NCT05131451

ACCESS: AI for pediatriC diabetiC Eye examS Study

Autonomous AI for Diabetic Retinopathy Screening in Youth (AI-DR): A Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if providing in clinic point-of-care autonomous AI diabetic retinopathy exams improves screening rates compared to standard of care referral to an eye care provider, in a randomized control trial in a racially and ethnically diverse cohort of youth.

Detailed description

This study will recruit 164 individuals ages 8-21 with type 1 and type 2 diabetes. Participants will be randomized to usual care (referral to an eye care provider for a dilated eye exam) or the intervention arm and undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants in the intervention group will receive the diabetic eye exam results immediately from the autonomous AI system, and if abnormal will be referred to an eye care provider for a dilated eye exam. Participants in the standard of care group will have 6 months to complete the diabetic eye exam.

Conditions

• Type 1 Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Point of Care Autonomous AI diabetic retinopathy exam	Participants will get a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.

Timeline

• Start date: 2021-11-24
• Primary completion: 2022-12-06
• Completion: 2022-12-31
• First posted: 2021-11-23
• Last updated: 2023-11-02
• Results posted: 2023-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study