Status:
COMPLETED
Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children
Lead Sponsor:
Menicon Co., Ltd.
Collaborating Sponsors:
Universidad Europea de Madrid
Clinica novovision
Conditions:
Myopia, Progressive
Children, Only
Eligibility:
All Genders
6-12 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04806711
Start Date
March 1 2007
End Date
March 1 2018
Last Update
March 19 2021
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