Optimizing Light Exposure for Myopia Prevention and Control (LightSPAN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 396
- 试验地点
- 10
- 主要终点
- Cycloplegic auto-refraction
研究概览
简要总结
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.
- 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)
- 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.
- 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.
详细描述
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: 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:
- evidence-based lighting designs and policy recommendations for classrooms;
- a user-friendly, smart digital eyecare companion that aligns perfectly with Singapore's Smart Nation Initiative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •All subjects meeting any of the exclusion criteria at baseline will be excluded from participation.
- •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
结局指标
主要结局
Cycloplegic auto-refraction
时间窗: 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)
Measured using autoref/kerato/pachy/tonometer
Axial Length
时间窗: 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)
Measured using non-contact optical biometer
Choroidal Thickness
时间窗: 1 year, once every 6 months (Baseline, Month 6, Month 12 Visit)
Measured using optical coherence tomography (OCT) scan
次要结局
- Retinal and choroidal perfusion(1 year, once every 6 months (Baseline, Month 6, Month 12 Visit))
- Corneal Curvature(1 year, once every 6 months (Baseline, Month 6, Month 12 Visit))
- Corneal Thickness(1 year, once every 6 months (Baseline, Month 6, Month 12 Visit))
- Impulse control(1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit))
- Cognitive flexibility(1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit))
- Processing speed(1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit))
- Spatial working memory(1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit))
- Content working memory(1 year, once every 3 months (Baseline, Month 3, Month 6, Month 9 , Month 12 Visit))
- Sleep quantity(1 year or at least 1 week per month for 1 year)
- Sleep efficiency(1 year or at least 1 week per month for 1 year)
- Height(1 year, at baseline and 12 months from baseline)
- Weight(1 year, at baseline and 12 months from baseline)
- Visual acuity(1 year, once every 6 months (Baseline, Month 6, Month 12 Visit))
研究者
Raymond P. Najjar, PhD
Assistant Professor
National University of Singapore