摘要目的:观察配戴角膜塑形镜矫治近视过程中和停戴后眼球生物学参数的变化,评估角膜塑形镜对近视儿童眼球生物学参数的影响.方法:随机对照研究.收集在北京同仁眼科中心就诊的低中度近视儿童100例,平均年龄(11.0±1.9)岁.将受试者随机均分为2组,分别配戴角膜塑形镜(角膜塑形镜组)和框架眼镜(框架眼镜组).分别于基线、配戴6个月和1年并停戴1个月后测量散瞳后等效球镜度(SE)、眼轴长度(AL)、中央角膜厚度(CCT)、前房深度(ACD)和晶状体厚度(CLT).采用重复测量设计资料的方差分析、独立样本t检验对数据进行统计学分析.结果:最终91例近视儿童完成研究.框架眼镜组(46例)和角膜塑形镜组(45例)的基线AL、CCT、ACD、CLT比较差异无统计学意义.框架眼镜组和角膜塑形镜组儿童,配戴6个月后AL延长量分别为0.21 mm和0.10 mm(t=3.213,P=0.002),1年后分别为0.34 mm和0.23 mm(t=2.388,P=0.019).与基线相比,角膜塑形镜组6个月后,CCT、ACD及CLT的变化量分别为-4.80μm、-0.03 mm及+0.02 mm,与框架眼镜组相比差异有统计学意义(t=6.284,P<0.001;t=4.473,P<0.001;t=-3.971,P<0.001);角膜塑型镜组配戴1年并停戴1个月后,三者变化量分别为+3.45μm、-0.01 mm及+0.03 mm,其中ACD和CLT的变化量与框架眼镜组相比差异具有统计学意义(t=2.829,P=0.006;t=-3.589,P<0.001).结论:角膜塑形镜可有效减缓近视儿童AL的延长、减小ACD和增加CLT,且停戴1个月后效果依然存在.

abstractsObjective: To measure the effect of orthokeratology lenses on ocular biometric parameters in children with low to moderate myopia. Methods: In this randomized controlled trial, 100 children with low to moderate myopia with an average age of 11.0±1.9 years were recruited at the clinical center of Beijing Tongren Hospital. Subjects were randomly assigned to an orthokeratology lens group or a spectacles group. Cycloplegic refraction, axial length (AL), central corneal thickness (CCT), anterior chamber depth (ACD), and crystalline lens thickness (CLT) were measured at baseline and at six months. One year later, the children in the orthokeratology group were asked to pause wearing the lenses for one month, after which the measurements were repeated. Data were analyzed by repeated measures analysis of variance and by independent t-tests. Results: Nine subjects dropped out from the trial. There were no statistically significant differences between the spectacle (46 cases) and the orthokeratology (45 cases) groups at baseline or for characteristics such as age, gender, cycloplegic refraction, AL, CCT, ACD, and CLT. The increase in AL for the orthokeratology group was slower than that in the spectacles group both at 6 months (0.10 mm vs. 0.21 mm, t=3.213, P=0.002). Following the one month pause in orthokeratology lens wear after one year of wearing them, the increase in AL of the orthokeratology group, 0.23 mm, was smaller than that of the spectacle group, 0.34 mm (t=2.388, P=0.019). For children in the orthokeratology group, after six months of lens wear, the CCT and ACD decreased by 4.80 μm and 0.03 mm (t=6.284, P<0.001; t=4.473, P<0.001), respectively, and the CLT increased by 0.02 mm (t=-3.971, P<0.001) compared to baseline. After the one month pause following the year of lens wear, CCT rebounded by 3.45 μm, while the ACD decreased by 0.01 mm (t=2.829, P=0.006) and CLT decreased by 0.03 mm (t=-3.589, P<0.001), respectively. Except for CCT, the changes were all significantly different from those in the spectacles group. Conclusions:Orthokeratology can have large and long-lasting effects on controlling axial elongation, decreasing ACD, and increasing CLT. The effects remained after a one month pause of orthokeratology lens wear.