Myopia, ProgressiveNCT05756959
Myopia Control Combined PBM With Myopic Defocus Lens in Children
A study testing PBM, Peripheral defocus spectacles and Single vision spectacles in people with Myopia, Progressive, run by Beijing Airdoc Technology Co., Ltd. at 1 site in China.
Trial summary
To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- PBM, Peripheral defocus spectacles and Single vision spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2022to 31 Dec 2027
- 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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent by the supervision of the children
- 6~13 years old (including both the 6 and 13)
- SE range: -0.50~-5.50D
- Astigmatism <=2.00D
- BCVA >=0.8
- Anisometropia <=1.50D
- Confirmed to no use of other myopia control intervention
Who cannot join
- Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.)
- Halo, glare, toutic, ADHD, psoriasis
- Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction.
- Squint, ocular lesion or acute imflammation.
- Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lei Qiao, PHD, MD contact
China1 site, 1 recruiting
- Recruiting
the first people's hospital of Xuzhou
Xuzhou, Jiangsu, 210000
Ying Li, MD.Ph.D., +8615162130727, 834582241@qq.com
Weiming Yang, MD. PhD
About this study
Official title: Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month
To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.
Read the detailed description
myopic children with age from 6 ~13 years old. And refraction from -0.50D~-5.50D.
The red light is low lever laser therapy at wavelength of 650nm.
- Conditions
- Myopia, Progressive
- Being tested
- PBM, Peripheral defocus spectacles, Single vision spectacles
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBMDevice
Also called Low lever light therapy; low intensity red light therapy; low lever laser therapy; repeated red light therapy
PBM, is a low intensity red light at wavelength of 650nm; Peripheral defocus spectacels is a peripheral design glasseses for correct myopia and control myopia
Peripheral defocus spectaclesDevice
Also called Myopic defocus spectacles for myopia control
plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina
Single vision spectaclesDevice
Also called single vision glasseses for myopia correction lenses
Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)
| Study group | Role | What they receive |
|---|---|---|
| PBM therapy + SVS | Experimental | Low lever red light therapy with single vision spectacles Receives: Device: PBM; Device: Single vision spectacles |
| Peripheral defocus spectacles | Experimental | a spectacles with special design with peripheral myopic defocus to control myopia progression Receives: Device: Peripheral defocus spectacles |
| PBM +Peripheral defocus spectacles | Experimental | Low lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression Receives: Device: PBM; Device: Peripheral defocus spectacles |
| Control | Placebo comparator | single vision spectacles only as the control Receives: Device: Single vision spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
axial length (mm)
Axial length changes at follow-up of 6 month from baseline will be measured by IOLmaster 500 at the same site by the same examiner with the mean values of 5 times measurements at either time.
Changes in axial length (mm) without cycloplegia are to be measured by IOLmaster(Carl Zeiss). Five measurements will be taken and then averaged.
Measured: 6 month
SE (Diopter, D)
changes of cycloplegic spherical equivalent from baseline will be measured under cycloplegic refraction by autorefractor. Five measured by the same autorefractor are to be obtained for each eye.
Measured: 6 month
Secondary outcomes (4)
UCVA (logMar visual acuity record)
Uncorrected visual acuity will be measured under 5-meter distance logMar Visual acuity chart without any aid （including the spectacles or contact lens) at baseline and at follow-up
Measured: 6 month
BCVA (logMar visual acuity record)
Best corrected visual acuity will be measured under the same 5-meter distance logMar Visual acuity as the UCVA both at baseline and at follow-up.
Measured: 6 month
OCT
Opitcal coherence tomography(OCT) record
The marcular sturcture and image scanned by the optical coherent topography will be measured by linear scan at the marcular by the same Optical coherence tomography with the same examiner and the same instrument both at baseline and at follow-up
Measured: 6-month
SFCT （um)
Sub-forveal choroidal thickness will be measured with the same software in the same Optical coherence tomography (OCT) at the location from the foveal center manually
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 posted7 Mar 2023
- Study start12 Dec 2022
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Dec 2027 (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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First People's Hospital of Xuzhou
- Responsible party
- Sponsor
- Investigators
- Yan Wang, BA, Study director, The First People's Hospital of Xuzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756959
- Sponsor's protocol ID
- Xuzhou First People's Hospital
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month
- ClinicalTrials.gov ID
- NCT05756959
- Acronym / sponsor ID
- Xuzhou First People's Hospital
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Beijing Airdoc Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First People's Hospital of Xuzhou
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 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.
To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.
Detailed description
myopic children with age from 6 ~13 years old. And refraction from -0.50D~-5.50D.
The red light is low lever laser therapy at wavelength of 650nm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PBM therapy + SVS | Experimental | Device: PBM, Device: Single vision spectaclesLow lever red light therapy with single vision spectacles |
| Peripheral defocus spectacles | Experimental | Device: Peripheral defocus spectaclesa spectacles with special design with peripheral myopic defocus to control myopia progression |
| PBM +Peripheral defocus spectacles | Experimental | Device: PBM, Device: Peripheral defocus spectaclesLow lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression |
| Control | Placebo comparator | Device: Single vision spectaclessingle vision spectacles only as the control |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Informed consent by the supervision of the children
- 6~13 years old (including both the 6 and 13)
- SE range: -0.50~-5.50D
- Astigmatism <=2.00D
- BCVA >=0.8
Key exclusion criteria (5 listed)
- Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.)
- Halo, glare, toutic, ADHD, psoriasis
- Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction.
- Squint, ocular lesion or acute imflammation.
- Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.
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 |
|---|---|---|
| PBMAlso: Low lever light therapy; low intensity red light therapy; low lever laser therapy; repeated red light therapyPBM, is a low intensity red light at wavelength of 650nm; Peripheral defocus spectacels is a peripheral design glasseses for correct myopia and control myopia | Device | PBM +Peripheral defocus spectacles, PBM therapy + SVS |
| Peripheral defocus spectaclesAlso: Myopic defocus spectacles for myopia controlplus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina | Device | PBM +Peripheral defocus spectacles, Peripheral defocus spectacles |
| Single vision spectaclesAlso: single vision glasseses for myopia correction lensesDistance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction) | Device | Control, PBM therapy + SVS |
Primary outcome
axial length (mm)
Time frame: 6 month
Axial length changes at follow-up of 6 month from baseline will be measured by IOLmaster 500 at the same site by the same examiner with the mean values of 5 times measurements at either time. Changes in axial length (mm) without cycloplegia are to be measured by IOLmaster(Carl Zeiss). Five measurements will be taken and then averaged.
SE (Diopter, D)
Time frame: 6 month
changes of cycloplegic spherical equivalent from baseline will be measured under cycloplegic refraction by autorefractor. Five measured by the same autorefractor are to be obtained for each eye.
4 secondary outcomes
UCVA (logMar visual acuity record)
Time frame: 6 month
BCVA (logMar visual acuity record)
Time frame: 6 month
OCT
Time frame: 6-month
SFCT （um)
Time frame: 6-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 9 Mar 2023.
- 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.
Lei Qiao, PHD, MD contact
Yan Wang, BA study director
The First People's Hospital of Xuzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBM, Peripheral defocus spectacles and Single vision spectacles 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 7 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: looking for participants now, as of the sponsor's last update on 9 Mar 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?
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?
Contact Ying Li, MD, PHD (+8615162130727, 834582241@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
axial length (mm) (time frame: 6 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 9 Mar 2023.