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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04160988
• Other study ID #: QCR19002
• Status: Completed
• Start date: December 16, 2019
• Est. completion date: May 11, 2020

Study information

• Verified date: January 2021
• Source: Acer Being Health Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 703
• Est. completion date: May 11, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Retinal Diseases

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Acer Being Health Inc.	National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	To evaluate the clinical performance of VeriSee DR by determining the sensitivity.; Sensitivity = 100% x TP/(TP+FN)	2 months
Primary	Specificity	To evaluate the clinical performance of VeriSee DR by determining the specificity.; Specificity = 100% x TN/(TN+FP)	2 months
Secondary	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
Secondary	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
Secondary	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