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

NCT ID: NCT07340931

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-01-31

Brief Summary

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

Detailed Description

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.

Conditions

Myopia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

pediatric patient with Essilor® myopia-control spectacle lenses

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Pierre Lebranchu, MD PhD

Role: CONTACT

pierre.lebranchu@chu-nantes.fr

+33 2 53 48 28 57

Alexandra Poinas, PhD

Role: CONTACT

alexandra.poinas@chu-nantes.fr

+ 33 2 53 48 28 57

Other Identifiers

AP_PL_Stellar

Identifier Type: -

Identifier Source: org_study_id