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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
The children in the experimental group will wear Blue star MAX-5 spectacle lens and receive follow-up examinations every half year.
The children in the single-vision lenses group will wear single-vision spectacle lens and receive follow-up examinations every half year.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
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.
Time frame: 2 years
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.
Time frame: 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).
Time frame: 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.
Time frame: 2 years
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