[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611153":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":76,"collaborators":78,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":26,"enrollmentInfo":97,"targetDuration":26,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RDIA group","EXPERIMENTAL","The proposed intervention is the provision of universal screening for DR with retinography performed on a mobile fundus camera under mydriasis supported by a computer program in adults with diabetes mellitus; based on the diagnosis made by the computer program, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification.",[13],"Diagnostic Test: Mobile retinography interpreted by artificial intelligence",{"label":15,"type":16,"description":17,"interventionNames":18},"RDOF group","ACTIVE_COMPARATOR","The proposed control is the provision of universal screening for DR in adults with diabetes mellitus with retinography performed on a mobile fundus camera under mydriasis and with obtained images being interpreted remotely by ophthalmologists; based on the diagnosis made by the ophthalmologist, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification.",[19],"Diagnostic Test: Mobile retinography interpreted by ophthalmologists",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Mobile retinography interpreted by artificial intelligence","All participants will undergo mobile retinal photography in primary care by a trained nursing assistant. If randomized to RDIA group, their photos will be analyzed by artificial intelligence.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Mobile retinography interpreted by ophthalmologists","All participants will undergo mobile retinal photography in primary care by a trained nursing assistant. If randomized to RDOF group, their photos will be interpreted remotely by ophthalmologists.",[15],[32],{"name":33,"affiliation":34,"role":35},"Beatriz D Schaan, MD, PhD","Hospital de Clínicas de Porto Alegre","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+55 51 3359-8127","bschaan@hcpa.edu.br",[42],{"facility":34,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Porto Alegre","Rio Grande do Sul","90035-903","Brazil","BR",{"type":50,"coordinates":51},"Point",[52,53],-51.23019,-30.03283,{"lat":53,"lon":52},[56,57,59,61,63,66,68,70,72,74],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":58,"role":35,"phone":26,"phoneExt":26,"email":26},"Fernando K Malerbi, MD, PhD",{"name":60,"role":35,"phone":26,"phoneExt":26,"email":26},"Caio Vinicius Regatieri, MD, PhD",{"name":62,"role":35,"phone":26,"phoneExt":26,"email":26},"Dimitris RV Rados, MD, PhD",{"name":64,"role":65,"phone":26,"phoneExt":26,"email":26},"Greice Caletti, PhD","SUB_INVESTIGATOR",{"name":67,"role":35,"phone":26,"phoneExt":26,"email":26},"Jeruza L Neyeloff, MD, PhD",{"name":69,"role":65,"phone":26,"phoneExt":26,"email":26},"Luis Filipe Nakayama, MD",{"name":71,"role":35,"phone":26,"phoneExt":26,"email":26},"Natan Katz, MD, PhD",{"name":73,"role":65,"phone":26,"phoneExt":26,"email":26},"Gabriel Leivas, MD",{"name":75,"role":65,"phone":26,"phoneExt":26,"email":26},"Josiane Schneiders",{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[79,82,84],{"name":80,"class":81},"Fundação de Amparo à Pesquisa do Estado de São Paulo","OTHER_GOV",{"name":83,"class":6},"Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil",{"name":85,"class":86},"TelessaúdeRS \u002F UFRGS","UNKNOWN","100611153","artificial-intelligence-for-diagnosing-diabetic-retinopathy-in-primary-care-100611153",false,"NCT07236879","Artificial Intelligence for Diagnosing Diabetic Retinopathy in Primary Care","Effects of Artificial Intelligence-based Diabetic Retinopathy Screening on Timely Access to Treatment in Individuals With Diabetes","AID-DR","Inclusion Criteria:\n\n* Adults (\\> 18 years old) diagnosed with diabetes mellitus who agree to participate in the study.\n\nExclusion Criteria:\n\n* Any contraindication for pharmacological mydriasis (such as knowledge of having closed-angle glaucoma, pregnancy).\n* Life expectancy less than 6 months","ALL","18 Years",{"count":98,"type":99},922,"ESTIMATED","INTERVENTIONAL",[102],"NA","This is a clinical trial to evaluate the effects of universal screening for diabetic retinopathy (DR) and diabetic macular edema (DME) using artificial intelligence (AI) in the interpretation of fundus photographs obtained by trained nursing assistant using a portable fundus camera in a primary care setting, compared with images obtained by the same method, but interpreted by ophthalmologists.",[105],"Diabetic Retinopathy",[107,108,109],"screening","diabetic retinopathy","artificial intelligence","2025-11-17",{"date":112,"type":113},"2025-11-19","ACTUAL",{"date":115,"type":113},"2024-08-08",{"date":117,"type":99},"2026-12",{"name":5,"class":6},1]