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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-14
SponsorFangbiao Tao

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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

Treatment groups

380 Participants
are divided into 4 treatment groups
Group A: Ear acupoint pressure pellet intervention groupExperimental treatment 1 intervention
Group B: Atropine intervention groupExperimental treatment 1 intervention
Group C: Joint Intervention GroupExperimental treatment 1 intervention
Group D: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
24 months
2

Change in Spherical Equivalent Refraction

Measured by an auto-refractor at baseline and 6 months after intervention to assess the progression of myopia

Time frame
24 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fangbiao Tao

Lead sponsor

Anhui Medical University

Sponsor institution

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