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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001696-14 | EudraCT Number | ||
| 22/384-EC_P | Other Identifier | CEIm Hospital Clínico San Carlos |
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| Name | Class |
|---|---|
| Cooperativa de Ensino Superior, Politécnico e Universitário | OTHER |
| Novovision | UNKNOWN |
| Instituto de Cirugia Ocular | OTHER |
| Miranza Virgen de Lujan |
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A 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. 300 children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. The study group will be composed of 150 children wearing MyoCare while the control group will be composed of 150 children wearing Clearview. The inclusion criteria will be myopia with a spherical equivalent between -0.75D and -5.00D, astigmatism < 1.50D, and anisometropia < 1.00D, as well as having a historical evolution of at least -0.50 The primary outcome is to compare the mean annual progression of the spherical equivalent between both groups. The secondary outcomes are axial length, choroidal thickness, phorias, and accommodative status of both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Myocare |
|
| Control | Active Comparator | Clearview |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyoCare | Device | Children assigned to the study group will wear ZEISS MyoCare lenses, while those assigned to the control group will wear conventional ZEISS ClearView single-vision lenses in their spectacles. Both lenses will be made of the same material (MR8) and hard as well as anti-reflection coating (ZEISS DuraVision Platinum) and will have the same surface treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective refraction | Objective refraction will be taken after cycloplegia as the mean of 3 measurements with the i.profiler (Carl Zeiss Meditec AG, Jena, Germany) autorefractometer. The mean annual progression of the objective refraction will be compared between myopic children treated with ZEISS MyoCare lenses and those who wear a conventional single-vision lens. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | 1. To compare the mean annual progression of axial length between myopic children treated with ZEISS MyoCare lenses and those who wear a conventional single-vision lens. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Complutense de Madrid | Madrid | 28037 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40296784 | Derived | Alvarez-Peregrina C, Sanchez-Tena MA, Villa-Collar C, Martinez-Perez C, de Corcuera-Terrero B, Liu N, Li W, Sankaridurg P, Ohlendorf A; Clinical Evaluation of MyoCare in Europe - the CEME Study Group. Clinical evaluation of MyoCare in Europe (CEME) for myopia management: One-year results. Ophthalmic Physiol Opt. 2025 Jun;45(4):1025-1035. doi: 10.1111/opo.13517. Epub 2025 Apr 29. | |
| 37848908 |
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| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| UNKNOWN |
| ICQO Instituto Quirúrgico de Oftalmología | UNKNOWN |
| CPO Clinica Privada de Oftalmologia, S.A. | UNKNOWN |
| Carl Zeiss Meditec, Inc. | INDUSTRY |
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| ClearView | Device | Children assigned to the study group will wear ZEISS MyoCare lenses, while those assigned to the control group will wear conventional ZEISS ClearView single-vision lenses in their spectacles. Both lenses will be made of the same material (MR8) and hard as well as anti-reflection coating (ZEISS DuraVision Platinum) and will have the same surface treatments. |
|
| Derived |
| Alvarez-Peregrina C, Sanchez-Tena MA, Martinez-Perez C, Villa-Collar C; Clinical Evaluation of MyoCare in Europe -the CEME Study Group; Ohlendorf A. Clinical Evaluation of MyoCare in Europe (CEME): study protocol for a prospective, multicenter, randomized, double-blinded, and controlled clinical trial. Trials. 2023 Oct 17;24(1):674. doi: 10.1186/s13063-023-07696-0. |