Clinical trial NCT05847894: Assisting Pulmonary Disease Diagnosis With Ophthalmic Artificial Intelligence Technology
Official title: Assisting Pulmonary Disease Diagnosis With Ophthalmic Artificial Intelligence Technology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Diseases
Ophthalmological Diagnostic Techniques
Artificial Intelligence
Keywords: Pulmonary Diseases
Ophthalmological Diagnostic Techniques
Artificial intelligence
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Guangzhou Medical University
name: Shenzhen Third People's Hospital
name: Guangzhou Kindness Health Care Center (Guangzhou Jiubang Shanxin Clinic Ltd), Guangzhou, China
First posted: 2023-05-08
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Receiver Operating Characteristic curve
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Kindness Health Care Center (Guangzhou Jiubang Shanxin Clinic Ltd)
state: Guangdong
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
state: Guangdong
Study officials:
References: