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Verisee Software for Diabetic Retinopathy Screening

Primary Purpose

Diabetic Retinopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
VeriSee®
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetic Retinopathy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Division of Endocrinology and Metabolism in Taichung Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Verisee

Arm Description

Screening diabetic retinopathy using Verisee software

Outcomes

Primary Outcome Measures

diagnostic accuracy
diagnostic accuracy compared to the baseline

Secondary Outcome Measures

Screening rate of diabetic retinopathy
Screening rate of diabetic retinopathy in patients with diabetes
Changes in HbA1c
Changes in HbA1c
Referral rate of diabetic retinopathy
Successful referral rate for referrable diabetic retinopathy

Full Information

First Posted
October 18, 2020
Last Updated
November 15, 2020
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04631653
Brief Title
Verisee Software for Diabetic Retinopathy Screening
Official Title
The Clinical Benefit of an Artificial Intelligence Software Implementation on Diabetic Retinopathy Screening
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Examine the diagnostic accuracy in referred participants
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verisee
Arm Type
Experimental
Arm Description
Screening diabetic retinopathy using Verisee software
Intervention Type
Device
Intervention Name(s)
VeriSee®
Intervention Description
Screening of diabetic retinopathy using a validated deep learning-based software,VeriSee®
Primary Outcome Measure Information:
Title
diagnostic accuracy
Description
diagnostic accuracy compared to the baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Screening rate of diabetic retinopathy
Description
Screening rate of diabetic retinopathy in patients with diabetes
Time Frame
12 months
Title
Changes in HbA1c
Description
Changes in HbA1c
Time Frame
3 months
Title
Referral rate of diabetic retinopathy
Description
Successful referral rate for referrable diabetic retinopathy
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I-Te Lee, MD,PhD
Phone
+886-4-23592525
Ext
3070
Email
itlee@vghtc.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Hsuan Li, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Te Lee, MD,PhD
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Verisee Software for Diabetic Retinopathy Screening

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