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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Myopia Rebound Rate
Study Overview
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.
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%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: gradual withdrawal of medication (Drug)
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.
Intervention: Auricular acupressure (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.
Intervention: Sham auricular acupressure (Procedure)
Outcomes
Primary Outcomes
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.
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%
Secondary Outcomes
- 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.)
- AL 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.)
- choroidal thickness (ChT)(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)(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)(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.)