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

Not Applicable

Completed

• Conditions: Myopia, Progressive; Children, Only
• Interventions: Device: Menicon Z Night; Device: Control

• Registration Number: NCT04806711
• Lead Sponsor: Menicon Co., Ltd.

Brief Summary

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 contact lenses over an 11-year period.

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

Study Timeline

• Study Start: 2007-03-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-17
• Last Update Submitted: 2021-03-17
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menicon Z Night	Menicon Z Night	The experimental arm consist of a group of Menicon Z Night orthokeratology contact lens wearers
Control	Control	The active comparator arm consist of a control group of distance, single-vision glasses and contact lens wearers

Primary Outcome Measures

Name	Time	Method
Axial length	11 years	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.