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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Myopic amblyopia comprehensive treatment instrument is produced by Suzhou Industrial Park Zuoguan Medical Equipment Co., LTD.
Optometry with glasses as a routine treatment
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, China
Change from baseline in axial length of the left and right eyes
The axis of the eye was assessed utilizing the IOL Master (version 5.02, Carl Zeiss, Jena, Germany), which employed simulated eye calibration prior to measurements. To ensure accuracy, three consecutive measurements were taken, and the average value was obtained. If the difference between any two measurements exceeded 0.05mm, a re-measurement was performed.
Time frame: baseline, 30days, 90 days, 180 days
Changes of equivalent spherical mirror after mydriatic optometry
Based on previous experience, this instrument requires a treatment duration of 180 days to demonstrate its preventive and control effects. Therefore, the 180-day data changes will be utilized as the evaluation indicator.
Time frame: baseline, 180 days
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