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

Menicon Co., Ltd.30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia, Progressive Children, Only

Interventions

Menicon Z NightDEVICE

Children wearing Menicon Z Night orthokeratology contact lenses

ControlDEVICE

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Axial length

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

Time frame: Seven years

Data from ClinicalTrials.gov

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