Optimizing Light Exposure for Myopia Prevention and Control (LightSPAN)

NCT06631339 | Recruiting

• 1 other identifier: NUS-IRB-2023-767
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 5

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.

• 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

Keywords

Light Exposure; Digital Intervention; Myopia; Myopia Prevention; Cognition; Light Intervention; Behaviour changing phone application; Classroom; School-based; School; Singapore; Primary School; Light therapy; Myopia-control

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (13)

• 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)

Other Outcomes (6)

• Daytime average light levels (lux)

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

• Daytime average melanopic lux

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

• Time spent outdoors (questionnaires)

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

Study Arms (3)

Technical Intervention (n=132)

EXPERIMENTAL

Technical refinement of classroom lighting + Sham LightUP phone application (s-LightUP)

Other: Light Intervention

Digital Intervention (n=132)

EXPERIMENTAL

Standard classroom lighting + Interventional LightUP phone application (i-LightUP)

Behavioral: Digital Intervention

Control Group (n=132)

PLACEBO COMPARATOR

Standard care or control group which involves standard classroom lighting + Sham LightUP app (s-LightUP).

Other: Control Group

Interventions

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.

Technical Intervention (n=132)

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).

Digital Intervention (n=132)

Control Group OTHER

Standard Classroom Lighting + Sham LightUP phone application

Control Group (n=132)

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead
• Technical University of Munich Campus for Research Excellence And Technological Enterprise (TUMCREATE): collaborator

Study Sites (5)

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

Singapore, 119276, Singapore

RECRUITING

Marymount Convent School

Singapore, 297754, Singapore

RECRUITING

Bedok Green Primary School

Singapore, 469317, Singapore

RECRUITING

Westwood Primary School

Singapore, 649188, Singapore

RECRUITING

Wellington Primary School

Singapore, 757702, Singapore

RECRUITING

MeSH Terms

Conditions

Myopia; Refractive Errors

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Raymond P. Najjar, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond P. Najjar, PhD

CONTACT

006566018519; lightspan@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Primary School-based, 12-Month, semi-randomised, controlled, double-blinded, 3 study arm (n=132 per arm) trial.

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): January 26, 2027
• Study Completion (Estimated): January 26, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (5)