Optimizing Light Exposure for Myopia Prevention and Control (LightSPAN)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 10
Healthy Volunteers: t
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• 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

Locations
Other Locations
Singapore
Bedok Green Primary School
RECRUITING
Singapore
Marymount Convent School
RECRUITING
Singapore
National University of Singapore, Yong Loo Lin School of Medicine, Department of Ophthalmology, Eye N Brain Research Lab
RECRUITING
Singapore
Wellington Primary School
RECRUITING
Singapore
Westwood Primary School
RECRUITING
Singapore
Contact Information
Primary
Raymond P. Najjar, PhD
lightspan@nus.edu.sg
006566018519
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2027-01-26
Participants
Target number of participants: 396
Treatments
Experimental: Technical Intervention (n=132)
Technical refinement of classroom lighting + Sham LightUP phone application (s-LightUP)
Experimental: Digital Intervention (n=132)
Standard classroom lighting + Interventional LightUP phone application (i-LightUP)
Placebo_comparator: Control Group (n=132)
Standard care or control group which involves standard classroom lighting + Sham LightUP app (s-LightUP).
Related Therapeutic Areas
Sponsors
Leads: National University of Singapore
Collaborators: Technical University of Munich Campus for Research Excellence And Technological Enterprise (TUMCREATE)

This content was sourced from clinicaltrials.gov