Status:
COMPLETED
Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia
Lead Sponsor:
Menicon Co., Ltd.
Conditions:
Myopia, Progressive
Children, Only
Eligibility:
All Genders
6-12 years
Phase:
NA
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 ...
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 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04806698
Start Date
March 1 2007
End Date
March 1 2015
Last Update
March 19 2021
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