Optimizing Light Exposure for Myopia Prevention and Control (LightSPAN)
National University of Singapore
396 participants
Oct 21, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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.
- Presenting visual acuity or best corrected visual acuity (BCVA) better or equal to LogMAR 0.2 (equivalent to Snellen 6/9 or better) in each eye
- Normal Intraocular pressure (not more than 21mmHg)
- No ocular conditions (e.g., optic nerve disease, glaucoma, retinal diseases) except for refractive error.
- No ocular conditions affecting the accuracy of the ophthalmic examinations
- In good general health with no significant systemic diseases that may affect eye health
Exclusion Criteria4
- 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)
- Any other conditions precluding adherence to the protocol including unwillingness to refrain from myopia control treatment for the duration of the study
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Interventions
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
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06631339