Myopia ProgressionVERCORSNCT07462897
Evaluation of the Effectiveness of a New Generation of Myopia Control Lens on the Progression of Myopia in Children Aged 6 to 14 Years
A study testing MCL1 and MCL2 in people with Myopia Progression, run by Essilor International at 1 site in France.
Trial summary
The goal of this clinical investigation is to learn how much a new generation of myopia control lens (MCL1 - Myopia Control Lens 1) is helpful in reducing myopia progression in children from 6 to 14 yo. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Myopia Progression
- What is being tested?
- MCL1 and MCL2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2026to May 2028
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Refractive error in spherical equivalent (SE) ≤ -0.5 D and ≥ -4.5 D on each eye (autorefraction under cycloplegia)
- Astigmatism ≤ 2.00 D for each eye
- Anisometropia (difference in SE between the 2 eyes) ≤ 1.00 D
- Corrected maximum distance visual acuity in each eye≥ 8/10 (equivalent to +0.1 LogMAR)
- Written consent of the 2 holders of parental authority (or only one in the case of exclusive parental authority) and agreement of the participant
Who cannot join
- Past or current use of any type of myopic control solution (braking lenses, atropine, orthokeratology, multifocal contact lenses, etc
- Strabismus (in the test of masking near or far with the best correction)
- Amblyopia
- Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down syndrome, etc.)
- Presence of trauma in at least one eye - Presence of inflammatory pathologies in at least one eye
- History of intraocular surgery (cataracts, filtering surgery, intravitreal surgery) in at least one eye
Show all 14Show fewer
- Past or current use of growth hormones
- Use of ocular or systemic drugs that, in the opinion of the investigator, may significantly affect pupil size, accommodation, or refractive status.
- Wearing contact lenses
- Allergy or intolerance to cycloplegic eye drops (cyclopentolate 0.5%)
- Known allergy or intolerance to eyeglass frame materials
- Children with specific visual disorders requiring personalized treatments other than conventional corrective lenses.
- Intolerance to conventional optical corrections
- Lack of cooperation in wearing corrective lenses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild
Paris, 75019
Thibaut Chapron, MD, +33.1.48.03.65.56, tchapron@for.paris
About this study
Official title: Evaluation of the Effectiveness of a New Generation of Myopia Control Lens, Producing a Higher Myopic Control Signal Than That Produced by a Previous Generation Lens, on the Progression of Myopia in Children Aged 6 to 14 Years
The goal of this clinical investigation is to learn how much a new generation of myopia control lens (MCL1 - Myopia Control Lens 1) is helpful in reducing myopia progression in children from 6 to 14 yo. The main questions it aims to answer is: How much this new generation of lens, called MCL1, slows down the growth of the eye? Researchers will compare MCL1 to a former generation of myopia control lens (i.e. MCL2) but with better vision quality.
Participants will:
- Wear MCL1 on right eye and MCL2 on left eye for 6 months and MCL2 on rigth eye and MCL1 on left eye for the next 6 months;
- Visit the hospital at 6 and 12 months for tests;
- Answer weekly questionnaires on compliance wearing glasses, quality of vision and out-of-school activities.
Read the detailed description
Myopia is a global public health issue that could affect nearly 5 billion people by 2050. It progresses rapidly in children, increasing the risk of severe ocular diseases. Several solutions exist to slow its progression, including ophthalmic lenses, which are effective and free of side effects. Essilor® Stellest® lenses, incorporating H.A.L.T. technology with aspherical lenslets, slow axial eye elongation with an efficacy comparable to high-dose atropine.
A new version of this product provides an enhanced myopia-control signal thanks to increased optical parameters of the lenslets. A recent study has demonstrated its superior effectiveness in Asian children aged 6 to 10. The present study aims to assess its performance in European children, compared with another myopia control lens, which delivers the same myopia-control signal as the original Stellest® lens but with better visual quality.
The study will take into account interindividual variability in efficacy, particularly with respect to age-a key factor in myopia progression (which is high between ages 6 and 8). Three age groups will be analyzed (6-8, 9-11, and 12-14 years). A secondary objective is to explore the impact of individual ocular parameters on lens effectiveness.
- Conditions
- Myopia Progression
- Being tested
- MCL1, MCL2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCL1Device
Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children.
MCL2Device
Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children.
| Study group | Role | What they receive |
|---|---|---|
| OD: MCL 1; OS: MCL 2 | Experimental | Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 1, MCL 1 will be worn in the right eye, and MCL 2 in the left eye for a period of 6 months. Receives: Device: MCL1; Device: MCL2 |
| OD: MCL 2; OS: MCL 1 | Experimental | Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 2, MCL 2 will be worn in the right eye, and MCL 1 in the left eye for a period of 6 months. Receives: Device: MCL1; Device: MCL2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in axial length
Measured: 6-month
Secondary outcomes (3)
Change from baseline in cycloplegic spherical equivalent
Measured: 6-month
Effect of optical parameters, assessed at baseline, on myopia control efficacy of MCL1 and MCL2 at 6-month.
Correlation between amount of ocular aberrations (Root Mean Square of global High Order Aberrations) at baseline and the change of eye length induced by wearing MCL1 vs MCL2 at 6-month.
Measured: 6-month
Effect of self-reported exposure time to natural light on myopia control efficacy of MCL1 and MCL2 at 6-month
Correlation between self-reported weekly hours of exposure to natural outdoor light, assessed with questionnaires each week and averaged at 6-month, and the change of axial length induced by wearing MCL1 vs MCL2 at 6-month.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start18 Mar 2026
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia ProgressionStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462897
- Sponsor's protocol ID
- WS10442
- Other IDs
- 2025-A02213-46
- Acronym
- VERCORS
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a New Generation of Myopia Control Lens, Producing a Higher Myopic Control Signal Than That Produced by a Previous Generation Lens, on the Progression of Myopia in Children Aged 6 to 14 Years
- ClinicalTrials.gov ID
- NCT07462897
- Acronym / sponsor ID
- VERCORS / WS10442
- Conditions
- Myopia Progression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 10 Mar 2026 (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 clinical investigation is to learn how much a new generation of myopia control lens (MCL1 - Myopia Control Lens 1) is helpful in reducing myopia progression in children from 6 to 14 yo. The main questions it aims to answer is: How much this new generation of lens, called MCL1, slows down the growth of the eye? Researchers will compare MCL1 to a former generation of myopia control lens (i.e. MCL2) but with better vision quality.
Participants will:
- Wear MCL1 on right eye and MCL2 on left eye for 6 months and MCL2 on rigth eye and MCL1 on left eye for the next 6 months;
- Visit the hospital at 6 and 12 months for tests;
- Answer weekly questionnaires on compliance wearing glasses, quality of vision and out-of-school activities.
Detailed description
Myopia is a global public health issue that could affect nearly 5 billion people by 2050. It progresses rapidly in children, increasing the risk of severe ocular diseases. Several solutions exist to slow its progression, including ophthalmic lenses, which are effective and free of side effects. Essilor® Stellest® lenses, incorporating H.A.L.T. technology with aspherical lenslets, slow axial eye elongation with an efficacy comparable to high-dose atropine.
A new version of this product provides an enhanced myopia-control signal thanks to increased optical parameters of the lenslets. A recent study has demonstrated its superior effectiveness in Asian children aged 6 to 10. The present study aims to assess its performance in European children, compared with another myopia control lens, which delivers the same myopia-control signal as the original Stellest® lens but with better visual quality.
The study will take into account interindividual variability in efficacy, particularly with respect to age-a key factor in myopia progression (which is high between ages 6 and 8). Three age groups will be analyzed (6-8, 9-11, and 12-14 years). A secondary objective is to explore the impact of individual ocular parameters on lens effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OD: MCL 1; OS: MCL 2 | Experimental | Device: MCL1, Device: MCL2Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 1, MCL 1 will be worn in the right eye, and MCL 2 in the left eye for a period of 6 months. |
| OD: MCL 2; OS: MCL 1 | Experimental | Device: MCL1, Device: MCL2Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 2, MCL 2 will be worn in the right eye, and MCL 1 in the left eye for a period of 6 months. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Refractive error in spherical equivalent (SE) ≤ -0.5 D and ≥ -4.5 D on each eye (autorefraction under cycloplegia)
- Astigmatism ≤ 2.00 D for each eye
- Anisometropia (difference in SE between the 2 eyes) ≤ 1.00 D
- Corrected maximum distance visual acuity in each eye≥ 8/10 (equivalent to +0.1 LogMAR)
- Written consent of the 2 holders of parental authority (or only one in the case of exclusive parental authority) and agreement of the participant
Key exclusion criteria (14 listed)
- Past or current use of any type of myopic control solution (braking lenses, atropine, orthokeratology, multifocal contact lenses, etc
- Strabismus (in the test of masking near or far with the best correction)
- Amblyopia
- Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down syndrome, etc.)
- Presence of trauma in at least one eye - Presence of inflammatory pathologies in at least one eye
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 |
|---|---|---|
| MCL1Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children. | Device | OD: MCL 1; OS: MCL 2, OD: MCL 2; OS: MCL 1 |
| MCL2Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children. | Device | OD: MCL 1; OS: MCL 2, OD: MCL 2; OS: MCL 1 |
Primary outcome
Change from baseline in axial length
Time frame: 6-month
3 secondary outcomes
Change from baseline in cycloplegic spherical equivalent
Time frame: 6-month
Effect of optical parameters, assessed at baseline, on myopia control efficacy of MCL1 and MCL2 at 6-month.
Time frame: 6-month
Effect of self-reported exposure time to natural light on myopia control efficacy of MCL1 and MCL2 at 6-month
Time frame: 6-month
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 23 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCL1 and MCL2 in people with Myopia Progression, run by Essilor International at 1 site in France.
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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Contact Thibaut Chapron, MD (00331 48 03 65 56, tchapron@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in axial length (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.