A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy

Verily Life Sciences LLC13 sites in 1 country1,012 target enrollmentSeptember 30, 2021

ConditionsDiabetic Retinopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Retinopathy
Sponsor: Verily Life Sciences LLC
Enrollment: 1012
Locations: 13
Primary Endpoint: Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, observational study with primary endpoints to determine the sensitivity and specificity of two investigational software devices that detect the presence of more than mild diabetic retinopathy (mtmDR) in healthcare settings.

Registry

clinicaltrials.gov

Start Date

September 30, 2021

End Date

May 23, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Verily Life Sciences LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Documented diagnosis of Type I or Type II diabetes mellitus:
•meet the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
•Age 22 or older
•Understand the study and volunteer to sign the informed consent

Exclusion Criteria

•Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses).
•Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion.
•History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
•Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy.
•Currently participating in an interventional study.
•Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation, etc.).
•Participant is contraindicated for imaging by fundus imaging system used in the study; e.g.
•Participant is hypersensitive to light (side effect of medication or due to unknown etiology)
•Participant has undergone photodynamic therapy (PDT)
•Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops).