Recruiting

AI for Pediatric Eye Exams

Sponsor:

Johns Hopkins University

Code:

NCT05463289

Conditions

Type 1 Diabetes

Type 2 Diabetes

Cystic Fibrosis-related Diabetes

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

Interventions

Point of Care Autonomous AI diabetic retinopathy exam

Study Details

Brief 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.

Conditions

Type 1 Diabetes

Type 2 Diabetes

Cystic Fibrosis-related Diabetes

Study ID

NCT05463289

Start date

Jul 11, 2022

Status verified date

Jun, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

Point of Care Autonomous AI diabetic retinopathy exam

Participants 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.

Primary outcome measure

  • Proportion screened for diabetic retinopathy [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Risa M Wolf, MD

4109556463RWolf@jhu.edu

Alvin Liu, MD

tliu25@jhmi.edu

Locations

Johns Hopkins Pediatric Diabetes Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Risa M Wolf, MD

410-955-6463rwolf@jhu.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Diabetic Retinopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-02.