The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial

Shanghai Eye Disease Prevention and Treatment Center

Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control.

Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.

Inclusion Criteria:

• At least one eye with cycloplegic optometric spherical equivalent of -5.00 to -10.00D and best corrected distant visual acuity of at least 0.5 and near visual acuity of at least 1.0, Titmus Stereo acuity ≤ 80 seconds, Vision with external occultation of ≤ 10 prismatic diopters , vision with internal occultation of ≤ 6-8 prismatic diopters, and astigmatism equal to or less than -2.50D;
• Myopia progression greater than 0.5D in the past year;
• Possess normal cognitive and verbal communication abilities to actively cooperate with the prescribed treatment;
• Written informed consent from the guardian and the child.

Exclusion Criteria:

• Diseases of the study eye: keratitis, cone cornea, congenital cataract, glaucoma, fundus diseases; combined with inflammation of the anterior or posterior segment of the eye, such as acute conjunctivitis, iridocyclitis;
• Systemic diseases affecting the use of drugs: albinism, epilepsy, severe psychoneurological disorders, congenital heart disease, cardiac arrhythmias;
• Atropine allergy;
• Very low birth weight less than 1500 g;
• Previous treatment with anticholinergics including atropine within the previous 1 year, or use of OK lenses, multifocal soft lenses within 3 months;
• Other conditions judged by the investigator to be unsuitable for participation in the trial.