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

NCT04160988 | Completed Results

• 1 other identifier: QCR19002
• Study Type: observational
• Target: 703
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  To evaluate the clinical performance of VeriSee DR by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN)

  2 months

• Specificity

  To evaluate the clinical performance of VeriSee DR by determining the specificity. Specificity = 100% x TN/(TN+FP)

  2 months

Secondary Outcomes (3)

• Positive Predictive Values (PPV)

  2 months

• Negative Predictive Values (NPV)

  2 months

• Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR

  2 months

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Persons with diabetes, twenty years of age or older, who have been referred to an ophthalmologists for a dilated eye examination to detect diabetic retinopathy.

You may qualify if:

• Subjects enrolled in this study should meet all the following criteria.
• Subject with age ≥ 20 years old
• Subject with documented diagnosis of diabetes mellitus
• 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.
• Subject's image includes macula and optic nerve as judged by the ophthalmologist.

You may not qualify if:

• Subjects will be excluded if they meet any of the following criteria.
• The color fundus photography image previously used by VeriSee DR during the development process and pre-clinical test
• 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.

Sponsors & Collaborators

• Acer Being Health Inc.: lead
• National Taiwan University Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

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

Johnny.Lu@acer.com

886-6-26963131

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: November 7, 2019
• First Posted: November 13, 2019
• Study Start: December 16, 2019
• Primary Completion: January 31, 2020
• Study Completion: May 11, 2020
• Last Updated: January 29, 2021
• Results First Posted: January 29, 2021

Record last verified: 2021-01

Locations

TW (1)