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Optimizing Light Exposure for Myopia Prevention and Control (LightSPAN)

Not Applicable
Recruiting
Conditions
Myopia
Light; Therapy, Complications
Myopia Progression
Short-Sighted
Myopia; Refractive Error
Interventions
Other: Light Intervention
Behavioral: Digital Intervention
Other: Control Group
Registration Number
NCT06631339
Lead Sponsor
National University of Singapore
Brief 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.

Detailed Description

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
396
Inclusion Criteria

  • Subject must meet all the inclusion criteria below to participate in this study.

    1. Written Informed Consent form from parent / legal guardian and assent from child subject has been obtained
    2. Is between 7 to 10 years of age at start of study intervention which is 2 January 2025
    3. Studying in either Primary 2 or 3 classes of the participating school(s) in academic year 2025
    4. 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
    5. Normal Intraocular pressure (not more than 21mmHg)
    6. No ocular conditions (e.g., optic nerve disease, glaucoma, retinal diseases) except for refractive error.
    7. No ocular conditions affecting the accuracy of the ophthalmic examinations
    8. In good general health with no significant systemic diseases that may affect eye health
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Exclusion Criteria

  • All subjects meeting any of the exclusion criteria at baseline will be excluded from participation.

    1. Previous or ongoing myopia control treatment (including but not limited to orthokeratology, atropine, pirenzepine, myopia control spectacle and contact lenses, light therapy)
    2. Ongoing participation in other myopia prevention and control research trials
    3. 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)
    4. 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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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Technical Intervention (n=132)Light InterventionTechnical refinement of classroom lighting + Sham LightUP phone application (s-LightUP)
Digital Intervention (n=132)Digital InterventionStandard classroom lighting + Interventional LightUP phone application (i-LightUP)
Control Group (n=132)Control GroupStandard care or control group which involves standard classroom lighting + Sham LightUP app (s-LightUP).
Primary Outcome Measures
NameTimeMethod
Cycloplegic auto-refraction1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)

Measured using autoref/kerato/pachy/tonometer

Axial Length1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)

Measured using non-contact optical biometer

Choroidal Thickness1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)

Measured using optical coherence tomography (OCT) scan

Secondary Outcome Measures
NameTimeMethod
Retinal and choroidal perfusion1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)

Measured using optical coherence tomography angiography (OCT-A) function within OCT machine used to measure choroidal thickness.

Corneal Curvature1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)

Measured using autoref/kerato/pachy/tonometer.

Corneal Thickness1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)

Measured using autoref/kerato/pachy/tonometer.

Impulse control1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit)

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.

Cognitive flexibility1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit)

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.

Processing speed1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit)

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).

Spatial working memory1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit)

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.

Content working memory1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit)

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.).

Sleep quantity1 year or at least 1 week per month for 1 year

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.

Sleep efficiency1 year or at least 1 week per month for 1 year

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.

Height1 year, at baseline and 12 months from baseline

Height of the participant in cm

Weight1 year, at baseline and 12 months from baseline

Weight of the participant in Kg

Visual acuity1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)

LogMAR visual acuity test

Trial Locations

Locations (4)

National University of Singapore, Yong Loo Lin School of Medicine, Department of Ophthalmology, Eye N Brain Research Lab

🇸🇬

Singapore, Singapore

Bedok Green Primary School

🇸🇬

Singapore, Singapore

Westwood Primary School

🇸🇬

Singapore, Singapore

Wellington Primary School

🇸🇬

Singapore, Singapore

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