NCT05957458

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

Retrospective Study of Photobiomodulation Therapy on Myopia Control With Airdoc Red Light at Wavelength of 650nm

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Beijing Airdoc Technology Co., Ltd. · Industry
• Sex: All
• Age: 4 Years – 41 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Myopia
• Amblyopia
• Refractive Error - Myopia Axial
• Ametropia

Interventions

Type	Name	Description
DEVICE	Airdoc device of red light for Myopia	This light is Narrow-Band, Long-Wavelength Lighting with three different illumination (400lux, 800lux, 1200lux) or irridiance (1.2mW, 0.6mW, 0.37mW) respectively. And the wavelength is 650nm. It allows biocular therapy.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2023-05-31
• First posted: 2023-07-24
• Last updated: 2023-07-24

Locations

1 site across 1 country: China