Using Stellest Lenses and Low-concentration Atropine to Control Myopia in Children

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

This study is testing whether using Stellest lenses with a low dose of atropine can help control the worsening of nearsightedness in children aged 6 to 12.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: Essilor-Polylite Taiwan Co., Ltd. (industry)
• Locations: 1 site (Kaohsiung)
• Trial ID: NCT06344429 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of Stellest lenses combined with low-concentration atropine in controlling myopia progression among children aged 6 to 12. The research aims to compare the outcomes of using Stellest lenses alone, Stellest lenses with atropine, and single vision lenses with atropine. The methodology includes measuring the impact on eye growth and myopia severity over time, leveraging both optical defocus and pharmacological intervention. The study addresses the increasing prevalence of myopia, particularly in East Asia, and seeks to provide a safer alternative to high-concentration atropine treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 to 12 years with mild to moderate myopia and no significant eye disorders.

Not a fit: Patients with strabismus, amblyopia, or other significant eye diseases will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the progression of myopia in children, lowering the risk of severe eye conditions later in life.

How similar studies have performed: Previous studies have shown promising results with similar approaches, particularly in using low-concentration atropine for myopia control, making this study a continuation of established research.

Eligibility criteria

Inclusion Criteria:

1. Children aged 6\~12 year-old.
2. Equivalent diopter: -0.75\~-4.00 D.
3. Astigmatism and anisometropia \<2.50 D.
4. Best corrected visual acuity of one eye reaches 1.0.

Exclusion Criteria:

1. Strabismus, amblyopia, and abnormal binocular vision.
2. Other eye diseases.
3. Have a history of using myopia control products within six months.

Where this trial is running

Kaohsiung

• Kaohsiung Chang Gung Memorial Hospital — Kaohsiung, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Eric Tsai

Conditions: Myopia