ARDA Software for the Detection of mtmDR
- Conditions
- Diabetic Retinopathy
- Interventions
- Diagnostic Test: ARDA software application
- Registration Number
- NCT04905459
- Lead Sponsor
- Verily Life Sciences LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1012
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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)
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Age 22 or older
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Understand the study and volunteer to sign the informed consent
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Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses).
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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.
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Currently participating in an interventional study.
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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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Retinal Imaging and Mydriatic Agents ARDA software application Subjects will undergo several types of retinal imaging before and after administration of mydriatic agent. Subjects will be administered mydriatic medication to dilate their pupils.
- Primary Outcome Measures
Name Time Method Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images 1 day Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images 1 day Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images 1 day Specificity of ARDA mtmDR for detection of mtmDR in UWF images 1 day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Christie Clinic
🇺🇸Champaign, Illinois, United States
Catalina Research Institute
🇺🇸Montclair, California, United States
Riverside Diabetes Clinic
🇺🇸Riverdale, Maryland, United States
PMG Research of Winston Salem
🇺🇸Winston-Salem, North Carolina, United States
The Heart and Medical Center, P.C
🇺🇸Durant, Oklahoma, United States
BMG The Endocrine Clinic
🇺🇸Memphis, Tennessee, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
MedStar Health Research Institute Baltimore
🇺🇸Baltimore, Maryland, United States
Western Michigan University
🇺🇸Kalamazoo, Michigan, United States
Diabetes & Endocrinology Associates of Stark County, Inc
🇺🇸Canton, Ohio, United States
Clinical Trials Network
🇺🇸Houston, Texas, United States
Midwestern University
🇺🇸Glendale, Arizona, United States