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| Name | Class |
|---|---|
| The First People's Hospital of Xuzhou | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBM therapy + SVS | Experimental | Low lever red light therapy with single vision spectacles |
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| Peripheral defocus spectacles | Experimental | a spectacles with special design with peripheral myopic defocus to control myopia progression |
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| PBM +Peripheral defocus spectacles | Experimental | Low lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression |
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| Control | Placebo Comparator | single vision spectacles only as the control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBM | Device | 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 |
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| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Any adverse event reported by subjects or doctors related or un-related to the product during the whole study period | 6 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Li, MD, PHD | Contact | +8615162130727 | 834582241@qq.com | |
| Lei Qiao, PHD, MD | Contact | +15162127602 |
| Name | Affiliation | Role |
|---|---|---|
| Yan Wang, BA | The First People's Hospital of Xuzhou | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first people's hospital of Xuzhou | Recruiting | Xuzhou | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Peripheral defocus spectacles | Device | plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina |
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| Single vision spectacles | Device | Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction) |
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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 |