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

N/ANot Yet RecruitingNCT07340931

Nantes University Hospital50 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Myopia

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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. Exclusion Criteria: * Patients with strabismus, amblyopia, or syndromic myopia

Outcomes

Primary Outcomes

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

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.

Time frame: At 6 months after initiation of lens wear

Central Contacts

Pierre Lebranchu, MD PhD

CONTACT

+33 2 53 48 28 57 pierre.lebranchu@chu-nantes.fr

Alexandra Poinas, PhD

CONTACT

+ 33 2 53 48 28 57 alexandra.poinas@chu-nantes.fr

Data from ClinicalTrials.gov

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