ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-21
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty
Diagnosis of Type 2 diabetes
Patients with Type 1 or Type 2 diabetes,
8-21 years of age with known diabetic retinopathy (true positives).
Disqualifiers
Known diabetic eye exam in the last 12 months
Trial design
Treatments tested in this trial
- Point of Care Autonomous AI diabetic retinopathy exam
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Eye Institute (NEI)
Collaborator
Juvenile Diabetes Research Foundation
Collaborator
Source ClinicalTrials.gov