NCT07581925

Brief Summary

Oculomics is an emerging interdisciplinary field that deciphers multi-dimensional, high-throughput ocular data to predict, diagnose, and monitor systemic diseases and health span.In recent years, artificial Intelligence may provide insight into exploring the potential covert association behind and reveal some early ocular architecture changes in individuals with systemic diseases. The investigators conducted a survey to explore the association between the eye and systemic diseases via deep learning, to develop and evaluate different deep learning models to predict the systemic diseases such as 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
775

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

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

April 10, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

4.3 years

First QC Date

May 6, 2026

Last Update Submit

May 11, 2026

Conditions

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 (2)

  • sensitivity of the deep learning system

    baseline

  • specificity of the deep learning system

    baseline

Study Arms (4)

development dataset 01

ocular images collected from the Third Affiliated Hospital of Sun Yat-sen University

Diagnostic Test: Systemic diseases such as Hepatobiliary Disorders

development dataset 02

ocular images collected from Pazhou Medical Centre of Aikang Health Care

Diagnostic Test: Systemic diseases such as Hepatobiliary Disorders

test dataset 01

ocular images collected from the Third Affiliated Hospital of Sun Yat-sen University

Diagnostic Test: Systemic diseases such as Hepatobiliary Disorders

test dataset 02

ocular images collected from Pazhou Medical Centre of Aikang Health Care

Diagnostic Test: Systemic diseases such as 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 02test dataset 01test dataset 02

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ocular images collected from the Third Affiliated Hospital of Sun Yat-sen University and Pazhou Medical Centre of Aikang Health Care

You may qualify if:

  • The quality of ocular images should clinical acceptable.
  • Complete clinical information such as baseline demographic characteristics, the history of systematic diseases and so on.

You may not qualify if:

  • Individuals diagnosed with severe eye diseases or acute systematic diseases.
  • Incompatible with ocular examinations.

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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 12, 2026

Study Start

April 10, 2020

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations