Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
NCT07151001
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Diabetes
- Diabetic Retinopathy
Eligibility basics and study details
- Study type
- Observational
- Phase
- Not applicable
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- iHealthScreen Inc
- Last updated on ClinicalTrials.gov
- September 2, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
New York · 1
- iHealthScreen Inc. · Richmond Hill, NY
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.