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The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.
This is a 3-year prospective, multicenter, randomized, and single-masked*, parallel-group controlled clinical study. The purpose of this study is to evaluate the safety and efficacy of wearing Novel spectacle lenses to correct myopic ametropia, slow the progression of myopia and axial elongation in myopic children as compared to the use of single vision spectacles lenses.
The treatment arms are:
Single-masked:
The investigator responsible for conducting ocular data measurements related to the primary and secondary endpoints will be masked. The participants will not be informed the treatment arm during the clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model-A Novel Spectacle lens | Experimental |
| |
| Model-B Novel Spectacle lens | Experimental |
| |
| Single Vision Spectacle lens | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Model-A Novel spectacle lens | Device | Model-A Novel spectacle lenses will be given to 1 arm to wear for 36 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | The difference of Axial length changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants. | 24 months |
| Spherical equivalent cycloplegic autorefraction | The difference of spherical equivalent cycloplegic autorefraction changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | 36 months | |
| Spherical equivalent cycloplegic autorefraction | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Beijing | China | ||||
| Guangzhou Aier Eye Hospital |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Model-B Novel spectacle lens | Device | Model-B Novel spectacle lenses will be given to 1 arm to wear for 36 months |
|
| Single vision spectacle lens | Device | Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months |
|
| Guangzhou |
| China |
| Eye and ENT Hospital of Fudan University | Shanghai | China |
| Shengyang He Eye Specialist Hospital | Shengyang | China |
| Tianjin Medical University Eye Hospital | Tianjin | China |