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Completed

NCT Number: NCT05957458

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

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.

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Key information

Conditions

Myopia Amblyopia Ametropia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Refractive Error - Myopia Axial Refractive Errors Sensation Disorders Signs and Symptoms Vision Disorders

Age range

4 year–41 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qiu Jenny

Beijing, Haidian District, 100089, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Airdoc device of red light for Myopia

Device

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.

Other names: low lever laser therapy, photobiomodulation therapy, low lever light therapy

Primary outcomes

  1. Axial length shortening comparing to that value of baseline (mm）

    Time frame: 12-month

    Measured with optial coherent methods with the same device assistant with the same techinician

  2. Axial length shortening comparing to that value of baseline (mm）

    Time frame: 1-month

    Measured with optial coherent methods with the same device assistant with the techinician

  3. Axial length shortening comparing to that value of baseline (mm）

    Time frame: 6-month

    Measured with optial coherent methods with the same device assistant with the same techinician

Secondary outcomes

  1. Refractive changes at the follow-up from the baseline (D)

    Time frame: 12-month

    Spherical Equivalence were recorded with the right eyes only

Sponsors and collaborators

Lead sponsor

Beijing Airdoc Technology Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: MCPT

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 24, 2023
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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