Verisee Software for Diabetic Retinopathy Screening

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04631653

Enrollment

1000

Registered

2020-11-17

Start date

2020-12-01

Completion date

2023-12-31

Last updated

2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

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.

Interventions

DEVICEVeriSee®

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Intervention model description

Examine the diagnostic accuracy in referred participants

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
diagnostic accuracy	12 months	diagnostic accuracy compared to the baseline

Secondary

Measure	Time frame	Description
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

Countries

Taiwan

Contacts

Primary ContactI-Te Lee, MD,PhD

itlee@vghtc.gov.tw+886-4-23592525

Backup ContactYu-Hsuan Li, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026