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OpenTrials
Completed

NCT Number: NCT04806698

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

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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Key information

Conditions

Myopia, Progressive Children, Only Eye Diseases Myopia Myopia, Degenerative Refractive Errors

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menicon Z Night

Device

Children wearing Menicon Z Night orthokeratology contact lenses

Control

Device

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

Primary outcomes

  1. Axial length

    Time frame: Seven years

    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

Sponsors and collaborators

Lead sponsor

Menicon Co., Ltd.

Industry

Registry information

Acronym: MCOS7

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2021
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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