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OpenTrials
Completed

NCT Number: NCT04905459

ARDA Software for the Detection of mtmDR

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Midwestern University, Glendale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • Known pregnancy or possibility of pregnancy

Treatment and study plan

ARDA software application

Diagnostic Test

Subject images will be sent to the investigational ARDA software

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Verily Life Sciences LLC

Industry

Collaborators

  • Google LLC.
  • Nikon Corporation
  • Optos, PLC
  • The Emmes Company, LLC

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 27, 2021
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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