[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07222293":3,"trial-entities:NCT07222293":109,"trial-summary:NCT07222293":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":30,"primary_purpose":17,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":17,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":57,"locations":60,"central_contacts":100,"overall_officials":104,"references":107,"see_also_links":108},"NCT07222293","25-02-199","Assessment of AI Program 'DRISTi' as a Screening Tool","Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations","RECRUITING","2026-03","2025-12","2025-12-09","2025-11-23","Artelus AI","INDUSTRY",false,"A study will be conducted to demonstrate that DRISTi will correctly diagnose Diabetic Retinopathy (e.g., mtmDR, PDR, DME) in eyes of patients with diabetes. Participants who have been diagnosed with diabetes mellitus and meet the other inclusion\u002Fexclusion criteria will be invited to participate and will consent to have ophthalmic images taken. These images will be analyzed by DRISTi AI software and evaluated by an ophthalmic reading center. The results will be compared, and a statistical analysis will be completed to ensure statistical significance in the outcomes thus proving DRISTi is an effective DR diagnosis tool.",null,[19],"Diabetic Retinopathy (DR)",[21,22,23,24,25,26,27,28,29],"Artificial Intelligence","Ophthalmic Device","AI","Diabetic Retinopathy","Diabetes","DR","Screening","Online\u002FOffline","Fundus Camera","OBSERVATIONAL",[],{"count":33,"type":34},900,"ESTIMATED",[36],{"type":37,"name":38,"description":39},"DIAGNOSTIC_TEST","Fundus Image Grading","The image is graded by a fully automated AI device",[41],{"measure":42,"description":43,"timeFrame":44},"Accuracy of AI Grade","AI generated image grades are directly compared to a Human generated image grade","From time of arrival to completion of diagnostic tests, up to 8 hours",[],"ALL","21 Years",true,{"inclusion":50,"exclusion":51,"raw_text":56},[],[52,53,54,55],"Adults unable to consent (individuals w\u002F impaired decision-making capacity)","Individuals who are not yet adults (infants, children, teenagers)","Pregnant women","Prisoners","Inclusion Criteria:\n\n1. Ability to sign and date the informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Age (≥)21 years of age or older\n4. Diagnosed with diabetes mellitus as per criteria established by the World Health Organization (WHO) or the American Diabetes Association (ADA)\n\n   1. Hemoglobin A1c (HbA1c) ≥ 6.5%\n   2. Fasting Plasma Glucose (FPG) ≥ 126 mg\u002FdL (7.0 mmol\u002FL)\n   3. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg\u002FdL (11.1 mmol\u002FL)\n\nExclusion Criteria:\n\n1. Persistent visual impairment in one or both eyes;\n2. History of macular edema or retinal vascular (vein or artery) occlusion;\n3. History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;\n4. Subject is contraindicated for fundus photography (for example, has light sensitivity);\n5. Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;\n6. Subject is currently enrolled in an interventional study of an investigational device or drug for the same condition; or\n7. Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs\n8. Subject falls into one of the below categories:\n\n   * Adults unable to consent (individuals w\u002F impaired decision-making capacity)\n   * Individuals who are not yet adults (infants, children, teenagers)\n   * Pregnant women\n   * Prisoners",[58,59],"ADULT","OLDER_ADULT",[61,83],{"facility":62,"status":8,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":80},"New Century Ophthalmology - Oxford","Oxford","North Carolina","27565","United States",[68,73,77],{"name":69,"role":70,"phone":71,"email":72},"Jeanne Champion, Site Coordinator Oxford","CONTACT","9192347003","Jeanne@ncophth.com",{"name":74,"role":70,"phone":75,"email":76},"Chaitan Walia, Study Coordinator, BA","3129738490","cpwalia7@gmail.com",{"name":78,"role":79},"Vinod Jindal, MD","PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},36.3107,-78.59083,{"facility":84,"status":8,"city":85,"state":64,"zip":86,"country":66,"contacts":87,"geoPoint":97},"New Century Ophthalmology - Raleigh","Raleigh","27617",[88,92,93,96],{"name":89,"role":70,"phone":90,"email":91},"Adriana Valencia, Site Coordinator Raleigh","9192347406","Adriana@ncophth.com",{"name":74,"role":70,"phone":75,"email":76},{"name":94,"role":95},"Sumeet Jindal, MD","SUB_INVESTIGATOR",{"name":78,"role":79},{"lat":98,"lon":99},35.7721,-78.63861,[101,103],{"name":102,"role":70,"phone":71,"email":72},"Jeanne Champion, Primary Site Coordinator Oxford",{"name":89,"role":70,"phone":90,"email":91},[105],{"name":78,"affiliation":106,"role":79},"New Century Ophthalmology",[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111,24],"Diabetes Mellitus",[],{"nct_id":4,"found":48,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an observational study involving about 900 participants. It is designed to compare the results from an AI program with evaluations from eye specialists.","completed","Assessment of AI Program 'DRISTi' for Diabetic Retinopathy Screening","This study is testing an artificial intelligence (AI) program called 'DRISTi' to see how accurately it can screen for Diabetic Retinopathy (DR), an eye condition that can affect people with diabetes. We are looking for about 900 adults, aged 21 or older, who have been diagnosed with diabetes. If you join, ophthalmic images (pictures of your eyes) will be taken. These images will be analyzed by the DRISTi AI software and also by eye specialists. The goal is to compare these results to show that DRISTi can correctly identify different types of Diabetic Retinopathy. This study aims to prove DRISTi is an effective tool for diagnosing DR.","Your participation involves diagnostic tests completed within 8 hours from your arrival. No further follow-up is specified after this period.",107,"You would need to sign a consent form and have ophthalmic images taken. The diagnostic tests, including image taking, are expected to be completed within 8 hours.","Not stated in the trial record.",[],"v2"]