Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03973762
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2019-05-27
Brief Title:
A Blinded Self-control Trial to Evaluate an Artificial Intelligence Based CAD System for Diabetic Retinography
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Blinded Self-control Trial to Evaluate an Artificial Intelligence Based CAD System for Diabetic Retinography
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety and performance of an innovative artificial intelligence based Computer-Aided DiagnosisCAD system for diabetic retinography Retinal images of patients with diabetes mellitus or diabetic retinopathyDR 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
Detailed Description:
1 Retinal images were collected retrospectively according to the following inclusionexclusion 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 cant 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 identificationID 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
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 cant 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 identificationID 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None