Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy

Part of paid clinical trials in Richmond Hill, New York.

Sponsor: iHealthScreen Inc
Study ID: NCT07151001
Status: Recruiting

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Conditions

Diabetes
Diabetic Retinopathy

Eligibility Criteria

Sex: ALL
Age: 22 Years - N/A
Healthy Volunteers: Accepted

Interventions

No intervention — DEVICE
No intervention. Evaluate the automated DR screening software.

Study Details

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.