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

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

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 over a 7-year period.

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

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menicon Z Night<br>The experimental arm includes a group of children wearing Menicon Z Night orthokeratology contact lenses for 7 years | Device: Menicon Z Night<br>* Children wearing Menicon Z Night orthokeratology contact lenses<br>|
| Active Comparator: Control<br>The active comparator arm includes a control group of children wearing distance, single-vision glasses or soft contact lenses | Device: Control<br>* Children wearing distance single-vision glasses or distance single-vision soft contact lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Seven years |