To assess the safety and efficacy of children at high risk of myopia aged 6-9 years who wore low-grade hyperopia corrective glasses for 12 months to prevent myopia

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400085051

Enrollment

Unknown

Registered

2024-05-30

Start date

2024-06-01

Completion date

Unknown

Last updated

2024-06-03

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

Conditions

hyperopia

Interventions

Low-grade hyperopia correction single light group:Wear single-vision glasses for farsightedness

Low-grade hyperopia correction defocus group:Wear farsighted-corrected defocus glasses

Control group:Myopia prevention and control related education

Eligibility

Sex/Gender

All

Age

6 Years to 9 Years

Inclusion criteria

Inclusion criteria: (1) Age 6-9 years old (2) The equivalent spherical power under cycloplegia in both eyes is +0.50D~+2.00D (3) Binocular astigmatism= 1.0D (based on the average value of objective refraction examination after cycloplegia) (4) Binocular spherical equivalent anisometropia = 1.0D (5) Best corrected visual acuity = 5.0 (6) It was located between the 25th percentile and 95th percentile curves of the normal percentage curve of AL/CR in children aged 4-18 years in China (7) Voluntarily participate in this clinical trial and sign the informed consent form

Exclusion criteria

Exclusion criteria: (1) The patient has a history of ocular lesions, surgery, systemic or neurological abnormalities (2) Patients with strabismus and amblyopia in the initial refraction examination (3) Abnormal intraocular pressure (intraocular pressure 21mmHg or intraocular pressure difference >5mmHg) (4) Those who are unable to have regular eye examinations (5) Have participated in any myopia control clinical research trial within three months, and have used or are currently using rigid contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, light feeding instruments, low-concentration atropine drugs, etc.; (6) dominant strabismus; The amount of distance or near heterophorismus = 20 prisms

Design outcomes

Primary

Measure	Time frame
Change from baseline in axial length at 12 months ± 30 days before cycloplegia;	—

Secondary

Measure	Time frame
Change from baseline in objective refraction equivalent spherical power after cycloplegia;Change value from baseline subjective refraction;Change from baseline in axial length before cycloplegia;	—

Countries

China

Contacts

Public ContactXinjie Mao

Eye Hospital Affiliated to Wenzhou Medical University

mxj@mail.eye.ac.cn+86 137 0588 0472

Outcome results

None listed

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