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Clinical Trials in China / NCT07746752
Recruiting Not applicable

School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve

NCT07746752 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Phase
Not applicable
Started
2026-06-01
Last updated
2026-08-05

Condition(s) studied

MyopiaRefractive ErrorsHyperopia

Investigational drug(s) / intervention(s)

Wearable Device-Supported Myopia Prevention ProgramEye Health Education

Wearable Device-Supported Myopia Prevention Program: The wearable device-supported program will use smart wearable wristbands to monitor outdoor activity time and provide reminders. Students in the intervention group will be encouraged to increase outdoor activity, with targets of at least 1 hour per day on school days and at least 2 hours per day on weekends. Data recorded by the wearable device will be used to quantify daily outdoor activity and assess adherence to the intervention.

Eye Health Education: Routine school-based eye health education will include general guidance on healthy visual behaviors, including reducing prolonged near work, maintaining appropriate reading posture and lighting conditions, performing standard eye exercises, and undergoing regular eye examinations.

Study summary

This is a prospective, school-based randomized controlled trial designed to evaluate a wearable device-supported outdoor activity program for myopia prevention in primary school students with adequate hyperopic reserve. Enrolled students in grades 1 to 4 will be randomly assigned to either a wearable device-supported outdoor activity program plus routine school-based eye health education or routine school-based eye health education alone. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, incident myopia, intervention adherence, and safety outcomes over 12 months.

Eligibility

Sex
ALL
Min age
6 Years
Max age
11 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Students in grades 1 to 4 from participating schools. * Non-myopic children with adequate hyperopic reserve at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye within the following age-specific reference ranges: +1.72 D to +2.45 D at age 6 years; +1.48 D to +2.00 D at age 7 years; +1.19 D to +1.79 D at age 8 years; +1.11 D to +1.38 D at age 9 years; +0.92 D to +1.16 D at age 10 years; and +0.83 D to +1.07 D at age 11 years. * Written informed consent provided by a parent or legal guardian, with assent obtained from the child when appropriate. Exclusion Criteria: * Strabismus, amblyopia, or other ocular abnormalities. * Systemic disease or other medical conditions that may affect study participation. * Has received any myopia prevention intervention in the past 3 months. * Any other condition judged by the study doctors to make participation inappropriate.

Primary outcome measure(s)

  • Change in Axial Length — Baseline to 12 months
    Change in axial length is defined as the difference between axial length measured at 12 months and axial length measured at baseline.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Eye Disease Prevention and Treatment Center Shanghai Shanghai Municipality Recruiting

More Shanghai Eye Disease Prevention and Treatment Center trials in China

Dual-Action Lenses for Slowing Myopia in Children and Teens: A Randomized, Double-Blind Trial Starting soon
School-based Myopia Control Trial for Children With Premyopia or Myopia Recruiting
Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults Starting soon
LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia Recruiting
AI-Stratified Myopia Control for Children in Remote Areas Starting soon

Other trials for the same condition

Dual-Action Lenses for Slowing Myopia in Children and Teens: A Randomized, Double-Blind Trial Starting soon
School-based Myopia Control Trial for Children With Premyopia or Myopia Recruiting
Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults Starting soon
650nm Low-level Red-light for Myopia Control and Prevention in Children Active, not recruiting
The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery? Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07746752 on ClinicalTrials.gov ↗ ← All trials in China