Myopia Control Combined PBM With Myopic Defocus Lens in Children (NCT05756959) | Clinical Trial Compass
RecruitingNot Applicable
Myopia Control Combined PBM With Myopic Defocus Lens in Children
China304 participantsStarted 2022-12-12
Plain-language 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.
Who can participate
Age range6 Years – 13 Years
SexALL
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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.