Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia (MCOS7)

Menicon

Status

Completed

Conditions

Children, Only

Myopia, Progressive

Treatments

Device: Control

Device: Menicon Z Night

Study type

Interventional

Funder types

Industry

Identifiers

NCT04806698

MCOS7

Details and patient eligibility

About

To assess the long-term efficacy of the Menicon Z Night orthokeratology contact lens in controlling the progression of childhood myopia

Full description

This prospective, controlled, parallel, longitudinal study compared the axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group over a 7-year period.

Enrollment

30 patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Be 6 to 12 years of age, both ages inclusive
A low-to-moderate level of myopia (between -0.75 and -4.00 D) and of astigmatism (≤ 1.00 D)
Neophyte contact lens wearer
Be successfully fitted with spectacles or orthokeratology contact lenses
Be able to achieve, through spherical refraction correction, a logMAR visual acuity of 0.8 or better in each eye
Be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits
White European ethnicity

Exclusion criteria

Systemic or ocular disease affecting ocular health
Use of any systemic or topical medications that could affect ocular physiology or contact lens performance
Any lid or anterior segment abnormalities for which contact lens wear could be contraindicated
CCLRU grade ≥ 2 for any given anterior segment ocular clinical signs
Aphakic, amblyopic, and atopic individuals
Refractive astigmatism ≥ ½ spherical refraction
Previous contact lens wear