Auricular Acupressure Reduces Rebound Effects After Discontinuation of Atropine

Ningbo Eye Hospital

Status: Not yet enrolling

Conditions: Myopia

Treatments: Drug: gradual withdrawal of medication; Procedure: Sham auricular acupressure; Procedure: Auricular acupressure

Study type: Interventional

Funder types: Other

Identifiers

NCT07129889

Ningbo Eye Hospital

Details and patient eligibility

About

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.

Full description

This study is a randomized, single-blind, three-arm controlled trial. At least 180 participants will be randomly assigned to one of three groups: the atropine tapering group, the AA group, and the sham auricular acupressure (SAA) group. All treatments will be conducted over 1.5 years, with a 6-month follow-up. The primary outcome measure is the rate of myopia rebound. Secondary outcome measures include annual growth rate of spherical equivalent (SE), annual growth rate of axial length (AL), annual delay rate of SE, annual delay rate of AL, annual delay rate of SE, annual delay rate of AL, choroidal thickness (ChT), choroidal vascular index (CVI), and choroidal vascular volume (CVV). Intention-to-treat and per-protocol analyses will be conducted, with a significance level set at 5%.

Enrollment: 180 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

the atropine tapering group

Active Comparator group

Description:

Patients were administered 0.01% atropine eye drops using a gradual reduction method (Shenyang Xingqi Eye Pharmaceutical Co., Ltd., Shenyang, China, National Medical Products Administration license number: H20243320, 0.04 mg) . 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.

Treatment:

Drug: gradual withdrawal of medication

Auricular acupressure

Experimental group

Description:

AA therapy will be added to the gradual reduction method of 0.01% atropine eye drops. As shown in Figure 1. 2; Table 2, ear acupoints: Shenmen (TF4), Heart (CO15), Liver (CO12), Spleen (CO13), Kidney (CO10), and Eye (LO5). The acupuncturist first uses a metal probe to locate the ear acupoints and asks the patient if they feel "deqi," such as heat, numbness, swelling, or pain. After confirming the ear acupoints, the ears are cleaned with a 75% ethanol solution and dried with sterile, dry cotton balls. Subsequently, the acupuncturist uses the left hand to stabilize the ear while the right hand uses tweezers to apply adhesive tape (10 × 10 mm) containing Wangbuluxing seeds (Wujiang Jiacheng Acupuncture Instrument Co., Ltd., Suzhou, China) to the selected auricular regions.

Treatment:

Procedure: Auricular acupressure

Sham Auricular acupressure

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham auricular acupressure