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This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy.
This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Arm 1 | Experimental | Single vision, impact-resistant spectacle lenses |
|
| Test Arm 2 | Other | Single vision, impact-resistant spectacle lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single vision, impact-resistant spectacle lenses; Test Arm | Device | Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spherical equivalent refraction | Change in spherical equivalent refraction from baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | Change in axial length from baseline | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer S Hill, BS | Contact | 678-361-4877 | jhill@sightglassvision.com | |
| Vanessa Tasso, MA, MBA | Contact | 949-751-7039 | vtasso@sightglassvision.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elsa Pao, OD | Recruiting | Oakland | California | 94607 | United States |
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Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables will be masked.
| Single vision, impact-resistant spectacle lenses; Control Arm | Device | Single vision, impact-resistant spectacle lenses |
|
| Scripps Poway Eyecare | Recruiting | San Diego | California | 92131 | United States |
|
| Pacific Rims Optometry | Recruiting | San Francisco | California | 94127 | United States |
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| Paje Optometric | Recruiting | Santa Ana | California | 92704 | United States |
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| Omega Vision Center | Recruiting | Longwood | Florida | 32779 | United States |
|
| Marietta Eye Clinic | Recruiting | Marietta | Georgia | 30060 | United States |
|
| Ilinois College of Optometry | Recruiting | Chicago | Illinois | 60616 | United States |
|
| Kannarr Eye Care | Recruiting | Pittsburg | Kansas | 66762 | United States |
|
| New England College of Optometry | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Advanced Eyecare PC | Recruiting | Raytown | Missouri | 64133 | United States |
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| Athens Eye Care | Recruiting | Athens | Ohio | 45701 | United States |
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| Procare Vision Centers, Inc. | Recruiting | Granville | Ohio | 43023 | United States |
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| Texas State Optical - Dowlen | Recruiting | Beaumont | Texas | 77706 | United States |
|
| Bellaire Family Eye Care | Recruiting | Bellaire | Texas | 77401 | United States |
|
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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