Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children

Menicon Co., Ltd.20 enrolled

Overview

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 of distance, single-vision glasses and or distance, single-vision soft contact lenses over an 11-year period.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia, Progressive Children, Only

Interventions

Menicon Z NightDEVICE

Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children

ControlDEVICE

Distance, single-vision glasses were used as a control

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 axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and soft contact lens wearers. Measurements of axial length were taken with the Zeiss IOLMaster (Carl Zeiss Jena GmbH, Jena, Germany). Three separate measurements of axial length were recorded per subject and per visit, and a mean obtained.

Time frame: 11 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.