Myopia, ProgressiveMCOSNCT04806763
Myopia Control With Orthokeratology Contact Lenses in Spain
A study testing Menicon Z Night in people with Myopia, Progressive and Children, Only, run by Menicon Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive, Children, Only, Contact Lens Complication
- What is being tested?
- Menicon Z Night
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2007to 1 Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Myopia, Progressive, Children, Only, Contact Lens Complication, Perception, Self, Axial Myopia
- Being tested
- Menicon Z Night, Control
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menicon Z NightDevice
To assess the use of Menicon Z Night contact lenses for reducing myopia progression in children
ControlDevice
Distance, single-vision glasses were used as control
| Study group | Role | What they receive |
|---|---|---|
| Menicon Z Night | Experimental | The experimental group is allocated to wear Menicon Z Night orthokeratology contact lenses for two years Receives: Device: Menicon Z Night |
| Glasses | Active comparator | The active comparator includes a group that was allocated to wear distance, single-vision glasses for two years Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Secondary outcomes (2)
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.
Measured: Two years
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Mar 2007
- Primary completion1 Mar 2010
- Study completion1 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myopia, ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, controlled, longitudinal
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menicon Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Europea de Madrid, Aston University, Clinica novovision
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806763
- Sponsor's protocol ID
- MCOS
- Acronym
- MCOS
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22729437Santodomingo-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.
PubMed 22773180Santodomingo-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.
PubMed 23392299
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Control With Orthokeratology Contact Lenses in Spain
- ClinicalTrials.gov ID
- NCT04806763
- Acronym / sponsor ID
- MCOS / MCOS
- Conditions
- Myopia, Progressive, Children, Only, Contact Lens Complication, Perception, Self, Axial Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Menicon Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Universidad Europea de Madrid, Aston University, Clinica novovision
- Study start
- 1 Mar 2007 (actual)
- Primary completion
- 1 Mar 2010 (actual)
- Study completion
- 1 Mar 2010 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, controlled, longitudinal
| Arm | Type | Receives |
|---|---|---|
| Menicon Z Night | Experimental | Device: Menicon Z NightThe experimental group is allocated to wear Menicon Z Night orthokeratology contact lenses for two years |
| Glasses | Active comparator | Device: ControlThe active comparator includes a group that was allocated to wear distance, single-vision glasses for two years |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menicon Z NightTo assess the use of Menicon Z Night contact lenses for reducing myopia progression in children | Device | Menicon Z Night |
| ControlDistance, single-vision glasses were used as control | Device | Glasses |
Primary outcome
Axial length
Time frame: Two years
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.
2 secondary outcomes
Adverse events
Time frame: Two years
Patient-reported outcomes
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Results publication: PubMed 22729437Santodomingo-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 publication: PubMed 22773180Santodomingo-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 publication: PubMed 23392299Santodomingo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Menicon Z Night in people with Myopia, Progressive and Children, Only, run by Menicon Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04806763, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.