Clinical Evaluation of VeriSee AMD in Screening for Age-Related Macular Degeneration

A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee AMD) for Screening of Age-Related Macular Degeneration

An observational study is designed to evaluate the clinical performance of VeriSee AMD for potential age-related macular degeneration (AMD) screening from color fundus photography images. The sensitivity and specificity of VeriSee AMD's automated image analysis for screening AMD will be determined through the comparison with the gold standard, which is the judgment of AMD by the ophthalmologists.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration, Age Related; Maculopathy, Age Related

Detailed Description

This is a retrospective, single-center, observational study to assess the clinical performance of VeriSee AMD in screening for potential age-related macular degeneration (AMD).

Potential subjects with images of color fundus photography will be selected for eligibility, and then the ophthalmologist further confirms the images with legible quality. Three independent ophthalmologists (or evaluators) having more than 6 years of experience in retina will evaluate AMD from the color fundus photography images with different sequences of images independently. These three evaluators are different from the ophthalmologist who is responsible for deciding subject's eligibility. The evaluators determine the severity of AMD based on the four-level scale which is the AMD Severity Scale stated in Age-Related Eye Disease Study (AREDS) Report No. 6. Before the study, the training section is necessary to ensure the consensus of the AMD severity grading among three evaluators. The severity determined by the majority of the grade the three evaluators gave is considered the gold/reference standard in this study. Therefore, level 1 and level 2 are classified as non-mtl3AMD, while level 3 and advanced AMD (level 4) are classified as mtl3AMD. The clinical performance displayed as sensitivity and specificity will be determined by comparing the AMD results between VeriSee AMD and the gold standard.

VeriSee AMD is intended to screen AMD from the images taken by color fundus photography, which can assist the physicians to assess whether further examination for retinopathy by the ophthalmologist is needed. The screening result of AMD will be non-mtl3AMD or mtl3AMD for the physicians' reference and does not intend to diagnose AMD, detect concomitant diseases, or treat AMD.

• Study Type: Observational
• Enrollment (Actual): 986

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

People fifty years of age or older have color fundus photography images.

Description

Inclusion Criteria:

• Subject with age ≥ 50 years old

• Subject with image taken by color fundus photography that meet the following requirement:

  1. The resolution of image is 271x271 pixels or higher;
  2. The angle view of image is 45 or 50 degree.
• Subject's image includes macula as judged by the ophthalmologist.

Exclusion Criteria:

• The color fundus photography image previously used by VeriSee AMD during the development process and pre-clinical test
• The macula 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?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	To evaluate the clinical performance of VeriSee AMD by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN)	1 day
Specificity	To evaluate the clinical performance of VeriSee AMD by determining the Specificity. Specificity = 100% x TN/(TN+FP)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Predictive Values (PPV)	To evaluate the clinical performance of VeriSee AMD by determining the positive predictive values (PPV). Positive predictive value (PPV) =100% x TP/(TP+FP)	1 day
Negative Predictive Values (NPV)	To evaluate the clinical performance of VeriSee AMD by determining the negative predictive values (NPV). Negative predictive value (NPV) = 100% x TN/(FN+TN)	1 day
The Percentage of Subjects' Images With Insufficient Quality as Judged by VeriSee AMD	The percentage of the images with insufficient quality as determined by VeriSee AMD will be presented.	1 day

Collaborators and Investigators

• Sponsor: Acer Medical Inc.
• Collaborators: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): August 10, 2022

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 23, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: AHCI21001

Drug and device information, study documents

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