Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
Recruiting
Observational Study
Diabetes
Diabetic Retinopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 922 (estimated)
- Sponsor
- iHealthScreen Inc · Industry
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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 n…
Trial Locations
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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/pr…
Contacts