NCT07151001Recruiting
Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
Pivotal Trial of Automated AI-based System for Early Diagnosis of Diabetic Retinopathy Using Retinal Color Imaging
Source: ClinicalTrials.gov · Last updated 2 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 922 (estimated)
- First submitted
- 27 Aug 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- iHealthScreen Inc
- Diseases
- Diabetic eye disease
- NCT number
- NCT07151001
What you commit to
- Study type: Observational
- Planned participants: 922
- From 1 Jan 2025 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed with macular edema, any form of diabetic retinopathy, radiation retinopathy, or retinal vein occlusion
- Currently participating in another investigational eye study or actively receiving investigational product for DR or DME.
Other illness
- A condition that, in the opinion of the investigator, would preclude participation in the study;
- Contraindicated for imaging by fundus imaging systems used in the study because of hypersensitivity to light, recently underwent photodynamic therapy, or was taking medication that causes photosensitivity.
Other
- Unable to understand the study, Our unable to or unwilling to sign the informed consent
- participants who are experiencing persistent vision loss, blurred vision, or other vision problems that should be evaluated by an eye care provider
- subjects whose retinal images were used in training, validating, or developing the device
Who the study is looking for
- Age of Subjects: Patients ≥ 22 years of age.
- Gender of Subjects: Both males and females will be invited to participate.
- Subjects with diabetes (A1C level ≥ 6.5).
- Subjects must be willing and are able to comply with clinic visit, understand the study-related procedures/provisions, and provide signed informed consent.
Age in the registry: 22 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| iHealthScreen Inc. Coordinator of this site? Confirm its status | Richmond Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.