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A randomized, open, multicenter clinical trial of the effects of ophthalmoscope on axial development in children

A randomized, open, multicenter clinical trial of the effects of ophthalmoscope on axial development in children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066960
Enrollment
Unknown
Registered
2022-12-22
Start date
2021-10-07
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Myopia and amblyopia

Interventions

Optical Vision sky-n1201a, wavelength 650nm, power 0.37mw±0.02mw group 1:Optical Vision sky-n1201a, wavelength 650nm, power 0.37mw±0.02mw group 2
Optical vision sky-n1201a, wavelength 650nm, power 1.2mw group 1:Optical vision sky-n1201a, wavelength 650nm, power 1.2mw group 2
Skyn1201a, wavelength 650nm, power 0.6mw±0.2mw group 1:Skyn1201a, wavelength 650nm, power 0.6mw±0.2mw group 2
Optical Vision sky-n1201a, wavelength 650nm, power 0.37mw to 1.2mw±0.2mw group1:Optical Vision sky-n1201a, wavelength 650nm, power 0.37mw to 1.2mw±0.2mw group2

Sponsors

Tianjin Medical University Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Age range from 6 to 12 years old, gender unlimited; (2) Patients with myopia in one or both eyes, binocular diopter difference =1.00DS; (3) Those who voluntarily gave up other treatments during the study; (4) Voluntarily use the product according to regulations, and can cooperate with the doctor's examination work; (5) Before the experiment, the guardian agrees and signs the informed consent.

Exclusion criteria

Exclusion criteria: (1) Congenital fundus defects (2) There are congenital eye diseases (3) Congenital glaucoma (4) Halo patients (5) Patients with a history of tourette syndrome (6) Patients with ADHD history (7) Patients with a history of epilepsy (8) Patients with psoriasis (9) Patients with ocular hypertension (10) Participate in other clinical studies within three months (11) Subjects deemed unsuitable by the researcher

Design outcomes

Primary

MeasureTime frame
Axis change value;

Secondary

MeasureTime frame
Change in diopter;

Countries

China

Contacts

Public ContactQian Xuehan
Drqianxh@126.com13752468160

Outcome results

None listed

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