Artificial Intelligence for Vision Impairment from Diabetes

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether artificial intelligence (AI) can enhance eye care for people with diabetes by detecting eye disease during regular doctor visits. Participants will either receive usual care, involving a referral for a separate eye exam, or undergo AI screening, which includes taking eye photos and using AI to check for eye issues directly in the clinic. The trial aims to make important eye checks easier and faster. Suitable candidates include those with type 1 or 2 diabetes who haven't had an eye exam in the past year and have no known diabetic eye disease. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could simplify and accelerate eye care for diabetic patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that this AI is safe for screening diabetic eye disease?

Research has shown that using artificial intelligence (AI) to detect diabetic eye disease is safe for patients. In one study, researchers used AI with a special camera to take pictures of the eyes without dilation, which can be uncomfortable. The AI analyzed these images to identify signs of eye disease. This method proved safe and effective for people with diabetes, including younger patients.

Another study demonstrated that an FDA-approved AI system was highly accurate. It correctly identified diabetic eye disease 87% of the time and confirmed the absence of disease 90% of the time. These findings suggest that AI can serve as a reliable tool for eye screenings without any known safety issues for patients.12345

Why are researchers excited about this trial?

Researchers are excited about using artificial intelligence (AI) for vision impairment from diabetes because it offers a new approach to detecting eye disease. Unlike the usual care where patients need to visit an eye specialist for screenings, the AI intervention allows for autonomous identification of eye conditions right at the primary care clinic without needing a specialist's oversight. This method could potentially streamline the diagnostic process, making it faster and more accessible for patients. By simplifying the screening process, AI could lead to earlier detection and treatment, which is crucial for preventing vision loss in diabetes patients.

What evidence suggests that this AI is effective for vision impairment from diabetes?

Research has shown that AI systems excel at detecting diabetic retinopathy, an eye disease related to diabetes. One study found that the AI system correctly identified the disease in most cases, achieving a sensitivity of 88.9% and a specificity of 98.7%. This trial will compare the AI Intervention, which includes autonomous AI-based identification of eye disease, with Usual Care, where patients follow the clinic's standard practice for eye exams. Previous studies suggest that AI can be as effective as, or even better than, traditional screening methods. Additionally, using AI in screening programs has reduced vision loss from this condition and increased the number of patients attending their yearly eye exams. These findings suggest AI could be a powerful tool in managing eye health for people with diabetes.26789

Who Is on the Research Team?

RC

Roomsa Channa, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with type 1 or type 2 diabetes who have not had an eye exam for diabetic eye disease in the past year and do not already have known diabetic eye disease. Participants must be willing to share some personal data.

Inclusion Criteria

* Serve at least 267 patients with diabetes during the study period
* No point-of-care screening system in use for diabetic eye disease
* Agree to share limited identifiers data as requested
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

A 6-week baseline period is conducted in all clinics to establish initial conditions

6 weeks

Intervention

A 4-month intervention period where AI-based screening is implemented in selected clinics

4 months

Follow-up

Participants are monitored for completion of follow-up eye care within 5 months of recommendation

5 months

What Are the Treatments Tested in This Trial?

Interventions

  • AI

Trial Overview

The study compares a new AI-based screening tool used during regular doctor visits to detect diabetic eye disease versus usual care, across four primary care clinics. The goal is to see if AI improves early detection and follow-up.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: AI InterventionExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Citations

Real-world performance of an AI system for diabetic ... - PMC

The AI system achieved an area under the curve of 96.5%, sensitivity of 88.9%, specificity of 98.7%, and high predictive values for referable DR ...

Artificial Intelligence improves follow-up appointment ...

The findings suggest that integrating AI into screening programs could reduce the incidence of vision loss associated with diabetic retinopathy.

Effectiveness of AI-Based Tools in Detecting Diabetic ...

This table summarizes six eligible studies assessing AI-based tools for diabetic retinopathy detection in LMICs or LMIC-applicable settings, ...

AI-Enabled Diabetic Retinopathy Screening Programs ...

We set out to evaluate the accuracy of artificial intelligence (AI)-enabled diabetic retinopathy (DR) screening in our rural community, and how ...

The efficacy of artificial intelligence in diabetic retinopathy ...

AI systems have demonstrated strong diagnostic performance in detecting diabetic retinopathy, with sensitivity and specificity comparable to or exceeding ...

Artificial intelligence in proliferative diabetic retinopathy - PMC

Furthermore, AI-based models show promise in optimizing anti-VEGF therapy by enhancing therapeutic outcomes while reducing unnecessary ...

The SEE Study: Safety, Efficacy, and Equity of Implementing ...

Use of a nonmydriatic fundus camera with autonomous AI was safe and effective for the diabetic eye exam in youth in our study.

Autonomous Artificial Intelligence in Diabetic Retinopathy ...

Autonomous artificial intelligence (AI) increases health equity for patients who are more at risk for poor visual outcomes due to diabetic eye disease (DED) ...

Artificial Intelligence Detection of Diabetic Retinopathy - PMC

The IDx-DR system is an FDA-cleared AI point-of-care screening system with 87% sensitivity, 90% specificity, and 96% imageability for more than mild DR (mtmDR).