Myopia Control Combined PBM With Myopic Defocus Lens in Children
NCT ID: NCT05756959
Last Updated: 2023-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
304 participants
INTERVENTIONAL
2022-12-12
2027-12-31
Brief Summary
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Detailed Description
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The red light is low lever laser therapy at wavelength of 650nm.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PBM therapy + SVS
Low lever red light therapy with single vision spectacles
PBM
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
Single vision spectacles
Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)
Peripheral defocus spectacles
a spectacles with special design with peripheral myopic defocus to control myopia progression
Peripheral defocus spectacles
plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina
PBM +Peripheral defocus spectacles
Low lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression
PBM
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 spectacles
plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina
Control
single vision spectacles only as the control
Single vision spectacles
Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)
Interventions
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PBM
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 spectacles
plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina
Single vision spectacles
Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
6 Years
13 Years
ALL
No
Sponsors
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The First People's Hospital of Xuzhou
OTHER
Beijing Airdoc Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yan Wang, BA
Role: STUDY_DIRECTOR
The First People's Hospital of Xuzhou
Locations
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the first people's hospital of Xuzhou
Xuzhou, Jiangsu, China
Countries
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Central Contacts
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Lei Qiao, PHD, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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Xuzhou First People's Hospital
Identifier Type: -
Identifier Source: org_study_id
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