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.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy

• Study Type: Observational
• Enrollment (Actual): 703

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Persons with diabetes, twenty years of age or older, who have been referred to an ophthalmologists for a dilated eye examination to detect diabetic retinopathy.

Description

Inclusion Criteria:

• Subjects enrolled in this study should meet all the following criteria.

  1. Subject with age ≥ 20 years old
  2. Subject with documented diagnosis of diabetes mellitus

  3. 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.
  4. 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.

  1. The color fundus photography image previously used by VeriSee DR during the development process and pre-clinical test
  2. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	To evaluate the clinical performance of VeriSee DR by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN)	2 months
Specificity	To evaluate the clinical performance of VeriSee DR by determining the specificity. Specificity = 100% x TN/(TN+FP)	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Predictive Values (PPV)	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 months
Negative Predictive Values (NPV)	To evaluate the clinical performance of VeriSee DR by determining the negative predictive values (NPV). Negative predictive value (NPV) = 100% x TN/(FN+TN)	2 months
Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR	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.	2 months

Collaborators and Investigators

• Sponsor: Acer Being Health Inc.
• Collaborators: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): May 11, 2020

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 10, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: QCR19002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No