Overview
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.
Description
The main questions this double-blind, randomized controlled clinical study aims to answer
- are
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- To evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children.
- 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.
Eligibility
Inclusion Criteria:
- The age of the screening stage is 6-9 years, both sexes;
- One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was ≥-1.50D, and the best corrected far vision was at least 1.0;
- At least one of parents suffers from myopia (SE of at least one eye <=-3.00D);
- Parents have signed informed consent and agree to participate in screening and follow-up.
Exclusion Criteria:
- Parents disagree to sign the informed consent;
- Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery;
- Presence of other eye or systemic diseases;
- Allergies to low concentration atropine or sulfuric acid drugs;
- Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month;
- Presence of other situations that the researchers think is not appropriate for patients to be included in the project.