Clinical Evaluation of MyoCare in Europe (CEME)

Summary

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.

Conditions

• Myopia, Progressive

Interventions

DEVICE

MyoCare

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.

DEVICE

ClearView

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.

Sponsors & Collaborators

• Cooperativa de Ensino Superior, Politécnico e Universitário

  collaborator OTHER

• Novovision

  collaborator UNKNOWN

• Instituto de Cirugia Ocular

  collaborator OTHER

• Miranza Virgen de Lujan

  collaborator UNKNOWN

• ICQO Instituto Quirúrgico de Oftalmología

  collaborator UNKNOWN

• CPO Clinica Privada de Oftalmologia, S.A.

  collaborator UNKNOWN

• Carl Zeiss Vision International GmbH

  collaborator UNKNOWN

• Universidad Complutense de Madrid

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

13 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-15

Primary Completion

2025-06-30

Completion

2025-07-31

Countries

• Spain

Study Locations