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| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
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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.
Participants will:
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:
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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technical Intervention (n=132) | Experimental | Technical refinement of classroom lighting + Sham LightUP phone application (s-LightUP) |
|
| Digital Intervention (n=132) | Experimental | Standard classroom lighting + Interventional LightUP phone application (i-LightUP) |
|
| Control Group (n=132) | Placebo Comparator | Standard care or control group which involves standard classroom lighting + Sham LightUP app (s-LightUP). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cycloplegic auto-refraction | Measured using autoref/kerato/pachy/tonometer | 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit) |
| Axial Length | Measured using non-contact optical biometer | 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit) |
| Choroidal Thickness | Measured using optical coherence tomography (OCT) scan | 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal and choroidal perfusion | Measured using optical coherence tomography angiography (OCT-A) function within OCT machine used to measure choroidal thickness. | 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit) |
| Corneal Curvature |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime average light levels (lux) | Daytime average light levels (lux) collected using wearable light sensors. | 1 year or at least 1 week per month for 1 year |
| Daytime average melanopic lux | Daytime average melanopic lux collected using wearable light sensors. |
Inclusion Criteria:
Subject must meet all the inclusion criteria below to participate in this study.
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 Criteria:
All subjects meeting any of the exclusion criteria at baseline will be excluded from participation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raymond P. Najjar, PhD | Contact | 006566018519 | lightspan@nus.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Raymond P. Najjar, PhD | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Singapore, Yong Loo Lin School of Medicine, Department of Ophthalmology, Eye N Brain Research Lab | Recruiting | Singapore | 119276 | Singapore |
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Primary School-based, 12-Month, semi-randomised, controlled, double-blinded, 3 study arm (n=132 per arm) trial.
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This study is a double-blind, semi-randomised controlled trial in which neither the study participants, the investigators nor study personnel responsible for measuring and analysing the study outcomes will be aware of the treatment given.
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.
| Digital Intervention | Behavioral | 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 | Other | Standard Classroom Lighting + Sham LightUP phone application |
|
Measured using autoref/kerato/pachy/tonometer.
| 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit) |
| Corneal Thickness | Measured using autoref/kerato/pachy/tonometer. | 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. | 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. | 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. | 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.). | 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). | 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. | 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. | 1 year or at least 1 week per month for 1 year |
| Height | Height of the participant in cm | 1 year, at baseline and 12 months from baseline |
| Weight | Weight of the participant in Kg | 1 year, at baseline and 12 months from baseline |
| Visual acuity | LogMAR visual acuity test | 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit) |
| 1 year or at least 1 week per month for 1 year |
| Time spent outdoors (questionnaires) | Estimated time spent outdoors collected using questionnaires | 1 year or at least 1 week per month for 1 year |
| Time spent outdoors (wearables) | Calculated time spent outdoors collected using the wearable light sensors. | 1 year or at least 1 week per month for 1 year |
| Color vision | Color vision assessment using the Ishihara color vision test | Baseline |
| Cover test (distance and near) | Cover test to screen for strabismus | 1 year, repeated every 6 months |
| Marymount Convent School | Recruiting | Singapore | 297754 | Singapore |
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| Bedok Green Primary School | Recruiting | Singapore | 469317 | Singapore |
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| Westwood Primary School | Recruiting | Singapore | 649188 | Singapore |
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| Wellington Primary School | Recruiting | Singapore | 757702 | Singapore |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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