- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06119243
Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study (MENOK)
November 3, 2023 updated by: Pauline Kang, The University of New South Wales
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.
Study Overview
Study Type
Observational
Enrollment (Estimated)
230
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pauline Kang, PhD
- Phone Number: 612 9065 6112
- Email: p.kang@unsw.edu.au
Study Locations
-
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New South Wales
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Sydney, New South Wales, Australia, 2052
- School of Optometry and Vision Science, UNSW
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Contact:
- Pauline Kang, PhD
-
Principal Investigator:
- Pauline Kang, PhD
-
-
Queensland
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Kelvin Grove, Queensland, Australia, 4059
- Optometry and Vision Science, Queensland University of Technology
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Contact:
- Emily Pieterse, PhD
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-
-
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California
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Berkeley, California, United States, 94720
- School of Optometry, University of California, Berkeley
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Contact:
- Maria Liu, PhD
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Massachusetts
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Boston, Massachusetts, United States, 02115
- New England College of Optometry
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New York
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New York, New York, United States, 10036
- State University of New York (SUNY), College of Optometry
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Contact:
- Xiaoying Zhu, PhD
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-
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
- Child
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Myopic children will be recruited from the university based myopia control clinic.
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- Strabismus at distance or near, amblyopia or significant anisometropia (>1.50 D)
- 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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Near viewing duration
Time Frame: 12 months
|
Duration during near tasks
|
12 months
|
Near viewing distance
Time Frame: 12 months
|
Distance during near tasks
|
12 months
|
Outdoor time
Time Frame: 12 months
|
Ambient illumination to determine time spent outdoors
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective cycloplegic central refraction
Time Frame: 12 months
|
Change in objective refraction to measure myopia progression
|
12 months
|
Axial length
Time Frame: 12 months
|
Change in axial length to measure myopia progression
|
12 months
|
Subjective cycloplegic central refraction
Time Frame: 12 months
|
Change in subjective refraction to measure myopia progression
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Estimated)
November 1, 2023
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
October 30, 2023
First Submitted That Met QC Criteria
November 3, 2023
First Posted (Actual)
November 7, 2023
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 3, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MENOK
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
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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