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This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | TAMER lenses are used first for 6 months, followed by SV lenses for 6 months. |
|
| Group B | Experimental | SV lenses are used first for 6 months, followed by TAMER lenses for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAMER Lens Spectacle | Device | Regular daily wear of TAMER lens spectacle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Spherical Equivalent change | cycloplegic SE change | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Axial Length change | 6 months | |
| Spherical Equivalent change | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangui He | Contact | 021-62982727-817 | dllcrco@shsyf.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Disease Prevention and Treatment Center | Recruiting | Shanghai | Shanghai Municipality | 200041 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| SV lenses |
| Device |
SV lenses |
|