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Multicenter, randomized and controlled clinical trial of low-intensity single-wavelength red light combined with ear point for prevention and control of myopia in children and adolescents

Multicenter, randomized and controlled clinical trial of low-intensity single-wavelength red light combined with ear point for prevention and control of myopia in children and adolescents

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071618
Enrollment
Unknown
Registered
2023-05-19
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

observation group I:low-intensity single-wavelength red light and ear point
observation group II:low-intensity single-wavelength red light
observation group III:Ear point
Control group:no

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1) Children and adolescents aged 5-12 years old. 2) Myopia tendency: ? regulatory myopia (pseudomyopia); ? binocular hyperopia reserve is lower than the reference normal value of children of the same age (insufficient hyperopia reserve); ? binocular equivalent-0.50D.; ? 1.50D; ? binocular anisometropia 1.50D; ? 0.8 (log vision 4. 9); ? There are risk factors for myopia, such as myopia in both parents or high myopia; excessive eye growth or refraction (from hyperopia to myopia or myopia); excessive close eye time; significantly less outdoor time. 3) Children and adolescents with low grade myopia: diagnosis of myopia after ? cycloplegia, namely-0.50D; ? -3.00D; ? 1.0 (5.0); ? 1.50D; ? 1.50D. 4) The guardian has signed the informed consent form. 5) The subjects are willing to treat and can follow up the follow-up requirements of the study, and each test group should conduct corresponding intervention and scientific eye health education and education according to the requirements.

Exclusion criteria

Exclusion criteria: 1) Children who have already been diagnosed with strabismus and amblyopia; 2) Participated in any clinical study related to myopia prevention and control within 3 months; have used or are currently using myopia prevention and control products; 3) Secondary myopia caused by congenital eye disease or infant eye diseases, such as congenital cataract, congenital retinal disease, and retinopathy of prematurity; 4) The refractive media opacity (such as corneal lesions, crystal opacity, etc.) 5) Abnormal intraocular pressure (intraocular pressure 21mmHg or binocular intraocular pressure difference of 5mmHg); 6) Patients with optic nerve damage or congenital optic nerve dysfunction; 7) Suffering from systemic diseases that may affect the eyes, such as diabetes mellitus, Down syndrome, hyperthyroidism, etc 8) Only the single eye meets the inclusion criteria; 9) Those who cannot perform eye examinations regularly (or if the guardian of the minor cannot accompany the minor regularly); 10) Other reasons that the study doctor considered were not suitable for inclusion in the project.

Design outcomes

Primary

MeasureTime frame
axis oculi;Diopter;

Secondary

MeasureTime frame
Best corrected vision;

Countries

China

Contacts

Public ContactXiang Shengjin

Eye Hospital, Wenzhou Medical University

xsj4228@163.com+86 137 5871 5162

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026