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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973762
• Other study ID #: GTR201-Clinical
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: August 15, 2020

Study information

• Verified date: November 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1081
• Est. completion date: August 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Peking	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Tongren Hospital, Chinese PLA General Hospital, Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Se and Sp under investigation target 3	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).	through study completion,an average of four months
Secondary	Se and Sp under investigation target 1/2/4/5	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).	through study completion,an average of four months