Exploring the Effects of Treatment With Stellest Lenses and Low-concentration Atropine for Myopia Control Among Children.

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: t
View:

⁃ Children aged 6\

‣ 12 year-old.

⁃ Equivalent diopter: -0.75\

• 4.00 D.

⁃ Astigmatism and anisometropia \<2.50 D.

⁃ Best corrected visual acuity of one eye reaches 1.0.

Locations
Other Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Contact Information
Primary
Eric Tsai
erictsai@essilor.com.tw
+886 2-2528-8001
Time Frame
Start Date: 2023-08-20
Estimated Completion Date: 2025-08-20
Participants
Target number of participants: 100
Treatments
Experimental: Stellest lenses spectacle
34 children wear Stellest lenses for all day.
Experimental: Stellest lenses+0.05% atropine
33 children wear Stellest lenses for all day, and 0.05% atropine eye drops is dropped once nightly in both eyes.
Placebo_comparator: Single vision lenses+0.05% atropine
33 children wear Single lenses for all day, and 0.05% atropine eye drops is dropped once nightly in both eyes.
Sponsors
Leads: Essilor-Polylite Taiwan Co., Ltd.

This content was sourced from clinicaltrials.gov