NCT05597397

Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure

Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure Among Myopic Teenagers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 15 Years – 16 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to evaluate the effect of repeated low-level red-light (RLRL) therapy on the retinal function and structure among myopic teenagers.

Detailed description

Myopia constitutes a major threat to personal health globally for its increased prevalence. Moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration has been demonstrated. It is crucial to look for effective ways to control myopia in children to reduce risk of myopic pathologies in later life. Repeated low-level red-light (RLRL) therapy is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. A previous randomized clinical trial suggested that RLRL could effectively controlled myopia progression without clinically observable side effects. The purpose of this study is to evaluate the effect of RLRL on the retinal function and structure among myopic teenagers aged 15-16 years. The RLRL therapy will be carried out at school under supervision of the parents according to a standard protocol for the first month and then will be discontinued for 1 month. Detailed functional and structural examinations, including full field electroretinogram, multifocal electroretinogram, microperimetry, visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, cycloplegic spherical equivalent refraction, and biological parameters will be evaluated at 1 month, 2 months after enrollment.

Conditions

• Myopia
• Refractive Errors
• Eye Diseases
• Retina; Change

Interventions

Type	Name	Description
DEVICE	RLRL	In addition to SVS with power for correcting distance refraction, RLRL will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2022-10-28
• Last updated: 2024-11-05

Locations

1 site across 1 country: China