Clinical Evaluation of MyoCare in Europe (CEME)

Myopia, Progressive Clinical Trial

— CEME  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05919654
• Other study ID #: UCM-MIOPIA-01
• Secondary ID: 2022-001696-1422
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2023
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (8)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Carl Zeiss Vision International GmbH, Cooperativa de Ensino Superior, Politécnico e Universitário, CPO Clinica Privada de Oftalmologia, S.A., ICQO Instituto Quirúrgico de Oftalmología, Instituto de Cirugia Ocular, Miranza Virgen de Lujan, Novovision

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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