Myopia Control With Orthokeratology Con… | Clinical Trial

Key information

Conditions

Myopia, Progressive Axial Myopia Children, Only Contact Lens Complication Eye Diseases Myopia Myopia, Degenerative Perception, Self Refractive Errors

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children in comparison with a group of distance, single-vision glasses over a 2-year period. Efficacy was evaluated by assessing differences in the axial length between groups. Safety was evaluated by comparing the incidence of adverse events between groups. Differences between groups in patient-reported outcomes were evaluated using a questionnaire that assessed vision-related quality-of-life measures.

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

To assess the use of Menicon Z Night contact lenses for reducing myopia progression in children

Control

Device

Distance, single-vision glasses were used as control

Primary outcomes

Axial length

Time frame: Two years

To compare axial length growth between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Measurements of axial length (in millimeters) 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.

Secondary outcomes

Adverse events

Time frame: Two years

To compare the incidence of adverse events between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Adverse events were classified into serious, significant, or non-significant. Recurrences of the same adverse event(s) in the same or fellow eye at any of the subsequent study visits were classified as separate events; bilateral events will be counted as two separate events. The incidence of adverse events was calculated as a percentage of eyes per annum.
Patient-reported outcomes

Time frame: Two years

To compare vision-related quality-of-life measures between children wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. The pediatric refractive error profile survey was used to compare patient-reported outcomes in terms of the vision-specific quality of life between children in the Menicon Z Night and control groups. The survey consists of 26 statements scored from 1 (poor quality of life) to 5 (good quality of life), then scaled from 0 to 100 by subtracting 1 from the raw score of each question and multiplying by 25. The mean score of all items was calculated as the overall score. The survey includes 11 scales: overall vision, near vision, far distance vision, symptoms, appearance, satisfaction, activities, academics, handling, peer perception, and overall score.

Sponsors and collaborators

Lead sponsor

Menicon Co., Ltd.

Industry

Collaborators

Aston University
Clinica novovision
Universidad Europea de Madrid

Registry information

Acronym: MCOS

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Mar 19, 2021
Registry last updated: Mar 26, 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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Completed