Clinical Evaluation of MyoCare in Europe (CEME)

Universidad Complutense de Madrid

Status

Active, not recruiting

Conditions

Myopia, Progressive

Treatments

Device: ClearView

Device: MyoCare

Study type

Interventional

Funder types

Other

Identifiers

NCT05919654

2022-001696-14 (EudraCT Number)

22/384-EC_P (Other Identifier)

UCM-MIOPIA-01

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

6 to 13 years old

Volunteers

Accepts Healthy Volunteers

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