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
Qualifiers
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
Treatments tested in this trial
- Auricular Acupressure
- Eye Health Education
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov