This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.
The main questions this double-blind, randomized controlled clinical study aims to answer are: 1. To evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children. 2. To evaluate the effectiveness of low concentration atropine in controlling refractive and axial progression. Patients are randomly divided into three treatment groups with different atropine concentrations(0.01%, 0.02%, 0.04%) and one control group with atropine dissolvant. Patients are required to use the eye drops every night for one year and record after daily usage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
428
low concentration atropine (0.01%)
low concentration atropine (0.02%)
low concentration atropine (0.04%)
Xiangui He
Shanghai, Shanghai Municipality, China
RECRUITINGCumulative Incidence of Myopia
Effectiveness Evaluation
Time frame: 1 year
Changes in SE (after cycloplegia)
Effectiveness Evaluation
Time frame: 1 year
Changes in AL
Effectiveness Evaluation
Time frame: 1 year
Changes in visual acuity
Effectiveness Evaluation
Time frame: 1 year
Changes in Choroidal Thickness
Effectiveness Evaluation
Time frame: 1 year
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Placebo eye drop