An interventional study of Defocus Spectacle Lenses and Auricular Acupressure in Myopia and Refractive Errors, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Recruiting at 1 site in China. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Not applicable, Interventional, and Prevention
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.
This prospective, school-based randomized controlled trial will be conducted among primary school students with premyopia or myopia. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the study criteria for premyopia or myopia based on cycloplegic spherical equivalent refraction and whose parents or legal guardians provide written informed consent.
Premyopia is defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D. Myopia is defined as cycloplegic spherical equivalent refraction in the worse eye less than or equal to -0.50 D.
Within each participating school, students will be stratified by grade and randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive defocus spectacle lenses combined with auricular acupressure according to the study protocol. The control group will receive defocus spectacle lenses alone according to the study protocol. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. Auricular acupressure will be delivered by trained medical personnel using auricular acupressure patches applied to selected auricular acupoints according to the standardized study protocol.
Comprehensive ophthalmic examinations will be conducted at baseline and 12 months according to the study protocol. An interim follow-up visit will be conducted at 6 months, including visual acuity assessment, non-cycloplegic autorefraction, and axial length measurement. The primary outcome is the change in axial length from baseline to 12 months. Secondary outcomes include the change in cycloplegic spherical equivalent refraction, adherence to the assigned intervention, and safety outcomes and adverse events.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 358 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 66 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the intervention group will receive defocus spectacle lenses combined with auricular acupressure during the 12-month study period. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. In addition, auricular acupressure will be performed by trained medical personnel according to the study protocol.
Device: Defocus Spectacle Lenses · Other: Auricular Acupressure
Participants in the control group will receive defocus spectacle lenses alone during the 12-month study period. The lenses will be prescribed and fitted according to the same standardized procedures as those used in the intervention group, but participants will not receive auricular acupressure.
Device: Defocus Spectacle Lenses
Defocus 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 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.
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 months
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 months
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 period
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 period
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.
Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 12 months is below that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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Shanghai Eye Disease Prevention and Treatment Center