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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Point of Care Autonomous AI diabetic retinopathy exam
Diagnostic testParticipants will undergo point-of-care diabetic retinopathy screening using autonomous artificial intelligence software to interpret retinal images taken with a non-mydriatic fundus camera and providing an immediate result.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Diabetic Retinopathy Exam at the point of careOther 1 intervention
Trial outcomes
Primary outcomes
1
Proportion screened for diabetic retinopathy
Equivalence in proportion screened for diabetic retinopathy of white and non-white youth with autonomous AI
Time frame
Day 1Secondary outcomes
1
Percentage of agreement in interpretation of retinal images
Agreement in interpretation of retinal images between autonomous AI and consensus grading by ophthalmologists
Time frame
Day 12
Sensitivity of autonomous AI vs. prognostic standard
Sensitivity of autonomous AI in detecting diabetic retinopathy in youth compared to the prognostic standard. This will be analyzed in the ACCESS2 trial cohort alone, and also in the ACCESS2 trial cohort with the enriched cohort of youth with known diabetic retinopathy.
Time frame
Day 13
Specificity of autonomous AI vs. prognostic standard
Specificity of autonomous AI in detecting diabetic retinopathy in youth compared to the prognostic standard. This will be analyzed in the ACCESS2 trial cohort alone, and also in the ACCESS2 trial cohort with the enriched cohort of youth with known diabetic retinopathy.
Time frame
Day 14
Proportion with diabetic retinopathy
Proportion of participants with diabetic retinopathy, including none, mild, moderate or severe DR.
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Eye Institute (NEI)
Collaborator
Juvenile Diabetes Research Foundation
Collaborator
Source ClinicalTrials.gov