A multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with IDx-DR.
A multi-center Study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.
Study Type
OBSERVATIONAL
Enrollment
626
Fundus camera
Infinity Clinical Research
Norco, California, United States
Dream Team
Pomona, California, United States
East Cost Institute for Research
Jacksonville, Florida, United States
Ocean Wellness Center
Miami Gardens, Florida, United States
Sensitivity and Specificity Corrected for Enrichment
Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1
Time frame: Day 1
Observed Sensitivity and Specificity, Level II
Estimation diagnosability, and observed sensitivity and specificity
Time frame: Day 1
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Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Logan Health
Kalispell, Montana, United States
Lillestol Research, LLC
Fargo, North Dakota, United States
Allure Health
Friendswood, Texas, United States
Mt. Olympus Medical Research
Sugar Land, Texas, United States