NCT07151001 · iHealthScreen Inc
Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
What this study is about
In this pivotal trial, we aim to perform a forward-looking study to find the effectiveness 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Unable to understand the study, Our unable to or unwilling to sign the informed consent
- Previously diagnosed with macular edema, any form of diabetic retinopathy, radiation retinopathy, or retinal vein occlusion
- 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
- Currently participating in another investigational eye study or actively receiving investigational product for DR or DME.
- 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.
Where
- Richmond Hill, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 2, 2025 · Source of record for eligibility and locations