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This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYPRESS Extension Test Arm | Experimental | Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm |
|
| CYPRESS Extension Control Arm | Placebo Comparator | Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel spectacle lens design | Device | Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | Test vs. control axial length change from baseline | 72 months |
| Spherical equivalent refraction (SER) | Test vs. control spherical equivalent refraction (SER) change from baseline | 72 months |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | Change from baseline | 42 months |
| SER | Change from baseline | 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Optometric Group | Whittier | California | 90606 | United States | ||
| Omega Vision Center, PA |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Spectacle lenses | Device | Single vision, impact resistant spectacle lenses |
|
| Longwood |
| Florida |
| 32779 |
| United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Haik Humble | West Monroe | Louisiana | 71291 | United States |
| Advanced Eyecare PC | Raytown | Missouri | 64133 | United States |
| SUNY School of Optometry | New York | New York | 10036 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Dunes Eye Consultants | Dakota Dunes | South Dakota | 57049 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| Dr. Bridgitte Shen Lee (PI) | Houston | Texas | 77205 | United States |
| William J Bogus, OD, FAAO | Salt Lake City | Utah | 84106 | United States |
| Centre for Ocular Research and Education | Waterloo | Ontario | N2L 3G1 | Canada |