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MyopiaNCT07129889

Auricular Acupressure Reduces Rebound Effects After Discontinuation of Atropine

A study testing gradual withdrawal of medication and Auricular acupressure in people with Myopia, run by Ningbo Eye Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Myopia
What is being tested?
gradual withdrawal of medication and Auricular acupressure
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteChina
Study dates
2 Dec 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Ningbo Eye Hospital

    Ningbo, Zhejiang

    Zengfang Zengfang Yu, +8615267893682, yuzengfang1993@163.com

Other trials in China

About this study

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

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.

Read the 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
Being tested
gradual withdrawal of medication, Auricular acupressure, Sham auricular acupressure
Keywords
Auricular acupressure, myopia, atropine, rebound effect, randomized controlled trial
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gradual withdrawal of medicationDrug

    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.

  • Auricular acupressureProcedure or surgery

    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.

  • Sham auricular acupressureProcedure or surgery

    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.

Study groups in NCT07129889
Study groupRoleWhat they receive
the atropine tapering groupActive comparatorPatients 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.
Receives: Drug: gradual withdrawal of medication
Auricular acupressureExperimentalAA 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.
Receives: Procedure: Auricular acupressure
Sham Auricular acupressureSham comparatorAcupuncturists 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.
Receives: Procedure: Sham auricular acupressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%

    Measured: 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 outcomes (9)
  1. 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)

    Measured: 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

  2. 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)

    Measured: 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

  3. 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|

    Measured: 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.

  4. 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|

    Measured: 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.

  5. 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%

    Measured: Measurements are taken at 6 months, and 12 months after intervention, 6 months after dose reduction, and 6 months after discontinuation of medication.

  6. 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%

    Measured: Measurements are taken at 6 months, and 12 months after intervention, 6 months after dose reduction, and 6 months after discontinuation of medication.

  7. 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.

    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.

  8. 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.

    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.

  9. 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.

    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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start2 Dec 2025 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07129889
Sponsor's protocol ID
Ningbo Eye Hospital
Status last verified
Aug 2025
First submitted
7 Aug 2025
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing gradual withdrawal of medication and Auricular acupressure in people with Myopia, run by Ningbo Eye Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zengfang Yu (+8615267893682, yuzengfang1993@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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