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

Not yet recruiting

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

• Registration Number: NCT07003165
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-25
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Study Start: 2025-07
• Primary Completion: 2029-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

• Age ≥ 7 years
• Voluntary informed consent

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cost-effectiveness	Baseline,6months,12months	Incremental Cost per True Positive Case Detected

Secondary Outcome Measures

Name	Time	Method
Eye disease detection rate	Baseline,6months,12months
Accuracy of multiple intelligent screening analysis models	Baseline
Screening participation rate	baseline