Optimizing Light Exposure for Myopia Prevention and Control (LightSPAN)

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.

Conditions

• Myopia
• Light; Therapy, Complications
• Myopia Progression
• Short-Sighted
• Myopia; Refractive Error

Interventions

OTHER

Light Intervention

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.

BEHAVIORAL

Digital Intervention

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).

OTHER

Control Group

Standard Classroom Lighting + Sham LightUP phone application

Sponsors & Collaborators

• Technical University of Munich Campus for Research Excellence And Technological Enterprise (TUMCREATE)

  collaborator UNKNOWN

• National University of Singapore

  lead OTHER

Principal Investigators

• Raymond P. Najjar, PhD · National University of Singapore

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

10 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-21

Primary Completion

2027-01-26

Completion

2027-01-26

Countries

• Singapore

Study Locations