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OpenTrials
Completed

NCT Number: NCT04806711

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

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.

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

Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children

Control

Device

Distance, single-vision glasses were used as a control

Primary outcomes

  1. Axial length

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Menicon Co., Ltd.

Industry

Collaborators

  • Clinica novovision
  • Universidad Europea de Madrid

Registry information

Acronym: MCOS11

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
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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