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Orthokeratology is becoming popular for the treatment of myopia children. Many studies have shown that orthokeratology is effective in temporarily reducing refractive error, and is also helpful for controlling myopia progression. However, the mechanism for its slowing myopia progression and rebound effect after the treatment have not been clearly studied. In addition, the effect of orthokeratology among Chinese children has not been evaluated with randomized controlled trial.This study is to assess the effect of orthokeratology versus spectacles on myopia progression in school-aged Chinese children during two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthokeratology in the first year | Experimental | The participants would wear orthokeratology in the first year and then switch to spectacle in the second year |
|
| Spectacle in the first year | Active Comparator | The participants would wear spectacle in the first year and then changed to orthokeratology in the second year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthokeratology | Device |
| ||
| Spectacle |
| Measure | Description | Time Frame |
|---|---|---|
| Refraction | The participants will be measured for their cycloplegic central refractive error before and after wearing the orthokeratology. Peripheral refraction will also be measured by WAM-5500. | Change from baseline at 1 year |
| Axial length | The Lenstar will be used to measure the axial length. | Change from baseline at 1 year |
| Refraction | Change from baseline at 2 years | |
| Axial length | Change from baseline at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tear film break up time(BUT) | Change from baseline at 1 year | |
| Self evaluation of comfortableness | Change from baseline at 1 year | |
| Corneal endothelial cell density |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ningli Wang, MD,PhD | Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Device |
|
|
| Change from baseline at 1 year |
| Tear film break up time(BUT) | Change from baseline at 2 years |
| Self evaluation of comfortness | Change from baseline at 2 years |
| Corneal endothelial cell density | Change from baseline at 2 years |