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

Sponsor
Fangbiao Tao
Study ID
NCT07475585
Status
Not Yet Recruiting

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Conditions

  • Ear Acupressure Pellets
  • Eye Axis
  • Hyperopia Reserve
  • Low-concentration Atropine Eye Drops
  • Myopia

Eligibility Criteria

Sex
ALL
Age
4 Years - 14 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Mar 16, 2026
Start date
Mar 30, 2026
Status verified
Mar 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
380 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.
  • Experimental: 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.

Primary Outcome Measure

Change in Axial Length from Baseline [ Time Frame: 24 months ]

Central Contacts

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