MyopiaSLOMESNCT06263946
Essilor® Stellest® Lenses Multicentre European Study (SLOMES)
A study testing Essilor® Stellest® spectacle lenses in people with Myopia, run by Essilor International at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Myopia
- What is being tested?
- Essilor® Stellest® spectacle lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 Mar 2024to 4 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - 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
Who cannot join
- - 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
Show all 9Show fewer
- - Participation in another study which may influence vision or interfere with study assessments
- - Myopia onset before 5 years of age
- - Contact lens wearers
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
France1 site
Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department
Paris, 75019
Ireland1 site
Centre for Eye Research Ireland (CERI) - TU DUBLIN
Dublin, D07 H6K8
About this study
Official 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.
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.
- Conditions
- Myopia
- Being tested
- Essilor® Stellest® spectacle lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essilor® Stellest® spectacle lensesDevice
patients will be asked to wear Essilor® Stellest® spectacle lenses more than 12 hours per day for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Essilor® Stellest® spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cycloplegic axial length
in mm (millimeter) compared to expected change based on axial length at baseline (in each eye).
Measured: 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).
Measured: from baseline to 24 months
Secondary outcomes (10)
Change in refraction progression centile
compared to expected change based on refraction centile positions at baseline (in each eye).
Measured: from 12 months to 24 months visits.
Change in cycloplegic axial length
in mm (millimeter) compared to expected change based on axial length at baseline (in each eye).
Measured: from baseline to 12 months and 24 months
Change in cycloplegic autorefraction
compared to expected change based on refraction centile positions at baseline (in each eye).
Measured: from baseline to 12 months and 24 months
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)
Measured: during the first and second year of the Myopia Outcome Study of Atropine In Children (MOSAIC) study
Change in axial length
in mm (millimeter) compared to that observed in control group participants of the MOSAIC study (in each eye)
Measured: during the first and second year (separate comparisons for each year) of the MOSAIC study.
Change in choroidal thickness
in μm (micrometre) compared to that observed in control group participants of the MOSAIC study (in each eye)
Measured: during the first and second year (separate comparisons for each year) of the MOSAIC study.
Change in refraction
in D (Diopter) compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye)
Measured: during the first and second year (separate comparisons for each year) of the MOSAIC study.
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)
Measured: during the first and second year (separate comparisons for each year) of the MOSAIC study.
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)
Measured: during the first and second year (separate comparisons for each year) of the MOSAIC study
Change in Paediatric Refractive Error Profile (PREP-2) score
Change in Paediatric Refractive Error Profile (PREP-2) score
Measured: from baseline (pre- Essilor® Stellest®) to 12 and 24 months (post- Essilor® Stellest®)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start22 Mar 2024
- Primary completion4 May 2027 (estimated)
- Study completion4 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- multicentre, European, prospective
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aude Couturier, Professor, Principal investigator, Hôpital Fondation Adolphe de Rothschild - PARIS - FRANCEIan Flitcroft, Professor, Principal investigator, Centre for Eye Research Ireland (CERI) - DUBLIN - IRELANDCaroline Klaver, Professor, Principal investigator, ERASMUS Medical Center - ROTTERDAM - NETHERLANDS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263946
- Sponsor's protocol ID
- WS10337
- Acronym
- SLOMES
- Status last verified
- Aug 2026
- First submitted
- 29 Jan 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 33811039Bao 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 35357402Li 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06263946
- Acronym / sponsor ID
- SLOMES / WS10337
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 4 May 2027 (estimated)
- Study completion
- 4 May 2027 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multicentre, European, prospective
| Arm | Type | Receives |
|---|---|---|
| Essilor® Stellest® spectacle lenses | Other | Device: Essilor® Stellest® spectacle lensespatients will be asked to wear Essilor® Stellest® spectacle lenses for a full time wear (>12 hours daily) for 24 months |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- - Myopia as determined by cycloplegic autorefraction as follows:
- - 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
Key exclusion criteria (9 listed)
- - Concomitant or previous therapies for myopia
- - Eye diseases/conditions:
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essilor® Stellest® spectacle lensespatients will be asked to wear Essilor® Stellest® spectacle lenses more than 12 hours per day for 24 months. | Device | Essilor® Stellest® spectacle lenses |
Primary outcome
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).
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).
10 secondary outcomes
Change in refraction progression centile
Time frame: from 12 months to 24 months visits.
Change in cycloplegic axial length
Time frame: from baseline to 12 months and 24 months
Change in cycloplegic autorefraction
Time frame: 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
Change in axial length
Time frame: 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.
Change in refraction
Time frame: 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.
Change in choroidal thickness
Time frame: during the first and second year (separate comparisons for each year) of the MOSAIC study
Change in Paediatric Refractive Error Profile (PREP-2) score
Time frame: from baseline (pre- Essilor® Stellest®) to 12 and 24 months (post- Essilor® Stellest®)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 33811039Bao 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.
- Background: PubMed 35357402Bao 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.
- Background: PubMed 37040846Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essilor® Stellest® spectacle lenses in people with Myopia, run by Essilor International at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Ireland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cycloplegic axial length (time frame: from baseline to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263946, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.