Myopia, ProgressiveNCT05761379
Clinical Study of Light Therapy to Control Myopia Progression in Children
A study testing Photobiomodualtion Therapy and Single vision spectacles for correction myopia in people with Myopia, Progressive, run by Beijing Airdoc Technology Co., Ltd. at 1 site in China.
Trial summary
Low-lever red light therapy (LLLT) has been used to control myopia progression in China for a few years besides amblyopia therapy for a few decades. This study is to test the efficacy of PBM therapy to myopia children as well as to compare two types of PBM therapy to control myopia progression within one month. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- Photobiomodualtion Therapy and Single vision spectacles for correction myopia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2023to 30 Dec 2024
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is not limited;
- Equivalent sphere (SER): -0.50D ~ -6.00D (including-0.50 and-6.00D);
- Best corrected vision in one eye under glasses correction: 0.1 log MAR;
- No strabismus: no more than 15 prism constant dominance strabismus after far and near cover tests;
- No myopia control measures within the previous 4 weeks: such as orthokeratology lens, gradient lens, double light lens, eye drops for myopia control (such as atropine), myopia defocus glasses, red light for myopia control, other specially designed myopia light treatment instruments or contact lenses for special design to control myopia (such as Misight);
Who cannot join
- Any ocular(including constant dominant strabismus with more than 15 prisms) and systemic diseases or abnormalities can significantly affect visual function or promote the progression of myopia;
- Other interventions for myopia control before 4 weeks before enrollment, For example, orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control, other specially designed comprehensive treatment devices, myopia, amblyopia, or specially designed contact lenses (such as Misight), etc.
- Subject participated in other clinical trials within 4 weeks before the enrollment;
- The investigator for safety reasons or the interests of the patient, Other circumstances in which the patient should not participate in this trial, If suffering from serious heart, liver and kidney disease. -
Trial locations and contacts
1 site in 1 country.
Chao He, Ph.D. contact
China1 site, 1 recruiting
- Recruiting
Eye & ENT hospital of Fudan university
Shanghai, Shanghai Municipality, 200031
Meiyan Li, MD.Ph.D.
Weiming Yang, MD. PhD
About this study
Official title: Clinical Study of Low Lever Red Light Therapy With 650nm to Control Myopia Progression in Children
Low-lever red light therapy (LLLT) has been used to control myopia progression in China for a few years besides amblyopia therapy for a few decades. This study is to test the efficacy of PBM therapy to myopia children as well as to compare two types of PBM therapy to control myopia progression within one month.
Read the detailed description
LLLT utilized the 650-nm red light to provide sufficient energy to stimulate the tissue without causing damage to the surrounding tissues. And several researchers reported the long-term efficacy of LLLT in slowing the progression of myopia to date. These studies were reported various illumination and irradiance. This study is to test the efficacy of LLLT comparing to the control group as well as to test whether two types of lighting design will be different to the efficacy and safety.
- Conditions
- Myopia, Progressive
- Being tested
- Photobiomodualtion Therapy, Single vision spectacles for correction myopia
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodualtion TherapyDevice
Also called Myopia light therapy; Low lever light therapy; Low lever laser therapy; Low intensity red light thearpy
low lever light therapy with laser semi-conductor at wavelength of 650nm
Single vision spectacles for correction myopiaDevice
Also called Glasseses
Provide the distance best corrected vision acuity of refractive error of myopia for all the groups
| Study group | Role | What they receive |
|---|---|---|
| PBM therapy 1 | Experimental | PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.6±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. The lighting spot for therapy is a dot. Only one eye will be treated with PBM therapy. Receives: Device: Photobiomodualtion Therapy; Device: Single vision spectacles for correction myopia |
| PBM therapy 2 | Experimental | PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.3±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. Only one eye will be treated with PBM therapy. Receives: Device: Photobiomodualtion Therapy; Device: Single vision spectacles for correction myopia |
| Control | Placebo comparator | Single vision spectacles correction only. Receives: Device: Single vision spectacles for correction myopia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in axial length (mm）
Changes of axial length at 1-Month follow-up from baseline with IOLmaster 500
Axial length measurement at baseline and at follow-up with IOLmaster(Carl Zeiss). Five measurements were taken and averaged. The changes will be calculated by the formula as below: Change in axial length ( mm ) = Axial length value at follow-up baseline
Measured: at 1-month Follow-up
Secondary outcomes (4)
Changes in cycloplegic autorefraction (diopters, D)
Objective refraction measured by using Autorefractor. Five measurements are obtained for each eye and the average of spherical equivalence was used for statistical analysis. The measurements will be both with cycloplegia at baseline and at follow-up. The changes in cycloplegic autorefraction are calculated in the mean value of each group.
Measured: at 1-month Follow-up and at baseline
Changes of choroidal thickness under macular foveal (um)
Swept-source optical coherence tomography (OCT) and OCT angiography were used To measure choroidal fovea thickness at baseline and at follow-up. To avoid the effects of circadian rhythm on the results, OCT scanning was performed twice by the same investigator between 8:00 A.M. and 2:00 P.M. at baseline and 1-month follow-up. Two independent skilled professionals measured the sub-foveal choroidal thickness （SFChT) using a linear measurement program during the OCT scan. To increase the visibility of the choroid, the enhanced depth imaging mode was used. We defined the thinnest part of the macula in the image as the fovea. The SFChT was measured from the outermost part of the retinal pigment epithelium to the inner layer of the the choroidoscleral interface.
Measured: at 1-month Follow-up and at baseline
Changes of cornea power
Changes in the central anterior cornea power by the value measured from auto-refraction. The mean values will be recorded as well as the mean values at follow-up of 1 month
Measured: at 1-month Follow-up and at baseline
Change in retina fovea perfusion density (RFPD, %)
Swept-source optical coherence tomography (OCT) angiography is used to measure retina fovea perfusion density (RFPD). The TowardPi OCTA allow for the in vivo visualization of three-dimensional (3-D) vascular networks in the retina and choroid. The OCTA images were acquired by the TowardPi-3D spatial identification algorithm. The retina vessels and choriocapillaris were identified by higher order moments decorrelation algorithm. The medium- and large-sized choroid vessels from Sattler's layer and Haller's layer were visualized by 3D threshold segmentation algorithm. In this study, the retinal and choroidal images were obtained with an area of 18*18 mm centered on the fovea. In addition, for a comprehensive analysis of the macular zone, we adopted the Early Treatment Diabetic Retinopathy Study (ETDRS) grid using the instrument's software which was adjusted for each individual participant's ocular magnification.
Measured: at 1-month Follow-up and at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start28 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myopia, ProgressiveStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Low lever red light therapy with Model : Sky-n1201c at the wavelength of 650nm; 3 minutes illumination for both eyes, administered twice daily at the interview of 4 hours. Children in the red light therapy group wore single vision spectacles the entire day and under red light therapy (power, 0.6mW; wavelength, 650nm; Beijing Airdoc MPC Co. Ltd, Beijing, China) twice per day for 3 minutes each session, with at least a 4-hour interval between sessions. There were no specific guidelines for room illumination. After the first measurement session, each child returned for follow-up examinations at 1, 3, and 6 months and completed all the aforementioned examinations.
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eye & ENT Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- Xingtao Zhou, M.D. PhD., Study chair, Eye & ENT Hospital of Fudan UniversityWeicun Chen, MD, PhD, Study director, Eye & ENT Hospital of Fudan UniversityMeiyan Li, MD, PhD, Study director, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761379
- Sponsor's protocol ID
- BeijingAirdoc
- Status last verified
- Jul 2023
- First submitted
- 3 Feb 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang W, Lin F, Li M, Wei R, Zhou J, Zhou X. Immediate Effect in the Retina and Choroid after 650 nm Low-Level Red Light Therapy in Children. Ophthalmic Res. 2023;66(1):312-318. doi: 10.1159/000527787. Epub 2022 Oct 31.
PubMed 36315988Liu G, Li B, Rong H, Du B, Wang B, Hu J, Zhang B, Wei R. Axial Length Shortening and Choroid Thickening in Myopic Adults Treated with Repeated Low-Level Red Light. J Clin Med. 2022 Dec 17;11(24):7498. doi: 10.3390/jcm11247498.
PubMed 36556114
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Low Lever Red Light Therapy With 650nm to Control Myopia Progression in Children
- ClinicalTrials.gov ID
- NCT05761379
- Acronym / sponsor ID
- BeijingAirdoc
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Eye & ENT Hospital of Fudan University
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 9 Mar 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.
Low-lever red light therapy (LLLT) has been used to control myopia progression in China for a few years besides amblyopia therapy for a few decades. This study is to test the efficacy of PBM therapy to myopia children as well as to compare two types of PBM therapy to control myopia progression within one month.
Detailed description
LLLT utilized the 650-nm red light to provide sufficient energy to stimulate the tissue without causing damage to the surrounding tissues. And several researchers reported the long-term efficacy of LLLT in slowing the progression of myopia to date. These studies were reported various illumination and irradiance. This study is to test the efficacy of LLLT comparing to the control group as well as to test whether two types of lighting design will be different to the efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Low lever red light therapy with Model : Sky-n1201c at the wavelength of 650nm; 3 minutes illumination for both eyes, administered twice daily at the interview of 4 hours. Children in the red light therapy group wore single vision spectacles the entire day and under red light therapy (power, 0.6mW; wavelength, 650nm; Beijing Airdoc MPC Co. Ltd, Beijing, China) twice per day for 3 minutes each session, with at least a 4-hour interval between sessions. There were no specific guidelines for room illumination. After the first measurement session, each child returned for follow-up examinations at 1, 3, and 6 months and completed all the aforementioned examinations.
| Arm | Type | Receives |
|---|---|---|
| PBM therapy 1 | Experimental | Device: Photobiomodualtion Therapy, Device: Single vision spectacles for correction myopiaPBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.6±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. The lighting spot for therapy is a dot. Only one eye will be treated with PBM therapy. |
| PBM therapy 2 | Experimental | Device: Photobiomodualtion Therapy, Device: Single vision spectacles for correction myopiaPBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.3±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. Only one eye will be treated with PBM therapy. |
| Control | Placebo comparator | Device: Single vision spectacles for correction myopiaSingle vision spectacles correction only. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is not limited;
- Equivalent sphere (SER): -0.50D ~ -6.00D (including-0.50 and-6.00D);
- Best corrected vision in one eye under glasses correction: 0.1 log MAR;
- No strabismus: no more than 15 prism constant dominance strabismus after far and near cover tests;
- No myopia control measures within the previous 4 weeks: such as orthokeratology lens, gradient lens, double light lens, eye drops for myopia control (such as atropine), myopia defocus glasses, red light for myopia control, other specially designed myopia light treatment instruments or contact lenses for special design to control myopia (such as Misight);
Key exclusion criteria (4 listed)
- Any ocular(including constant dominant strabismus with more than 15 prisms) and systemic diseases or abnormalities can significantly affect visual function or promote the progression of myopia;
- Other interventions for myopia control before 4 weeks before enrollment, For example, orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control, other specially designed comprehensive treatment devices, myopia, amblyopia, or specially designed contact lenses (such as Misight), etc.
- Subject participated in other clinical trials within 4 weeks before the enrollment;
- The investigator for safety reasons or the interests of the patient, Other circumstances in which the patient should not participate in this trial, If suffering from serious heart, liver and kidney disease. -
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 |
|---|---|---|
| Photobiomodualtion TherapyAlso: Myopia light therapy; Low lever light therapy; Low lever laser therapy; Low intensity red light thearpylow lever light therapy with laser semi-conductor at wavelength of 650nm | Device | PBM therapy 1, PBM therapy 2 |
| Single vision spectacles for correction myopiaAlso: GlassesesProvide the distance best corrected vision acuity of refractive error of myopia for all the groups | Device | Control, PBM therapy 1, PBM therapy 2 |
Primary outcome
Changes in axial length (mm）
Time frame: at 1-month Follow-up
Changes of axial length at 1-Month follow-up from baseline with IOLmaster 500 Axial length measurement at baseline and at follow-up with IOLmaster(Carl Zeiss). Five measurements were taken and averaged. The changes will be calculated by the formula as below: Change in axial length ( mm ) = Axial length value at follow-up baseline
4 secondary outcomes
Changes in cycloplegic autorefraction (diopters, D)
Time frame: at 1-month Follow-up and at baseline
Changes of choroidal thickness under macular foveal (um)
Time frame: at 1-month Follow-up and at baseline
Changes of cornea power
Time frame: at 1-month Follow-up and at baseline
Change in retina fovea perfusion density (RFPD, %)
Time frame: at 1-month Follow-up and at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 36315988Yang W, Lin F, Li M, Wei R, Zhou J, Zhou X. Immediate Effect in the Retina and Choroid after 650 nm Low-Level Red Light Therapy in Children. Ophthalmic Res. 2023;66(1):312-318. doi: 10.1159/000527787. Epub 2022 Oct 31.
- Background: PubMed 36556114Liu G, Li B, Rong H, Du B, Wang B, Hu J, Zhang B, Wei R. Axial Length Shortening and Choroid Thickening in Myopic Adults Treated with Repeated Low-Level Red Light. J Clin Med. 2022 Dec 17;11(24):7498. doi: 10.3390/jcm11247498.
- Individual participant dataSharing planned: No
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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.
Chao He, Ph.D. contact
Xingtao Zhou, M.D. PhD. study chair
Eye & ENT Hospital of Fudan University
Weicun Chen, MD, PhD study director
Eye & ENT Hospital of Fudan University
Meiyan Li, MD, PhD study director
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodualtion Therapy and Single vision spectacles for correction myopia in people with Myopia, Progressive, 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 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenny Qiu, M.D. (+8618510386815, qiukaikai0620@airdoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in axial length (mm） (time frame: at 1-month Follow-up). 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 NCT05761379, which also lists 2 linked publications.
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 1 Aug 2023.