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

Completed

Conditions: Maculopathy, Age Related
Macular Degeneration, Age Related

Registration Number: NCT05593913

Lead Sponsor: Acer Medical Inc.

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 986

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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