Clinical Study of Light Therapy to Control Myopia Progression in Children
Myopia, Progressive
About this trial
This is an interventional treatment trial for Myopia, Progressive
Eligibility Criteria
Inclusion Criteria: Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is not limited; Equivalent sphere (SER): -0.50D ~ -6.00D (including-0.50 and-6.00D); Best corrected vision in one eye under glasses correction: 0.1 log MAR; No strabismus: no more than 15 prism constant dominance strabismus after far and near cover tests; No myopia control measures within the previous 4 weeks: such as orthokeratology lens, gradient lens, double light lens, eye drops for myopia control (such as atropine), myopia defocus glasses, red light for myopia control, other specially designed myopia light treatment instruments or contact lenses for special design to control myopia (such as Misight); Exclusion Criteria: Any ocular(including constant dominant strabismus with more than 15 prisms) and systemic diseases or abnormalities can significantly affect visual function or promote the progression of myopia; Other interventions for myopia control before 4 weeks before enrollment, For example, orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control, other specially designed comprehensive treatment devices, myopia, amblyopia, or specially designed contact lenses (such as Misight), etc. Subject participated in other clinical trials within 4 weeks before the enrollment; The investigator for safety reasons or the interests of the patient, Other circumstances in which the patient should not participate in this trial, If suffering from serious heart, liver and kidney disease. -
Sites / Locations
- Eye & ENT hospital of Fudan universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
PBM therapy 1
PBM therapy 2
Control
PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.6±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. The lighting spot for therapy is a dot. Only one eye will be treated with PBM therapy.
PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.3±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. Only one eye will be treated with PBM therapy.
Single vision spectacles correction only.