NCT04631653

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

3.1 years

First QC Date

October 18, 2020

Last Update Submit

November 15, 2020

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • diagnostic accuracy

    diagnostic accuracy compared to the baseline

    12 months

Secondary Outcomes (3)

  • Screening rate of diabetic retinopathy

    12 months

  • Changes in HbA1c

    3 months

  • Referral rate of diabetic retinopathy

    12 months

Study Arms (1)

Verisee

EXPERIMENTAL

Screening diabetic retinopathy using Verisee software

Device: VeriSee®

Interventions

VeriSee®DEVICE

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

Verisee

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Endocrinology and Metabolism in Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • I-Te Lee, MD,PhD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Te Lee, MD,PhD

CONTACT

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

Yu-Hsuan Li, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Examine the diagnostic accuracy in referred participants
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2020

First Posted

November 17, 2020

Study Start

December 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

November 17, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)