Effects of Auricular Point Pressing With Pellets in Children With Insufficient Hyperopia Reserve

March 11, 2026 updated by: Fangbiao Tao

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

(1) 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.

Exclusion Criteria:

(1) 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ear acupoint pressure pellet intervention group
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.
Behavioral: Ear acupoint pressure pellet intervention group
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.
Experimental: Atropine intervention group
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.
Drug: Atropine intervention group
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.
Experimental: Joint Intervention Group
Received both auricular acupressure pill intervention and atropine intervention simultaneously
Combination product: Joint intervention Group
Received both auricular acupressure pill intervention and atropine intervention simultaneously
Active Comparator: control group
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.
Other: control group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fangbiao Tao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20251216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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