School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorShanghai Eye Disease Prevention and Treatment Center
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Wearable Device-Supported Myopia Prevention Program
BehavioralThe 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
BehavioralRoutine 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.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Axial Length
Change in axial length is defined as the difference between axial length measured at 12 months and axial length measured at baseline.
Time frame
Baseline to 12 monthsSecondary outcomes
1
Change in Cycloplegic Spherical Equivalent Refraction
Change in cycloplegic spherical equivalent refraction is defined as the difference between the 12-month value and the baseline value.
Time frame
Baseline to 12 months2
Incidence of Myopia During Follow-up
Defined as the proportion of participants who develop myopia during follow-up, with myopia defined as uncorrected visual acuity less than 5.0 in either eye and non-cycloplegic spherical equivalent refraction less than -0.50 D in either eye.
Time frame
During the 12-month follow-up period3
Adherence to Wearable Device Use
Defined as adherence to wearing the study wearable device during the intervention period, as assessed using data recorded by the wearable device.
Time frame
During the 12-month follow-up period4
Safety Outcomes and Adverse Events
Defined as the occurrence of any adverse events related to wearable device use or increased outdoor activity, including skin irritation, device-related discomfort, eye discomfort related to sunlight exposure, or outdoor activity-related injuries.
Time frame
During the 12-month follow-up periodSponsors and contacts
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Source ClinicalTrials.gov