Effect of a Myopia Prediction System on Myopia Prevention and Control

Not Applicable

Not yet recruiting

• Conditions: Myopia; Randomized Controlled Trials; Artificial Intelligence (AI)
• Interventions: Other: Feedback on Predicted High Myopia Risk at Age 18 Using the Myopia Prediction System; Other: Feedback on Ophthalmic Examinations

• Registration Number: NCT06633393
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary

The global rise in myopia, particularly among children and adolescents in China, underscores the inadequacy of current prevention strategies, indicating that conventional screening and education alone are insufficient to curb the prevalence. Integrating personalized myopia prediction into routine care may enhance risk awareness, promote proactive prevention, and improve adherence to medical advice, ultimately reducing the future burden of high myopia.

A myopia prediction system based on artificial intelligence was previously developed, accurately predicting future high myopia risk using efficient, robust, and easily accessible predictive factors, including age, spherical equivalent, and the annual progression of spherical equivalent. This study aims to conduct a prospective, one-year, cluster randomized controlled clinical trial to investigate the effectiveness of this prediction system in preventing and controlling myopia in school-aged children.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-09
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14
• Study Start: 2024-11-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• The participant and their guardian voluntarily signed the informed consent form
• Has the record of eye refraction examination in the past year
• Aged 9 to 11 years, regardless of gender

Exclusion Criteria

• High myopia(spherical equivalent ≤ -6.00 D)
• Ocular diseases other than myopia (e.g., strabismus, amblyopia, congenital cataract, juvenile glaucoma, retinal diseases).
• Systemic diseases that may affect vision or visual development (e.g., diabetes or other endocrine disorders, cardiovascular or respiratory diseases, Down syndrome)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Feedback on Predicted High Myopia Risk at Age 18 Using the Myopia Prediction System	At baseline and six months, feedback on ophthalmic examination results and future high myopia risk at 18 years of age using the myopia prediction system
Experimental Arm	Feedback on Ophthalmic Examinations	At baseline and six months, feedback on ophthalmic examination results and future high myopia risk at 18 years of age using the myopia prediction system
Control Arm	Feedback on Ophthalmic Examinations	At baseline and six months, feedback on ophthalmic examination results.

Primary Outcome Measures

Name	Time	Method
Proportion of Individuals Predicted to Develop High Myopia at Age 18 by the Myopia Prediction System	1 year	At the end of the one-year study, the Myopia Prediction System will be used to predict whether students will develop high myopia at age 18 in both the intervention and control groups. The Proportion of Individuals Predicted to Develop High Myopia at Age 18 by the Myopia Prediction System is calculated as the total number of students in each group predicted to develop high myopia by age 18, divided by the total number of students in the respective group.
Cumulative Clinical Visit Rate for Myopia Prevention and Control	Within 3 months after each intervention	The Cumulative Clinical Visit Rate Proportion of Clinical Visits for Myopia Prevention and Control is the proportion of students in the intervention or control group who visited a hospital or clinic for myopia-related care (e.g., refractive exams and treatment) at least once within three months of either intervention. It is calculated as the number of students in each group who attended a clinical visit within three months of at least one intervention, divided by the total number of students in the respective group.

Secondary Outcome Measures

Name	Time	Method
Screen Time	1 year	Daily usage time of electronic devices (computer/smartphone/tablet computer) will be calculated
Outdoor Activity Time	1 year	Daily outdoor activity time will be calculated
Myopia Incidence Rate	1 year	1-year myopia incidence rate = number of new myopia cases within one year / number of non-myopic cases at baseline \* 100%
Changes in Spherical Equivalent	1 year	Change in spherical equivalent (non-cycloplegic autorefraction) will be calculated

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China