Essilor® Stellest® Lenses Multicentre European Study (SLOMES) (SLOMES)

November 27, 2025 updated by: Essilor International

Post Market Clinical Follow-up Study to Demonstrate the Efficacy, Safety, Acceptability and Quality of Life Implications of Essilor® Stellest® Spectacle Lenses in Slowing Myopia Progression in Children and Adolescents.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The trial design is a multicentre, European, prospective, interventional study with single group assignment. The investigational medical device Essilor® Stellest® is a CE marked, myopia control spectacle lens. The trial period for all participants is 24 months. The recruiting period is 6 to 9 months depending on countries / sites for a total of 150 participants (50 in Ireland, 75 in France and 25 in The Netherlands).

The secondary objectives are:

  • To evaluate the acceptability of Essilor® Stellest® spectacle lenses in slowing myopia progression.
  • To evaluate the quality-of-life implications for children and adolescents.
  • To evaluate the safety of Essilor® Stellest® spectacle lenses in slowing myopia progression.
  • To evaluate the effect of Essilor® Stellest® spectacle lenses on choroidal thickness.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department
  • Ireland
      • Dublin, Ireland, D07 H6K8
        • Centre for Eye Research Ireland (CERI) - TU DUBLIN
  • Netherlands
      • Rotterdam, Netherlands, 3015
        • Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Essilor® Stellest® spectacle lenses
patients will be asked to wear Essilor® Stellest® spectacle lenses for a full time wear (>12 hours daily) for 24 months
Device: Essilor® Stellest® spectacle lenses
patients will be asked to wear Essilor® Stellest® spectacle lenses more than 12 hours per day for 24 months.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in refraction progression centile
Time Frame: from 12 months to 24 months visits.
compared to expected change based on refraction centile positions at baseline (in each eye).
from 12 months to 24 months visits.
Change in cycloplegic autorefraction
Time Frame: from baseline to 12 months and 24 months
compared to expected change based on refraction centile positions at baseline (in each eye).
from baseline to 12 months and 24 months
Change in Paediatric Refractive Error Profile (PREP-2) score
Time Frame: from baseline (pre- Essilor® Stellest®) to 12 and 24 months (post- Essilor® Stellest®)
Change in Paediatric Refractive Error Profile (PREP-2) score
from baseline (pre- Essilor® Stellest®) to 12 and 24 months (post- Essilor® Stellest®)
Change in cycloplegic axial length
Time Frame: from baseline to 12 months and 24 months
in mm (millimeter) compared to expected change based on axial length at baseline (in each eye).
from baseline to 12 months and 24 months
Change in refraction
Time Frame: during the first and second year of the Myopia Outcome Study of Atropine In Children (MOSAIC) study
in D (Diopter) compared to that observed in control group participants of MOSAIC Study (myopia control trial conducted in Ireland from 2019 to 2023) (in each eye)
during the first and second year of the Myopia Outcome Study of Atropine In Children (MOSAIC) study
Change in axial length
Time Frame: during the first and second year (separate comparisons for each year) of the MOSAIC study.
in mm (millimeter) compared to that observed in control group participants of the MOSAIC study (in each eye)
during the first and second year (separate comparisons for each year) of the MOSAIC study.
Change in choroidal thickness
Time Frame: during the first and second year (separate comparisons for each year) of the MOSAIC study.
in μm (micrometre) compared to that observed in control group participants of the MOSAIC study (in each eye)
during the first and second year (separate comparisons for each year) of the MOSAIC study.
Change in refraction
Time Frame: during the first and second year (separate comparisons for each year) of the MOSAIC study.
in D (Diopter) compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye)
during the first and second year (separate comparisons for each year) of the MOSAIC study.
Change in axial length vs atropine
Time Frame: during the first and second year (separate comparisons for each year) of the MOSAIC study.
in mm (millimeter) compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye)
during the first and second year (separate comparisons for each year) of the MOSAIC study.
Change in choroidal thickness
Time Frame: during the first and second year (separate comparisons for each year) of the MOSAIC study
in μm (micrometre) compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye)
during the first and second year (separate comparisons for each year) of the MOSAIC study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essilor International

Investigators

  • Principal Investigator: Ian Flitcroft, Professor, Centre for Eye Research Ireland (CERI) - DUBLIN - IRELAND
  • Principal Investigator: Caroline Klaver, Professor, ERASMUS Medical Center - ROTTERDAM - NETHERLANDS
  • Principal Investigator: Aude Couturier, Professor, Hôpital Fondation Adolphe de Rothschild - PARIS - FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2024

Primary Completion (Estimated)

April 23, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS10337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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