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

Children, Only Clinical Trial

— MCOS11  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806711
• Other study ID #: MCOS11
• Status: Completed
• Phase: N/A
• Start date: March 1, 2007
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2021
• Source: Menicon Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Device:
• Menicon Z Night
Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children
• Control
Distance, single-vision glasses were used as a control

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Menicon Co., Ltd.	Clinica novovision, Universidad Europea de Madrid

References & Publications (2)

Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutiérrez-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: 10.1080/02713683.201 — View Citation

Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutiérrez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length	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.	11 years