Authors: Fu Aicun, Zhao Bingxin, Zhang Junjie, Zhang Jinsong, Li Binbin, Li Xiuhong, Shang Lina, Lyu Yong
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To observe the adverse effects of 0.01% atropine sulfate eye drops on myopic children.
A prospective non-randomized controlled trial was conducted.Ninety-nine myopic children (99 right eyes) were randomly assigned to experimental group(55 cases) and control group(44 cases). Myopic children of experimental group wore completely corrected frame glasses, while 0.01% atropine sulfate eye drop was dropped into each eye once a day before going to bed.Myopic children in control group only wore completely corrected frame glasses.The follow-up time was 4 months.Best corrected visual acuity (BCVA), intraocular pressure (IOP), change of pupil diameter (PD) and amplitude of accommodation, symptoms of discomfort after medication were observed.This study followed the Helsinki declaration and was approved by Ethic Committee of the First Affiliated Hospital of Zhengzhou University.Informed consent was signed by the parents of each patient.
No significant differences were found in best corrected distance visual acuity (BCDVA), best corrected near visual acuity(BCNVA) and IOP between the two groups before and 4 months after treatment (BCDVA: Fgroup=3.880, P=0.112; Ftime=27.220, P=0.413; BCNVA: Fgroup=5.200, P=0.311; Ftime=38.200, P=0.116, IOP: Fgroup=12.350, P=0.214; Ftime=22.300, P=0.146). After 4 months treatment, the PD was (6.99±0.64)mm in the experimental group, which was significantly higher than that before treatment(P<0.001). The PD of the experimental group was higher than that of the control group after 4 months treatment, and the difference was statistically significant (P<0.01). The amplitude of accommodation in the experimental group was 14.01±3.98 after 4 months treatment.which was 1.20 D lower than that before treatment, the difference was statistically significant(P<0.01). The amplitude of accommodation of the experimental group was lower than that of the control group after 4 months treatment, the difference was statistically significant (P<0.01). Four cases (8%) appeared photophobia symptoms.Two cases and 2 cases appeared photophobia for 1 week or 2 weeks, respectively.However this symptom would relieve after wear sunglasses or sunshade caps in outdoor activities.One case (2%) appeared ocular itching and swelling after 1 month treatment, but disappeared after withdrawal.There were no other uncomfortable symptoms such as near sight blurring.
In mainland of China, the BCDVA, BCNVA and IOP of myopic children are stable; the PD is dilated and the amplitude of accommodation is decreased slightly after 4 months treatment of 0.01% atropine, and 10% children appear photophobia, but do not affect their study and life.