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Recruiting NCT05756959

Myopia Control Combined PBM With Myopic Defocus Lens in Children

Trial Parameters

Condition Myopia, Progressive
Sponsor Beijing Airdoc Technology Co., Ltd.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 304
Sex ALL
Min Age 6 Years
Max Age 13 Years
Start Date 2022-12-12
Completion 2027-08-01
Interventions
PBMPeripheral defocus spectaclesSingle vision spectacles

Brief 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 Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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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