Children, Only, Myopia, Progressive
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMenicon Z Night
Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children
DEVICEControl
Distance, single-vision glasses were used as a control
Sponsors
Universidad Europea de Madrid
Clinica novovision
Menicon Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, controlled, parallel, longitudinal
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | 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. |
Outcome results
None listed