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ARDA Software for the Detection of mtmDR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04905459
Recruitment Status : Completed
First Posted : May 27, 2021
Last Update Posted : June 6, 2022
Sponsor:
Collaborators:
Google LLC.
Optos, PLC
Nikon Corporation
The Emmes Company, LLC
Information provided by (Responsible Party):
Verily Life Sciences LLC

Study Description
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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.

Condition or disease Intervention/treatment
Diabetic Retinopathy Diagnostic Test: ARDA software application

Study Design
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Study Type : Observational
Actual Enrollment : 1012 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy
Actual Study Start Date : September 30, 2021
Actual Primary Completion Date : May 23, 2022
Actual Study Completion Date : May 23, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Retinal Imaging and Mydriatic Agents
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.
 Diagnostic Test: ARDA software application
Subject images will be sent to the investigational ARDA software


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images [ Time Frame: 1 day ]
  2. Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images [ Time Frame: 1 day ]
  3. Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images [ Time Frame: 1 day ]
  4. Specificity of ARDA mtmDR for detection of mtmDR in UWF images [ Time Frame: 1 day ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sites in the U.S.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04905459


Locations
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United States, Arizona
Midwestern University
Glendale, Arizona, United States, 85308
United States, Arkansas
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72404
United States, California
Catalina Research Institute
Montclair, California, United States, 91763
United States, Illinois
Christie Clinic
Champaign, Illinois, United States, 61822
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
MedStar Health Research Institute Baltimore
Baltimore, Maryland, United States, 21239
Riverside Diabetes Clinic
Riverdale, Maryland, United States, 20737
United States, Michigan
Western Michigan University
Kalamazoo, Michigan, United States, 49008
United States, North Carolina
PMG Research of Winston Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Diabetes & Endocrinology Associates of Stark County, Inc
Canton, Ohio, United States, 44718
United States, Oklahoma
The Heart and Medical Center, P.C
Durant, Oklahoma, United States, 74701
United States, Tennessee
BMG The Endocrine Clinic
Memphis, Tennessee, United States, 38119
United States, Texas
Clinical Trials Network
Houston, Texas, United States, 77074
Sponsors and Collaborators
Verily Life Sciences LLC
Google LLC.
Optos, PLC
Nikon Corporation
The Emmes Company, LLC
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Verily Life Sciences LLC
ClinicalTrials.gov Identifier: NCT04905459    
Other Study ID Numbers: 101703
First Posted: May 27, 2021    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases