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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the atropine tapering group | Active Comparator | 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. |
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| Auricular acupressure | Experimental | 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. |
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| Sham Auricular acupressure | Sham Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Myopia Rebound Rate | 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% | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| spherical equivalent annual growth(SEA) | SE annual growth is defined as the annualized amount of SE after ciliary muscle paralysis. SE annual growth = SE change value / follow-up duration (y) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients who meet any of the following criteria will not be eligible to participate in the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zengfang Yu | Contact | +8615267893682 | yuzengfang1993@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo Eye Hospital | Ningbo | Zhejiang | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2024 | Aug 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parental Consent Form | Jul 4, 2024 | Aug 4, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form for Children | Jul 4, 2024 | Aug 4, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 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. |
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| 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. |
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| Axial length annual growth(ALA) | The annual growth rate of AL is the annualized value of AL.The measurement method involves taking five consecutive measurements and calculating the average value. Annual growth rate of AL = Change in AL value / Follow-up duration (y) | 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 | The SE delay is defined as the difference between the annual change in SE in the AA group, SAA group, and atropine withdrawal group after ciliary muscle paralysis. SE delay = |control group SEA - experimental group SEA| | 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 | The AL-year delay is defined as the difference between the AL-year change in the AA group, SAA group, and atropine gradual withdrawal group. AL-year delay = |control group ALA - experimental group 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 months, and 6 months after discontinuation of medication. |
| SE year delay rate | The SE annual delay rate is defined as the ratio of the SE annual delay amount to the SE annual change amount in the control group multiplied by 100%. SE annual delay rate = SE annual delay amount / SE annual change amount in the control group * 100% | 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 | The AL annual delay rate is defined as the ratio of the AL annual delay amount to the AL annual change amount in the control group multiplied by 100%. AL annual delay rate = AL annual delay amount / AL annual change amount in the control group * 100% | 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) | The Sub-Surface Optical Coherence Tomography Angiography (SS-OCTA) system employs Deep Layer™ artificial intelligence for layered measurement of choroidal thickness. Choroidal thickness measurement in the macular region: The macular region of the examined eye is designated as the scanning area, with the fovea centralis as the center, and a radial scan is performed in an ETDRS concentric circle pattern. Choroidal thickness is automatically calculated by the system. In the magnified OCTA image, measurements are taken below the fovea centralis, with nine regions-temporal, nasal, superior, inferior, superior temporal, inferior nasal, inferior temporal, and superior nasal-within the 0-3mm, 0-6mm, and 0-9mm ranges of the macula. The system automatically calculates the average choroidal thickness across the three ranges. | 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) | The measurement method for choroidal thickness and choroidal vascular volume uses B-scan mode, with a 9.00 × 9.00 mm vascular OCT scan centered on the fovea of each eye. The system automatically identifies the choroidal vascular structure, reconstructs the choroidal vascular morphology, and quantifies the choroidal vascular volume and vascular index. The vascular index and vascular index within the ETDRS ring range of 0-3 mm, 0-6 mm, and 0-9 mm are measured. | 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) | The measurement method for choroidal thickness and choroidal vascular volume uses B-scan mode, with a 9.00 × 9.00 mm vascular OCT scan centered on the fovea of each eye. The system automatically identifies the choroidal vascular structure, reconstructs the choroidal vascular morphology, and quantifies the choroidal vascular volume and vascular index. The vascular index and vascular index within the ETDRS ring range of 0-3 mm, 0-6 mm, and 0-9 mm are measured. | 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. |