Ophthalmic Diseases (Specific Types Not Restricted)NCT07003165
Research on a New Intelligent Mobile Screening and Diagnosis Pattern for Ocular Diseases
An observational study of Ophthalmic Diseases (Specific Types Not Restricted) and Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
The global distribution of primary ophthalmic medical resources is uneven, and the traditional eye disease screening model has problems such as low efficiency, high cost and limited coverage. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ophthalmic Diseases (Specific Types Not Restricted), Cataract, Refraction Error
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to May 2029
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: community sample or primary care clinic
Who may be able to join
- Age ≥ 7 years
- Voluntary informed consent
Who cannot join
- -Inability to complete the required examinations with the help of others due to old age, infirmity, poor general condition, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The global distribution of primary ophthalmic medical resources is uneven, and the traditional eye disease screening model has problems such as low efficiency, high cost and limited coverage. With the development of artificial intelligence and other technologies, it provides technical support for the construction of intelligent mobile screening model for eye diseases. The investigator's team has developed the 5G intelligent ophthalmic vehicle and served tens of thousands of people in 108 cities nationwide, initially verifying the feasibility of the new intelligent mobile screening model. However, the application effect, acceptance and influencing factors of this model in different regions are not clear, and there is a lack of economic benefit analysis based on real-world data. In this study, the investigators will conduct a cross-sectional study of large-scale population screening for blinding eye diseases in grassroots areas through the smart mobile screening model, focusing on the screening effectiveness and cost-effectiveness of the smart mobile screening model, integrating real-world multimodal eye health data, developing multiple smart screening analysis models, and exploring its adaptability and direction of improvement in grassroots areas.
- Conditions
- Ophthalmic Diseases (Specific Types Not Restricted), Cataract, Refraction Error, Diabetic Retinopathy (DR), Age Related Macular Degeneration (ARMD)
- Medical subject headings
- Cataract, Refractive Errors, Diabetic Retinopathy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intelligent Mobile Group | Participants were first screened for mobile eye health risk classification, and those who met the requirements were further screened by eye examination on the mobile clinic and suspected cases were recommended to be referred to higher level hospitals for consultation, and corresponding data were collected at different visit points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness
Incremental Cost per True Positive Case Detected
Measured: Baseline,6months,12months
Secondary outcomes (3)
Eye disease detection rate
Measured: Baseline,6months,12months
Accuracy of multiple intelligent screening analysis models
Measured: Baseline
Screening participation rate
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmic Diseases (Specific Types Not Restricted)Studies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003165
- Sponsor's protocol ID
- 2025KYPJ044
- Status last verified
- May 2025
- First submitted
- 25 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on a New Intelligent Mobile Screening and Diagnosis Pattern for Ocular Diseases
- ClinicalTrials.gov ID
- NCT07003165
- Acronym / sponsor ID
- 2025KYPJ044
- Conditions
- Ophthalmic Diseases (Specific Types Not Restricted), Cataract, Refraction Error, Diabetic Retinopathy (DR), Age Related Macular Degeneration (ARMD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 4 Jun 2025 (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.
The global distribution of primary ophthalmic medical resources is uneven, and the traditional eye disease screening model has problems such as low efficiency, high cost and limited coverage. With the development of artificial intelligence and other technologies, it provides technical support for the construction of intelligent mobile screening model for eye diseases. The investigator's team has developed the 5G intelligent ophthalmic vehicle and served tens of thousands of people in 108 cities nationwide, initially verifying the feasibility of the new intelligent mobile screening model. However, the application effect, acceptance and influencing factors of this model in different regions are not clear, and there is a lack of economic benefit analysis based on real-world data. In this study, the investigators will conduct a cross-sectional study of large-scale population screening for blinding eye diseases in grassroots areas through the smart mobile screening model, focusing on the screening effectiveness and cost-effectiveness of the smart mobile screening model, integrating real-world multimodal eye health data, developing multiple smart screening analysis models, and exploring its adaptability and direction of improvement in grassroots areas.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intelligent Mobile Group | – | –Participants were first screened for mobile eye health risk classification, and those who met the requirements were further screened by eye examination on the mobile clinic and suspected cases were recommended to be referred to higher level hospitals for consultation, and corresponding data were collected at different visit points. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community sample or primary care clinic
Key inclusion criteria (2 listed)
- Age ≥ 7 years
- Voluntary informed consent
Key exclusion criteria (1 listed)
- -Inability to complete the required examinations with the help of others due to old age, infirmity, poor general condition, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cost-effectiveness
Time frame: Baseline,6months,12months
Incremental Cost per True Positive Case Detected
3 secondary outcomes
Eye disease detection rate
Time frame: Baseline,6months,12months
Accuracy of multiple intelligent screening analysis models
Time frame: Baseline
Screening participation rate
Time frame: baseline
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 4 Jun 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmic Diseases (Specific Types Not Restricted) and Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Lin Haotian (86-13802793086, haot.lin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness (time frame: Baseline,6months,12months). 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 4 Jun 2025.