Clinical Evaluation of MyoCare in Europe (CEME)

Not Applicable

Active, not recruiting

• Conditions: Myopia, Progressive
• Interventions: Device: MyoCare; Device: ClearView

• Registration Number: NCT05919654
• Lead Sponsor: Universidad Complutense de Madrid

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-15
• Study First Submitted: 2023-05-31
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-06-26
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	MyoCare	Myocare
Control	ClearView	Clearview

Primary Outcome Measures

Name	Time	Method
Objective refraction	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Axial length	2 years	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.

Trial Locations

Locations (1)

Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain