Clinical trial NCT04905459: ARDA Software for the Detection of mtmDR
Official title: A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Verily Life Sciences LLC
Sponsor class: INDUSTRY
Collaborators: name: Google LLC.
name: Optos, PLC
name: Nikon Corporation
name: The Emmes Company, LLC
First posted: 2021-05-27
Enrollment: 1012
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sites in the U.S.

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.


Eligibility criteria: Inclusion Criteria:

1. 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)
2. Age 22 or older
3. Understand the study and volunteer to sign the informed consent

Exclusion Criteria:

1. Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses).
2. Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion.
3. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
4. Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy.
5. Currently participating in an interventional study.
6. 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.).
7. Participant is contraindicated for imaging by fundus imaging system used in the study; e.g.

   1. Participant is hypersensitive to light (side effect of medication or due to unknown etiology)
   2. Participant has undergone photodynamic therapy (PDT)
   3. Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops).
8. Known pregnancy or possibility of pregnancy

Primary outcomes:
measure: Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images
timeFrame: 1 day
measure: Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images
timeFrame: 1 day
measure: Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images
timeFrame: 1 day
measure: Specificity of ARDA mtmDR for detection of mtmDR in UWF images
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Midwestern University
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Montclair
country: United States
facility: Catalina Research Institute
state: California
city: Champaign
country: United States
facility: Christie Clinic
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: MedStar Health Research Institute Baltimore
state: Maryland
city: Riverdale
country: United States
facility: Riverside Diabetes Clinic
state: Maryland
city: Kalamazoo
country: United States
facility: Western Michigan University
state: Michigan
city: Winston-Salem
country: United States
facility: PMG Research of Winston Salem
state: North Carolina
city: Canton
country: United States
facility: Diabetes & Endocrinology Associates of Stark County, Inc
state: Ohio
city: Durant
country: United States
facility: The Heart and Medical Center, P.C
state: Oklahoma
city: Memphis
country: United States
facility: BMG The Endocrine Clinic
state: Tennessee
city: Houston
country: United States
facility: Clinical Trials Network
state: Texas
Study officials:
References: