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NCT04631653 Clinical Trial

Verisee Software for Diabetic Retinopathy Screening

Diabetic Retinopathy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04631653
Other study ID # SE20294A
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2023

Study information
Verified date November 2020
Source Taichung Veterans General Hospital
Contact I-Te Lee, MD,PhD
Phone +886-4-23592525
Email itlee@vghtc.gov.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Adults - Patients with diabetes - Cooperation to fundal scopic examination Exclusion Criteria: - Diabetic duration < 5 years in patients with type 1 diabetes - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Taiwan Division of Endocrinology and Metabolism in Taichung Veterans General Hospital Taichung

Sponsors (1)
Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnostic accuracy diagnostic accuracy compared to the baseline 12 months
Secondary Screening rate of diabetic retinopathy Screening rate of diabetic retinopathy in patients with diabetes 12 months
Secondary Changes in HbA1c Changes in HbA1c 3 months
Secondary Referral rate of diabetic retinopathy Successful referral rate for referrable diabetic retinopathy 12 months
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