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

NCT05593913 | Completed Results

• 1 other identifier: AHCI21001
• Study Type: observational
• Target: 986
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration, Age Related; Maculopathy, Age Related

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Positive Predictive Values (PPV)

  1 day

• Negative Predictive Values (NPV)

  1 day

• The Percentage of Subjects' Images With Insufficient Quality as Judged by VeriSee AMD

  1 day

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Subject with age ≥ 50 years old
• Subject with image taken by color fundus photography that meet the following requirement:
• The resolution of image is 271x271 pixels or higher;
• The angle view of image is 45 or 50 degree.
• Subject's image includes macula as judged by the ophthalmologist.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acer Medical Inc.: lead
• National Taiwan University Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Regulator Manager
• Organization: Acer Medical Inc.

AcerMedicalofficial@gmail.com

886-2-26960366

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 26, 2022
• Study Start: January 17, 2022
• Primary Completion: March 3, 2022
• Study Completion: August 10, 2022
• Last Updated: January 22, 2024
• Results First Posted: January 22, 2024

Record last verified: 2023-04

Locations

TW (1)