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A Prospective, randomized, controlled double masked trial to assess the performance of Myoslow lens in slowing myopia progression in children.
The following study measures will be assessed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single vision | Active Comparator | Single vision glasses |
|
| myoslow | Experimental | The Myoslow spectacle lens is based on the Defocus Incorporated Multiple Segments (DIMS) mechanism of action. This lens provides the same optical image as the Defocusing Incorporated Soft Contact Lens (DISC) without the drawbacks inherent with contact lens fitting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myoslow | Device | The Myoslow spectacle lens is based on the Defocus Incorporated Multiple Segments (DIMS) mechanism of action. This lens provides the same optical image as the Defocusing Incorporated Soft Contact Lens (DISC) without the drawbacks inherent with contact lens fitting. |
| Measure | Description | Time Frame |
|---|---|---|
| spherical equivalent error | Change in spherical equivalent refractive error from baseline to 24-month visit | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | Mean change in axial length (mm) from baseline at 24-month visit (Based on Biometry) | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haim Stolovitch, MD | Crystal Optic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba MC | Ramat Gan | Israel |
coded data only
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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RCT
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Participants and site staff will be masked to the assigned arm
|
| Single Vision | Device | Single vision glasses |
|