Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia

Not Applicable

Completed

• Conditions: Children, Only; Myopia, Progressive
• Interventions: Device: Menicon Z Night; Device: Control

• Registration Number: NCT04806698
• Lead Sponsor: Menicon Co., Ltd.

Brief Summary

To assess the long-term efficacy of the Menicon Z Night orthokeratology contact lens in controlling the progression of childhood myopia

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 over a 7-year period.

Study Timeline

• Study Start: 2007-03-01
• Primary Completion: 2015-03-01
• Study Completion: 2015-03-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-17
• Last Update Submitted: 2021-03-17
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menicon Z Night	Menicon Z Night	The experimental arm includes a group of children wearing Menicon Z Night orthokeratology contact lenses for 7 years
Control	Control	The active comparator arm includes a control group of children wearing distance, single-vision glasses or soft contact lenses

Primary Outcome Measures

Name	Time	Method
Axial length	Seven years	To compare 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 or soft contact lenses