A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus

Acer Being Health

Status: Completed

Conditions: Diabetic Retinopathy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04160988

QCR19002

Details and patient eligibility

About

This study is to evaluate the clinical performance of VeriSee DR for DR screening from color fundus photography images in patients with diabetes mellitus. The sensitivity and specificity of VeriSee DR's automated image analysis for screening the diabetes retinopathy will be determined.

Enrollment: 703 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects enrolled in this study should meet all the following criteria.

  1. Subject with age ≥ 20 years old

  2. Subject with documented diagnosis of diabetes mellitus

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

     • The resolution of image is 1024×1024 pixels or higher;
     • The angle view of image is 45 or 50 degree.

  4. Subject's image includes macula and optic nerve as judged by the ophthalmologist.

Exclusion criteria

• Subjects will be excluded if they meet any of the following criteria.

  1. The color fundus photography image previously used by VeriSee DR during the development process and pre-clinical test
  2. The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the ophthalmologist.

Trial design