ClinicalTrials.gg
Not yet recruitingNCT07003165Updated Jun 4, 2025

Research on a New Intelligent Mobile Screening and Diagnosis Pattern for Ocular Diseases

An observational study in Ophthalmic Diseases (Specific Types Not Restricted), Cataract and Refraction Error, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting. Open to participants aged 7 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
15,000
Ages
7 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Ophthalmic Diseases (Specific Types Not Restricted)
  • Cataract
  • Refraction Error
  • Diabetic Retinopathy (DR)
  • Age Related Macular Degeneration (ARMD)
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 15,000 is above the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

community sample or primary care clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 7 years
  • Voluntary

Exclusion criteria

Exclusion Criteria:

-Inability to complete the required examinations with the help of others due to old age, infirmity, poor general condition, etc.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
15,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Cost-effectiveness

    Incremental Cost per True Positive Case Detected

    Time frame: Baseline,6months,12months

Secondary outcomes

  1. Eye disease detection rate

    Time frame: Baseline,6months,12months

  2. Accuracy of multiple intelligent screening analysis models

    Time frame: Baseline

  3. Screening participation rate

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2025; primary completion for May 2029, 46 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2025
First posted
Jun 4, 2025
StartEst.
Jul 2025
Primary completionEst.
May 2029
CompletionEst.
May 2029
Last update
Jun 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07003165
Responsible party
Sponsor
First posted
Jun 4, 2025
Start date
Jul 2025 (estimated)
Primary completion
May 2029 (estimated)
Completion
May 2029 (estimated)
Last update
Jun 4, 2025

Study contacts

Lin Haotian
Contact
haot.lin@hotmail.com
86-13802793086
Xiao Wei
Contact
xiaow33@mail2.sysu.edu.cn
86-13535160850

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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