Auricular Acupressure Reduces Rebound Effects After Discontinuation of Atropine

Sponsor
Ningbo Eye Hospital
Study ID
NCT07129889
Status
Not Yet Recruiting

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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 19, 2025
Start date
Dec 2, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Experimental: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

Myopia Rebound Rate [ Time Frame: 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. ]

Central Contacts

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