Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

NCT06263946 · tracked via the Priya Life Science Ireland tracker

Sponsor

Essilor International

Phase

Not applicable

Started

2024-03-22

Last updated

2026-08-21

Condition(s) studied

Myopia

Investigational drug(s) / intervention(s)

Essilor® Stellest® spectacle lenses

Essilor® Stellest® spectacle lenses: patients will be asked to wear Essilor® Stellest® spectacle lenses more than 12 hours per day for 24 months.

Study summary

The goal of this post-market clinical follow up Study is to demonstrate the efficacy, safety, acceptability, and quality of life implications of Essilor® Stellest® spectacle lenses in slowing myopia progression in European children and adolescents. Participants will receive Essilor® Stellest® at inclusion visit and will be asked for a full time wear (\>12 hours daily) for 24 months. The primary endpoints are the change in axial length and cycloplegic autorefraction from baseline to 24 months compared to expected change based on axial length and refraction centile positions at baseline.

Eligibility

Sex

ALL

Min age

6 Years

Max age

16 Years

Healthy volunteers

Inclusion Criteria: 1. \- Myopia as determined by cycloplegic autorefraction as follows: * Each meridian SER of plano to - 8;00 D in each eye * Astigmatism \< 2.50 D * Anisometropia ≤ 1.50 D 2. \- Monocular corrected VA of at least 0.2 LogMAR in both eyes 3. \- Age: 6 - 16 years old, inclusive at the time of inclusion 4. \- Ability to understand treatment and give valid assent 5. \- Ability to comply with the protocol to get reliable study measurements Exclusion Criteria: 1. \- Concomitant or previous therapies for myopia 2. \- Eye diseases/conditions: * Strabismus by cover test at near or distance * Any ocular disease that would influence refractive development e.g. retinal disease, cataract, ptosis * Any systemic or neurodevelopmental conditions that may influence refractive development 3. \- Use of ocular or systemic medication which may affect myopia progression or visual acuity through known effects on retina, accommodation, or significant elevation of intraocular pressure 4. \- Participation in another study which may influence vision or interfere with study assessments 5. \- Myopia onset before 5 years of age 6. \- Contact lens wearers

Primary outcome measure(s)

Change in cycloplegic axial length — from baseline to 24 months
in mm (millimeter) compared to expected change based on axial length at baseline (in each eye).
Change in cycloplegic autorefraction — from baseline to 24 months
in D (Diopter) compared to expected change based on refraction centile positions at baseline (in each eye).

Trial sites (3)

Facility	City	Region
Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department	Paris	France
Centre for Eye Research Ireland (CERI) - TU DUBLIN	Dublin	Ireland
Erasmus Medical Center	Rotterdam	Netherlands

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 NCT06263946 on ClinicalTrials.gov ↗ ← All trials in Ireland