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| Name | Class |
|---|---|
| He Eye Specialist Hospital | UNKNOWN |
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Myopia is one of the most common visual impairments worldwide.This not only poses long-term risks to individual health but also imposes significant medical and economic burdens on society. [6] Therefore, delaying the onset of myopia and effectively controlling its progression has become an urgent issue that needs to be addressed.In recent years, a new type of highly aspherical lenslet (HAL) has been proposed. Its optical design includes a refractive correction area in the central region and a peripheral annular area. This annular area can form a "myopic defocus zone", increasing the myopic defocus signal around the retina. Studies have confirmed that this design can effectively slow down the progression of myopia in already myopic children. However, it is currently unclear whether this lens has a preventive effect on children who are not yet myopic but have a risk of developing myopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants will be wearing with-the-rule astigmatic defocus lens glasses. The lens was prescribed with 0.00 diopters. It is recommended to wear it for ≥ 10 hours per day |
|
| Group B | Experimental | Participants will be wearing with-the-rule astigmatic defocus lens glasses (non-plano defocus spectacles); the central optical zone degree completely correct their baseline under cycloplegia refractive errors. It is recommended to wear it for ≥ 10 hours per day |
|
| Group C (control group) | Placebo Comparator | Participants will be wearing traditional single vision lens, lens has no correction function. It is recommended to wear it for ≥ 10 hours per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| With-the-Rule Astigmatic Defocus Lens | Other | The lens was prescribed with 0.00 diopters |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the axial length | The changes in axial length of the eyes in the experimental group and the control group in the first and second years | baseline, 6-month, 12-month, 18-month, 24-month |
| Change in the spherical equivalent | The changes in spherical equivalent in the experimental group and the control group in the first and second years | Baseline, 6-month, 12-month, 18-month, 24-month |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in axial length | Changes in axial length from baseline to year 1 and year 2 in the plano defocus and non-plano defocus experimental groups. | Baseline, 6-month, 12-month, 18-month, 24-month |
| Change in equivalent spherical |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guanghao Qin | Contact | +8618842664420 | qinguanghao2020@163.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014785 | Vision, Ocular |
| ID | Term |
|---|---|
| D055537 | Light Signal Transduction |
| D015398 | Signal Transduction |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
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| With-the-Rule Astigmatic Defocus Lens (Non-plano) |
| Other |
The magnitude of the central optical zone completely corrected their refractive errors under baseline cycloplegia |
|
| Single Vision | Other | The lenses do not have corrective functions |
|
Changes in spherical equivalent refraction from baseline to year 1 and year 2 in the plano defocus and non-plano defocus experimental groups.
| Baseline, 6-month, 12-month, 18-month, 24-month |
| D002468 |
| Cell Physiological Phenomena |
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009799 | Ocular Physiological Phenomena |