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Auricular Acupressure Reduces Rebound Effects After Discontinuation of Atropine
Condition(s) studied
Myopia
Investigational drug(s) / intervention(s)
gradual withdrawal of medicationAuricular acupressureSham auricular acupressure
gradual withdrawal of medication: The dose was reduced by one day each month, ultimately reducing atropine treatment from seven days per week to complete withdrawal within six months, with a six-month follow-up.
Auricular acupressure: First, treat the ear acupoint on one side, then leave the tape in place for 5 days. On the 6th day, remove the tape, rest for 2 days, and on the 8th day, apply new tape to the other side of the ear. Changing the tape aims to minimize adverse event (AE) that may result from prolonged stimulation on one side. Additionally, participants will be instructed to self-administer vertical pressure on the Wangbuluxing seeds 15-20 times to achieve sensation, with a duration of 4-5 times daily. The treatment process will last for 18 months, with a follow-up at 6 months.
Sham auricular acupressure: Acupuncturists will use a gradual reduction method with 0.01% atropine eye drops, as used in the control group, and apply skin-colored adhesive tape without Wang Bu Liu Xing seeds to the ear acupoints. During treatment, no massage or acupoint pressure will be applied. The SAA group will follow the same protocol as the AA group for compensatory AA treatment at the end of the study.
Study summary
0.01% atropine is an effective measure for controlling myopia in children and is widely used in Asia for this purpose. However, there is a phenomenon of rebound and worsening of myopia after discontinuation of the medication. Auricular acupressure (AA) is gaining attention as a complementary therapy for myopia control. However, there is a lack of rigorous studies evaluating the effectiveness of AA in reducing rebound after discontinuing atropine eye drops in myopic children. Our study aims to assess the efficacy and safety of AA in reducing rebound after discontinuing atropine in myopic children.
Eligibility
Inclusion Criteria:
1. Meets the diagnostic criteria for myopia;
2. Age 6-12 years, no gender restrictions;
3. Single or bilateral spherical refractive error between -1.00 and -4.00 D (astigmatism ≤ 1.50 D, anisometropia ≤ 1.50 D);
4. Best-corrected visual acuity in both eyes of 0.20 logMAR or higher;
5. Intraocular pressure (IOP) less than 21 mmHg;
6. Informed consent form signed by a guardian, voluntarily participating.
Exclusion Criteria:
Patients who meet any of the following criteria will not be eligible to participate in the study:
1. Eye conditions other than refractive errors (e.g., strabismus, amblyopia, keratitis, glaucoma, cataracts, retinal detachment, etc.);
2. Patients with systemic conditions that may affect refractive development (e.g., Down syndrome, Marfan syndrome);
3. Patients with uncontrolled systemic diseases or debilitating conditions, immune deficiencies, or severe primary diseases of the cardiovascular, hepatic, renal, or hematopoietic systems, immune system disorders, or psychiatric conditions;
4. Patients with a history of allergies or hypersensitivity to multiple medications;
5. Patients who have undergone ocular surgery within the past 4 weeks prior to screening;
6. Patients planning to undergo ocular surgery within one year of enrollment;
7. Patients who have participated in other drug clinical trials within the past 3 months prior to screening; Patients who are unable to cooperate with treatment, observation, and assessment.
Primary outcome measure(s)
- Myopia Rebound Rate — Statistical analysis was performed at 3 months and 6 months after dose reduction, and at 1 month, 3 months, and 6 months after discontinuation of medication.
The myopia rebound rate is defined as the ratio of the number of individuals experiencing myopia rebound to the total number of individuals in each group. The rebound effect is defined as the rate of myopia progression after discontinuation of treatment exceeding the rate observed during the treatment phase. The rebound effect is assessed based on changes in AL or SE. To enable direct comparison, all data were standardized to an annual rate (mm/y or D/y) by dividing the change in SE or AL by the duration of follow-up (y).
Myopia relapse rate = number of relapses / total number of participants × 100%
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Ningbo Eye Hospital |
Ningbo |
Zhejiang |
|
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