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

NCT07151001 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 922

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

No intervention

No intervention. Evaluate the automated DR screening software.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • iHealthScreen Inc

    lead INDUSTRY

Principal Investigators

  • Alauddin Bhuiyan, PhD · iHealthScreen Inc

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07151001 on ClinicalTrials.gov