Auricular Acupressure Reduces Rebound Effects After Discontinuation of Atropine

NCT ID: NCT07129889

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-02
• Study Completion Date: 2027-06-30

Brief 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.

Detailed 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%.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

the atropine tapering group

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.

Group Type: ACTIVE_COMPARATOR

gradual withdrawal of medication

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Auricular acupressure

Intervention Type: PROCEDURE

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.

Group Type: SHAM_COMPARATOR

Sham auricular acupressure

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ningbo Eye Hospital

Ningbo, Zhejiang, China

Countries

China

Central Contacts

Zengfang Yu

Role: CONTACT

yuzengfang1993@163.com

+8615267893682

Facility Contacts

Zengfang Zengfang Yu

Role: primary

yuzengfang1993@163.com

+8615267893682

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Parental Consent Form

View Document

Document Type: Informed Consent Form: Informed Consent Form for Children

View Document

Other Identifiers

Ningbo Eye Hospital

Identifier Type: -

Identifier Source: org_study_id