NCT05919654

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

October 30, 2023

Status Verified

June 1, 2023

Enrollment Period

2.8 years

First QC Date

May 31, 2023

Last Update Submit

October 25, 2023

Conditions

Myopia, Progressive

Keywords

myopia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Axial length

    2 years

Study Arms (2)

Treatment

EXPERIMENTAL

Myocare

Device: MyoCare

Control

ACTIVE COMPARATOR

Clearview

Device: ClearView

Interventions

MyoCareDEVICE

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.

Treatment
ClearViewDEVICE

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.

Control

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28037, Spain

Location

Related Publications (1)

  • Alvarez-Peregrina C, Sanchez-Tena MA, Martinez-Perez C, Villa-Collar C; Clinical Evaluation of MyoCare in Europe -the CEME Study Group; Ohlendorf A. Clinical Evaluation of MyoCare in Europe (CEME): study protocol for a prospective, multicenter, randomized, double-blinded, and controlled clinical trial. Trials. 2023 Oct 17;24(1):674. doi: 10.1186/s13063-023-07696-0.

    PMID: 37848908DERIVED

MeSH Terms

Conditions

Myopia, DegenerativeMyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 26, 2023

Study Start

September 15, 2022

Primary Completion

June 30, 2025

Study Completion

July 31, 2025

Last Updated

October 30, 2023

Record last verified: 2023-06

Locations

ES(1)