Myopia Control Combined PBM With Myopic Defocus Lens in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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myopic children with age from 6  13 years old. And refraction from -0.50D -5.50D. The red light is low lever laser therapy at wavelength of 650nm.

Official Title
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Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month

Conditions
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Myopia, Progressive

Intervention / Treatment
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* Device: PBM
* Device: Peripheral defocus spectacles
* Device: Single vision spectacles


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBM therapy + SVS<br>Low lever red light therapy with single vision spectacles | Device: PBM<br>* 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<br>* Other names: Low lever light therapy; low intensity red light therapy; low lever laser therapy; repeated red light therapy;Device: Single vision spectacles<br>* Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)<br>* Other names: single vision glasseses for myopia correction lenses;|
| Experimental: Peripheral defocus spectacles<br>a spectacles with special design with peripheral myopic defocus to control myopia progression | Device: Peripheral defocus spectacles<br>* plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina<br>* Other names: Myopic defocus spectacles for myopia control;|
| Experimental: PBM +Peripheral defocus spectacles<br>Low lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression | Device: PBM<br>* 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<br>* Other names: Low lever light therapy; low intensity red light therapy; low lever laser therapy; repeated red light therapy;Device: Peripheral defocus spectacles<br>* plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina<br>* Other names: Myopic defocus spectacles for myopia control;|
| Placebo Comparator: Control<br>single vision spectacles only as the control | Device: Single vision spectacles<br>* Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)<br>* Other names: single vision glasseses for myopia correction lenses;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| axial length (mm) | Axial length changes at follow-up of 6 month from baseline will be measured by IOLmaster 500 at the same site by the same examiner with the mean values of 5 times measurements at either time. Changes in axial length (mm) without cycloplegia are to be measured by IOLmaster(Carl Zeiss). Five measurements will be taken and then averaged. | 6 month | 
| SE (Diopter, D) | changes of cycloplegic spherical equivalent from baseline will be measured under cycloplegic refraction by autorefractor. Five measured by the same autorefractor are to be obtained for each eye. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UCVA (logMar visual acuity record) | Uncorrected visual acuity will be measured under 5-meter distance logMar Visual acuity chart without any aid （including the spectacles or contact lens) at baseline and at follow-up | 6 month | 
| BCVA (logMar visual acuity record) | Best corrected visual acuity will be measured under the same 5-meter distance logMar Visual acuity as the UCVA both at baseline and at follow-up. | 6 month | 
| OCT | Opitcal coherence tomography(OCT) record The marcular sturcture and image scanned by the optical coherent topography will be measured by linear scan at the marcular by the same Optical coherence tomography with the same examiner and the same instrument both at baseline and at follow-up | 6-month | 
| SFCT （um) | Sub-forveal choroidal thickness will be measured with the same software in the same Optical coherence tomography (OCT) at the location from the foveal center manually | 6-month |