Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults (MCPT)

Beijing Airdoc Technology

Status: Completed

Conditions: Refractive Error - Myopia Axial; Myopia; Ametropia; Amblyopia

Treatments: Device: Airdoc device of red light for Myopia

Study type: Interventional

Funder types: Industry

Identifiers

NCT05957458

Airdoc MPC Co.Ltd.

Details and patient eligibility

About

Photobiomodulation therapy, that is, Low-level red-light technology provides a new and innovative myopia control approach. This strategy enables relatively high energies of light to be delivered at much shorter durations of exposure to induce the myopia control effect. The efficacy of the low-level red-light technology has been proven in a Chinese populationb for the recent 3 years with evidence based papers and amazing results. However, there's not yet evidence to demonstrate the relationship between the dose response effect of photobiomodulation therapy on myopia control at the different age lever.

Full description

Previous trial has demonstrated that 3-minutes per session twice a day repeated low-level red-light treatment at the irridiance of 2.3mW（2.0~2.5mW) controlled 87.7% of refraction progression and 76.8% of axial length elongation when the time of compliance to the treatment was 75%. Retrospective analyze other irriadance of 1.2mW, 0.6mW and 0.37mW culturally diverse groups will confirm and translate this technology into a solution for myopia control globally.

Enrollment: 300 patients

Sex: All

Ages: 4 to 41 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Myopia or near Myopia with younger age
• Without other intervention of myopia control, including atropine, Misight contact lens, special design lens to control myopia, orthokeratology and other red light devices.
• Follow-up at least once
• With baseline data of ocular parameters before the follow-up

Exclusion criteria

• Photophobia
• Allergy to red light
• Severe ocular progressing diseases or systemic diseases
• The data is unacceptable with reasonable explanations

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Moderate irradiance of PBM therapy to myopia

Experimental group

Description:

The PBM therapy irradiance is about 0.60mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration.

Treatment:

Device: Airdoc device of red light for Myopia

Extra low irradiance PBM therapy group

Sham Comparator group

Description:

The PBM therapy irradiance is about 0.37mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration.

Treatment:

Device: Airdoc device of red light for Myopia

high lever PBM therapy group

Experimental group

Description:

The PBM therapy irradiance is about 1.20mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration.

Treatment:

Device: Airdoc device of red light for Myopia

Control

No Intervention group

Description:

Without PBM therapy group.