It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length.The goal is to test which power (1.2mW and 0.6mW) is better in myopic children for 3 month's follow-up and also to test how to get better result with the increaing or decreasing lighting power for the total 6 month follow-up results .
It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Each group has 25 myopic children. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm are randomized to be allocated into the 3 groups. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length. All groups will be wearing a special lens named by Stellest with high aspherical lens design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
A medical device with ultra low lever laser irradiance of 0.6mW or 1.2mW at the surface of cornea. And the therapy lasts 3 minutes with the 4 hours or more interval of break.
Customer designed power and fitting to each subject for all the study periods.
Shanghai Children Medical Center
Shanghai, China
RECRUITINGMean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
Measured with IOLmaster 500 or Lenstar at follow-up from baseline
Time frame: 3-month
Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
Measured with IOLmaster 500 or Lenstar at follow-up from baseline
Time frame: 6-month
Mean Change of Refractive Error at follow-up from Baseline (mm)
Measured with autorefractor; Spherical Equivalence is calculated.
Time frame: 3-month
Mean Change of Refractive Error at follow-up from Baseline (mm)
Measured with autorefractor; Spherical Equivalence is calculated according to the formular of SE=Spherical +1/2 \* Cyclinder Diopter.
Time frame: 6-month
Mean Change of Choroidal Thickness (um)
Measured with Optical Coherence Topography (OCT)
Time frame: 3-month
Mean Change of Choroidal Thickness (um)
Measured with Optical Coherence Topography (OCT)
Time frame: 6-month
Change of Fundus
Mesured with color fundus camera with Artificial Intelligence Database
Time frame: 6-month
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