Effect of a Myopia Prediction System on Myopia Prevention and Control

NCT06633393 | Not Yet Recruiting

• 1 other identifier: 2024KYPJ102
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Randomized Controlled Trials; Artificial Intelligence (AI)

Keywords

Myopia Prediction; Randomized Controlled Trials; Artificial Intelligence (AI)

Outcome Measures

Primary Outcomes (2)

• Proportion of Individuals Predicted to Develop High Myopia at Age 18 by the Myopia Prediction System

  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.

  1 year

• Cumulative Clinical Visit Rate for Myopia Prevention and Control

  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.

  Within 3 months after each intervention

Secondary Outcomes (4)

• Myopia Incidence Rate

  1 year

• Changes in Spherical Equivalent

  1 year

• Screen Time

  1 year

• Outdoor Activity Time

  1 year

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

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

Control Arm

ACTIVE COMPARATOR

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

Other: Feedback on Ophthalmic Examinations

Interventions

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

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.

Experimental Arm

Feedback on Ophthalmic Examinations OTHER

At baseline and six months, participants will be provided with the results of their ophthalmic examinations.

Control Arm; Experimental Arm

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Related Publications (1)

• Lin H, Long E, Ding X, Diao H, Chen Z, Liu R, Huang J, Cai J, Xu S, Zhang X, Wang D, Chen K, Yu T, Wu D, Zhao X, Liu Z, Wu X, Jiang Y, Yang X, Cui D, Liu W, Zheng Y, Luo L, Wang H, Chan CC, Morgan IG, He M, Liu Y. Prediction of myopia development among Chinese school-aged children using refraction data from electronic medical records: A retrospective, multicentre machine learning study. PLoS Med. 2018 Nov 6;15(11):e1002674. doi: 10.1371/journal.pmed.1002674. eCollection 2018 Nov.

  PMID: 30399150 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Haotian Lin, M.D., Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yahan Yang, M.D., Ph.D

CONTACT

+86 15521013933; yah.yang39@qq.com

Xinwei Chen, M.D.

CONTACT

+86 13535382011; cxw20000709@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 9, 2024
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)