Verisee Software for Diabetic Retinopathy Screening

Taichung Veterans General Hospital

Status: Unknown

Conditions: Diabetic Retinopathy

Treatments: Device: VeriSee®

Study type: Interventional

Funder types: Other

Identifiers

NCT04631653

SE20294A

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Verisee

Experimental group

Description:

Screening diabetic retinopathy using Verisee software

Treatment:

Device: VeriSee®