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

Beijing Airdoc Technology

Status: Enrolling

Conditions: Myopia; Amblyopia

Treatments: Device: repeated ultra low lever red light

Study type: Interventional

Funder types: Industry

Identifiers

NCT05811598

Beijing Airdoc Technology Co.,

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Device: repeated ultra low lever red light

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

Experimental group

Description:

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

Treatment:

Device: repeated ultra low lever red light