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RECRUITING
NCT07151001

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

Sponsor: iHealthScreen Inc

View on ClinicalTrials.gov

Summary

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.

Official title: Pivotal Trial of Automated AI-based System for Early Diagnosis of Diabetic Retinopathy Using Retinal Color Imaging

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

922

Start Date

2025-01-01

Completion Date

2027-07-31

Last Updated

2025-09-02

Healthy Volunteers

Yes

Interventions

DEVICE

No intervention

No intervention. Evaluate the automated DR screening software.

Locations (1)

iHealthScreen Inc.

Richmond Hill, New York, United States