New-generation myopia-control lenses versus an earlier lens for children 6–14
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
Run by Essilor International · NCT07462897 · Data updated 2026-11-12
This test tries whether a new myopia-control lens (MCL1) slows eye growth more than a previous-generation lens (MCL2) in children aged 6 to 14.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 14 Years |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | Essilor International Industry-sponsored |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | March 18, 2026 |
| Main results expected | April 2028 |
| Study ends | May 2028 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07462897 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–14 with mild to moderate myopia (spherical equivalent −0.5 to −4.5 D), astigmatism ≤2.00 D, good corrected visual acuity, no prior myopia-control treatments, and parental consent.
✕Probably not a fit
Children with refractive errors outside the specified range, existing amblyopia or strabismus, prior myopia-control treatments, or ocular/systemic conditions affecting refraction are unlikely to receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants will wear MCL1 on the right eye and MCL2 on the left eye for six months, then swap lenses for the next six months in a within-subject crossover design. Clinical visits at 6 and 12 months will include cycloplegic autorefraction and axial length measurements to quantify myopia progression. Weekly questionnaires will record compliance, perceived vision quality, and out-of-school activities. The trial compares an enhanced optical lenslet signal (MCL1) with a comparator lens designed for improved visual quality and will analyze responses across three age bands (6–8, 9–11, 12–14) and individual ocular factors.
Why it matters
Potential benefit: If successful, the new lens could slow axial eye growth in children and reduce their long-term risk of serious myopia-related eye disease.
How similar studies have gone: Similar lenses using aspherical lenslet technology have previously shown superior efficacy in slowing axial elongation in Asian children, so the approach has prior supportive evidence though results in European children need confirmation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where it's running
-
Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild
Paris, France Recruiting
Study contacts
- Study coordinator: Thibaut Chapron, MD
- Email: tchapron@for.paris
- Phone: 00331 48 03 65 56
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.