Bright Classrooms
Country
People’s Republic of China
Background issues
The prevalence of myopia is rising, making its control a significant global health challenge, particularly in China where over half of the children with visual impairment lack glasses. Established interventions like orthokeratology and low-dose atropine are effective but require proactive family involvement, limiting their practicality in less developed regions. School-based interventions, such as increased outdoor time, are proven to slow myopia onset but face resistance and implementation challenges. Repeated low-level red light (RLRL) therapy has emerged as a promising intervention, reducing myopia progression by 65-87.7% in controlled trials without causing visual changes or ocular damage. However, the broader applicability, long-term sustainability, and economic implications of RLRL therapy remain unclear. To address these gaps, the multi-centred Bright Classrooms RCT will evaluate a large-scale, school-based myopia prevention model using RLRL therapy in China, assessing treatment acceptability, cost-effectiveness, and the stability of myopia prevention effects after six months of treatment.
Trial design
We are conducting a multi-centred, school-based cluster-randomised controlled trial to investigate the efficacy, cost-effectiveness, acceptability, and long-term stability of repeated low-level red light (RLRL) therapy for myopia prevention and treatment in primary school-aged Chinese children. The trial will involve 4,800 children aged between six and nine years (Grades One to Three) from 16 primary schools in the Wenzhou urban areas. Each school will have six classes, with approximately 50 children per class. Children will be randomly assigned (1:1) to either the RLRL intervention group or the control group. Students who develop myopia will receive free glasses.
Outcomes
The primary outcome will be the incidence and progression of myopia in the intervention and control groups. We will also assess the acceptability of the treatment to schools, parents, and children, as well as the cost-effectiveness and long-term sustainability of the intervention. Additionally, a random sample of 20% of the schools will be evaluated for the stability of myopia prevention effects after six months of treatment.
Timeline
- 30 months
- Data collection estimated to end in Q4 2027
ClinicalTrials.gov Identifier: NCT05156190
