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

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT04160988
• Lead Sponsor: Acer Being Health Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-10
• Study First Posted: 2019-11-13
• Study Start: 2019-12-16
• Primary Completion: 2020-01-31
• Study Completion: 2020-05-11
• Results First Submitted: 2020-11-19
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Results First Posted: 2021-01-29
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 703

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Negative Predictive Values (NPV)	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)
Positive Predictive Values (PPV)	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)
Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan