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

Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Study ID
NCT07746752
Status
Recruiting
Apply to this trial

Conditions

  • Hyperopia
  • Myopia
  • Refractive Errors

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Accepted

Interventions

  • Wearable Device-Supported Myopia Prevention Program — BEHAVIORAL
    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 — BEHAVIORAL
    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 Details

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.

Key Dates

First listed
Aug 5, 2026
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group
    Participants in the intervention group will receive a wearable device-supported outdoor activity program in addition to routine school-based eye health education during the 12-month study period.
  • Active Comparator: Control Group
    Participants in the control group will receive routine school-based eye health education and maintain their usual daily activities during the 12-month study period. They will not receive structured outdoor activity targets, wearable device-supported outdoor activity monitoring, or reminders.

Primary Outcome Measure

Change in Axial Length [ Time Frame: Baseline to 12 months ]

Central Contacts

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