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

NCT07003165 | Not Yet Recruiting

• 1 other identifier: 2025KYPJ044
• Study Type: observational
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Cost-effectiveness

  Incremental Cost per True Positive Case Detected

  Baseline,6months,12months

Secondary Outcomes (3)

• Eye disease detection rate

  Baseline,6months,12months

• Accuracy of multiple intelligent screening analysis models

  Baseline

• Screening participation rate

  baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample or primary care clinic

You may qualify if:

• Age ≥ 7 years
• Voluntary informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

MeSH Terms

Conditions

Cataract; Refractive Errors; Diabetic Retinopathy; Macular Degeneration

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Degeneration

Central Study Contacts

Lin Haotian

CONTACT

86-13802793086; haot.lin@hotmail.com

Xiao Wei

CONTACT

86-13535160850; xiaow33@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 4, 2025

Record last verified: 2025-05