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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05847894
Other study ID # 2023KYPJ111
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2023
Est. completion date May 2024

Study information

Verified date April 2023
Source Zhongshan Ophthalmic Center, Sun Yat-sen University
Contact Weixing Zhang, M.D.
Phone 8615602211660
Email zhangwx98@mail2.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10000
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ophthalmic examination
Various ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc.
Pulmonary Examination
Various pulmonary examination modalities, including radiography, chest CT, pulmonary function measurement, etc.

Locations

Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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