Verisee Software for Diabetic Retinopathy Screening | NCT04631653

Studies
Verisee Software for Diabetic Retinopathy Screening

NCT04631653

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Nov 17, 2020Actual

Enrollment

1,000Estimated

Phase

Not Applicable

Conditions

Diabetic Retinopathy

Interventions

VeriSee®

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Oct 18, 2020

First Submission Date that Met QC Criteria

Nov 15, 2020

First Posted Date

Nov 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2020

Last Update Posted Date

Nov 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Verisee	Experimental	Screening diabetic retinopathy using Verisee software	Device: VeriSee®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VeriSee®	Device	Screening of diabetic retinopathy using a validated deep learning-based software,VeriSee®	Verisee

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Screening rate of diabetic retinopathy	Screening rate of diabetic retinopathy in patients with diabetes	12 months
Changes in HbA1c	Changes in HbA1c

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults
Patients with diabetes
Cooperation to fundal scopic examination

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
I-Te Lee, MD,PhD	Contact	+886-4-23592525	3070	itlee@vghtc.gov.tw
Yu-Hsuan Li, MD	Contact

Overall Officials

Name	Affiliation	Role
I-Te Lee, MD,PhD	Taichung Veterans General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Endocrinology and Metabolism in Taichung Veterans General Hospital		Taichung		407	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided