China is a major country in myopia, with the highest number of teenagers suffering from myopia. Controlling the progression of myopia and the related complications caused by axial elongation have clinical significance and social value. Currently. There is a lack of researches on the impact of specially designed myopia control spectacle lens in adolescents aged 12 and above. Therefore, The researchers plan to conduct a randomized controlled trial among myopia adolescents aged 12-17 in middle and high schools in Guangzhou, to test and verify the safety and effectiveness of CARE1.02 on myopia control compared with single-vision spectacle lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
760
Participants in the intervention group will wear CARE1.02 and receive the follow-up checks.
Participants in the control group will wear single-vision spectacle lens and receive the follow-up checks.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Changes of spherical equivalent refraction (SER) at one year
The difference of SER at one year from baseline. SER will be measured after cycloplegia
Time frame: 1 year
Changes of axial length (AL) at one year
The difference of AL at one year from baseline.
Time frame: 1 year
Change of anterior chamber depth (ACD) at one year
The difference of ACD at one year from baseline.
Time frame: 1 year
Change of lens thickness (LT) at one year
The difference of LT at one year from baseline.
Time frame: 1 year
Change of corneal curvature (CR) at one year
The difference of CR at one year from baseline.
Time frame: 1 year
Best corrected visual acuity at one year
Best corrected visual acuity
Time frame: 1 year
Binocular visual function at one year
Binocular visual function
Time frame: 1 year
Choroidal thickness at one year
The difference of Choroidal thickness at one year from baseline.
Time frame: 1 year
Visual scale score at 1 year
Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2)
Time frame: 1 year
Time length of wearing spectcales at one year
Time length of wearing spectcales collected every half year
Time frame: 1 year
Safty of wearing the spectacle lens
Safty of wearing the spectacle lens which is a qualitative outcome will be evaluated every half year by prespecified measures and definations through symptoms and signs, intraocular pressure#slit lamp and ocular fundus checks.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.