NCT06717048

Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression

An Exploratory Study on the Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 8 Years – 10 Years
• Healthy volunteers: Accepted

Summary

To explore the minimum power and frequency of Repeated Low-level Red-light (RLRL) to control myopia progression in low-myopic children aged 8-10 years, and the rebound effect of low-myopic children after discontinuation of RLRL with different combinations of power and frequency.

Detailed description

Myopia has emerged as a significant public health concern in East Asia. The excessive elongation of the axial length ( AL)of the eye, particularly as myopia progresses to high myopia, is associated with mechanical stretching and thinning of the choroid and sclera. This can lead to vision-threatening complications such as myopic macular degeneration, macular hemorrhage, retinal detachment, cataracts, and glaucoma. Given the serious consequences of high myopia and its associated complications, early and effective prevention and control of myopia become a primary focus in safeguarding visual health and enhancing quality of life. In recent years, RLRL holds significant potential as an effective strategy for preventing and controlling myopia in children and adolescents. However, recent researches prompt further questions: Is the current power of RLRL exposure optimal? Can the frequency of exposure be refined? What is the relationship among exposure power, frequency and myopia control? To explore these questions and clarify the effects of various combinations of exposure power and frequency on myopia progression following RLRL therapy, our research group plans to conduct a prospective, double-blind, single-center, randomized controlled clinical trial. This study aims to provide more comprehensive evidence to support this innovative intervention on myopia prevention and control.

Conditions

• Myopia
• Refractive Error - Myopia
• Choroidal Thickness
• Retina

Interventions

Type	Name	Description
DEVICE	Repeated Low-level Red-light	In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
DEVICE	Red LED	In addition to SVS with power for correcting distance refraction, red LED will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes.

Timeline

• Start date: 2024-12-09
• Primary completion: 2025-04-09
• Completion: 2025-06-09
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: China