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This study uses 1.585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images. In addition, the helical arrangement and reduced slit area can generate defocusing signals, inhibiting the development of myopia. Therefore, based on previous research, this study plans to evaluate the safety and effectiveness of 1.585 double helix defocus lens PC frame eyeglasses in controlling the progression of myopia in children and adolescents through a randomized controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Double Helix Design Defocus Lens Spectacle (RACE) for 2 years |
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| Group B | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double Helix Design Defocus Lens Spectacle (RACE) | Device | Double Helix Design Defocus Lens Spectacle wearing more than 10h/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spherical Equivalent change | cycloplegic SE change | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Axial Length change | 1 year | |
| Visual Acuity change | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangui He | Shanghai | Shanghai Municipality | 201103 | China |
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| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| single-vision spetacle lens | Device | single-vision spetacle lens wearing more than 10h/day. |
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