Effect of a Myopia Prediction System on Myopia Prevention and Control
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-11
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Feedback on Predicted High Myopia Risk at Age 18 Using the Myopia Prediction System
Other interventionAt 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.
Feedback on Ophthalmic Examinations
Other interventionAt baseline and six months, participants will be provided with the results of their ophthalmic examinations.
Treatment groups
20,000 Participants
are divided into 2 treatment groupsGroup A: Experimental ArmExperimental treatment 2 interventions
Group B: Control ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year2
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.
Time frame
Within 3 months after each interventionSecondary outcomes
1
Myopia Incidence Rate
1-year myopia incidence rate = number of new myopia cases within one year / number of non-myopic cases at baseline \* 100%
Time frame
1 year2
Changes in Spherical Equivalent
Change in spherical equivalent (non-cycloplegic autorefraction) will be calculated
Time frame
1 year3
Screen Time
Daily usage time of electronic devices (computer/smartphone/tablet computer) will be calculated
Time frame
1 year4
Outdoor Activity Time
Daily outdoor activity time will be calculated
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov
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