Clinical Evaluation of MyoCare in Europe (CEME) (CEME)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Device: MyoCare; Device: ClearView

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28037
    • Universidad Complutense de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Myocare	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.
Active Comparator: Control; Clearview	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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: UCM-MIOPIA-01; 2022-001696-14 (EudraCT Number); 22/384-EC_P (Other Identifier: CEIm Hospital Clínico San Carlos)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No