Verisee Software for Diabetic Retinopathy Screening

Sponsor

Taichung Veterans General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04631653

Collaborator

(none)

1,000

Enrollment

Location

Arm

Anticipated Duration (Months)

27.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aim to improve the diagnostic accuracy and the clinical referral rate for diabetic retinopathy by using a deep learning-based software.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Device: VeriSee®	N/A

Detailed Description

Diabetic retinopathy (DR) is the leading cause of blindness among working-age patients with type 2 diabetes. According to previous studies, early screening and timely treatment can reduce the risk of worsening DR and blindness. International guidelines recommend that screening for DR be performed at least once every year for patients with type 2 diabetes. The investigators will implement a validated deep learning-based software, VeriSee®, in clinics, and evaluate the benefits on diagnostic accuracy and the clinical referral rate for diabetic retinopathy after implementation of this software.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Examine the diagnostic accuracy in referred participantsExamine the diagnostic accuracy in referred participants

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

The Clinical Benefit of an Artificial Intelligence Software Implementation on Diabetic Retinopathy Screening

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Verisee Screening diabetic retinopathy using Verisee software	Device: VeriSee® Screening of diabetic retinopathy using a validated deep learning-based software,VeriSee®

Arm

Intervention/Treatment

Experimental: Verisee

Screening diabetic retinopathy using Verisee software

Device: VeriSee®

Screening of diabetic retinopathy using a validated deep learning-based software,VeriSee®

Outcome Measures

Primary Outcome Measures

diagnostic accuracy [12 months]
diagnostic accuracy compared to the baseline

Secondary Outcome Measures

Screening rate of diabetic retinopathy [12 months]
Screening rate of diabetic retinopathy in patients with diabetes
Changes in HbA1c [3 months]
Changes in HbA1c
Referral rate of diabetic retinopathy [12 months]
Successful referral rate for referrable diabetic retinopathy

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults
Patients with diabetes
Cooperation to fundal scopic examination

Exclusion Criteria:

Diabetic duration < 5 years in patients with type 1 diabetes
Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Endocrinology and Metabolism in Taichung Veterans General Hospital	Taichung		Taiwan	407

Sponsors and Collaborators

Taichung Veterans General Hospital

Investigators

Principal Investigator: I-Te Lee, MD,PhD, Taichung Veterans General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taichung Veterans General Hospital

ClinicalTrials.gov Identifier:

NCT04631653

Other Study ID Numbers:

SE20294A

First Posted:

Nov 17, 2020

Last Update Posted:

Nov 17, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Diseases

Diabetic Retinopathy

Study Results

No Results Posted as of Nov 17, 2020