Verisee Software for Diabetic Retinopathy Screening

Not Applicable

• Conditions: Diabetic Retinopathy

• Registration Number: NCT04631653
• Lead Sponsor: Taichung Veterans General Hospital

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.

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 Timeline

• Study First Submitted: 2020-10-18
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-15
• Last Update Submitted: 2020-11-15
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17
• Study Start: 2020-12-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy	12 months	diagnostic accuracy compared to the baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Division of Endocrinology and Metabolism in Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan