NCT07129889

Auricular Acupressure Reduces Rebound Effects After Discontinuation of Atropine

The Efficacy and Safety of Auricular Acupressure for Reducing the Rebound Phenomenon in Myopic Children After Discontinuing 0.01% Atropine Eye Drops: A Three-Arm, Blinded Randomized Controlled Trial Study Protocol

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Ningbo Eye Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
PROCEDURE	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.
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.

Timeline

• Start date: 2025-12-02
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

1 site across 1 country: China