NCT06633393

Effect of a Myopia Prediction System on Myopia Prevention and Control

Impact of Feedback Based on the Myopia Prediction System on High Myopia Risk and Consultation Behavior in School-aged Children: a Cluster Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20,000 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 9 Years – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopia
• Randomized Controlled Trials
• Artificial Intelligence (AI)

Interventions

Type	Name	Description
OTHER	Feedback on Predicted High Myopia Risk at Age 18 Using the Myopia Prediction System	At baseline and six months, participants will be provided with the results of their predicted risk of high myopia at age 18 based on the myopia prediction system.
OTHER	Feedback on Ophthalmic Examinations	At baseline and six months, participants will be provided with the results of their ophthalmic examinations.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2024-10-09
• Last updated: 2024-10-15

Locations

1 site across 1 country: China