Assisting Pulmonary Disease Diagnosis With Ophthalmic Artificial Intelligence Technology

May 19, 2025 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou Kindness Health Care Center (Guangzhou Jiubang Shanxin Clinic Ltd)
        • Contact:
          • Bin Xu
          • Phone Number: +86 13925155511
      • Shenzhen, Guangdong, China
        • Recruiting
        • Shenzhen Third People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Test group
Individuals with one or more pulmonary diseases
Diagnostic test: Ophthalmic examination
Various ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc.
Diagnostic test: Pulmonary Examination
Various pulmonary examination modalities, including radiography, chest CT, pulmonary function measurement, etc.
Control group
Individuals who do not suffer from pulmonary diseases
Diagnostic test: Ophthalmic examination
Various ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc.
Diagnostic test: Pulmonary Examination
Various pulmonary examination modalities, including radiography, chest CT, pulmonary function measurement, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Receiver Operating Characteristic curve
Time Frame: Through study completion, an average of 1 year
Determining the accuracy of diagnosing pulmonary disease with ophthalmic examination
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Collaborators

The First Affiliated Hospital of Guangzhou Medical University
Shenzhen Third People's Hospital
Guangzhou Kindness Health Care Center (Guangzhou Jiubang Shanxin Clinic Ltd), Guangzhou, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2020

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023KYPJ111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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