AI Tool for Early Diagnosis of Diabetic Retinopathy
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
Who this trial is looking for
This trial is looking for adults with diabetes to test a new AI tool for early diagnosis of eye problems caused by diabetes. Participants will need to visit a clinic for screenings.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 22 years old.
- I have diabetes with an A1C level of 6.5 or higher.
- I can understand the study and sign the consent form.
- I am willing to attend clinic visits.
You may not be able to join if
- I cannot understand the study or sign the consent form.
- I have a history of diabetic retinopathy or other serious eye problems.
- I have ongoing vision issues that need eye care.
- I have previously participated in another eye study.
- I have a condition that my doctor thinks would prevent my participation.
- I am too sensitive to light for the imaging used in the study.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
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