MyopiaMCPTNCT05957458
Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults
A study testing Airdoc device of red light for Myopia in people with Myopia and Amblyopia, run by Beijing Airdoc Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 41 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Amblyopia, Refractive Error - Myopia Axial
- What is being tested?
- Airdoc device of red light for Myopia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 41 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Photophobia
- Allergy to red light
- Severe ocular progressing diseases or systemic diseases
- The data is unacceptable with reasonable explanations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Airdoc device of red light for Myopia
- Keywords
- Myopia, PBM therapy, LLLT
- Medical subject headings
- Myopia, Amblyopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airdoc device of red light for MyopiaDevice
Also called low lever laser therapy, photobiomodulation therapy, low lever light therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate irradiance of PBM therapy to myopia | Experimental | 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. Receives: Device: Airdoc device of red light for Myopia |
| Extra low irradiance PBM therapy group | Sham comparator | 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. Receives: Device: Airdoc device of red light for Myopia |
| high lever PBM therapy group | Experimental | 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. Receives: Device: Airdoc device of red light for Myopia |
| Control | No intervention | Without PBM therapy group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length shortening comparing to that value of baseline (mm）
Measured with optial coherent methods with the same device assistant with the same techinician
Measured: 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
Measured: 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
Measured: 6-month
Secondary outcomes (1)
Refractive changes at the follow-up from the baseline (D)
Spherical Equivalence were recorded with the right eyes only
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- QIU JENNY, MD, Principal investigator, Airdoc MPC Co, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957458
- Sponsor's protocol ID
- Airdoc MPC Co.Ltd.
- Acronym
- MCPT
- Status last verified
- Jul 2023
- First submitted
- 23 May 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36849626
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Photobiomodulation Therapy on Myopia Control With Airdoc Red Light at Wavelength of 650nm
- ClinicalTrials.gov ID
- NCT05957458
- Acronym / sponsor ID
- MCPT / Airdoc MPC Co.Ltd.
- Conditions
- Myopia, Amblyopia, Refractive Error - Myopia Axial, Ametropia
- Keywords
- Myopia, PBM therapy, LLLT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Moderate irradiance of PBM therapy to myopia | Experimental | Device: Airdoc device of red light for MyopiaThe 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. |
| Extra low irradiance PBM therapy group | Sham comparator | Device: Airdoc device of red light for MyopiaThe 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. |
| high lever PBM therapy group | Experimental | Device: Airdoc device of red light for MyopiaThe 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. |
| Control | No intervention | –Without PBM therapy group. |
Who may qualify
- Ages
- 4 to 41 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Photophobia
- Allergy to red light
- Severe ocular progressing diseases or systemic diseases
- The data is unacceptable with reasonable explanations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airdoc device of red light for MyopiaAlso: low lever laser therapy, photobiomodulation therapy, low lever light therapyThis 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. | Device | Extra low irradiance PBM therapy group, Moderate irradiance of PBM therapy to myopia, high lever PBM therapy group |
Primary outcome
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
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
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
1 secondary outcome
Refractive changes at the follow-up from the baseline (D)
Time frame: 12-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Background: PubMed 36849626Zhou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
QIU JENNY, MD principal investigator
Airdoc MPC Co, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airdoc device of red light for Myopia in people with Myopia and Amblyopia, run by Beijing Airdoc Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length shortening comparing to that value of baseline (mm） (time frame: 12-month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05957458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.