- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04806711
Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children (MCOS11)
March 17, 2021 updated by: Menicon Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Menicon Z Night
The experimental arm consist of a group of Menicon Z Night orthokeratology contact lens wearers
|
Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children
|
ACTIVE_COMPARATOR: Control
The active comparator arm consist of a control group of distance, single-vision glasses and contact lens wearers
|
Distance, single-vision glasses were used as a control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Axial length
Time Frame: 11 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2007
Primary Completion (ACTUAL)
March 1, 2018
Study Completion (ACTUAL)
March 1, 2018
Study Registration Dates
First Submitted
March 10, 2021
First Submitted That Met QC Criteria
March 17, 2021
First Posted (ACTUAL)
March 19, 2021
Study Record Updates
Last Update Posted (ACTUAL)
March 19, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCOS11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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