Stellest Lenses and Low-concentration Atropine Myopia Control Among Children - Trial NCT06344429

Timeline & Enrollment

Primary Outcome

Spherical equivalent refraction power,Axial length

Summary

The prevalence of myopia is increasing globally, especially in Asian countries. 70-80% of the
 young population suffers from myopia, and almost 20% have high myopia. High myopia can easily
 lead to blinding diseases, including retinal detachment, macular degeneration, and glaucoma.
 In Taiwan, according to a survey by the National Health Administration, the proportion of
 myopia among Grade 1 students has exceeded 81%.
 
 There are many ways to control myopia progression. High concentrations of atropine have been
 reported highly effective in the control of the myopia progression. However the accompanied
 side effects such as photophobia and near blurred vision. Recent research shows that
 low-concentration atropine can achieve similar control effect and more acceptable with much
 minimal side effect compared to high concentration of atropine.
 
 Multiple animal experiments have confirmed that giving retinal myopia defocus signals can
 effectively decrease the growth of the eye, thereby inhibiting the progression of myopia.
 Therefore, regarding lens design, myopic defocus does play an important role in myopia
 control, including orthokeratology lenses, multifocal soft contact lenses, and peripheral
 defocus lenses.
 
 Stellest, a myopia control lens based on the myopia defocus theory, is equipped with highly
 aspheric lenslet technology. In a recent study, compared with single vision lenses, Stellest
 significantly slowed down the myopia progression reaching 67% and retard axial elongation
 reaching 64% The purpose of this study is to explore the effectiveness of Stellest Lenses in
 controlling myopia in Taiwanese children and whether Stellest Lenses combined with
 low-concentration atropine eye drops can increase the effect of myopia control.

ICD-10 Classifications