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Clinical Trials/NCT04631653
NCT04631653
Unknown
Not Applicable

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

Taichung Veterans General Hospital1 site in 1 country1,000 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Retinopathy
Sponsor
Taichung Veterans General Hospital
Enrollment
1000
Locations
1
Primary Endpoint
diagnostic accuracy
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
December 31, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with diabetes
  • Cooperation to fundal scopic examination

Exclusion Criteria

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

Outcomes

Primary Outcomes

diagnostic accuracy

Time Frame: 12 months

diagnostic accuracy compared to the baseline

Secondary Outcomes

  • Screening rate of diabetic retinopathy(12 months)
  • Changes in HbA1c(3 months)
  • Referral rate of diabetic retinopathy(12 months)

Study Sites (1)

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