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

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia; Amblyopia; Ametropia; Refractive Error - Myopia Axial
• Intervention / Treatment: Device: Airdoc device of red light for Myopia

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Haidian District
    • Beijing, Haidian District, China, 100089
      • Qiu Jenny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate irradiance of PBM therapy to myopia; 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.	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.; Other Names: photobiomodulation therapy; low lever laser therapy; low lever light therapy
Sham Comparator: Extra low irradiance PBM therapy group; 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.	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.; Other Names: photobiomodulation therapy; low lever laser therapy; low lever light therapy
Experimental: high lever PBM therapy group; 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.	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.; Other Names: photobiomodulation therapy; low lever laser therapy; low lever light therapy
No Intervention: Control; Without PBM therapy group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length shortening comparing to that value of baseline (mm）	Measured with optial coherent methods with the same device assistant with the same techinician	12-month
Axial length shortening comparing to that value of baseline (mm）	Measured with optial coherent methods with the same device assistant with the techinician	1-month
Axial length shortening comparing to that value of baseline (mm）	Measured with optial coherent methods with the same device assistant with the same techinician	6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refractive changes at the follow-up from the baseline (D)	Spherical Equivalence were recorded with the right eyes only	12-month

Collaborators and Investigators

• Sponsor: Beijing Airdoc Technology Co., Ltd.
• Investigators: Principal Investigator: QIU JENNY, MD, Airdoc MPC Co, Ltd.

Publications and helpful links

General Publications

• Zhou L, Tong L, Li Y, Williams BT, Qiu K. Photobiomodulation therapy retarded axial length growth in children with myopia: evidence from a 12-month randomized controlled trial evidence. Sci Rep. 2023 Feb 27;13(1):3321. doi: 10.1038/s41598-023-30500-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: LLLT; Myopia; PBM therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Refractive Errors; Myopia; Amblyopia
• Other Study ID Numbers: Airdoc MPC Co.Ltd.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No