Optimizing Light Exposure for Myopia Prevention and Control (LightSPAN)
NCT ID: NCT06631339
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
396 participants
INTERVENTIONAL
2024-10-21
2027-01-26
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study team will document consent to participate and non-objection response to classroom lighting change. A 100% non-objection rate from the parents of students within one classroom will be required prior to changing the classroom lighting. Randomization: Classrooms randomly be assigned into technical or other arms (cluster). Students from classrooms not included in the technical arms will be randomized into control or digital intervention arm.
For the purpose of maintaining double-blind, all participants (parents) will be given LightUP application that will either be sham or interventional. Only a group of unmasked study personnel will know the treatment allocation and they will not be involved in data collection and analysis of results/data.
Study Groups
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Technical Intervention (n=132)
Technical refinement of classroom lighting + Sham LightUP phone application (s-LightUP)
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.
Digital Intervention (n=132)
Standard classroom lighting + Interventional LightUP phone application (i-LightUP)
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).
Control Group (n=132)
Standard care or control group which involves standard classroom lighting + Sham LightUP app (s-LightUP).
Control Group
Standard Classroom Lighting + Sham LightUP phone application
Interventions
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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.
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).
Control Group
Standard Classroom Lighting + Sham LightUP phone application
Eligibility Criteria
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Inclusion Criteria
2. Is between 7 to 10 years of age at start of study intervention which is 2 January 2025 or 1 January 2026
3. Studying in either Primary 2 or 3 classes of the participating school(s) in academic year 2025 or 2026.
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
Exclusion Criteria
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
7 Years
10 Years
ALL
Yes
Sponsors
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Technical University of Munich Campus for Research Excellence And Technological Enterprise (TUMCREATE)
UNKNOWN
National University of Singapore
OTHER
Responsible Party
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Raymond P. Najjar, PhD
Assistant Professor
Principal Investigators
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Raymond P. Najjar, PhD
Role: PRINCIPAL_INVESTIGATOR
National University of Singapore
Locations
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National University of Singapore, Yong Loo Lin School of Medicine, Department of Ophthalmology, Eye N Brain Research Lab
Singapore, , Singapore
Marymount Convent School
Singapore, , Singapore
Bedok Green Primary School
Singapore, , Singapore
Westwood Primary School
Singapore, , Singapore
Wellington Primary School
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NUS-IRB-2023-767
Identifier Type: -
Identifier Source: org_study_id
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