| ObjectiveTo evaluate the efficacy and safety of 0.01%and 0.02%atropine eye drops on myopia progression in children in the Central Plains of China,and observe its effect on the ocular biological parameters of myopic children.Materials and methodA prospective cohort study was performed in this research.Four hundred myopic children who visited the First Affiliated Hospital of Zhengzhou University from June 2016 to June 2017 were included in this cohort study.According to the wishes of the children and their guardians,they were divided into atropine treatment group(N=280)and control group(N=120),then the atropine treatment group was assigned to 0.02%atropine group(N=138)and 0.01%atropine group(N=142)in a random double-blind manner.The children in the two atropine treatment groups wore single-vision(SV)spectacles,with one drop of 0.02%or 0.01%atropine eye drop applied to both eyes once nightly.The children in control group only wore SV spectacles.Repeated measurements were performed every 4 months for a total of 2-year follow-up.The subjects’ spherical equivalent refractive error,axial length,pupil diameter,accommodation amplitude,astigmatism,corneal power,lens power,anterior chamber depth,intraocular pressure and occurrence of adverse reactions were observed and recorded before treatment and 4,8,12,16,20 and 24 months after treatment.The changes of the above indicators in the three groups over 2 years were compared and analyzed.Results1.Change in spherical equivalent refractive error of the three groups before and after treatmentThere are significant differences in spherical equivalent refractive error at different time-points before and after treatment in the three groups(Fgroup=6.880,P=0.002;Ftime=7.432,P=0.013;Finteraction=11.790,P<0.001).At 1 year and 2 years after treatment,the spherical equivalent refractive error of the three groups all increased compared with that before treatment,and the difference was statistically significant(all P<0.05).After 2 years of treatment,the increase of spherical equivalent refractive error in 0.02%atropine group and 0.01%atropine group were lower than those in the control group,with significant difference(all P<0.05),and the increase of spherical equivalent refractive error of 0.02%atropine group was lower than that of 0.01%atropine group,the difference was statistically significant(P<0.05).In each atropine group,the increase in spherical equivalent refractive error at the second year after treatment was no different from that at the first year(all P>0.05).2.Change in axial length of the three groups before and after treatmentThere are significant differences in axial length at different time-points before and after treatment in the three groups(Fgroup=8.293,P=0.016;Ftime=14.931,P=0.006;Finteraction=22.690,P<0.001).At 1 year and 2 years after treatment,the axial length of the three groups all increased compared with that before treatment,and the difference was statistically significant(all P<0.05).After 2 years of treatment,the increase of axial length in 0.02%atropine group and 0.01%atropine group were lower than those in the control group,with significant difference(all P<0.05),and the increase of axial length of 0.02%atropine group was lower than that of 0.01%atropine group,the difference was statistically significant(P<0.05).In each atropine group,the increase in axial length at the second year after treatment was no different from that at the first year(all P>0.05).3.Change in pupil diameter of the three groups before and after treatmentThe pupil diameter at different time-points before and after treatment of the three groups were statistically different(Fgrop=6.893,P=0.041;Ftime=2.992,P=0.026;Fnteraction=12.547,P<0.001).At 4 months and 2 years after treatment,the pupil diameter in both atropine group increased compared with that before treatment,the differences were statistically significant(all P<0.05);however,compared with that before treatment,there was no significant difference in pupil diameter in the control group(P>0.05).From 4 months to 2 years after treatment,the pupil diameter of the two atropine groups did not change significantly,and there was no difference between the two atropine groups(all P>0.05).4.Change in accommodation amplitude of the three groups before and after treatmentThe accommodation amplitude at different time-points before and after treatment of the three groups were statistically different(Fgroup=7.453,P=0.032;Ftime=15.676,P=0.002;Finteraction=24.226,P<0.001).At 4 months and 2 years after treatment,the accommodation amplitude was decreased compared with that before treatment,the differences were statistically significant(all P<0.05);however,compared with that before treatment,there was no significant difference in accommodation amplitude in the control group(P>0.05).From 4 months to 2 years after treatment,the accommodation amplitude of the two atropine groups did not change significantly,and there was no difference between the two atropine groups.5.Occurrence of adverse reactions in the three groupsAt the beginning of treatment,32(23%)and 33(23%)subjects in 0.02%and 0.01%atropine groups were photophobic in bright sunlight,and 7 subjects in each atropine group had mild near-vision blur.However,the symptoms of photophobia and near-vision blur were alleviated or disappeared over time.In 0.01%atropine group,1 patient presented with allergic symptoms.During the 2-year.follow-up period,none of the subjects in the two atropine groups experienced any other ocular or general discomfort associated with atropine.In the control group,3 subjects showed photophobia in bright sunlight,and 2 subjects appeared near-vision blur in the first week after the glasses were replaced.6.Change in total astigmatism and corneal astigmatism of the three groups before and after treatmentThe total astigmatism of the three groups increased gradually at different time-points before and after treatment,however the change trend of total astigmatism with time had no difference among groups(Fgroup=0.485,P=0.617;Ftime=51.506,P<0.001;Finteraction=0.630,P=0.598).The cornea astigmatism of the three groups were stable at different time-points before and after treatment,and there was no significant difference among groups(Fgroup=0.690,P=0.504;Ftime=17.521,P=0.107;Finteraction=0.457,P=0.749).7.Change in corneal power and lens power of the three groups before and after treatmentThe corneal power of the three groups were stable at different time-points before and after treatment,and there was no significant difference among groups(Fgroup=0.139,P=0.870;Ftime=1.149,P=0.286;Finteraction:1.883,P=0.116).The lens power of the three groups decreased gradually at different time points before and after treatment,however the change trend of the lens power with time had no difference among groups(Fgroup=2.190,P=0.117;Ftime=34.007,P<0.001;Fmteraction=1.776,P=0.139).8.Change in anterior chamber depth and intraocular pressure of the three groups before and after treatmentThe depth of anterior chamber of the three groups increased gradually at different time-points before and after treatment,however the change trend of the depth of anterior chamber with time had no difference among groups(Fgroup=0.312,P=0.733;Ftime=48.806,P<0.001;Finteraction=2.033,P=0.108).The intraocular pressure of the three groups was stable at different time points before and after treatment,and there was no significant difference between groups(Fgroup=0.312,P=0.467,P=0.629;Ftime=2.125,P=0.129;Finteraction=0.518,P=0.703).Conclusion1.0.02% and 0.01% atropine eye drops can effectively slow myopia progression and axial elongation of myopic children in the Central Plains of China,and 0.02% atropine had a better effect on myopia control than 0.01%atropine;the efficacy of each low-concentration atropine eye drops in the second year was no different from that in the first year.2.The effects of 0.02% and 0.01% atropine eye drops on pupil diameter and accommodation were slight,and the incidence of adverse reactions was low,which does not affect children’s study and life.3.0.02% and 0.01% atropine eye drops had no effect on astigmatism,corneal power,lens power,anterior chamber depth and intraocular pressure. |
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