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

Completed Results posted Last updated 29 January 2021

What this trial tests

trial in Diabetic Retinopathy in 703 participants. Completed in 11 May 2020.

Timeline

16 December 2019

Primary endpoint
31 January 2020

11 May 2020

Quick facts

Lead sponsor	Acer Being Health Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	703
Start date	16 December 2019
Primary completion	31 January 2020
Estimated completion	11 May 2020
Sites	1 location across Taiwan

Conditions studied

• Diabetic Retinopathy — all drugs for Diabetic Retinopathy →

Sponsor

Acer Being Health Inc.

Who can join

20 and older, any sex, with Diabetic Retinopathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sensitivity Primary · 2 months

To evaluate the clinical performance of VeriSee DR by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN)

Group	Value	95% CI
Intended Use Population	95	92.48 – 96.82

Specificity Primary · 2 months

To evaluate the clinical performance of VeriSee DR by determining the specificity. Specificity = 100% x TN/(TN+FP)

Group	Value	95% CI
Test Group	89.9	85.37 – 96.43

Positive Predictive Values (PPV) Secondary · 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)

Group	Value	95% CI
Test Group	94.5	91.97 – 96.47

Negative Predictive Values (NPV) Secondary · 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)

Group	Value	95% CI
Intended Use Population	90.7	86.23 – 94.07

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

Group	Value	95% CI
Intended Use Population	28

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.