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The goal of this randomised controlled clinical trial is to compare the effects of a new type of concentric columnar microstructure lens and single-vision spectacle lenses on myopia progression in Chinese children aged 8-11 years with refractive error ranging from -0.50D to -6.00D. Participants will wear spectacles and receive follow-up examinations every half year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Blue star MAX-5 spectacle lens |
|
| Control | Active Comparator | Single-vision spectacle lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue star MAX-5 spectacle lens | Device | The children in the experimental group will wear Blue star MAX-5 spectacle lens and receive follow-up examinations every half year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of spherical equivalent refraction (SER) at two years | The difference of SER (Diopter) at two years compared with baseline SER. SER will be measured after cycloplegia. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of axial length (AL) at two years | The difference of AL (mm) at two years compared with baseline AL. AL will be measured by IOLMaster-700. | 2 years |
| Visual scale score at two years | Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2) is scaled from 0 (poor quality of life) to 100 (good quality of life). |
| Measure | Description | Time Frame |
|---|---|---|
| Change of lens thickness (LT) at two years | The difference of LT (mm) at two years compared with baseline LT. LT will be measured by IOLMaster-700. | 2 years |
| Change of corneal power (CP) at two years | The difference of CP (diopter) at two years compared with baseline CP. CP will be measured by IOLMaster-700. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Ge | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Single-vision spectacle lens | Device | The children in the single-vision lenses group will wear single-vision spectacle lens and receive follow-up examinations every half year. |
|
| 2 years |
| Incidence of adverse event during study period | Adverse event is a comprehensive qualitative outcome measure that will be evaluated based on the participants' symptoms and signs, intraocular pressure, slit lamp and fundus examinations, as well as lens and frame damage. The evaluation will be conducted every six months according to the predetermined definition of abnormalities in the above examinations. | 2 years |
| 2 years |
| Best corrected visual acuity at two years | Best corrected visual acuity will be measured at baseline and two years by EDTRS visual acuity chart. | 2 years |
| Binocular visual function at two years | Binocular visual function which is a qualitative outcome assessed by a series of tests will be measured every half year. | 2 years |
| Change of choroidal thickness at two years | The difference of Choroidal thickness (μm) at two years compared with baseline measure. Choroidal thickness will be measured by OCTA. | 2 years |