Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

NCT06263946 | Active Not Recruiting

• 1 other identifier: WS10337
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in cycloplegic axial length

  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

  in D (Diopter) compared to expected change based on refraction centile positions at baseline (in each eye).

  from baseline to 24 months

Secondary Outcomes (10)

• Change in refraction progression centile

  from 12 months to 24 months visits.

• Change in cycloplegic axial length

  from baseline to 12 months and 24 months

• Change in cycloplegic autorefraction

  from baseline to 12 months and 24 months

• Change in refraction

  during the first and second year of the Myopia Outcome Study of Atropine In Children (MOSAIC) study

• Change in axial length

  during the first and second year (separate comparisons for each year) of the MOSAIC study.

Study Arms (1)

Essilor® Stellest® spectacle lenses

OTHER

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

Interventions

Essilor® Stellest® spectacle lenses DEVICE

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

Essilor® Stellest® spectacle lenses

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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
• \- Monocular corrected VA of at least 0.2 LogMAR in both eyes
• \- Ability to understand treatment and give valid assent
• \- Ability to comply with the protocol to get reliable study measurements

You may not qualify if:

• \- Concomitant or previous therapies for myopia
• \- 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
• \- 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
• \- Participation in another study which may influence vision or interfere with study assessments
• \- Myopia onset before 5 years of age
• \- Contact lens wearers

Sponsors & Collaborators

• Essilor International: lead

Study Sites (3)

Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department

Paris, 75019, France

Location

Centre for Eye Research Ireland (CERI) - TU DUBLIN

Dublin, D07 H6K8, Ireland

Location

Erasmus Medical Center

Rotterdam, 3015, Netherlands

Location

Related Publications (3)

• Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.

  PMID: 33811039 BACKGROUND

• Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, Wang C, Li Y, Lim EW, Spiegel DP, Drobe B, Chen H. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 May 1;140(5):472-478. doi: 10.1001/jamaophthalmol.2022.0401.

  PMID: 35357402 BACKGROUND

• Li X, Huang Y, Yin Z, Liu C, Zhang S, Yang A, Drobe B, Chen H, Bao J. Myopia Control Efficacy of Spectacle Lenses With Aspherical Lenslets: Results of a 3-Year Follow-Up Study. Am J Ophthalmol. 2023 Sep;253:160-168. doi: 10.1016/j.ajo.2023.03.030. Epub 2023 Apr 10.

  PMID: 37040846 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Aude Couturier, Professor

  Hôpital Fondation Adolphe de Rothschild - PARIS - FRANCE

  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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicentre, European, prospective

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 16, 2024
• Study Start: March 22, 2024
• Primary Completion (Estimated): April 23, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); FR (1); NL (1)