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

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

Study Overview

• Status: Recruiting
• Conditions: Myopia

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Pierre Lebranchu, MD PhD; Phone Number: +33 2 53 48 28 57; Email: pierre.lebranchu@chu-nantes.fr
• Study Contact Backup: Name: Alexandra Poinas, PhD; Phone Number: + 33 2 53 48 28 57; Email: alexandra.poinas@chu-nantes.fr

Study Locations

• France
  • Nantes
    • Nantes, Nantes, France, 44000
      • Recruiting
      • CHU Nantes - Ophthalmology Department
      • Contact: Alexandra Poinas; Phone Number: +33 2 40 08 33 33; Email: alexandra.poinas@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with myopia followed at the Ophthalmology Departments of Nantes University Hospital and Strasbourg University Hospital, as well as at the Centre Ophtalmologique de l'Hippodrome in Lambersart.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
pediatric patient with Essilor® myopia-control spectacle lenses; pediatric patient with Essilor® myopia-control spectacle lenses Stellet 2.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 6 months after initiation of lens wear

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: compliance; myopia; visual correction
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Myopia; Patient Compliance
• Other Study ID Numbers: AP_PL_Stellar

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No