Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children (MCOS11)

Menicon

Status: Completed

Conditions: Children, Only; Myopia, Progressive

Treatments: Device: Control; Device: Menicon Z Night

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04806711

MCOS11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Menicon Z Night

Experimental group

Description:

The experimental arm consist of a group of Menicon Z Night orthokeratology contact lens wearers

Treatment:

Device: Menicon Z Night

Control

Active Comparator group

Description:

The active comparator arm consist of a control group of distance, single-vision glasses and contact lens wearers

Treatment:

Device: Control