Myopia Control Combined PBM With Myopic Defocus Lens in Children
Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month
Beijing Airdoc Technology Co., Ltd.
304 participants
Dec 12, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Informed consent by the supervision of the children
- ~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 Criteria5
- 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.
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Interventions
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
plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina
Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05756959