NCT07104513

Efficacy and Influencing Factors of Repeated Low-level Red-light in Myopia

Study on the Long-term Efficacy Evaluation and Influencing Factors of Repeated Low-level Red-light Therapy in Myopia Prevention and Control in Children

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Ruihua Wei · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Accepted

Summary

To evaluate the long-term efficacy of repeated low-level red-light (RLRL) therapy in the prevention and control of myopia in children, and to analyze the key factors influencing its efficacy (such as individual differences and compliance), with the aim of providing evidence-based support for the optimization of clinical myopia prevention and control strategies.

Detailed description

This is a real world multi-centre study. The devices are connected to the internet with an automated diary function to record treatment sessions and to monitor patient compliance.The total sample size of 3000 arerandomly allocated into treatment groups,observation for 1 year and more.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Red Light	use red light twice per day, both eyes. use red light for one year in The RLRL-1year Group. use red light for two year in The RLRL-2years Group. red light for three years in The RLRL-3years Group.red light for more than three years in The RLRL- more than 3years Group.

Timeline

• Start date: 2020-09-28
• Primary completion: 2028-07-28
• Completion: 2030-07-28
• First posted: 2025-08-05
• Last updated: 2025-09-08

Locations

2 sites across 1 country: China