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Stellest Lenses and Low-concentration Atropine Myopia Control Among Children

NCT06344429 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-04

No results posted yet for this study

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.

Conditions

  • Myopia

Interventions

DEVICE

Stellest Lenses

All subjects are recruited and randomized to 3 treatment groups at the baseline visit. A Group：Stellest Lenses spectacle (ST)

COMBINATION_PRODUCT

Stellest Lenses+0.05% atropine

All subjects are recruited and randomized to 3 treatment groups at the baseline visit. B Group：Combined Treatment

DRUG

Single vision Lenses+0.05% atropine

All subjects are recruited and randomized to 3 treatment groups at the baseline visit. C Group：0.05% Atropine with single vision

Sponsors & Collaborators

  • Essilor-Polylite Taiwan Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-20
Primary Completion
2024-08-20
Completion
2025-08-20

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06344429 on ClinicalTrials.gov