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

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.

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%.

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.