Actively Recruiting
Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
Led by iHealthScreen Inc · Updated on 2025-09-02
922
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
I
iHealthScreen Inc
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 22 years of age or older
- Both males and females are invited to participate
- Diagnosed with diabetes with A1C level 6.5 or higher
- Willing and able to comply with clinic visits and study procedures
- Able to provide signed informed consent
You will not qualify if you...
- Unable to understand the study or unwilling/unable to sign informed consent
- Previously diagnosed with macular edema, any diabetic retinopathy, radiation retinopathy, or retinal vein occlusion
- Experiencing persistent vision loss, blurred vision, or other vision problems needing evaluation
- Retinal images previously used in training or development of the device
- Currently participating in another investigational eye study or receiving investigational treatment for DR or DME
- Any condition that investigator believes precludes participation
- Contraindications for fundus imaging such as hypersensitivity to light, recent photodynamic therapy, or photosensitive medication use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
iHealthScreen Inc.
Richmond Hill, New York, United States, 11418
Actively Recruiting
Research Team
A
Alauddin Bhuiyan
CONTACT
F
Fariha Nuha, BS (Comp. Biology)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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