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Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

NCT06263946 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-01

No results posted yet for this 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.

Conditions

  • Myopia

Interventions

DEVICE

Essilor® Stellest® spectacle lenses

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

Sponsors & Collaborators

  • Essilor International

    lead INDUSTRY

Principal Investigators

  • Aude Couturier, Professor · Hôpital Fondation Adolphe de Rothschild - PARIS - FRANCE

  • Ian Flitcroft, Professor · Centre for Eye Research Ireland (CERI) - DUBLIN - IRELAND

  • Caroline Klaver, Professor · ERASMUS Medical Center - ROTTERDAM - NETHERLANDS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-22
Primary Completion
2027-04-23
Completion
2027-04-30

Countries

  • France
  • Ireland
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06263946 on ClinicalTrials.gov