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This is a randomized, controlled, open-label, evaluator-blinded, multicenter, clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SightGlass Vision Test Arm Groups I (formerly test group) | Experimental | Single vision, impact-resistant spectacle lenses |
|
| SightGlass Vision Test Arm Groups II (formerly control group) | Experimental | Single vision, impact-resistant spectacle lenses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel spectacle lens design | Device | Use of spectacle lenses may reduce the rate of progression of juvenile myopia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Axial length Group I | Change in axial length from baseline to 36 months | 12 months |
| Axial length Group II | Change in axial length from baseline to 12 months | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
1. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate
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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 |
|---|---|---|---|---|---|---|
| Aier Eye Hospital | Recruiting | Changsha | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Evaluator/Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked to participant's former treatment group.
| West China Hospital | Recruiting | Chengdu | China |
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| Zhongshan Ophthalmic Center | Not yet recruiting | Guangzhou | China |
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| Fudan University EENT | Recruiting | Shanghai | China |
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| Tianjin Eye Hospital | Recruiting | Tianjin | China |
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