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临床试验/NCT07340931
NCT07340931招募中不适用

Pilot Study on the Adaptation and Tolerance of Essilor® Myopia-control Spectacle Lenses

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Adaptation and tolerance of Essilor® Stellest® 2.0 myopia-control spectacle lenses

研究概览

简要总结

This observational pilot study aims to evaluate the adaptation and tolerance of Essilor® Stellest® myopia-control spectacle lenses in children with progressive myopia. The objective is to assess real-life compliance and comfort during lens wear, as these factors are essential for long-term therapeutic adherence and overall visual health outcomes

详细描述

Myopia is a refractive error in which light rays from distant objects focus in front of the retina, resulting in blurred distance vision. It is most commonly caused by an elongation of the axial length of the eye. Myopia has become a major public health issue of the 21st century, with estimates suggesting that nearly 50% of the global population will be myopic by 2050. High myopia significantly increases the risk of serious ocular complications, including glaucoma, early cataract, myopic maculopathy, retinal tears, and detachments. Myopia typically begins in childhood and tends to appear earlier and progress faster than in previous generations, with onset now occurring around 6-7 years of age instead of 12-13. Early detection and appropriate optical correction can have a substantial impact on a child's academic performance and quality of life, as good vision is closely linked to both. Progressive myopia, a form that worsens over time, requires active management to slow or halt its progression and prevent high myopia. Among available approaches, optical devices such as Essilor® Stellest® lenses have shown promise in myopia control. However, their real-world effectiveness depends not only on optical performance but also on the child's ability to adapt to and tolerate the lenses, which directly influences daily wear time and long-term compliance. This observational study therefore focuses on evaluating the adaptation and tolerance of Essilor® Stellest® lenses prescribed to children with progressive myopia in routine clinical practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged 6 to 16 years with progressive myopia.
  • Spherical equivalent ≤ -0.50 D under cycloplegia and presence of at least one risk factor (age < 10 years, progression ≥ 0.50 D/year, axial length increase ≥ 0.2 mm/year, high myopia ≤ -6.00 D and/or axial length ≥ 26 mm, both parents myopic, at least one parent highly myopic, or Asian origin).
  • Patient covered by the French social security system.
  • Patient and legal guardians providing oral non-opposition to participate in the study.

排除标准

  • Patients with strabismus, amblyopia, or syndromic myopia

研究组 & 干预措施

pediatric patient with Essilor® myopia-control spectacle lenses

pediatric patient with Essilor® myopia-control spectacle lenses Stellet 2.0

结局指标

主要结局

Adaptation and tolerance of Essilor® Stellest® 2.0 myopia-control spectacle lenses

时间窗: At 6 months after initiation of lens wear

Evaluation of the adaptation and tolerance of Essilor® Stellest® 2.0 lenses in children with progressive myopia, using the PREP-2 quality-of-life questionnaire (56 items) to assess comfort, visual satisfaction, and overall acceptance after regular use.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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