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Evaluate the effectiveness of different lithographic microstructured myopia management lenses in controlling the progression of myopia in children and adolescents, as well as the safety and comfort of wearing them. Explore effective defocus microlens designs for myopia control and the feasibility of applying lithographic microstructured myopia management lenses in myopia prevention and control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photolithography microstructure myopia management lens (A) | Experimental |
| |
| Photolithography microstructure myopia management lens (B) | Experimental |
| |
| Photolithography microstructure myopia management lens (C) | Experimental |
| |
| Myopia Management Lenses (highly aspherical lenslets) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myopia management lens | Device | Microstructure myopia management lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in spherical equivalent (SE) | Changes in spherical equivalent (SE) of mydriatic refraction compared to baseline (D) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in axial length (AL) | Changes in axial length (AL) compared to baseline (mm) | 12 months |
| Changes in choroidal thickness (ChT) | Changes in choroidal thickness (ChT) compared to baseline (μm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University | Shanghai | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2025 | Mar 30, 2026 |
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| 12 months |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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