Clinical Study of Light Therapy to Control Myopia Progression in Children

Beijing Airdoc Technology

Status: Enrolling

Conditions: Myopia, Progressive

Treatments: Device: Single vision spectacles for correction myopia; Device: Photobiomodualtion Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05761379

BeijingAirdoc

Details and patient eligibility

About

Low-lever red light therapy (LLLT) has been used to control myopia progression in China for a few years besides amblyopia therapy for a few decades. This study is to test the efficacy of PBM therapy to myopia children as well as to compare two types of PBM therapy to control myopia progression within one month.

Full description

LLLT utilized the 650-nm red light to provide sufficient energy to stimulate the tissue without causing damage to the surrounding tissues. And several researchers reported the long-term efficacy of LLLT in slowing the progression of myopia to date. These studies were reported various illumination and irradiance. This study is to test the efficacy of LLLT comparing to the control group as well as to test whether two types of lighting design will be different to the efficacy and safety.

Enrollment: 83 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is not limited;
2. Equivalent sphere (SER): -0.50D ~ -6.00D (including-0.50 and-6.00D);
3. Best corrected vision in one eye under glasses correction: 0.1 log MAR;
4. No strabismus: no more than 15 prism constant dominance strabismus after far and near cover tests;
5. No myopia control measures within the previous 4 weeks: such as orthokeratology lens, gradient lens, double light lens, eye drops for myopia control (such as atropine), myopia defocus glasses, red light for myopia control, other specially designed myopia light treatment instruments or contact lenses for special design to control myopia (such as Misight);

Exclusion criteria

1. Any ocular(including constant dominant strabismus with more than 15 prisms) and systemic diseases or abnormalities can significantly affect visual function or promote the progression of myopia;
2. Other interventions for myopia control before 4 weeks before enrollment, For example, orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control, other specially designed comprehensive treatment devices, myopia, amblyopia, or specially designed contact lenses (such as Misight), etc.
3. Subject participated in other clinical trials within 4 weeks before the enrollment;
4. The investigator for safety reasons or the interests of the patient, Other circumstances in which the patient should not participate in this trial, If suffering from serious heart, liver and kidney disease. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 3 patient groups, including a placebo group

PBM therapy 1

Experimental group

Description:

PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.6±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. The lighting spot for therapy is a dot. Only one eye will be treated with PBM therapy.

Treatment:

Device: Single vision spectacles for correction myopia

Device: Photobiomodualtion Therapy

PBM therapy 2

Experimental group

Description:

PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.3±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. Only one eye will be treated with PBM therapy.

Treatment:

Device: Single vision spectacles for correction myopia

Device: Photobiomodualtion Therapy

Control

Placebo Comparator group

Description:

Single vision spectacles correction only.

Treatment:

Device: Single vision spectacles for correction myopia