MyopiaMENOKNCT06119243
Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study
An observational study of Myopia, run by The University of New South Wales at 5 sites in 2 countries.
Trial summary
Currently, optical and pharmacological interventions have been developed to prevent the progression of childhood myopia. However, no myopia control strategy has been shown to have complete efficacy in controlling myopia progression in children. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Myopia
- What is being tested?
- Vivior
- Type of treatment
- Medical device
- How many people
- 230 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 21 Mar 2023to 31 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Myopic children will be recruited from the university based myopia control clinic. Some clinical sites have collaborated with community optometry practices so support recruitment.
Who may be able to join
- Aged 6 to below 14 years old
- Spherical equivalent myopic refractive error greater than -0.50 D
- Best corrected logMAR visual acuity of 0.1 or better in each eye for 6- to 14-year-old children, and 0.2 logMAR or better than in each eye for 4 and 5-year-old children (adjusted for age-related expectations)
- Good ocular and general health that would not preclude them from myopia control
- Competent enough in English to fully understand the participant information and consent form
- Willing to undergo treatment to slow myopia progression for one year
Who cannot join
- Strabismus at distance or near, or amblyopia
- Systemic or ocular conditions that may affect contact lens use (e.g. severe allergy) or refractive development (e.g. ptosis)
- Previous history of ocular surgery, trauma or chronic ocular disease that may affect their vision
- Ocular or systemic medication use which may interfere or interact with myopia treatment or ocular development
- Child, parents or guardians not willing to comply with treatment and/or follow-up schedule and planning to migrate or move during the one-year study duration
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites, 2 recruiting
- Active, not recruiting
School of Optometry, University of California, Berkeley
Berkeley, California, 94720
- Recruiting
New England College of Optometry
Boston, Massachusetts, 02115
Fuensanta Vera-Diaz, PhD
- Not yet recruiting
State University of New York (SUNY), College of Optometry
New York, New York, 10036
Xiaoying Zhu, PhD
Australia2 sites, 2 recruiting
- Recruiting
Optometry and Vision Science, Queensland University of Technology
Kelvin Grove, Queensland, 4059
Emily Pieterse, PhD
- Recruiting
School of Optometry and Vision Science, UNSW
Sydney, New South Wales, 2052
Pauline Kang, PhD, p.kang@unsw.edu.au
Pauline Kang, PhD
About this study
Official title: Multicenter Study of Near Vision Behavior and Outdoor Time in Children Undergoing Myopia Control
Currently, optical and pharmacological interventions have been developed to prevent the progression of childhood myopia. However, no myopia control strategy has been shown to have complete efficacy in controlling myopia progression in children. One possible reason is that risk factors contributing to the development of myopia were not controlled in previous clinical studies including time outdoors and near vision behaviour. This study aims to quantify time spent outdoors and near vision behavior in myopic children and its impact on myopia control efficacy. The outcomes of this study will guide clinicians on risk management and improve responses to existing treatments for progressive myopia.
- Conditions
- Myopia
- Being tested
- Vivior
- Keywords
- Myopia, Myopia control, Progressive myopia, Near vision behavior, Outdoor activity, Environment, Light exposure
- Medical subject headings
- Myopia, Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViviorDevice
The Vivior is a wearable clip-on sensor that objectively quantifies near viewing distance and duration, and ambient illumination. The Vivior will be attached to the spectacles frame of children undergoing myopia control treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Near viewing duration
Duration during near tasks
Measured: 12 months
Near viewing distance
Distance during near tasks
Measured: 12 months
Outdoor time
Ambient illumination to determine time spent outdoors
Measured: 12 months
Secondary outcomes (3)
Objective cycloplegic central refraction
Change in objective refraction to measure myopia progression
Measured: 12 months
Axial length
Change in axial length to measure myopia progression
Measured: 12 months
Subjective cycloplegic central refraction
Change in subjective refraction to measure myopia progression
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start21 Mar 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Queensland University of Technology, New England College of Optometry, State University of New York College of Optometry, University of California, Berkeley
- Responsible party
- Principal investigator, Pauline Kang, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119243
- Sponsor's protocol ID
- MENOK
- Acronym
- MENOK
- Status last verified
- Dec 2024
- First submitted
- 30 Oct 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Near Vision Behavior and Outdoor Time in Children Undergoing Myopia Control
- ClinicalTrials.gov ID
- NCT06119243
- Acronym / sponsor ID
- MENOK / MENOK
- Conditions
- Myopia
- Keywords
- Myopia, Myopia control, Progressive myopia, Near vision behavior, Outdoor activity, Environment, Light exposure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Queensland University of Technology, New England College of Optometry, State University of New York College of Optometry, University of California, Berkeley
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Nov 2023 (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.
Currently, optical and pharmacological interventions have been developed to prevent the progression of childhood myopia. However, no myopia control strategy has been shown to have complete efficacy in controlling myopia progression in children. One possible reason is that risk factors contributing to the development of myopia were not controlled in previous clinical studies including time outdoors and near vision behaviour. This study aims to quantify time spent outdoors and near vision behavior in myopic children and its impact on myopia control efficacy. The outcomes of this study will guide clinicians on risk management and improve responses to existing treatments for progressive myopia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Myopic children will be recruited from the university based myopia control clinic. Some clinical sites have collaborated with community optometry practices so support recruitment.
Key inclusion criteria (6 listed)
- Aged 6 to below 14 years old
- Spherical equivalent myopic refractive error greater than -0.50 D
- Best corrected logMAR visual acuity of 0.1 or better in each eye for 6- to 14-year-old children, and 0.2 logMAR or better than in each eye for 4 and 5-year-old children (adjusted for age-related expectations)
- Good ocular and general health that would not preclude them from myopia control
- Competent enough in English to fully understand the participant information and consent form
Key exclusion criteria (5 listed)
- Strabismus at distance or near, or amblyopia
- Systemic or ocular conditions that may affect contact lens use (e.g. severe allergy) or refractive development (e.g. ptosis)
- Previous history of ocular surgery, trauma or chronic ocular disease that may affect their vision
- Ocular or systemic medication use which may interfere or interact with myopia treatment or ocular development
- Child, parents or guardians not willing to comply with treatment and/or follow-up schedule and planning to migrate or move during the one-year study duration
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 |
|---|---|---|
| ViviorThe Vivior is a wearable clip-on sensor that objectively quantifies near viewing distance and duration, and ambient illumination. The Vivior will be attached to the spectacles frame of children undergoing myopia control treatment. | Device | – |
Primary outcome
Near viewing duration
Time frame: 12 months
Duration during near tasks
Near viewing distance
Time frame: 12 months
Distance during near tasks
Outdoor time
Time frame: 12 months
Ambient illumination to determine time spent outdoors
3 secondary outcomes
Objective cycloplegic central refraction
Time frame: 12 months
Axial length
Time frame: 12 months
Subjective cycloplegic central refraction
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- 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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by The University of New South Wales at 5 sites in 2 countries.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Kang, PhD (612 9065 6112, p.kang@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near viewing duration (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2024.