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The purpose of this study is to demonstrate that the test spectacle lens is safe and effective in slowing myopia progression in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Innovative myopia control spectacle lens | Experimental |
| |
| Single vision spectacle lens | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| innovative myopia control spectacle lens | Device | using a innovative spectacle lens to control myopia progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | Change in axial length from baseline | 36 Months |
| Cycloplegic spherical equivalent refraction | Change in cycloplegic spherical equivalent refraction from baseline | 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | Change in axial length from baseline | 24 Months |
| Cycloplegic spherical equivalent refraction | Change in cycloplegic spherical equivalent refraction from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Poway Optometry | San Diego | California | 92131 | United States | ||
| Sabal Eye Care |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Single vision spectacle lens | Device | single vision spectacle lens for myopia and astigmatism correction |
|
| 24 Months |
| Longwood |
| Florida |
| 32779 |
| United States |
| Illinois College of Optometry | Chicago | Illinois | 60616 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| New England College of Optometry | Boston | Massachusetts | 02115 | United States |
| SUNY College of Optometry | New York | New York | 10036 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Mann Eye Institute | Houston | Texas | 77002 | United States |