Auricular Acupressure Reduces Rebound Effects After Discontinuation of Atropine

Official title

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

Overview

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%.

Interventions

• 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 treatmen
• 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.

Primary outcome measures

• 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.]

Secondary outcome measures (9)

• spherical equivalent annual growth(SEA) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Measurements are taken at 6 months, and 12 months after intervention, 6 months after dose reduction, and 6 months after discontinuation of medication.]
• AL year delay rate [Time frame: Measurements are taken at 6 months, and 12 months after intervention, 6 months after dose reduction, and 6 months after discontinuation of medication.]
• choroidal thickness (ChT) [Time frame: Measurements were taken at the start of the trial, 3, 6, 9, and 12 months after the intervention, 3 and 6 months after dose reduction, and 1, 3, and 6 months after discontinuation of medication.]
• choroidal vascular index (CVI) [Time frame: Measurements were taken at the start of the trial, 3, 6, 9, and 12 months after the intervention, 3 and 6 months after dose reduction, and 1, 3, and 6 months after discontinuation of medication.]
• choroidal vascular volume (CVV) [Time frame: Measurements were taken at the start of the trial, 3, 6, 9, and 12 months after the intervention, 3 and 6 months after dose reduction, and 1, 3, and 6 months after discontinuation of medication.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Ningbo Eye Hospital — Ningbo

Identifiers

NCT: NCT07129889 · Ningbo Eye Hospital

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗