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出境医 / 临床实验 / A Blinded, Self-control Trial to Evaluate an Artificial Intelligence Based CAD System for Diabetic Retinography

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

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Device: DR Grading with CAD Other: DR Grading by expert panel Not Applicable

Detailed 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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1081 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This trial aims to evaluate the diagnostic performance of a CAD system for retinal images； And DR grading by clinicians is used as the golden standard.
Masking: Single (Investigator)
Masking Description: Investigator responsible for CAD system operation is masked to the expert panel grading result.
Primary Purpose: Diagnostic
Official Title: A Blinded, Self-control Trial to Evaluate an Artificial Intelligence Based CAD System for Diabetic Retinography
Actual Study Start Date : May 31, 2019
Actual Primary Completion Date : July 15, 2020
Actual Study Completion Date : August 15, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: DR Grading with CAD
DR Grading with CAD
 Device: DR Grading with CAD
A CAD system is used to make DR grading.
DR Grading by expert panel
DR Grading by expert panel
 Other: DR Grading by expert panel
DR Grading by expert panel
Outcome Measures
Primary Outcome Measures :
  1. Se and Sp under investigation target 3 [ Time Frame: through study completion，an average of four months ]
    1.investigation target 3: Negative: DR grading of 0 or 1; Positive: DR grading of 2 or higher; After completion of DR grading by expert panel and CAD system, results of the CAD system were compared to the results of human grading, which is considered the gold standard, using measures as sensitivity(Se) and specificity(Sp).


Secondary Outcome Measures :
  1. Se and Sp under investigation target 1/2/4/5 [ Time Frame: through study completion，an average of four months ]
    investigation target 1: Negative : DR grading of 0 ; Positive : DR grading of 1 or higher; investigation target 2: Negative : DR grading of 0,1 or 2 ; Positive : DR grading of 3 or higher; investigation target 4: Negative : no clinically significant DME; Positive : clinically significant DME; investigation target 5: Negative : no clinically significant DME and DR grading of 0, 1 or 2 ; Positive : clinically significant DME or DR grading of 3 or higher; After completion of DR grading by expert panel and CAD system, results of the CAD system were compared to the results of human grading, which is considered the gold standard, using measures as sensitivity(Se) and specificity(Sp).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • incomplete patient identification information
Contacts and Locations

Locations
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China, Beijing
Peking Union Medical College Hospital
Peking, Beijing, China, 100005
Sponsors and Collaborators
Peking Union Medical College Hospital
Peking University People's Hospital
Beijing Tongren Hospital
Chinese PLA General Hospital
Investigators
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Principal Investigator: Chen Youxin, Professor Peking Union Medical College Hospital
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE May 31, 2019
Actual Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019) 		Se and Sp under investigation target 3 [ Time Frame: through study completion，an average of four months ]
1.investigation target 3: Negative: DR grading of 0 or 1; Positive: DR grading of 2 or higher; After completion of DR grading by expert panel and CAD system, results of the CAD system were compared to the results of human grading, which is considered the gold standard, using measures as sensitivity(Se) and specificity(Sp).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019) 		Se and Sp under investigation target 1/2/4/5 [ Time Frame: through study completion，an average of four months ]
investigation target 1: Negative : DR grading of 0 ; Positive : DR grading of 1 or higher; investigation target 2: Negative : DR grading of 0,1 or 2 ; Positive : DR grading of 3 or higher; investigation target 4: Negative : no clinically significant DME; Positive : clinically significant DME; investigation target 5: Negative : no clinically significant DME and DR grading of 0, 1 or 2 ; Positive : clinically significant DME or DR grading of 3 or higher; After completion of DR grading by expert panel and CAD system, results of the CAD system were compared to the results of human grading, which is considered the gold standard, using measures as sensitivity(Se) and specificity(Sp).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Blinded, Self-control Trial to Evaluate an Artificial Intelligence Based CAD System for Diabetic Retinography
Official Title  ICMJE A Blinded, Self-control Trial to Evaluate an Artificial Intelligence Based CAD System for Diabetic Retinography
Brief 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.
Detailed 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This trial aims to evaluate the diagnostic performance of a CAD system for retinal images； And DR grading by clinicians is used as the golden standard.
Masking: Single (Investigator)
Masking Description:
Investigator responsible for CAD system operation is masked to the expert panel grading result.
Primary Purpose: Diagnostic
Condition  ICMJE Diabetic Retinopathy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: DR Grading with CAD
    DR Grading with CAD
    Intervention: Device: DR Grading with CAD
  • DR Grading by expert panel
    DR Grading by expert panel
    Intervention: Other: DR Grading by expert panel
Publications *
  • Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.
  • Williams GA, Scott IU, Haller JA, Maguire AM, Marcus D, McDonald HR. Single-field fundus photography for diabetic retinopathy screening: a report by the American Academy of Ophthalmology. Ophthalmology. 2004 May;111(5):1055-62. Review.
  • Gulshan V, Peng L, Coram M, Stumpe MC, Wu D, Narayanaswamy A, Venugopalan S, Widner K, Madams T, Cuadros J, Kim R, Raman R, Nelson PC, Mega JL, Webster DR. Development and Validation of a Deep Learning Algorithm for Detection of Diabetic Retinopathy in Retinal Fundus Photographs. JAMA. 2016 Dec 13;316(22):2402-2410. doi: 10.1001/jama.2016.17216.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2020) 		1081
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2019) 		1080
Actual Study Completion Date  ICMJE August 15, 2020
Actual Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • incomplete patient identification information
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973762
Other Study ID Numbers  ICMJE GTR201-Clinical
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Youxin Chen, Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE
  • Peking University People's Hospital
  • Beijing Tongren Hospital
  • Chinese PLA General Hospital
Investigators  ICMJE
Principal Investigator: Chen Youxin, Professor Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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