Verisee Software for Diabetic Retinopathy Screening
- Conditions
- Diabetic Retinopathy
- Interventions
- Device: VeriSee®
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- Adults
- Patients with diabetes
- Cooperation to fundal scopic examination
- Diabetic duration < 5 years in patients with type 1 diabetes
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Verisee VeriSee® Screening diabetic retinopathy using Verisee software
- 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