Back to resultsMyopia Control With Orthokeratology Contact Lenses in Spain (MCOS)
Primary Purpose
Myopia, Progressive, Children, Only, Contact Lens Complication
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Menicon Z Night
Control
Sponsored by
About this trial
This is an interventional treatment trial for Myopia, Progressive
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Menicon Z Night
Glasses
Arm Description
The experimental group is allocated to wear Menicon Z Night orthokeratology contact lenses for two years
The active comparator includes a group that was allocated to wear distance, single-vision glasses for two years
Outcomes
Primary Outcome Measures
Axial length
To compare axial length growth between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Measurements of axial length (in millimeters) 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.
Secondary Outcome Measures
Adverse events
To compare the incidence of adverse events between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Adverse events were classified into serious, significant, or non-significant. Recurrences of the same adverse event(s) in the same or fellow eye at any of the subsequent study visits were classified as separate events; bilateral events will be counted as two separate events. The incidence of adverse events was calculated as a percentage of eyes per annum.
Patient-reported outcomes
To compare vision-related quality-of-life measures between children wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. The pediatric refractive error profile survey was used to compare patient-reported outcomes in terms of the vision-specific quality of life between children in the Menicon Z Night and control groups. The survey consists of 26 statements scored from 1 (poor quality of life) to 5 (good quality of life), then scaled from 0 to 100 by subtracting 1 from the raw score of each question and multiplying by 25. The mean score of all items was calculated as the overall score. The survey includes 11 scales: overall vision, near vision, far distance vision, symptoms, appearance, satisfaction, activities, academics, handling, peer perception, and overall score.
Full Information
NCT ID
NCT04806763
First Posted
March 10, 2021
Last Updated
March 23, 2021
Sponsor
Menicon Co., Ltd.
Collaborators
Universidad Europea de Madrid, Aston University, Clinica novovision
1. Study Identification
Unique Protocol Identification Number
NCT04806763
Brief Title
Myopia Control With Orthokeratology Contact Lenses in Spain
Acronym
MCOS
Official Title
Myopia Control With Orthokeratology Contact Lenses in Spain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2007 (Actual)
Primary Completion Date
March 1, 2010 (Actual)
Study Completion Date
March 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menicon Co., Ltd.
Collaborators
Universidad Europea de Madrid, Aston University, Clinica novovision
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children.
Detailed Description
The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children in comparison with a group of distance, single-vision glasses over a 2-year period. Efficacy was evaluated by assessing differences in the axial length between groups. Safety was evaluated by comparing the incidence of adverse events between groups. Differences between groups in patient-reported outcomes were evaluated using a questionnaire that assessed vision-related quality-of-life measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive, Children, Only, Contact Lens Complication, Perception, Self, Axial Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, controlled, longitudinal
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Menicon Z Night
Arm Type
Experimental
Arm Description
The experimental group is allocated to wear Menicon Z Night orthokeratology contact lenses for two years
Arm Title
Glasses
Arm Type
Active Comparator
Arm Description
The active comparator includes a group that was allocated to wear distance, single-vision glasses for two years
Intervention Type
Device
Intervention Name(s)
Menicon Z Night
Intervention Description
To assess the use of Menicon Z Night contact lenses for reducing myopia progression in children
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Distance, single-vision glasses were used as control
Primary Outcome Measure Information:
Title
Axial length
Description
To compare axial length growth between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Measurements of axial length (in millimeters) 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.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Adverse events
Description
To compare the incidence of adverse events between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Adverse events were classified into serious, significant, or non-significant. Recurrences of the same adverse event(s) in the same or fellow eye at any of the subsequent study visits were classified as separate events; bilateral events will be counted as two separate events. The incidence of adverse events was calculated as a percentage of eyes per annum.
Time Frame
Two years
Title
Patient-reported outcomes
Description
To compare vision-related quality-of-life measures between children wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. The pediatric refractive error profile survey was used to compare patient-reported outcomes in terms of the vision-specific quality of life between children in the Menicon Z Night and control groups. The survey consists of 26 statements scored from 1 (poor quality of life) to 5 (good quality of life), then scaled from 0 to 100 by subtracting 1 from the raw score of each question and multiplying by 25. The mean score of all items was calculated as the overall score. The survey includes 11 scales: overall vision, near vision, far distance vision, symptoms, appearance, satisfaction, activities, academics, handling, peer perception, and overall score.
Time Frame
Two years
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
White European
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22729437
Citation
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.
Results Reference
result
PubMed Identifier
22773180
Citation
Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Orthokeratology vs. spectacles: adverse events and discontinuations. Optom Vis Sci. 2012 Aug;89(8):1133-9. doi: 10.1097/OPX.0b013e318263c5af.
Results Reference
result
PubMed Identifier
23392299
Citation
Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Myopia control with orthokeratology contact lenses in Spain: a comparison of vision-related quality-of-life measures between orthokeratology contact lenses and single-vision spectacles. Eye Contact Lens. 2013 Mar;39(2):153-7. doi: 10.1097/ICL.0b013e31827a0241.
Results Reference
result
Learn more about this trial
Myopia Control With Orthokeratology Contact Lenses in Spain
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