An observational study in Diabetic Retinopathy, sponsored by Digital Diagnostics, Inc.. Active, not recruiting at 9 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Digital Diagnostics, Inc. · Observational
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.
Primary care clinic - sampling method: non-probability sequential, invitation to volunteer
Documented diagnosis of diabetes mellitus, as per any of the following:
Exclusion Criteria:
Contraindication for imaging by devices used in the study due to any of the following:
Subjects imaged with a fundus camera
Device: handheld fundus camera
Fundus camera
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
Precision substudy
Evaluate the repeatability and reproducibility of IDx-DR with the camera in protocol DXSDR006. Additionally, another IRB-approved R\&R study (i.e., similar to DXSDR006 precision substudy) was conducted to evaluate parameters that may optimize R\&R outcomes.
Time frame: ~1-month after Day 1
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Digital Diagnostics, Inc.