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

NCT07340931 | Not Yet Recruiting

• 1 other identifier: AP_PL_Stellar
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Myopia

Keywords

myopia; visual correction; compliance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

pediatric patient with Essilor® myopia-control spectacle lenses

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

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with strabismus, amblyopia, or syndromic myopia

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Myopia; Patient Compliance

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01