Ear Acupressure Pellets, Eye Axis, Hyperopia Reserve, Low-concentration Atropine Eye Drops, Myopia
Conditions
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.
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.
Interventions
BEHAVIORALEar 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.
DRUGAtropine 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.
COMBINATION_PRODUCTJoint intervention Group
Received both auricular acupressure pill intervention and atropine intervention simultaneously
OTHERcontrol 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
Sponsors
Fangbiao Tao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Axial Length from Baseline | 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 |
| Change in Spherical Equivalent Refraction | 24 months | Measured by an auto-refractor at baseline and 6 months after intervention to assess the progression of myopia |
Contacts
CONTACT韶君 许
CONTACT恬 胡
Outcome results
None listed