Auricular Acupressure Reduces Rebound Effects After Discontinuation of Atropine

NCT07129889 | Not Yet Recruiting

• 1 other identifier: Ningbo Eye Hospital
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

Auricular acupressure; myopia; atropine; rebound effect; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Myopia Rebound Rate

  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%

  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.

Secondary Outcomes (9)

• spherical equivalent annual growth(SEA)

  The measurement method is the same as above, with three consecutive measurements taken and the average calculated. Measurements are taken at 3, 6, and 9 months after intervention, 3 and 6 months after dose reduction, and 1, 3, and 6 months after disconti

• Axial length annual growth(ALA)

  Measurements are taken at 3 months, 6 months, 9 months, and 12 months after intervention, 3 months and 6 months after dose reduction, and 1 month, 3 m

• SE year delay amount

  Measurements are taken at 3 months, 6 months, 9 months, and 12 months after intervention, 3 months and 6 months after dose reduction, and 1 month, 3 months, and 6 months after discontinuation of medication.

• AL year delay amount

  Measurements are taken at 3 months, 6 months, 9 months, and 12 months after intervention, 3 months and 6 months after dose reduction, and 1 month, 3 months, and 6 months after discontinuation of medication.

• SE year delay rate

  Measurements are taken at 6 months, and 12 months after intervention, 6 months after dose reduction, and 6 months after discontinuation of medication.

Study Arms (3)

the atropine tapering group

ACTIVE COMPARATOR

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.

Drug: gradual withdrawal of medication

Auricular acupressure

EXPERIMENTAL

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.

Procedure: Auricular acupressure

Sham Auricular acupressure

SHAM COMPARATOR

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.

Procedure: Sham auricular acupressure

Interventions

gradual withdrawal of medication 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.

the atropine tapering group

Auricular acupressure 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.

Auricular acupressure

Sham auricular acupressure 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.

Sham Auricular acupressure

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Meets the diagnostic criteria for myopia;
• Age 6-12 years, no gender restrictions;
• Single or bilateral spherical refractive error between -1.00 and -4.00 D (astigmatism ≤ 1.50 D, anisometropia ≤ 1.50 D);
• Best-corrected visual acuity in both eyes of 0.20 logMAR or higher;
• Intraocular pressure (IOP) less than 21 mmHg;
• Informed consent form signed by a guardian, voluntarily participating.

You may not qualify if:

• Patients who meet any of the following criteria will not be eligible to participate in the study:
• Eye conditions other than refractive errors (e.g., strabismus, amblyopia, keratitis, glaucoma, cataracts, retinal detachment, etc.);
• Patients with systemic conditions that may affect refractive development (e.g., Down syndrome, Marfan syndrome);
• 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;
• Patients with a history of allergies or hypersensitivity to multiple medications;
• Patients who have undergone ocular surgery within the past 4 weeks prior to screening;
• Patients planning to undergo ocular surgery within one year of enrollment;
• 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.

Sponsors & Collaborators

• Ningbo Eye Hospital: lead

Study Sites (1)

Ningbo Eye Hospital

Ningbo, Zhejiang, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Zengfang Yu

CONTACT

+8615267893682; yuzengfang1993@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 19, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)