Verisee Software for Diabetic Retinopathy Screening

Overview

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

Full Title of Study: “The Clinical Benefit of an Artificial Intelligence Software Implementation on Diabetic Retinopathy Screening”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Verisee
    • Screening diabetic retinopathy using Verisee software

Clinical Trial Outcome Measures

Primary Measures

  • diagnostic accuracy
    • Time Frame: 12 months
    • diagnostic accuracy compared to the baseline

Secondary Measures

  • Screening rate of diabetic retinopathy
    • Time Frame: 12 months
    • Screening rate of diabetic retinopathy in patients with diabetes
  • Changes in HbA1c
    • Time Frame: 3 months
    • Changes in HbA1c
  • Referral rate of diabetic retinopathy
    • Time Frame: 12 months
    • Successful referral rate for referrable diabetic retinopathy

Participating in This Clinical Trial

Inclusion Criteria

  • Adults – Patients with diabetes – Cooperation to fundal scopic examination Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taichung Veterans General Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • I-Te Lee, MD,PhD, Principal Investigator, Taichung Veterans General Hospital
  • Overall Contact(s)
    • I-Te Lee, MD,PhD, +886-4-23592525, itlee@vghtc.gov.tw

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