NCT05847894

Brief Summary

This study intends to collect ophthalmologic examination results, pulmonary examination results and related indexes from patients with pulmonary disease and control populations, and combine big data analysis and artificial intelligence technology to explore whether new methods can be provided for early screening strategies for pulmonary disease with the aid of ophthalmologic examination, and thus assist in identifying the types of pulmonary disease and determining disease prognosis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

5.8 years

First QC Date

April 20, 2023

Last Update Submit

May 19, 2025

Conditions

Pulmonary DiseasesOphthalmological Diagnostic TechniquesArtificial Intelligence

Keywords

Pulmonary DiseasesOphthalmological Diagnostic TechniquesArtificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Area Under the Receiver Operating Characteristic curve

    Determining the accuracy of diagnosing pulmonary disease with ophthalmic examination

    Through study completion, an average of 1 year

Study Arms (2)

Test group

Individuals with one or more pulmonary diseases

Diagnostic Test: Ophthalmic examinationDiagnostic Test: Pulmonary Examination

Control group

Individuals who do not suffer from pulmonary diseases

Diagnostic Test: Ophthalmic examinationDiagnostic Test: Pulmonary Examination

Interventions

Ophthalmic examinationDIAGNOSTIC_TEST

Various ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc.

Control groupTest group
Pulmonary ExaminationDIAGNOSTIC_TEST

Various pulmonary examination modalities, including radiography, chest CT, pulmonary function measurement, etc.

Control groupTest group

Eligibility Criteria

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

The study population was recruited from people who visited the cooperative medical unit for lung screening, and from people who were recruited through publicity at the unit and in the community.

You may qualify if:

  • Those aged ≥18 years; or those aged \<18 years who can cooperate with the relevant examination and are accompanied and informed by a guardian;
  • People with respiratory-related diseases who were to undergo pulmonary examination, or those who volunteered to participate in the trial through publicity recruitment;
  • expected survival time of 3 months or more;
  • Those with no previous serious underlying disease and no history of serious eye disease;
  • Those who can cooperate with ophthalmologic and pulmonary-related examinations and have regular follow-up examinations;
  • Those who gave informed consent to the study prior to the trial and voluntarily signed the informed consent form;
  • Other conditions that can be included in the study as judged by the investigator.

You may not qualify if:

  • Patients who are unable to complete ophthalmology or pulmonary-related examinations and regular follow-ups due to serious diseases, trauma or surgery (serious ophthalmology diseases such as extremely poor vision that cannot be fixed, ocular atrophy, severe refractive interstitial clouding that prevents fundus photography, etc.);
  • People with poor compliance due to various reasons such as alcohol or drug dependence, or mental disorders;
  • Those without informed consent;
  • Other conditions judged by the investigator to be unsuitable for participation in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Guangzhou Kindness Health Care Center (Guangzhou Jiubang Shanxin Clinic Ltd)

Guangzhou, Guangdong, China

RECRUITING

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Weixing Zhang, M.D.

CONTACT

8615602211660zhangwx98@mail2.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 8, 2023

Study Start

June 29, 2020

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 23, 2025

Record last verified: 2025-05

Locations

CN(4)