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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06119243




Registration number
NCT06119243
Ethics application status
Date submitted
30/10/2023
Date registered
7/11/2023
Date last updated
7/11/2023

Titles & IDs
Public title
Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study
Scientific title
Multicenter Study of Near Vision Behavior and Outdoor Time in Children Undergoing Myopia Control
Secondary ID [1] 0 0
MENOK
Universal Trial Number (UTN)
Trial acronym
MENOK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Vivior

Treatment: Devices: Vivior
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Near viewing duration
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Near viewing distance
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Outdoor time
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
Objective cycloplegic central refraction
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Axial length
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Subjective cycloplegic central refraction
Timepoint [3] 0 0
12 months

Eligibility
Key inclusion criteria
1. Aged 6 to below 14 years old
2. Spherical equivalent myopic refractive error greater than -0.50 D
3. Best corrected logMAR visual acuity of 0.1 or better in each eye
4. Good ocular and general health that would not preclude them from myopia control
5. Competent enough in English to fully understand the participant information and consent form
6. Willing to undergo treatment to slow myopia progression for one year
Minimum age
6 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Strabismus at distance or near, amblyopia or significant anisometropia (>1.50 D)
2. Systemic or ocular conditions that may affect contact lens use (e.g. severe allergy) or refractive development (e.g. ptosis)
3. Previous history of ocular surgery, trauma or chronic ocular disease that may affect their vision
4. Ocular or systemic medication use which may interfere or interact with myopia treatment or ocular development
5. 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
School of Optometry and Vision Science, UNSW - Sydney
Recruitment hospital [2] 0 0
Optometry and Vision Science, Queensland University of Technology - Kelvin Grove
Recruitment postcode(s) [1] 0 0
2052 - Sydney
Recruitment postcode(s) [2] 0 0
4059 - Kelvin Grove
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland University of Technology
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
New England College of Optometry
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
State University of New York College of Optometry
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of California, Berkeley
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/study/NCT06119243
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pauline Kang, PhD
Address 0 0
Country 0 0
Phone 0 0
612 9065 6112
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06119243