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

NCT07340931 · tracked via the Priya Life Science France tracker

Sponsor

Nantes University Hospital

Phase

Observational

Started

2026-01-20

Last updated

2026-06-24

Condition(s) studied

Myopia

Study 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

Eligibility

Sex

ALL

Min age

6 Years

Max age

16 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
CHU Nantes - Ophthalmology Department	Nantes	Nantes	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07340931 on ClinicalTrials.gov ↗ ← All trials in France