School-based Myopia Prevention Trial for Children With Insufficient 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 auricular acupressure for myopia prevention in non-myopic primary school students with insufficient hyperopic reserve. Enrolled students in grades 1 to 4 will be randomly assigned to either an auricular acupressure intervention or usual daily activities without additional study-related myopia prevention intervention. 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 primary schools.
Non-myopic children with insufficient hyperopic reserve, defined as cycloplegic spherical equivalent refraction in the worse eye greater than +0.75 D and below the following age-specific upper limits: +1.72 D at age 6 years; +1.48 D at age 7 years; +1.19 D at age 8 years; +1.11 D at age 9 years; +0.92 D at age 10 years; and +0.83 D at age 11 years.
Written informed consent provided by a parent or legal guardian, with willingness to participate in baseline and follow-up assessments during the study period.
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.
Known skin sensitivity, local ear skin lesions, or other conditions judged unsuitable for auricular acupressure.
Trial design
Design model
Parallel
Treatments tested in this trial
Auricular Acupressure
Other interventionAuricular acupressure will be performed using adhesive patches containing vaccaria seeds applied to selected auricular acupoints, including liver, spleen, heart, eye, kidney, Mu 1, Mu 2, and Shenmen. The intervention will be delivered once weekly by trained medical personnel according to a standardized protocol. Each application will remain in place for 5 days, followed by a 2-day rest period, with the treated ear alternated weekly. Participants will be instructed to press the patches three times daily, in the morning, at noon, and before bedtime, with 10 to 20 presses each time. If patches fall off, loosen, or cause local discomfort, the school health teacher or study personnel will be informed and appropriate management will be provided.
Eye Health Education
BehavioralStandard school-based eye health education will include general guidance on healthy visual behaviors, near-work habits, reading posture, lighting conditions, eye exercises, and regular eye examinations.
Treatment groups
130 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
Defined as the difference in axial length between the 12-month follow-up visit and baseline.
Time frame
Baseline to 12 monthsSecondary outcomes
1
Change in cycloplegic spherical equivalent refraction
Defined as the difference in cycloplegic spherical equivalent refraction between the 12-month follow-up visit and baseline.
Time frame
Baseline to 12 months2
Incidence of myopia during follow-up
Defined as the proportion of participants who develop myopia during the 12-month follow-up period. Myopia is 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 auricular acupressure
Defined as adherence to scheduled auricular acupressure sessions during the study period.
Time frame
During the 12-month follow-up period4
Safety Outcomes and Adverse Events
Defined as the occurrence of any adverse events related to auricular acupressure, including local skin irritation, allergy, pain, itching, redness, swelling, or other ear discomfort.
Time frame
During the 12-month follow-up periodSponsors and contacts
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Source ClinicalTrials.gov