Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 21
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Maryland
Johns Hopkins Pediatric Diabetes Center
RECRUITING
Baltimore
Contact Information
Primary
Risa M Wolf, MD
RWolf@jhu.edu
4109556463
Backup
Alvin Liu, MD
tliu25@jhmi.edu
Time Frame
Start Date: 2022-07-11
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 500
Treatments
Other: Diabetic Retinopathy Exam at the point of care
Participants will undergo 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.
Sponsors
Collaborators: Juvenile Diabetes Research Foundation, National Eye Institute (NEI)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov