RecruitingNot ApplicableNCT05756959

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


Sponsor

Beijing Airdoc Technology Co., Ltd.

Enrollment

304 participants

Start Date

Dec 12, 2022

Study Type

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

Min Age: 6 YearsMax Age: 13 Years

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

DEVICEPBM

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

DEVICEPeripheral defocus spectacles

plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina

DEVICESingle vision spectacles

Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)


Locations(1)

the first people's hospital of Xuzhou

Xuzhou, Jiangsu, China

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NCT05756959


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