Effect of a Myopia Prediction System on Myopia Prevention and Control

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Myopia; Randomized Controlled Trials; Artificial Intelligence (AI)

Treatments: Other: Feedback on Ophthalmic Examinations; Other: Feedback on Predicted High Myopia Risk at Age 18 Using the Myopia Prediction System

Study type: Interventional

Funder types: Other

Identifiers

NCT06633393

2024KYPJ102

Details and patient eligibility

About

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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 9 to 11 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20,000 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

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

Treatment:

Other: Feedback on Predicted High Myopia Risk at Age 18 Using the Myopia Prediction System

Other: Feedback on Ophthalmic Examinations

Control Arm

Active Comparator group

Description:

At baseline and six months, feedback on ophthalmic examination results.

Treatment:

Other: Feedback on Ophthalmic Examinations