NCT05947019

Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults

Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults: A Randomized, Controlled, Multicenter Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to confirm the effectiveness and safety of low-level monochromatic red-light for high myopia control in adults

Detailed description

Currently, there is still a lack of effective methods for managing adult high myopia globally. The Elsing Myopia and Amblyopia Therapy Instrument, developed by Suzhou Industrial Park Zuoguan Medical Equipment Co., Ltd., has gained widespread usage in mainland China for amblyopia treatment and myopia control. This instrument utilizes low-intensity laser therapy (LLLT) for treatment, demonstrating improvements in visual acuity without any local or systemic side effects. The low-intensity laser induces photochemical reactions in the retina, such as enhancing cytochrome C oxidase activity, modulating gene expression to regulate the mitochondrial respiratory chain, and increasing the biological activity of nitric oxide. These mechanisms have been applied in the treatment of age-related macular degeneration and diabetic retinopathy. As the onset of myopia is closely linked to retinal signaling pathways, preliminary test data suggests that the instrument can significantly slow down myopia progression. This study aims to investigate the potential of low-intensity laser therapy in preventing and treating high myopia in adults, providing innovative approaches to mitigate the widespread impact of high myopia.

Conditions

• High Myopia

Interventions

Type	Name	Description
DEVICE	Myopic amblyopia comprehensive treatment instrument	Myopic amblyopia comprehensive treatment instrument is produced by Suzhou Industrial Park Zuoguan Medical Equipment Co., LTD.
DEVICE	Glasses	Optometry with glasses as a routine treatment

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2023-07-14
• Last updated: 2023-07-14

Locations

1 site across 1 country: China