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Active, Not Recruiting

NCT Number: NCT06263946

Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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
  • - Age: 6 - 16 years old, inclusive at the time of inclusion
  • - Ability to understand treatment and give valid assent
  • - Ability to comply with the protocol to get reliable study measurements

Exclusion criteria

  • - 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

Treatment and study plan

Essilor® Stellest® spectacle lenses

Device

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

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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

Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Registry information

Official study title

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.

Acronym: SLOMES

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 16, 2024
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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