School-based Myopia Control Trial for Children With Premyopia or Myopia
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 combined with defocus spectacle lenses for myopia control in primary school students with premyopia or myopia. Enrolled students in grades 1 to 4 will be randomly assigned to either defocus spectacle lenses combined with auricular acupressure or defocus spectacle lenses alone. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, adherence to the assigned intervention, and safety outcomes over 12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Students in grades 1 to 4 from participating primary schools.
Children with premyopia or myopia at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D for premyopia, or less than or equal to -0.50 D for myopia.
Written informed consent provided by a parent or legal guardian, and age-appropriate assent obtained from the child when applicable.
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
Defocus Spectacle Lenses
DeviceDefocus spectacle lenses will be prescribed and fitted for eligible participants according to standardized procedures. The lenses are designed to provide refractive correction while introducing peripheral myopic defocus for myopia control. Participants with premyopia will be instructed to wear the spectacles for at least 8 hours per day, while participants with myopia will be instructed to wear them for at least 12 hours per day. Lens fitting, adaptation, follow-up, and any lens or frame adjustments will be monitored and documented during the study period. If adjustments are required due to discomfort, prescription change, poor fit, or lens/frame damage, they will be managed according to standardized procedures whenever feasible. Participants will remain in their originally assigned group for the primary intention-to-treat analysis, and lens-wear adherence and major lens adjustments may be considered in per-protocol or sensitivity analyses.
Auricular Acupressure
Other interventionAuricular acupressure will be performed using auricular acupressure patches applied to selected auricular acupoints, including liver, spleen, heart, eye, kidney, Mu 1, Mu 2, and Shenmen. The intervention will be delivered once per week 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. Adherence to auricular acupressure will be assessed based on attendance at scheduled sessions, patch retention, and completion of participant pressing instructions recorded by study personnel or school health teachers. 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.
Treatment groups
358 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 from 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.
Time frame
Baseline to 12 monthsSecondary outcomes
1
Change in cycloplegic spherical equivalent refraction from baseline to 12 months
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
Adherence to the assigned intervention
Defined as adherence to the assigned intervention during the study period, including attendance at scheduled auricular acupressure sessions, patch retention, completion of participant pressing instructions, and spectacle lens wear as applicable.
Time frame
During the 12-month follow-up period3
Safety outcomes and adverse events
Defined as the occurrence of any adverse events related to auricular acupressure or defocus spectacle lens wear, including local skin irritation, allergy, pain, itching, redness, swelling, ear discomfort, visual discomfort, dizziness, or other spectacle-related discomfort.
Time frame
During the 12-month follow-up periodSponsors and contacts
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Source ClinicalTrials.gov