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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myopia, Progressive, Children, Only

Intervention / Treatment
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* Device: Menicon Z Night
* Device: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, controlled, parallel, longitudinal
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menicon Z Night<br>The experimental arm consist of a group of Menicon Z Night orthokeratology contact lens wearers | Device: Menicon Z Night<br>* Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children<br>|
| Active Comparator: Control<br>The active comparator arm consist of a control group of distance, single-vision glasses and contact lens wearers | Device: Control<br>* Distance, single-vision glasses were used as a control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 11 years |