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A Blinded, Self-control Trial to Evaluate an Artificial Intelligence Based CAD System for Diabetic Retinography

NCT03973762 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1081

Last updated 2020-11-03

No results posted yet for this study

Summary

To evaluate the safety and performance of an innovative artificial intelligence based Computer-Aided Diagnosis(CAD) system for diabetic retinography, Retinal images of patients with diabetes mellitus or diabetic retinopathy(DR) were collected retrospectively. All images were graded by a retinal specialists expert panel and the CAD device using the International Clinical Diabetic Retinopathy severity scale criteria. Investigator responsible for DR grading by CAD system is blinded to the DR grading results from the expert panel. Finally, DR grading results of the CAD system and experts were compared using sensitivity and specificity.

Conditions

Interventions

DEVICE

DR Grading with CAD

A CAD system is used to make DR grading.

OTHER

DR Grading by expert panel

DR Grading by expert panel

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER

  • Beijing Tongren Hospital

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Chen Youxin, Professor · Peking Union Medical College Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2020-07-15
Completion
2020-08-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03973762 on ClinicalTrials.gov