Status:
COMPLETED
ARDA Software for the Detection of mtmDR
Lead Sponsor:
Verily Life Sciences LLC
Collaborating Sponsors:
Google LLC.
Optos, PLC
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
22+ years
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 diabet...
Eligibility Criteria
Inclusion
- 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
- 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).
- Known pregnancy or possibility of pregnancy
Key Trial Info
Start Date :
September 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 23 2022
Estimated Enrollment :
1012 Patients enrolled
Trial Details
Trial ID
NCT04905459
Start Date
September 30 2021
End Date
May 23 2022
Last Update
June 6 2022
Active Locations (13)
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1
Midwestern University
Glendale, Arizona, United States, 85308
2
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72404
3
Catalina Research Institute
Montclair, California, United States, 91763
4
Christie Clinic
Champaign, Illinois, United States, 61822