Clinical Evaluation of MyoCare in Europe (CEME) (CEME)
Primary Purpose
Myopia, Progressive
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MyoCare
ClearView
Sponsored by
About this trial
This is an interventional treatment trial for Myopia, Progressive focused on measuring myopia
Eligibility Criteria
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
Sites / Locations
- Universidad Complutense de MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Control
Arm Description
Myocare
Clearview
Outcomes
Primary Outcome Measures
Objetive 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 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
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.
Full Information
NCT ID
NCT05919654
First Posted
May 31, 2023
Last Updated
June 22, 2023
Sponsor
Universidad Complutense de Madrid
Collaborators
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.
1. Study Identification
Unique Protocol Identification Number
NCT05919654
Brief Title
Clinical Evaluation of MyoCare in Europe (CEME)
Acronym
CEME
Official Title
Clinical Evaluation of MyoCare in Europe (CEME): Study Protocol for a Prospective, Multicenter, Randomized, Double-blinded, and Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
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.
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive
Keywords
myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Myocare
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Clearview
Intervention Type
Device
Intervention Name(s)
MyoCare
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ClearView
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objetive Refraction
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Axial Lenght
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28037
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Alvarez-Peregrina
Phone
+34913946847
Email
cristina_alvarez@ucm.es
Email
cris_petalo@yahoo.es
First Name & Middle Initial & Last Name & Degree
Miguel Ángel Sanchez-Tena
First Name & Middle Initial & Last Name & Degree
Cristina Alvarez-Peregrina
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Evaluation of MyoCare in Europe (CEME)
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