NCT04213183

Brief Summary

Artificial Intelligence may provide insight into exploring the potential covert association behind and reveal some early ocular architecture changes in individuals with hepatobiliary disorders. We conducted a pioneer work to explore the association between the eye and liver via deep learning, to develop and evaluate different deep learning models to predict the hepatobiliary disease by using ocular images.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,789

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

December 25, 2019

Last Update Submit

August 16, 2020

Conditions

Keywords

Hepatobiliary DiseaseArtificial IntelligenceEye Images

Outcome Measures

Primary Outcomes (1)

  • area under the receiver operating characteristic curve of the deep learning system

    The investigators will calculate the area under the receiver operating characteristic curve of deep learning system and compare this index between deep learning system and human doctors

    baseline

Secondary Outcomes (1)

  • sensitivity and specificity of the deep learning system

    baseline

Study Arms (5)

development dataset 01

Slit-lamp and retinal fundus images collected from Department of Hepatobiliary Surgery of the Third Affiliated Hospital of Sun Yat-sen University.

Diagnostic Test: Hepatobiliary Disorders

development dataset 02

Slit-lamp and retinal fundus images collected from Affiliated Huadu Hospital of Southern Medical University.

Diagnostic Test: Hepatobiliary Disorders

development dataset 03

Slit-lamp and retinal fundus images collected from Nantian Medical Centre of Aikang Health Care.

Diagnostic Test: Hepatobiliary Disorders

test dataset 01

Slit-lamp and retinal fundus images collected from Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University.

Diagnostic Test: Hepatobiliary Disorders

test dataset 02

Slit-lamp and retinal fundus images collected from Huanshidong Medical Centre of Aikang Health Care.

Diagnostic Test: Hepatobiliary Disorders

Interventions

The training dataset was used to train the deep learning model, which was validated and tested by the other two datasets.

development dataset 01development dataset 02development dataset 03test dataset 01test dataset 02

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Slit-lamp and retinal fundus images collected from Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, Affiliated Huadu Hospital of Southern Medical University, Nantian Medical Centre of Aikang Health Care, and Huanshidong Medical Centre of Aikang Health Care.

You may qualify if:

  • The quality of fundus and slit-lamp images should clinical acceptable.
  • More than 90% of the fundus image area including four main regions (optic disk, macular, upper and lower retinal vessel archs) are easy to read and discriminate.
  • More than 90% of the slit-lamp image area including three main regions (sclera, pupil, and lens) are easy to read and discriminate.

You may not qualify if:

  • Images with light leakage (\>10% of the area), spots from lens flares or stains, and overexposure were excluded from further analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Digestive System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 25, 2019

First Posted

December 30, 2019

Study Start

December 1, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations