Back to resultsMyopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults (MCPT)
Primary Purpose
Myopia, Amblyopia, Refractive Error - Myopia Axial
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Airdoc device of red light for Myopia
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Myopia, PBM therapy, LLLT
Eligibility Criteria
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
Sites / Locations
- Qiu Jenny
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Experimental
No Intervention
Arm Label
Moderate irradiance of PBM therapy to myopia
Extra low irradiance PBM therapy group
high lever PBM therapy group
Control
Arm 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.
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.
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.
Without PBM therapy group.
Outcomes
Primary Outcome Measures
Axial length shortening comparing to that value of baseline (mm）
Measured with optial coherent methods with the same device assistant with the same techinician
Axial length shortening comparing to that value of baseline (mm）
Measured with optial coherent methods with the same device assistant with the techinician
Axial length shortening comparing to that value of baseline (mm）
Measured with optial coherent methods with the same device assistant with the same techinician
Secondary Outcome Measures
Refractive changes at the follow-up from the baseline (D)
Spherical Equivalence were recorded with the right eyes only
Full Information
NCT ID
NCT05957458
First Posted
May 23, 2023
Last Updated
July 20, 2023
Sponsor
Beijing Airdoc Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05957458
Brief Title
Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults
Acronym
MCPT
Official Title
Retrospective Study of Photobiomodulation Therapy on Myopia Control With Airdoc Red Light at Wavelength of 650nm
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Airdoc Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Amblyopia, Refractive Error - Myopia Axial, Ametropia
Keywords
Myopia, PBM therapy, LLLT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three groups are all treated with PBM therapy with follow-up but they irradiance is different while one group is as the control.
Masking
None (Open Label)
Masking Description
No mask for all. Open and retrospective study.
Allocation
Non-Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate irradiance of PBM therapy to myopia
Arm Type
Experimental
Arm 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.
Arm Title
Extra low irradiance PBM therapy group
Arm Type
Sham Comparator
Arm 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.
Arm Title
high lever PBM therapy group
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Without PBM therapy group.
Intervention Type
Device
Intervention Name(s)
Airdoc device of red light for Myopia
Other Intervention Name(s)
low lever laser therapy, photobiomodulation therapy, low lever light therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Axial length shortening comparing to that value of baseline (mm）
Description
Measured with optial coherent methods with the same device assistant with the same techinician
Time Frame
12-month
Title
Axial length shortening comparing to that value of baseline (mm）
Description
Measured with optial coherent methods with the same device assistant with the techinician
Time Frame
1-month
Title
Axial length shortening comparing to that value of baseline (mm）
Description
Measured with optial coherent methods with the same device assistant with the same techinician
Time Frame
6-month
Secondary Outcome Measure Information:
Title
Refractive changes at the follow-up from the baseline (D)
Description
Spherical Equivalence were recorded with the right eyes only
Time Frame
12-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
QIU JENNY, MD
Organizational Affiliation
Airdoc MPC Co, Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qiu Jenny
City
Beijing
State/Province
Haidian District
ZIP/Postal Code
100089
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
36849626
Citation
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.
Results Reference
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Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults
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