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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04806698

Acronym

MCOS7

Enrollment

Registered

2021-03-19

Start date

2007-03-01

Completion date

2015-03-01

Last updated

2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Only, Myopia, Progressive

Brief summary

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

Detailed 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.

Interventions

DEVICEMenicon Z Night

Children wearing Menicon Z Night orthokeratology contact lenses

DEVICEControl

Children wearing distance single-vision glasses or distance single-vision soft contact lenses

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Axial length	Seven years	To compare the axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single vision glasses or soft contact lenses

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026