Myopia Control With Orthokeratology Contact Lenses in Spain (MCOS)

Menicon

Status: Completed

Conditions: Perception, Self; Children, Only; Contact Lens Complication; Myopia, Progressive; Axial Myopia

Treatments: Device: Menicon Z Night; Device: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04806763

MCOS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 69 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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69 participants in 2 patient groups

Menicon Z Night

Experimental group

Description:

The experimental group is allocated to wear Menicon Z Night orthokeratology contact lenses for two years

Treatment:

Device: Menicon Z Night

Glasses

Active Comparator group

Description:

The active comparator includes a group that was allocated to wear distance, single-vision glasses for two years

Treatment:

Device: Control