Clinical trial NCT05593913: Clinical Evaluation of VeriSee AMD in Screening for Age-Related Macular Degeneration
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration, Age Related
Maculopathy, Age Related
Lead sponsor: Acer Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Taiwan University Hospital
First posted: 2022-10-26
Enrollment: 986
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People fifty years of age or older have color fundus photography images.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity
timeFrame: 1 day
measure: Specificity
timeFrame: 1 day
Secondary outcomes:
measure: Positive Predictive Values (PPV)
timeFrame: 1 day
measure: Negative Predictive Values (NPV)
timeFrame: 1 day
measure: The Percentage of Subjects' Images With Insufficient Quality as Judged by VeriSee AMD
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: