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Automated AI-based System for Early Diagnosis of Diabetic Retinopathy

NCT05324189 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-04-12

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, an artificial intelligence (AI) based software tool on early diagnosis of Diabetic Retinopathy (DR)in the primary care, optometrist and other diabetes-screening 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 symptom 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

DIAGNOSTIC_TEST

Referable versus Non Referable Diabetic Retinopathy diagnostic test

Artificial intelligence read reports Referable versus Non Referable Diabetic Retinopathy

Sponsors & Collaborators

  • iHealthScreen Inc

    collaborator INDUSTRY

  • The New York Eye & Ear Infirmary

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-18
Primary Completion
2023-12-01
Completion
2024-12-01
FDA Device
Yes

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 NCT05324189 on ClinicalTrials.gov