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Verisee Software for Diabetic Retinopathy Screening

NCT ID: NCT04631653

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Examine the diagnostic accuracy in referred participants
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Verisee

Screening diabetic retinopathy using Verisee software

Group Type EXPERIMENTAL

VeriSee®

Intervention Type DEVICE

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

Interventions

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VeriSee®

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults
* Patients with diabetes
* Cooperation to fundal scopic examination

Exclusion Criteria

* Diabetic duration \< 5 years in patients with type 1 diabetes
* Pregnancy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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I-Te Lee, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Locations

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Division of Endocrinology and Metabolism in Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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I-Te Lee, MD,PhD

Role: CONTACT

Phone: +886-4-23592525

Email: [email protected]

Yu-Hsuan Li, MD

Role: CONTACT

Other Identifiers

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SE20294A

Identifier Type: -

Identifier Source: org_study_id