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NCT Number: NCT07475585

Effects of Auricular Point Pressing With Pellets in 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.

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Key information

Conditions

Myopia Ear Acupressure Pellets Eye Axis Eye Diseases Hyperopia Reserve Low-concentration Atropine Eye Drops Refractive Errors

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ear acupoint pressure pellet intervention group

Behavioral

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 group

Drug

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 Group

Combination Product

Received both auricular acupressure pill intervention and atropine intervention simultaneously

Control Group

Other

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

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

恬 胡

CONTACT

[email protected]

18779869959

韶君 许

CONTACT

[email protected]

18055151289

Sponsors and collaborators

Lead sponsor

Fangbiao Tao

Other

Registry information

Official study title

A Randomized Controlled Trial of Auricular Point Pressing With Pellets for Children With Insufficient Hyperopia Reserve

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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