Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study
ConditionMyopia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-14
SponsorThe University of New South Wales
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Vivior
DeviceThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Near viewing duration
Duration during near tasks
Time frame
12 months2
Near viewing distance
Distance during near tasks
Time frame
12 months3
Outdoor time
Ambient illumination to determine time spent outdoors
Time frame
12 monthsSecondary outcomes
1
Objective cycloplegic central refraction
Change in objective refraction to measure myopia progression
Time frame
12 months2
Axial length
Change in axial length to measure myopia progression
Time frame
12 months3
Subjective cycloplegic central refraction
Change in subjective refraction to measure myopia progression
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of New South Wales
Lead sponsor
Queensland University of Technology
Collaborator
New England College of Optometry
Collaborator
State University of New York College of Optometry
Collaborator
University of California, Berkeley
Collaborator
Source ClinicalTrials.gov