Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsoriHealthScreen Inc

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • No intervention

Treatment groups

922 Participants
are divided into 1 treatment group

Sponsors and collaborators

iHealthScreen Inc

Lead sponsor

National Institutes of Health (NIH)

Collaborator