The goal of this clinical trial is to evaluate whether the optimization of daily exposure to light in primary school children can lead to better myopia prevention and control. The trial also aims to better understand the impact of light exposure on sleep and cognitive performance in children.
This trial has 3 arms namely, (1) a technical intervention arm, (2) a digital intervention arm, and (3) a control arm.
1. technical intervention - which involves changing of classroom lighting in primary schools to ceiling lights that mimic the spectral composition of sunlight and fluctuates in intensity. Parents of children within that arm will have a sham smart-phone application (s-LightUP) 2. digital intervention - which involves standard classroom lighting and giving parents an interventional smart-phone application (i-LightUP) that will be coupled with their child's light and activity sensor (wrist worn device ). The interventional app will provide individually tailored recommendation based on their children's behaviour (data feedback that is collected from the light and activity monitoring watch). The interventional app would then send reminder prompts/notifications to encourage parents help their children achieve required amounts of myopia-preventive light quantum target set per day. 3. Standard care or control group which involves standard classroom lighting and parents having a sham smart-phone application (s-LightUP)
Participants will:
* be randomised to receive either no intervention (control group), technical intervention (light intervention that mimics sunlight) or digital intervention (parents having an app that syncs with child's light and activity sensor which will provide feedback to parents to encourage and recommends increment of outdoor activities and hours). * have their myopia progression monitored every 6 monthly and cognitive assessment done once every 3 months over a year. * wear the light and activity sensor watches throughout the 1-year study period as much as possible (minimum 1 week per month) except for wet water activities such as swimming, diving and showering for research data collection purpose.
Subject must meet all the inclusion criteria below to participate in this study.
Written Informed Consent form from parent / legal guardian and assent from child subject has been obtained
Is between 7 to 10 years of age at start of study intervention which is 2 January 2025 or 1 January 2026
Studying in either Primary 2 or 3 classes of the participating school(s) in academic year 2025 or 2026.
All subjects meeting any of the exclusion criteria at baseline will be excluded from participation.
Previous or ongoing myopia control treatment (including but not limited to orthokeratology, atropine, pirenzepine, myopia control spectacle and contact lenses, light therapy)
Ongoing participation in other myopia prevention and control research trials
Any systemic or neurologic diseases (e.g. cancer, epilepsy, Kawasaki disease) known to affect eye health or make the participant vulnerable to the ophthalmic examinations (e.g., light flash)
Parallel
Light Intervention
Other interventionLEDs mimicking the spectrum of sunlight (4000K) administered daily for 1 academic year, every school day, for the entire school day. The light levels generated by these LEDs will fluctuate throughout the day but will remain under 1000 lux.
Digital Intervention
BehavioralSmart-phone application (LightUP) will be synced daily to a child-worn light and activity sensor and will allow parents to track their children's outdoor time and exposure to brighter light levels across the day. The application will also nudge parents to increase their child's exposure to light (e.g., increase time outdoors, or sitting next to a window indoors) after school hours for better myopia prevention and control. i-LightUP aims to gradually assist parents in helping their children reach the ultimate goal of spending at least 2 hours per day in brighter light conditions (e.g., above 1000 lux).
Control Group
Other interventionStandard Classroom Lighting + Sham LightUP phone application
Cycloplegic auto-refraction
Measured using autoref/kerato/pachy/tonometer
Axial Length
Measured using non-contact optical biometer
Choroidal Thickness
Measured using optical coherence tomography (OCT) scan
Retinal and choroidal perfusion
Measured using optical coherence tomography angiography (OCT-A) function within OCT machine used to measure choroidal thickness.
Corneal Curvature
Measured using autoref/kerato/pachy/tonometer.
Corneal Thickness
Measured using autoref/kerato/pachy/tonometer.
Impulse control
Impulse control will be assessed using a validated, child-adapted task developed by collaborator Dr. Evelyn Law (NUS). The "Day and Night Cards" task or a similar task will be administered on tablets (one tablet per child). Impulse control will be quantified by the number of errors committed by the children during the task which involves shifting instructions and paradigms.
Daytime average light levels (lux)
Daytime average light levels (lux) collected using wearable light sensors.
Daytime average melanopic lux
Daytime average melanopic lux collected using wearable light sensors.
Time spent outdoors (questionnaires)
Estimated time spent outdoors collected using questionnaires
Time spent outdoors (wearables)
Calculated time spent outdoors collected using the wearable light sensors.
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National University of Singapore
Lead sponsor
Technical University of Munich
Collaborator
