Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2022-07-11
2026-03-30
Brief Summary
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Detailed Description
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In the AI for ChildrenS Diabetic Eye ExamS Study (ACCESS2), 398 participants will be enrolled to determine if point of care autonomous AI increases the proportion of minority and underserved youth screened for diabetic retinopathy. The autonomous AI interpretation will also be compared to consensus grading of retinal specialists to determine if there is agreement and to determine the diagnostic accuracy of the system in youth.
A cohort of youth with known diabetic retinopathy (true positives) will also be enrolled as an enriched population to determine the diagnostic accuracy of autonomous AI compared to the prognostic standard interpretation of a central reading center.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
8 Years
21 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Juvenile Diabetes Research Foundation
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Risa M Wolf, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Pediatric Diabetes Center
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Risa M Wolf, MD
Role: primary
References
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Channa R, Wolf R, Abramoff MD. Autonomous Artificial Intelligence in Diabetic Retinopathy: From Algorithm to Clinical Application. J Diabetes Sci Technol. 2021 May;15(3):695-698. doi: 10.1177/1932296820909900. Epub 2020 Mar 4.
Thomas CG, Channa R, Prichett L, Liu TYA, Abramoff MD, Wolf RM. Racial/Ethnic Disparities and Barriers to Diabetic Retinopathy Screening in Youths. JAMA Ophthalmol. 2021 Jul 1;139(7):791-795. doi: 10.1001/jamaophthalmol.2021.1551.
Wolf RM, Channa R, Abramoff MD, Lehmann HP. Cost-effectiveness of Autonomous Point-of-Care Diabetic Retinopathy Screening for Pediatric Patients With Diabetes. JAMA Ophthalmol. 2020 Oct 1;138(10):1063-1069. doi: 10.1001/jamaophthalmol.2020.3190.
Wolf RM, Liu TYA, Thomas C, Prichett L, Zimmer-Galler I, Smith K, Abramoff MD, Channa R. The SEE Study: Safety, Efficacy, and Equity of Implementing Autonomous Artificial Intelligence for Diagnosing Diabetic Retinopathy in Youth. Diabetes Care. 2021 Mar;44(3):781-787. doi: 10.2337/dc20-1671. Epub 2021 Jan 21.
Porter M, Channa R, Wagner J, Prichett L, Liu TYA, Wolf RM. Prevalence of diabetic retinopathy in children and adolescents at an urban tertiary eye care center. Pediatr Diabetes. 2020 Aug;21(5):856-862. doi: 10.1111/pedi.13037. Epub 2020 May 31.
Other Identifiers
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IRB00180692
Identifier Type: -
Identifier Source: org_study_id