NCT07462897 Evaluation of the Effectiveness of a New Generation of Myopia Control Lens on the Progression of Myopia in Children Aged 6 to 14 Years
| NCT ID | NCT07462897 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Essilor International |
| Condition | Myopia Progression |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 76 participants in total. It began in 2026-03-18 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07462897 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 14 Years, studying Myopia Progression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07462897 currently recruiting?
Yes, NCT07462897 is actively recruiting participants. Contact the research team at tchapron@for.paris for enrollment information.
Where is the NCT07462897 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07462897 clinical trial?
NCT07462897 is sponsored by Essilor International. The trial plans to enroll 76 participants.