Macular Degeneration, Age Related Clinical Trial
Official title:
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
NCT number | NCT05593913 |
Other study ID # | AHCI21001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 17, 2022 |
Est. completion date | August 10, 2022 |
Verified date | April 2023 |
Source | Acer Medical Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 986 |
Est. completion date | August 10, 2022 |
Est. primary completion date | March 3, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Acer Medical Inc. | National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity | To evaluate the clinical performance of VeriSee AMD by determining the sensitivity.
Sensitivity = 100% x TP/(TP+FN) |
1 day | |
Primary | Specificity | To evaluate the clinical performance of VeriSee AMD by determining the Specificity.
Specificity = 100% x TN/(TN+FP) |
1 day | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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