Assisting Pulmonary Disease Diagnosis With Ophthalmic Artificial Intelligence Technology

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05847894
Collaborator
The First Affiliated Hospital of Guangzhou Medical University (Other)
10,000
1
12
831.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ophthalmic examination
  • Diagnostic Test: Pulmonary Examination

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Assisting Pulmonary Disease Diagnosis With Ophthalmic Artificial Intelligence Technology
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Area Under the Receiver Operating Characteristic curve [Through study completion, an average of 1 year]

    Determining the accuracy of diagnosing pulmonary disease with ophthalmic examination

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University
  • The First Affiliated Hospital of Guangzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05847894
Other Study ID Numbers:
  • 2023KYPJ111
First Posted:
May 8, 2023
Last Update Posted:
May 8, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhongshan Ophthalmic Center, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 8, 2023