MyopiaNCT07475585
Effects of Auricular Point Pressing With Pellets in Children With Insufficient Hyperopia Reserve
A study testing Ear acupoint pressure pellet intervention group, Atropine intervention group and Joint intervention Group in people with Myopia and Ear Acupressure Pellets, run by Fangbiao Tao.
Trial summary
This project aims to address the trend of early onset and high myopia among children in China by focusing on insufficient hyperopia reserve, a key early warning indicator for myopia. A randomized controlled trial (RCT) will be conducted. Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Ear Acupressure Pellets, Hyperopia Reserve
- What is being tested?
- Ear acupoint pressure pellet intervention group, Atropine intervention group and Joint intervention Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 30 Jul 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 4 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- obtaining written informed consent signed by children and legal guardians;(2) children aged 4 to 14 years old;(3) computer optometry after ciliary muscle paralysis detects that the equivalent spherical power of any eye is between -0.50D and 0.75D (4) there are no other organic diseases affecting vision in both eyes;(5) binocular intraocular pressure ≤ 21mmHg.
Who cannot join
- subjects who have been diagnosed with myopia (2) subjects who may have eye diseases that affect vision or refractive errors (such as cataract and other lens injury diseases, glaucoma, macular degeneration, keratopathy, retinal detachment, severe vitreous opacity, etc.);(3) systemic diseases: central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary function, 8 severe liver and kidney dysfunction;(4) Binocular or monocular with dominant strabismus or any other pathological changes of the eye or acute inflammatory diseases of the eye;(5) allergic to atropine, compound Tobicamide and other drugs used in this study;(6) those who have participated in clinical trials of other drugs within 3 months before screening;(7) other conditions that the researchers think are not suitable.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial of Auricular Point Pressing With Pellets for Children With Insufficient Hyperopia Reserve
This project aims to address the trend of early onset and high myopia among children in China by focusing on insufficient hyperopia reserve, a key early warning indicator for myopia. A randomized controlled trial (RCT) will be conducted. The study will target children aged 4 to 14 with insufficient hyperopia reserve (equivalent spherical lens -0.50D to +0.75D). Through a prospective RCT design, the efficacy and safety of auricular point pressure therapy, low-concentration atropine eye drops, and their combination in delaying the onset of myopia will be systematically evaluated.
Read the detailed description
A total of 380 subjects are planned to be included and randomly divided into auricular point pressure pill group, atropine group, combined group and control group. The follow-up period is 18 months (12 months of intervention + 6 months after intervention). The primary endpoints are changes in spherical equivalent and axial length of the eye. The secondary endpoints include intraocular pressure, astigmatism and adverse events.
- Conditions
- Myopia, Ear Acupressure Pellets, Hyperopia Reserve, Low-concentration Atropine Eye Drops, Eye Axis
- Being tested
- Ear acupoint pressure pellet intervention group, Atropine intervention group, Joint intervention Group, control group
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear acupoint pressure pellet intervention groupBehavioural
According to the subject's choice or the doctor's advice, auricular point pressing with pellets is selected, and the application is changed once a week. During the operation, first press and hold the auricular points of "Ear Gate", "Auditory Palace", and "Auditory Meeting" for 30 seconds each; then rub the ears until they feel slightly warm and slightly red; then apply auricular point pressing with pellets to the points of "Spirit Gate", "Eye 1", "Eye 2", "Eye", "Kidney", "Liver", and "Spleen". This method can stimulate the meridians, regulate the qi of the eye meridians, improve the blood circulation of the children's eyes, and thereby relieve the spasm of the ciliary muscle.
Atropine intervention groupDrug
Initial treatment: 1 time per night, apply 0.01% atropine eye drops to both eyes (brand name: Xingqi Meioupin, Xingqi Pharmaceutical, 30 drops per box). If the refractive error of myopia progresses by ≥0.25D every 6 months or the eye axis grows by ≥0.1mm every 6 months, then increase to 0.01% atropine eye drops 2 times per day.
Joint intervention GroupCombination product
Received both auricular acupressure pill intervention and atropine intervention simultaneously
control groupOther
Only receive standardized eye hygiene education (such as increasing outdoor activity time and controlling close distance) (such as the duration and posture of eye use, ensuring adequate sleep, etc.) Do not perform auricular point pressing pills or drug intervention
| Study group | Role | What they receive |
|---|---|---|
| Ear acupoint pressure pellet intervention group | Experimental | A prospective randomized controlled trial (RCT) design was adopted. The study subjects were children with insufficient accommodative reserve (aged 4-14 years). For the children in this group, auricular acupressure pills were administered. Receives: Behavioral: Ear acupoint pressure pellet intervention group |
| Atropine intervention group | Experimental | A prospective randomized controlled trial (RCT) design was adopted, with children (aged 4-14 years) with insufficient myopia reserve as the research subjects. For the children in this group, low-concentration atropine eye drops were administered. Receives: Drug: Atropine intervention group |
| Joint Intervention Group | Experimental | Received both auricular acupressure pill intervention and atropine intervention simultaneously Receives: Combination Product: Joint intervention Group |
| control group | Active comparator | Only standardized eye hygiene education is provided (such as increasing outdoor activity time, controlling the duration and posture of close-up eye use, and ensuring adequate sleep, etc.), and no auricular acupressure or medication intervention is carried out. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Axial Length from Baseline
Axial length will be measured using the IOLMaster 700 at baseline and 6 months after intervention, and the difference between the two measurements will be calculated
Measured: 24 months
Change in Spherical Equivalent Refraction
Measured by an auto-refractor at baseline and 6 months after intervention to assess the progression of myopia
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fangbiao Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fangbiao Tao, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475585
- Sponsor's protocol ID
- 20251216
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Auricular Point Pressing With Pellets for Children With Insufficient Hyperopia Reserve
- ClinicalTrials.gov ID
- NCT07475585
- Acronym / sponsor ID
- 20251216
- Conditions
- Myopia, Ear Acupressure Pellets, Hyperopia Reserve, Low-concentration Atropine Eye Drops, Eye Axis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Fangbiao TaoUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to address the trend of early onset and high myopia among children in China by focusing on insufficient hyperopia reserve, a key early warning indicator for myopia. A randomized controlled trial (RCT) will be conducted. The study will target children aged 4 to 14 with insufficient hyperopia reserve (equivalent spherical lens -0.50D to +0.75D). Through a prospective RCT design, the efficacy and safety of auricular point pressure therapy, low-concentration atropine eye drops, and their combination in delaying the onset of myopia will be systematically evaluated.
Detailed description
A total of 380 subjects are planned to be included and randomly divided into auricular point pressure pill group, atropine group, combined group and control group. The follow-up period is 18 months (12 months of intervention + 6 months after intervention). The primary endpoints are changes in spherical equivalent and axial length of the eye. The secondary endpoints include intraocular pressure, astigmatism and adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ear acupoint pressure pellet intervention group | Experimental | Behavioral: Ear acupoint pressure pellet intervention groupA prospective randomized controlled trial (RCT) design was adopted. The study subjects were children with insufficient accommodative reserve (aged 4-14 years). For the children in this group, auricular acupressure pills were administered. |
| Atropine intervention group | Experimental | Drug: Atropine intervention groupA prospective randomized controlled trial (RCT) design was adopted, with children (aged 4-14 years) with insufficient myopia reserve as the research subjects. For the children in this group, low-concentration atropine eye drops were administered. |
| Joint Intervention Group | Experimental | Combination Product: Joint intervention GroupReceived both auricular acupressure pill intervention and atropine intervention simultaneously |
| control group | Active comparator | Other: control groupOnly standardized eye hygiene education is provided (such as increasing outdoor activity time, controlling the duration and posture of close-up eye use, and ensuring adequate sleep, etc.), and no auricular acupressure or medication intervention is carried out. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- obtaining written informed consent signed by children and legal guardians;(2) children aged 4 to 14 years old;(3) computer optometry after ciliary muscle paralysis detects that the equivalent spherical power of any eye is between -0.50D and 0.75D (4) there are no other organic diseases affecting vision in both eyes;(5) binocular intraocular pressure ≤ 21mmHg.
Key exclusion criteria (1 listed)
- subjects who have been diagnosed with myopia (2) subjects who may have eye diseases that affect vision or refractive errors (such as cataract and other lens injury diseases, glaucoma, macular degeneration, keratopathy, retinal detachment, severe vitreous opacity, etc.);(3) systemic diseases: central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary function, 8 severe liver and kidney dysfunction;(4) Binocular or monocular with dominant strabismus or any other pathological changes of the eye or acute inflammatory diseases of the eye;(5) allergic to atropine, compound Tobicamide and other drugs used in this study;(6) those who have participated in clinical trials of other drugs within 3 months before screening;(7) other conditions that the researchers think are not suitable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ear acupoint pressure pellet intervention groupAccording to the subject's choice or the doctor's advice, auricular point pressing with pellets is selected, and the application is changed once a week. During the operation, first press and hold the auricular points of "Ear Gate", "Auditory Palace", and "Auditory Meeting" for 30 seconds each; then rub the ears until they feel slightly warm and slightly red; then apply auricular point pressing with pellets to the points of "Spirit Gate", "Eye 1", "Eye 2", "Eye", "Kidney", "Liver", and "Spleen". This method can stimulate the meridians, regulate the qi of the eye meridians, improve the blood circulation of the children's eyes, and thereby relieve the spasm of the ciliary muscle. | Behavioural | Ear acupoint pressure pellet intervention group |
| Atropine intervention groupInitial treatment: 1 time per night, apply 0.01% atropine eye drops to both eyes (brand name: Xingqi Meioupin, Xingqi Pharmaceutical, 30 drops per box). If the refractive error of myopia progresses by ≥0.25D every 6 months or the eye axis grows by ≥0.1mm every 6 months, then increase to 0.01% atropine eye drops 2 times per day. | Drug | Atropine intervention group |
| Joint intervention GroupReceived both auricular acupressure pill intervention and atropine intervention simultaneously | Combination product | Joint Intervention Group |
| control groupOnly receive standardized eye hygiene education (such as increasing outdoor activity time and controlling close distance) (such as the duration and posture of eye use, ensuring adequate sleep, etc.) Do not perform auricular point pressing pills or drug intervention | Other | control group |
Primary outcome
Change in Axial Length from Baseline
Time frame: 24 months
Axial length will be measured using the IOLMaster 700 at baseline and 6 months after intervention, and the difference between the two measurements will be calculated
Change in Spherical Equivalent Refraction
Time frame: 24 months
Measured by an auto-refractor at baseline and 6 months after intervention to assess the progression of myopia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ear acupoint pressure pellet intervention group, Atropine intervention group and Joint intervention Group in people with Myopia and Ear Acupressure Pellets, run by Fangbiao Tao.
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 1 inclusion and 1 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 韶君 许 (18055151289, 601792160@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Axial Length from Baseline (time frame: 24 months). The study lists 2 primary outcomes in all. 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 16 Mar 2026.