Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2024-12-30

Brief Summary

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Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3\~ 6 year-old myopia treatment or slow myopia progression are seldom reported.

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Detailed Description

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Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3\~ 6 year-old myopia treatment or slow myopia progression are seldom reported. Here we design this control and random prospective study to find the two types light with different irridance to two ages (3\~4 years old and 5\~6 years old) respectively. Wether the dose and effectiveness exit or not for 3\~6- year- old myopia control.

Conditions

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Myopia Amblyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups for the 2 lighting lever (0.37mW and 0.6mW）for 2 groups of ages (3\~4 years old and 5\~6 years old)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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repeated red light therapy for 3~4 year-old myopia

0.37mW lighting with wavelength of 650nm for the age of 3\~4 years old(including both 3 and 4 years)myopia.

Group Type EXPERIMENTAL

repeated ultra low lever red light

Intervention Type DEVICE

Myopia indoor lighting therapy

repeated red light therapy for 5~6 year-old myopia

0.60mW lighting with wavelength of 650nm for the age of 5\~6 years old(including both 5 and 6 years)myopia.

Group Type EXPERIMENTAL

repeated ultra low lever red light

Intervention Type DEVICE

Myopia indoor lighting therapy

Interventions

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repeated ultra low lever red light

Myopia indoor lighting therapy

Intervention Type DEVICE

Other Intervention Names

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LLLT, PBM therapy

Eligibility Criteria

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Inclusion Criteria

* 3\~6 years old;
* Myopia Spherical Equivalence Refraction \<=-0.50D;
* Written Informed Consent;

Exclusion Criteria

* Cannot approval with written informed consent;
* Photophobia or allergy to red light;
* With other severe conditions the principle investigators refused to enroll this study

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No