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NCT05597163
Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
Conditions: Myopia, Progressive
Sex: All
Ages: 3 Years – 15 Years
Phase: NA
Enrollment: 588
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Summary
To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.
Eligibility Criteria
Inclusion Criteria:The age of the screening stage is 3-15 years, both sexes;One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;Informed consent from the guardian and the child.Exclusion Criteria:strabismus, amblyopia or other ocular abnormalities;The presence of systemic disease abnormalities;have taken myopia control treatment in the past month;Allergic to low concentration atropine or sulfuric acid drugs.
Source: ClinicalTrials.gov (NCT05597163). StuddyBuddy aggregates publicly available trial information.