A Blinded, Self-control Trial to Evaluate an Artificial Intelligence Based

Status Completed

Clinical Trial 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.

Clinical Trial Description

1. Retinal images were collected retrospectively according to the following inclusion/exclusion criterion: Inclusion Criterion: Clinical history of diabetes mellitus or diabetic retinopathy; Fully Gradable Images; around 45° field which covers optic disc and macula; complete patient identification information; Exclusion Criterion: incomplete patient identification information; 2. DR grading by expert panel At first, retinal images are graded by three experts independently, then they met for a consensus meeting to discuss cases without initial agreement. If they can't achieve consensus, a final decision is made by the principal investigator. Experts give a grading of both DR and Diabetic Macular Edema (DME) for each image according to the International Clinical Diabetic Retinopathy severity scale criteria and hard exudates around optic disc. 3. Blinding and DR grading by CAD system Before DR grading by CAD system, a randomized identification(ID) is assigned to each retinal image, which ensures that investigator responsible for CAD system operation is masked to the expert panel grading result. Both DR and DME grading is generated by the CAD system and the results are exported. 4. Unblinding Finally, all data are unblinded and results of the CAD system are compared to the results of human grading, which is considered the gold standard, using measures as sensitivity and specificity; ;

Study Design

Related Conditions & MeSH terms

Diabetic Retinopathy

Clinical Trial Details

NCT number	NCT03973762
Study type	Interventional
Source	Peking Union Medical College Hospital
Contact
Status	Completed
Phase	N/A
Start date	May 31, 2019
Completion date	August 15, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms