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NCT Number: NCT04160988

A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus

This study is to evaluate the clinical performance of VeriSee DR for DR screening from color fundus photography images in patients with diabetes mellitus. The sensitivity and specificity of VeriSee DR's automated image analysis for screening the diabetes retinopathy will be determined.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects enrolled in this study should meet all the following criteria.
  • Subject with age ≥ 20 years old
  • Subject with documented diagnosis of diabetes mellitus
  • Subject with image taken by color fundus photography that meet the following requirement:
  • The resolution of image is 1024×1024 pixels or higher;
  • The angle view of image is 45 or 50 degree.
  • Subject's image includes macula and optic nerve as judged by the ophthalmologist.

Exclusion criteria

  • Subjects will be excluded if they meet any of the following criteria.
  • The color fundus photography image previously used by VeriSee DR during the development process and pre-clinical test
  • The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the ophthalmologist.

Treatment and study plan

Primary outcomes

  1. Sensitivity

    Time frame: 2 months

    To evaluate the clinical performance of VeriSee DR by determining the sensitivity.

    Sensitivity = 100% x TP/(TP+FN)

  2. Specificity

    Time frame: 2 months

    To evaluate the clinical performance of VeriSee DR by determining the specificity.

    Specificity = 100% x TN/(TN+FP)

Secondary outcomes

  1. Positive Predictive Values (PPV)

    Time frame: 2 months

    To evaluate the clinical performance of VeriSee DR by determining the positive predictive values (PPV).

    Positive predictive value (PPV) =100% x TP/(TP+FP)

  2. Negative Predictive Values (NPV)

    Time frame: 2 months

    To evaluate the clinical performance of VeriSee DR by determining the negative predictive values (NPV).

    Negative predictive value (NPV) = 100% x TN/(FN+TN)

  3. Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR

    Time frame: 2 months

    To determine the percentage of subjects' images with insufficient quality as judged by VeriSee DR.

    The percentage of subjects who have the images with insufficient quality as determined by VeriSee DR will be presented.

Sponsors and collaborators

Lead sponsor

Acer Being Health Inc.

Industry

Collaborators

  • National Taiwan University Hospital

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2019
Registry last updated
Jan 29, 2021

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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