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
Qualifiers
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
Treatments tested in this trial
- Wearable Device-Supported Myopia Prevention Program
- Eye Health Education
Treatment groups
104 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov