Effects of Auricular Point Pressing With Pellets in Children With Insufficient Hyperopia Reserve
A Randomized Controlled Trial of Auricular Point Pressing With Pellets for Children With Insufficient Hyperopia Reserve
1 other identifier
interventional
380
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 16, 2026
CompletedStudy Start
First participant enrolled
March 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2027
March 16, 2026
March 1, 2026
1.3 years
March 4, 2026
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
24 months
Study Arms (4)
Ear acupoint pressure pellet intervention group
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALReceived both auricular acupressure pill intervention and atropine intervention simultaneously
control group
ACTIVE COMPARATOROnly 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.
Interventions
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.
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.
Received both auricular acupressure pill intervention and atropine intervention simultaneously
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
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fangbiao Taolead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 16, 2026
Study Start
March 30, 2026
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
July 30, 2027
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share