MyopiaNCT06232161
Sustained Effect of Red-light Therapy for Myopia Control: A 2-Year Post-Trial Follow-up Study
A study testing Red-light therapy device and Spectacles in people with Myopia, run by Beijing Airdoc Technology Co., Ltd. at 1 site in China.
Trial summary
To evaluate the long-term efficacy and safety of red-light therapy for myopia control over 2 years, and the potential rebound effect after treatment cessation. The Chinese myopic children who originally completed the one-year randomised controlled trial in the previous study were enrolled. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Red-light therapy device and Spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical diagnosis of myopia;
- Ages of 9~13 years old;
- Must be with best corrected visual acuity ≥20/25 (decimal record);
- Must be the subject in the previous study of 12-month red-light therapy of myopia;
Who cannot join
- Clinical diagnosis of glaucoma or retinal lesions;
- Clinical diagnosis of optic media lesions (e.g., central thick corneal scars, cataract);
- Clinical diagnosis of optic nerve dysfunction;
- Clinical diagnosis of amblyopia;
- Must be eligible for follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective,2-Year Post-Trial Follow-up Study of Sustained and Rebound Effect of Red-light Therapy for Myopia in Ningbo.
To evaluate the long-term efficacy and safety of red-light therapy for myopia control over 2 years, and the potential rebound effect after treatment cessation.
The Chinese myopic children who originally completed the one-year randomised controlled trial in the previous study were enrolled. Children continued or started to daily usage of red-light therapy were defined as the RL group, while those who stopped using red-light therapy and switched to single-vision spectacles (SVS) as well as those who continued to keep single-vision spectacles in the second year were both regarded as the SVS group. Red-light therapy was provided by an at-home desktop light device emitting red-light of 650 nm and was administered for 3 min at a time, twice a day. Changes in axial length (AL) and cycloplegic spherical equivalence refraction (SER) are to be measured and compared as well as the adverse effects including the rebound effect.
Read more
Red-light therapy has emerged as a novel myopia control treatment modality recently. A 12-month randomised controlled trial (RCT) conducted by our research team was thought to be earlier to evaluate the treatment of myopic children using red-light therapy. The trial demonstrated that PBM therapy was effective on myopia control, reducing axial elongation and spherical equivalence refraction (SER) progression 103% and 127% compared with single vision spectacle (SVS) over a 12-month period, respectively. The promising efficacy of red-light therapy has been further confirmed in other studies. In addition, satisfactory user acceptability and no unrecovered functional and structural damages were observed.
Myopia generally progresses throughout childhood and hence a study duration of 1 year is not sufficient to widely adopt the red-light therapy as a treatment strategy for myopia control. The sustainability of treatment efficacy, rebound phenomenon upon cessation of treatment, and potential risks and adverse effects in myopic children with longer-term PBM therapy, remain to be fully elucidated.
Thus, the aims of this post-trial follow-up study were to invite the participants to come back for a 24-month visit and to investigate the long-term efficacy and safety of continued red-light therapy as well as the potential rebound effect following red-light treatment cessation.
Read the detailed description
Interventions and visits All spectacle lenses were made for single focus with full correction for each subject as the first intervention throughout the whole procedure for both groups. PBM therapy was performed with a low-intensity laser (LD-A, Jilin LD Optoelectronics Technology, Jilin, China) with an irradiance of 0.35 ± 0.02 mW/cm2, a wavelength of 650 nm ± 10 nm, and illumination of approximately 400 lux on average at the first 12 month. At the second 12 months, non-randomized cohorts continued according to the willing to use the device from both groups. Once decided, those usage would be followed up for another 12 months for tracking the change of axial length as well as the change of refractive error. All the adverse effects and any harms are encouraged to report during the next 12 months' study.
- Conditions
- Myopia
- Being tested
- Red-light therapy device, Spectacles
- Keywords
- myopia, red-light therapy
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red-light therapy deviceDevice
Also called Repeated low-level red-light (RLRL) therapy, Low intensity red light (laser) therapy, Photobiomodulation therapy (PBM) therapy
Red-light therapy was performed with a low-intensity laser (LD-A, Jilin LD Optoelectronics Technology, Jilin, China) with an irradiance of 0.35 ± 0.02 mW/cm2, a wavelength of 650 nm ± 10 nm, and illumination of approximately 400 lux on average.
SpectaclesDevice
Single focus spectacles, that is to say, wearing glasseses with minus power lens
| Study group | Role | What they receive |
|---|---|---|
| red-light therapy group | Experimental | The red-light therapy group would be treated with red-light therapy twice daily including the single focus spectacles during the follow-up. Receives: Device: Red-light therapy device; Device: Spectacles |
| control group | Other | The control group including both the stopping red-light therapy group from the first 12 months (who obtained red-light therapy but stopped during the second 12-month follow-up) and those never use red-light therapy. Receives: Device: Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of axial length (mm) with the measurement of device named by IntraOcular Lens Master(IOLmaster 500)
The change of axial length (mm) from the 24 months and 12 months from the baseline for each subject; The right eye were considered for the comparison between groups.
The change value is recorded of the average from 5 values at the same follow-up
Measured: 12-month
Secondary outcomes (1)
Change of refractive error (D) with cycloplegic refraction with the same autorefractor
The change of refractive error (D) from the follow-up of each 12-month from the baseline. The right eye were considered for the comparison
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 posted30 Jan 2024
- Study start13 May 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- The first 12-month follow-up were parallel of two groups: treatment group and control group with randomized and single blind; While the second 12-month follow-up were chosen to be in the treatment group or in the control group depended on the willingness of red-light therapy from both patients and their family.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ningbo Eye Hospital
- Responsible party
- Principal investigator, Qiu Kaikai, Ningbo Eye Hospital
- Investigators
- LEI ZHOU, M.D., Study chair, Ningbo Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232161
- Sponsor's protocol ID
- Ningbo EYE Hospital
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective,2-Year Post-Trial Follow-up Study of Sustained and Rebound Effect of Red-light Therapy for Myopia in Ningbo.
- ClinicalTrials.gov ID
- NCT06232161
- Acronym / sponsor ID
- Ningbo EYE Hospital
- Conditions
- Myopia
- Keywords
- myopia, red-light therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Ningbo Eye Hospital
- Study start
- 13 May 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 2024 (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.
To evaluate the long-term efficacy and safety of red-light therapy for myopia control over 2 years, and the potential rebound effect after treatment cessation.
The Chinese myopic children who originally completed the one-year randomised controlled trial in the previous study were enrolled. Children continued or started to daily usage of red-light therapy were defined as the RL group, while those who stopped using red-light therapy and switched to single-vision spectacles (SVS) as well as those who continued to keep single-vision spectacles in the second year were both regarded as the SVS group. Red-light therapy was provided by an at-home desktop light device emitting red-light of 650 nm and was administered for 3 min at a time, twice a day. Changes in axial length (AL) and cycloplegic spherical equivalence refraction (SER) are to be measured and compared as well as the adverse effects including the rebound effect.
Red-light therapy has emerged as a novel myopia control treatment modality recently. A 12-month randomised controlled trial (RCT) conducted by our research team was thought to be earlier to evaluate the treatment of myopic children using red-light therapy. The trial demonstrated that PBM therapy was effective on myopia control, reducing axial elongation and spherical equivalence refraction (SER) progression 103% and 127% compared with single vision spectacle (SVS) over a 12-month period, respectively. The promising efficacy of red-light therapy has been further confirmed in other studies. In addition, satisfactory user acceptability and no unrecovered functional and structural damages were observed.
Myopia generally progresses throughout childhood and hence a study duration of 1 year is not sufficient to widely adopt the red-light therapy as a treatment strategy for myopia control. The sustainability of treatment efficacy, rebound phenomenon upon cessation of treatment, and potential risks and adverse effects in myopic children with longer-term PBM therapy, remain to be fully elucidated.
Thus, the aims of this post-trial follow-up study were to invite the participants to come back for a 24-month visit and to investigate the long-term efficacy and safety of continued red-light therapy as well as the potential rebound effect following red-light treatment cessation.
Detailed description
Interventions and visits All spectacle lenses were made for single focus with full correction for each subject as the first intervention throughout the whole procedure for both groups. PBM therapy was performed with a low-intensity laser (LD-A, Jilin LD Optoelectronics Technology, Jilin, China) with an irradiance of 0.35 ± 0.02 mW/cm2, a wavelength of 650 nm ± 10 nm, and illumination of approximately 400 lux on average at the first 12 month. At the second 12 months, non-randomized cohorts continued according to the willing to use the device from both groups. Once decided, those usage would be followed up for another 12 months for tracking the change of axial length as well as the change of refractive error. All the adverse effects and any harms are encouraged to report during the next 12 months' study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first 12-month follow-up were parallel of two groups: treatment group and control group with randomized and single blind; While the second 12-month follow-up were chosen to be in the treatment group or in the control group depended on the willingness of red-light therapy from both patients and their family.
| Arm | Type | Receives |
|---|---|---|
| red-light therapy group | Experimental | Device: Red-light therapy device, Device: SpectaclesThe red-light therapy group would be treated with red-light therapy twice daily including the single focus spectacles during the follow-up. |
| control group | Other | Device: SpectaclesThe control group including both the stopping red-light therapy group from the first 12 months (who obtained red-light therapy but stopped during the second 12-month follow-up) and those never use red-light therapy. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical diagnosis of myopia;
- Ages of 9~13 years old;
- Must be with best corrected visual acuity ≥20/25 (decimal record);
- Must be the subject in the previous study of 12-month red-light therapy of myopia;
Key exclusion criteria (5 listed)
- Clinical diagnosis of glaucoma or retinal lesions;
- Clinical diagnosis of optic media lesions (e.g., central thick corneal scars, cataract);
- Clinical diagnosis of optic nerve dysfunction;
- Clinical diagnosis of amblyopia;
- Must be eligible for follow-up.
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 |
|---|---|---|
| Red-light therapy deviceAlso: Repeated low-level red-light (RLRL) therapy, Low intensity red light (laser) therapy, Photobiomodulation therapy (PBM) therapyRed-light therapy was performed with a low-intensity laser (LD-A, Jilin LD Optoelectronics Technology, Jilin, China) with an irradiance of 0.35 ± 0.02 mW/cm2, a wavelength of 650 nm ± 10 nm, and illumination of approximately 400 lux on average. | Device | red-light therapy group |
| SpectaclesSingle focus spectacles, that is to say, wearing glasseses with minus power lens | Device | control group, red-light therapy group |
Primary outcome
Change of axial length (mm) with the measurement of device named by IntraOcular Lens Master(IOLmaster 500)
Time frame: 12-month
The change of axial length (mm) from the 24 months and 12 months from the baseline for each subject; The right eye were considered for the comparison between groups. The change value is recorded of the average from 5 values at the same follow-up
1 secondary outcome
Change of refractive error (D) with cycloplegic refraction with the same autorefractor
Time frame: 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Results publication: 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.
- The first 12-month follow-up report of PBM therapyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
LEI ZHOU, M.D. study chair
Ningbo Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red-light therapy device and Spectacles in people with Myopia, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 14 Feb 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change of axial length (mm) with the measurement of device named by IntraOcular Lens Master(IOLmaster 500) (time frame: 12-month). 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 NCT06232161, 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 14 Feb 2024.