[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"iHealthScreen Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100604552","pivotal-trial-of-automated-artificial-intelligence-ai-based-system-for-early-diagnosis-of-diabetic-retinopathy-100604552",false,"NCT07151001","Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy","Pivotal Trial of Automated AI-based System for Early Diagnosis of Diabetic Retinopathy Using Retinal Color Imaging","Inclusion Criteria:\n\n* Age of Subjects: Patients ≥ 22 years of age.\n* Gender of Subjects: Both males and females will be invited to participate.\n* Subjects with diabetes (A1C level ≥ 6.5).\n* Subjects must be willing and are able to comply with clinic visit, understand the study-related procedures\u002Fprovisions, and provide signed informed consent.\n\nExclusion Criteria:\n\n* Unable to understand the study, Our unable to or unwilling to sign the informed consent\n* Previously diagnosed with macular edema, any form of diabetic retinopathy, radiation retinopathy, or retinal vein occlusion\n* participants who are experiencing persistent vision loss, blurred vision, or other vision problems that should be evaluated by an eye care provider\n* subjects whose retinal images were used in training, validating, or developing the device\n* Currently participating in another investigational eye study or actively receiving investigational product for DR or DME.\n* A condition that, in the opinion of the investigator, would preclude participation in the study;\n* Contraindicated for imaging by fundus imaging systems used in the study because of hypersensitivity to light, recently underwent photodynamic therapy, or was taking medication that causes photosensitivity.",true,"ALL","22 Years",{"count":20,"type":21},922,"ESTIMATED","OBSERVATIONAL","In this pivotal trial, we aim to perform a prospective study to find the efficacy of iPredict-DR, an artificial intelligence (AI) based software tool on early diagnosis of Diabetic Retinopathy (DR) in the primary care and endocrinology clinics. DR is one of the leading causes of blindness in the United States and other developed countries. Every individual with diabetes is at risk of DR. It does not show any symptoms until the disease is progressed to advanced stages. If the disease is caught at an early stage, it can be prevented, managed, or treated effectively. Currently, screening for DR is done by the Ophthalmologists, which is limited to areas with limited availability. This is also time-consuming and expensive. All of these can be complemented by automated screening and set up the screening in the primary care clinics.",[25,26],"Diabetes","Diabetic Retinopathy",[28,29],"Early Diagnosis","Screening","RECRUITING","2025-08-27",{"date":33,"type":34},"2025-09-02","ACTUAL",{"date":36,"type":34},"2025-01-01",{"date":38,"type":21},"2027-07-31",{"name":40,"class":41},"iHealthScreen Inc","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":16,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":66,"locationsCount":42},"100599468","pivotal-trial-of-an-automated-ai-based-system-for-early-diagnosis-and-prediction-of-late-age-related-macular-degeneration-100599468","NCT07084883","Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration","Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration in Ophthalmology and Primary Care Settings","Inclusion Criteria:\n\n* Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent\n\nExclusion Criteria:\n\n* Already diagnosed with AMD, unable to provide informed consent and currently under treatment of retinal disease.","50 Years",{"count":52,"type":21},1076,"The purpose of this study is to perform a pivotal trial of iPredict, an automated AI-based system for early diagnosis and prediction of late AMD in primary care and ophthalmology settings. Patients will be invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved fundus camera (DRSPlus from Centervue Inc., CA), at their primary care doctor's office or general ophthalmologist office. The photos will then be transmitted securely and analyzed by computer in the cloud (telemedicine features). Sufficient accuracy of the automatic system has been established compared to the ophthalmologist's diagnosis. In this study, we aim to validate the system against the prospectively taken OCT image and color fundus images.",[55],"Age-related Macular Degeneration (AMD)",[29,57,58,59],"Prediction","age-related macular degeneration","AMD","2025-08-21",{"date":62,"type":34},"2025-08-28",{"date":64,"type":34},"2024-08-01",{"date":38,"type":21},{"name":40,"class":41},""]