Clinical Evaluation of MyoCare in Europe (CEME)

Sponsor

Universidad Complutense de Madrid (Other)

Overall Status

Recruiting

CT.gov ID

NCT05919654

Collaborator

Cooperativa de Ensino Superior, Politécnico e Universitário (Other), Carl Zeiss Meditec, Inc. (Industry), Novovision (Other), Instituto de Cirugia Ocular (Other), Miranza Virgen de Lujan (Other), ICQO Instituto Quirúrgico de Oftalmología (Other), CPO Clinica Privada de Oftalmologia, S.A. (Other)

300

Enrollment

Location

Arms

34.5

Anticipated Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia, Progressive	Device: MyoCare Device: ClearView	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Objetive 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 refration will be compared between myopic children treated with ZEISS MyoCare lenses and those who wear a conventional single-vision lens.

Secondary Outcome Measures

Axial Lenght [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Complutense de Madrid	Madrid		Spain	28037

Sponsors and Collaborators

Universidad Complutense de Madrid
Cooperativa de Ensino Superior, Politécnico e Universitário
Carl Zeiss Meditec, Inc.
Novovision
Instituto de Cirugia Ocular
Miranza Virgen de Lujan
ICQO Instituto Quirúrgico de Oftalmología
CPO Clinica Privada de Oftalmologia, S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universidad Complutense de Madrid

ClinicalTrials.gov Identifier:

NCT05919654

Other Study ID Numbers:

UCM-MIOPIA-01
2022-001696-14
22/384-EC_P

First Posted:

Jun 26, 2023

Last Update Posted:

Jun 26, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Universidad Complutense de Madrid

myopia

Additional relevant MeSH terms:

Myopia

Myopia, Degenerative

Study Results

No Results Posted as of Jun 26, 2023