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

Children, Only Clinical Trial

— MCOS7  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806698
• Other study ID #: MCOS7
• Status: Completed
• Phase: N/A
• Start date: March 1, 2007
• Est. completion date: March 1, 2015

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2015
• Est. primary completion date: March 1, 2015
• 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
Children wearing Menicon Z Night orthokeratology contact lenses
• Control
Children wearing distance single-vision glasses or distance single-vision soft contact lenses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Menicon Co., Ltd.

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length	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	Seven years