ClinicalTrials.gg
Active, not recruitingNCT06263946SLOMESUpdated Aug 21, 2026

Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

An interventional study of Essilor® Stellest® spectacle lenses in Myopia, sponsored by Essilor International. Active, not recruiting at 3 sites in 3 countries. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Essilor International · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
6 Years to 16 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 28 studies in Myopia by EssilorLuxottica — 14 open to participants now, 19 under way, none of them phase 3. Myopia · EssilorLuxottica.

Planned enrollment
4th of 28
150 · median 52
Started
2024
with 1 other
No phase
28 of 28
14 open now
Primary completion
2027-05
later than 9 of 18 live
Registered
8th of 28
by date

Among the 28 studies in Myopia by EssilorLuxottica, this one is the 4th largest by planned enrollment, is one of 2 that started in 2024, is one of 28 with no phase, reaches primary completion later than 9 of the 18 other live ones, and was the 8th registered.

Myopia

1,160 studies on the registry are indexed under Myopia; 226 are open to participants now.

Browse Myopia studies →

Open to participants now

14 of the 28 studies in Myopia by EssilorLuxottica are open now, in 5 countries. Recruiting first, the newest first:

9 more — sign in →

By country, each count listing its studies:

All 14 open studies →

Who these studies take

Of the 122 Myopia studies recruiting now, 19 (16%) set no upper age limit and 102 (84%) stop at 75 or younger; 86 take children under 18; 53 take healthy volunteers.

This study: 6 Years to 16 Years · all sexes · no healthy volunteers.

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02

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.

Read the 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.
03

Conditions studied

  • Myopia

Browse trials for

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceEssilor® Stellest® spectacle lenses

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

06

What researchers measure

Primary outcomes

  1. Change in cycloplegic axial length

    in mm (millimeter) compared to expected change based on axial length at baseline (in each eye).

    Time frame: from baseline to 24 months

  2. Change in cycloplegic autorefraction

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

    Time frame: from baseline to 24 months

Secondary outcomes

  1. Change in refraction progression centile

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

    Time frame: from 12 months to 24 months visits.

  2. Change in cycloplegic axial length

    in mm (millimeter) compared to expected change based on axial length at baseline (in each eye).

    Time frame: from baseline to 12 months and 24 months

  3. Change in cycloplegic autorefraction

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

    Time frame: from baseline to 12 months and 24 months

  4. Change in refraction

    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)

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

  5. Change in axial length

    in mm (millimeter) compared to that observed in control group participants of the MOSAIC study (in each eye)

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

  6. Change in choroidal thickness

    in μm (micrometre) compared to that observed in control group participants of the MOSAIC study (in each eye)

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

  7. Change in refraction

    in D (Diopter) compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye)

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

  8. Change in axial length vs atropine

    in mm (millimeter) compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye)

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

  9. Change in choroidal thickness

    in μm (micrometre) compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye)

    Time frame: during the first and second year (separate comparisons for each year) of the MOSAIC study

  10. Change in Paediatric Refractive Error Profile (PREP-2) score

    Change in Paediatric Refractive Error Profile (PREP-2) score

    Time frame: from baseline (pre- Essilor® Stellest®) to 12 and 24 months (post- Essilor® Stellest®)

07

Study locations

3 sites
08

References and documents

Publications

  • 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. PubMed 33811039 ↗
  • 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. PubMed 35357402 ↗
  • 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. PubMed 37040846 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for May 2027, 37 months after the start.

Of 234 industry-sponsored interventional studies with no phase under Myopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's planned 37 months is above that.

Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2024
First posted
Feb 16, 2024
StartActual
Mar 22, 2024
Primary completionEst.
May 4, 2027
CompletionEst.
May 4, 2027
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06263946
Responsible party
Sponsor
First posted
Feb 16, 2024
Start date
Mar 22, 2024
Primary completion
May 4, 2027 (estimated)
Completion
May 4, 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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