NCT07151001 Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
| NCT ID | NCT07151001 |
| Status | Recruiting |
| Phase | — |
| Sponsor | iHealthScreen Inc |
| Condition | Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 922 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 922 participants in total. It began in 2025-01-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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.
Contact & Investigator
Alauddin Bhuiyan, PhD
PRINCIPAL INVESTIGATOR
iHealthScreen Inc
Frequently Asked Questions
Who can join the NCT07151001 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07151001 currently recruiting?
Yes, NCT07151001 is actively recruiting participants. Contact the research team at bhuiyan@ihealthscreen.org for enrollment information.
Where is the NCT07151001 trial being conducted?
This trial is being conducted at Richmond Hill, United States.
Who is sponsoring the NCT07151001 clinical trial?
NCT07151001 is sponsored by iHealthScreen Inc. The principal investigator is Alauddin Bhuiyan, PhD at iHealthScreen Inc. The trial plans to enroll 922 participants.
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