Clinical Evaluation of MyoCare in Europe (CEME)

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of MyoCare in Europe (CEME): Study Protocol for a Prospective, Multicenter, Randomized, Double-blinded, and Controlled Clinical Trial.

Conditions
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Myopia, Progressive

Intervention / Treatment
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* Device: MyoCare
* Device: ClearView


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6-13 years Caucasian ethnicity Monocular/binocular decimal visual acuity with correction ≥ 1.00 Spherical equivalent between -0.75D and -5.00D Astigmatism < 1.50D Anisometropia < 1.00D Evolution of at least -0.50D in one year Exclusion Criteria: Presence of ocular pathology or a history of ocular and systemic abnormalities Strabismus or binocular vision problems History of eye surgery Having previously used some method to control myopia. Having contraindications for the application of drugs for cycloplegia/corneal anesthesia

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Myocare | Device: MyoCare<br>* 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.<br>|
| Active Comparator: Control<br>Clearview | Device: ClearView<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia