Pulmonary DiseasesNCT05847894
Assisting Pulmonary Disease Diagnosis With Ophthalmic Artificial Intelligence Technology
An observational study of Pulmonary Diseases and Ophthalmological Diagnostic Techniques, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 4 sites in China.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Diseases, Ophthalmological Diagnostic Techniques, Artificial Intelligence
- What is being tested?
- Ophthalmic examination and Pulmonary Examination
- How many people
- 10,000 participants
- Where
- 4 sitesChina
- Study dates
- 29 Jun 2020to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Haotian Lin, M.D., Ph.D, 8613802793086, haot.lin@hotmail.com
Xun Wang, M.D., Ph.D, 8615017541549, wangx48@mail2.sysu.edu.cn
- Recruiting
Guangzhou Kindness Health Care Center (Guangzhou Jiubang Shanxin Clinic Ltd)
Guangzhou, Guangdong
Bin Xu, +86 13925155511
- Recruiting
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Wenhua Liang, M.D., liangwh1987@163.com
- Recruiting
Shenzhen Third People's Hospital
Shenzhen, Guangdong
Weiyi Lai, +86 13556125580, zsyLaiwy@163.com
About this study
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.
- Being tested
- Ophthalmic examination, Pulmonary Examination
- Keywords
- Pulmonary Diseases, Ophthalmological Diagnostic Techniques, Artificial intelligence
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic examinationDiagnostic test
Various ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc.
Pulmonary ExaminationDiagnostic test
Various pulmonary examination modalities, including radiography, chest CT, pulmonary function measurement, etc.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Individuals with one or more pulmonary diseases Receives: Diagnostic Test: Ophthalmic examination; Diagnostic Test: Pulmonary Examination | |
| Control group | Individuals who do not suffer from pulmonary diseases Receives: Diagnostic Test: Ophthalmic examination; Diagnostic Test: Pulmonary Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic curve
Determining the accuracy of diagnosing pulmonary disease with ophthalmic examination
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start29 Jun 2020
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseasesStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847894
- Sponsor's protocol ID
- 2023KYPJ111
- Status last verified
- May 2026
- First submitted
- 20 Apr 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisting Pulmonary Disease Diagnosis With Ophthalmic Artificial Intelligence Technology
- ClinicalTrials.gov ID
- NCT05847894
- Acronym / sponsor ID
- 2023KYPJ111
- Keywords
- Pulmonary Diseases, Ophthalmological Diagnostic Techniques, Artificial intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- 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 start
- 29 Jun 2020 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Diagnostic Test: Ophthalmic examination, Diagnostic Test: Pulmonary ExaminationIndividuals with one or more pulmonary diseases |
| Control group | – | Diagnostic Test: Ophthalmic examination, Diagnostic Test: Pulmonary ExaminationIndividuals who do not suffer from pulmonary diseases |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmic examinationVarious ophthalmic examination modalities, including slit lamp photography, fundus photography, optical coherence tomography imaging and optical coherence tomography angiography, etc. | Diagnostic test | Control group, Test group |
| Pulmonary ExaminationVarious pulmonary examination modalities, including radiography, chest CT, pulmonary function measurement, etc. | Diagnostic test | Control group, Test group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Diseases and Ophthalmological Diagnostic Techniques, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weixing Zhang, M.D. (8615602211660, zhangwx98@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic curve (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.