ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Recruiting · NCT05463289 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
Point of Care Autonomous AI diabetic retinopathy exam
What this trial is about
The purpose of this study is to determine if use of a nonmydriatic fundus camera using autonomous artificial intelligence software at the point of care increases the proportion of underserved youth with diabetes screened for diabetic retinopathy, and to determine the diagnostic accuracy of the autonomous AI system in detecting diabetic retinopathy from retinal images of youth with diabetes.
Who can take part
Age range
8 Years to 21 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:
- Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty
- Diagnosis of Type 2 diabetes
- Enriched cohort:
- Patients with Type 1 or Type 2 diabetes,
- 8-21 years of age with known diabetic retinopathy (true positives).
- No time limit on last diabetic eye exam.
Exclusion criteria
- Known diabetic eye exam in the last 12 months
Where it is running
1 location listed across 1 US state.
- Johns Hopkins Pediatric Diabetes Center - Baltimore, Maryland, United States