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

NCT ID: NCT04806711

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-01
• Study Completion Date: 2018-03-01

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.

Conditions

Myopia, Progressive; Children, Only

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Menicon Z Night

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

Group Type: EXPERIMENTAL

Menicon Z Night

Intervention Type: DEVICE

Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children

Control

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DEVICE

Distance, single-vision glasses were used as a control

Interventions

Menicon Z Night

Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children

Intervention Type: DEVICE

Control

Distance, single-vision glasses were used as a control

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: collaborator

Clinica novovision

UNKNOWN

Sponsor Role: collaborator

Menicon Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Myopia control with orthokeratology contact lenses in Spain: refractive and biometric changes. Invest Ophthalmol Vis Sci. 2012 Jul 31;53(8):5060-5. doi: 10.1167/iovs.11-8005.

Reference Type: RESULT

PMID: 22729437 (View on PubMed)

Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R, Sugimoto K. Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia. Curr Eye Res. 2017 May;42(5):713-720. doi: 10.1080/02713683.2016.1221979. Epub 2016 Oct 21.

Reference Type: RESULT

PMID: 27767354 (View on PubMed)

Other Identifiers

MCOS11

Identifier Type: -

Identifier Source: org_study_id