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'automatic analysis of fundus images performed by the software tool based on artificial intelligence', 'type': 'DEVICE', 'description': 'the duration of the intervention is the analysis performed by the software tool based on fundus images acquired'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rui', 'role': 'CONTACT', 'email': 'chiara.rui@icare-world.com', 'phone': '00393357442593'}, {'name': 'Rumiato', 'role': 'CONTACT', 'email': 'ra.imaging@icare-world.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centervue SpA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}