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.
The primary objective of the study is to evaluate whether the optimization of daily exposure to light in primary school children can lead to better myopia prevention and control. To do so, we will evaluate the effectiveness, safety and feasibility of: 1. Arm 1: technical intervention which involves spectro-temporal refinement of classroom lighting in primary schools using full spectrum light emitting diodes (LEDs) (CCT: 4000K) in addition to intermittent fluctuations in light levels. Parents of children in that arm will have access to a sham version of the LightUP mobile application to facilitate communication with the study team and questionnaire collection during the study. 2. Arm 2: digital intervention which involves optimization of daily light exposure using an individualised behaviour-changing smart-phone application (Interventional LightUP application) coupled with child-worn light and activity sensors to provide parents with an individually tailored recommendation to adapt their children's behaviour and provide them with the required amounts of myopia-preventive light quantum/day. + standard classroom lighting As compared to: 3. Arm 3: Standard care or control group which involves standard classroom lighting and no access to the interventional version of the LightUP application. Parents of children in that arm will have access to a sham version of the LightUP mobile application to facilitate communication with the study team and questionnaire collection during the study. Our study will also lead to the following scalable and implementable outcomes: 1. evidence-based lighting designs and policy recommendations for classrooms; 2. a user-friendly, smart digital eyecare companion that aligns perfectly with Singapore's Smart Nation Initiative. A secondary objective of this study is to better understand the impact of light exposure on sleep and cognitive performance in children. This will be achieved through continuous wrist actigraphy monitoring and through cognitive assessments, performed in classrooms, using tablets (one tablet/child). The assessment consists of validated, child-adapted, higher cognitive tasks testing the following constructs: impulse control, spatial working memory, content working memory, cognitive flexibility, reaction time, and processing speed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
396
LEDs 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.
Smart-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).
Standard Classroom Lighting + Sham LightUP phone application
National University of Singapore, Yong Loo Lin School of Medicine, Department of Ophthalmology, Eye N Brain Research Lab
Singapore, Singapore
RECRUITINGMarymount Convent School
Singapore, Singapore
RECRUITINGBedok Green Primary School
Singapore, Singapore
RECRUITINGWestwood Primary School
Singapore, Singapore
RECRUITINGWellington Primary School
Singapore, Singapore
RECRUITINGCycloplegic auto-refraction
Measured using autoref/kerato/pachy/tonometer
Time frame: 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)
Axial Length
Measured using non-contact optical biometer
Time frame: 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)
Choroidal Thickness
Measured using optical coherence tomography (OCT) scan
Time frame: 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)
Retinal and choroidal perfusion
Measured using optical coherence tomography angiography (OCT-A) function within OCT machine used to measure choroidal thickness.
Time frame: 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)
Corneal Curvature
Measured using autoref/kerato/pachy/tonometer.
Time frame: 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)
Corneal Thickness
Measured using autoref/kerato/pachy/tonometer.
Time frame: 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)
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.
Time frame: 1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit)
Cognitive flexibility
Cognitive flexibility 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). Cognitive flexibility will be quantified by the number of errors committed by the children during the task which involves shifting instructions and paradigms.
Time frame: 1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit)
Spatial working memory
Spatial working memory will be assessed using a validated, child-adapted task developed by collaborator Dr. Evelyn Law (NUS). The "Eight Boxes" task or a similar task will be administered on tablets (one tablet per child). Spatial working memory will be quantified by the number of errors committed by the children during the task.
Time frame: 1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit)
Content working memory
Content working memory will also be assessed using a validated, child-adapted task developed by collaborator Dr. Evelyn Law (NUS). The "Eight Boxes" task or a similar task will be administered on tablets (one tablet per child). Content working memory will be quantified by the number of errors committed by the children during the task when remembering the content of different items in the task (e.g., strawberry, watermelon, etc.).
Time frame: 1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit)
Processing speed
Processing speed will be assessed from the previous cognitive tasks (e.g., Eight Boxes and Day and Night Cards" through the investigation of reaction time (ms) in response to the content of the tasks. The tasks will be administered on tablets (one tablet per child).
Time frame: 1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit)
Sleep quantity
This is a secondary outcome and will depend on the days of wear of the activity and light trackers. Night time sleep quantity (minutes) will be collected through actigraphy watches given to participants.
Time frame: 1 year or at least 1 week per month for 1 year
Sleep efficiency
This is a secondary outcome and will depend on the days of wear of the activity and light trackers. Night time sleep efficiency (%) calculated as the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes) will be measured using actigraphy watches given to participants.
Time frame: 1 year or at least 1 week per month for 1 year
Height
Height of the participant in cm
Time frame: 1 year, at baseline and 12 months from baseline
Weight
Weight of the participant in Kg
Time frame: 1 year, at baseline and 12 months from baseline
Visual acuity
LogMAR visual acuity test
Time frame: 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)
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