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

Fangbiao Tao

Status: Not yet enrolling

Conditions: Low-concentration Atropine Eye Drops; Eye Axis; Myopia; Ear Acupressure Pellets; Hyperopia Reserve

Treatments: Behavioral: Ear acupoint pressure pellet intervention group; Drug: Atropine intervention group; Combination Product: Joint intervention Group; Other: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT07475585

20251216

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 estimated patients

Sex: All

Ages: 4 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 4 patient groups

Ear acupoint pressure pellet intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Ear acupoint pressure pellet intervention group

Atropine intervention group

Experimental group

Description:

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.

Treatment:

Drug: Atropine intervention group

Joint Intervention Group

Experimental group

Description:

Received both auricular acupressure pill intervention and atropine intervention simultaneously

Treatment:

Combination Product: Joint intervention Group

control group

Active Comparator group

Description:

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.

Treatment:

Other: control group