NCT07354945

An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children

An Evaluation of Visual Comfort, Adaptation and Overall Satisfaction in Myopic Children Using A.M.L. Series of Lenses

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Essilor International · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research study is to understand the wearing experience of A.M.L. series of lenses in myopic children. The main questions it aims to answer are: * How quickly and effectively children adapt to the A.M.L. series of lenses? * The proportion of children who adapted to the A.M.L. series of lenses within 4 to 6 days? 40 myopic children aged 6 to 12 years will be recruited as participants, and all of them will be wearing A.M.L. series of lenses. Participants will: * Wear A.M.L. series of lenses for a period of 2 weeks * Visit at day 4-6, week 1 and week 2.

Detailed description

Myopia prevalence among Chinese children has increased markedly in recent years, representing a major public health concern. As myopia management options expand, expectations have shifted beyond efficacy alone to include wearing comfort, adaptation, and visual quality. Spectacle lenses remain the primary modality for myopia correction and play a critical role in daily visual experience. Optical defocus-based spectacle lenses with microlens designs have demonstrated efficacy in slowing myopia progression. Although existing studies have reported on the adaptation of spectacle lenses incorporating microlens designs, there are currently no data available for the A.M.L. series of lenses. This study aims to evaluate adaptation, wearing comfort, and user satisfaction with the A.M.L. series spectacle lenses. This is a one arm, prospective, interventional study, it will include 40 children, with adaptation, comfort, and satisfaction evaluated after 4 days, 1 week, and 2 weeks of lens wear.

Conditions

• Myopia
• Refractive Error

Interventions

Type	Name	Description
DEVICE	A.M.L. Series of Lenses	Participants will be wearing A.M.L. series of lenses for a period of 2 weeks.

Timeline

• Start date: 2026-01-02
• Primary completion: 2026-02-25
• Completion: 2026-04-27
• First posted: 2026-01-21
• Last updated: 2026-01-23

Locations

1 site across 1 country: China