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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-01

Study Completion Date

2015-03-01

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

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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.

Conditions

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Myopia, Progressive Children, Only

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Menicon Z Night

The experimental arm includes a group of children wearing Menicon Z Night orthokeratology contact lenses for 7 years

Group Type EXPERIMENTAL

Menicon Z Night

Intervention Type DEVICE

Children wearing Menicon Z Night orthokeratology contact lenses

Control

The active comparator arm includes a control group of children wearing distance, single-vision glasses or soft contact lenses

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DEVICE

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

Interventions

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Menicon Z Night

Children wearing Menicon Z Night orthokeratology contact lenses

Intervention Type DEVICE

Control

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

Intervention Type DEVICE

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes