Myopia, ProgressiveNCT05881655
Slow Myopia Progression With Different Irradiance Light
A study testing Airdoc Red Lighting Device in people with Myopia, Progressive, run by Beijing Airdoc Technology Co., Ltd. at 1 site in China.
Trial summary
It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm. The control group is to wear the same brand and design spectalces as those two study groups. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- Airdoc Red Lighting Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2023to 30 Dec 2025
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6~12 years old
- Refractive Error of Myopia within -0.50 D~-5.00 D, Anisometropia less or equal to 2.00D, The best corrected vision acuity is better or equal to 0.8 （decimal record).
- Written consent formed with supervisions and children with 6 month follow-up.
Who cannot join
- Photophobia or allergy to any cycloplegic eyedrops (such as tropcaine, cyclopentolate).
- Lesions in fundus or any part of eyeball with abnormal corrected vision such as keratoconus.
- Strabisumus with angles large or equal to 5 prism dioper.
- With other myopia control device such as atropine, Orthokeratology, Misight lens or other myopia control device.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Children Medical Center
Shanghai
Shanghai Children Medical Center Zhang, MD, +8618510386815, qiukaikai0620@airdoc.com
About this study
Official title: A Prospective Clinical Trial on Slow Myopia Progression With Two Different Irradiance Light at Baseline and Dynamic Changes at Follow-up
It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length.The goal is to test which power (1.2mW and 0.6mW) is better in myopic children for 3 month's follow-up and also to test how to get better result with the increaing or decreasing lighting power for the total 6 month follow-up results .
Read the detailed description
It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Each group has 25 myopic children. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm are randomized to be allocated into the 3 groups. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length. All groups will be wearing a special lens named by Stellest with high aspherical lens design.
- Conditions
- Myopia, Progressive
- Being tested
- Airdoc Red Lighting Device, Special Spectacles to Control 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.
Airdoc Red Lighting DeviceDevice
Also called Repeated Red Light, Low Lever Laser Therapy, Low Intensity Light Therapy, Photobiomodulation Therapy, Seconee, 650nm Red Light
A medical device with ultra low lever laser irradiance of 0.6mW or 1.2mW at the surface of cornea. And the therapy lasts 3 minutes with the 4 hours or more interval of break.
Special Spectacles to Control MyopiaDevice
Also called Essilor® Stellest™ Lenses, H.A.L.T lens
Customer designed power and fitting to each subject for all the study periods.
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | With 1.2mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia. Receives: Device: Airdoc Red Lighting Device; Device: Special Spectacles to Control Myopia |
| Study Group 2 | Experimental | With 0.6mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia. Receives: Device: Airdoc Red Lighting Device; Device: Special Spectacles to Control Myopia |
| Control Group | Placebo comparator | Wearing H.A.L.T lens to control myopia only. Receives: Device: Special Spectacles to Control Myopia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
Measured with IOLmaster 500 or Lenstar at follow-up from baseline
Measured: 3-month
Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
Measured with IOLmaster 500 or Lenstar at follow-up from baseline
Measured: 6-month
Secondary outcomes (5)
Mean Change of Refractive Error at follow-up from Baseline (mm)
Measured with autorefractor; Spherical Equivalence is calculated.
Measured: 3-month
Mean Change of Refractive Error at follow-up from Baseline (mm)
Measured with autorefractor; Spherical Equivalence is calculated according to the formular of SE=Spherical +1/2 * Cyclinder Diopter.
Measured: 6-month
Mean Change of Choroidal Thickness (um)
Measured with Optical Coherence Topography (OCT)
Measured: 3-month
Mean Change of Choroidal Thickness (um)
Measured with Optical Coherence Topography (OCT)
Measured: 6-month
Change of Fundus
Mesured with color fundus camera with Artificial Intelligence Database
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start20 May 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Medical Center
- Responsible party
- Sponsor
- Investigators
- Hong Liu, MD, PHD, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881655
- Sponsor's protocol ID
- Airdoc MPC
- Status last verified
- May 2023
- First submitted
- 20 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Trial on Slow Myopia Progression With Two Different Irradiance Light at Baseline and Dynamic Changes at Follow-up
- ClinicalTrials.gov ID
- NCT05881655
- Acronym / sponsor ID
- Airdoc MPC
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Medical Center
- Study start
- 20 May 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 31 May 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.
It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length.The goal is to test which power (1.2mW and 0.6mW) is better in myopic children for 3 month's follow-up and also to test how to get better result with the increaing or decreasing lighting power for the total 6 month follow-up results .
Detailed description
It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Each group has 25 myopic children. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm are randomized to be allocated into the 3 groups. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length. All groups will be wearing a special lens named by Stellest with high aspherical lens design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Device: Airdoc Red Lighting Device, Device: Special Spectacles to Control MyopiaWith 1.2mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia. |
| Study Group 2 | Experimental | Device: Airdoc Red Lighting Device, Device: Special Spectacles to Control MyopiaWith 0.6mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia. |
| Control Group | Placebo comparator | Device: Special Spectacles to Control MyopiaWearing H.A.L.T lens to control myopia only. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6~12 years old
- Refractive Error of Myopia within -0.50 D~-5.00 D, Anisometropia less or equal to 2.00D, The best corrected vision acuity is better or equal to 0.8 （decimal record).
- Written consent formed with supervisions and children with 6 month follow-up.
Key exclusion criteria (4 listed)
- Photophobia or allergy to any cycloplegic eyedrops (such as tropcaine, cyclopentolate).
- Lesions in fundus or any part of eyeball with abnormal corrected vision such as keratoconus.
- Strabisumus with angles large or equal to 5 prism dioper.
- With other myopia control device such as atropine, Orthokeratology, Misight lens or other myopia control device.
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 Red Lighting DeviceAlso: Repeated Red Light, Low Lever Laser Therapy, Low Intensity Light Therapy, Photobiomodulation Therapy, Seconee, 650nm Red LightA medical device with ultra low lever laser irradiance of 0.6mW or 1.2mW at the surface of cornea. And the therapy lasts 3 minutes with the 4 hours or more interval of break. | Device | Study Group 1, Study Group 2 |
| Special Spectacles to Control MyopiaAlso: Essilor® Stellest™ Lenses, H.A.L.T lensCustomer designed power and fitting to each subject for all the study periods. | Device | Control Group, Study Group 1, Study Group 2 |
Primary outcome
Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
Time frame: 3-month
Measured with IOLmaster 500 or Lenstar at follow-up from baseline
Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
Time frame: 6-month
Measured with IOLmaster 500 or Lenstar at follow-up from baseline
5 secondary outcomes
Mean Change of Refractive Error at follow-up from Baseline (mm)
Time frame: 3-month
Mean Change of Refractive Error at follow-up from Baseline (mm)
Time frame: 6-month
Mean Change of Choroidal Thickness (um)
Time frame: 3-month
Mean Change of Choroidal Thickness (um)
Time frame: 6-month
Change of Fundus
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- 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.
Hong Liu, MD, PHD principal investigator
Shanghai Children's Medical Center
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 Red Lighting Device 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 3 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 31 May 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 Sophia Wang, MD,PHD (+8618510386815, hechao@airdoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm) (time frame: 3-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2023.