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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02213-46 | Other Identifier | ANSM RCB |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCL1 | Device | Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in axial length | 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in cycloplegic spherical equivalent | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thibaut Chapron, MD | Contact | 00331 48 03 65 56 | tchapron@for.paris |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département d'Ophtalmologie, Hôpital Fondation Adolphe de Rothschild | Recruiting | Paris | 75019 | France |
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| MCL2 | Device | Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children. |
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| 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. | 6-month |