导语

如今人们更加重视屈光手术的整体视觉质量，而不仅仅是视力。角膜屈光手术诱发像差改变十分常见，但有晶状体眼人工晶状体植入发生像差改变的情况并不显著[9,10]。对于高度近视病例，有晶状体眼人工晶状体相较于SMILE的术后视觉质量更好[9,11,12]。但关于中度近视的文献却很有限。本研究探讨了EVO ICL和SMILE对中度近视患者的视觉和屈光效果。

研究结果由印度的Rajesh Sinha团队，于2024年9月发表在Indian Journal of Ophthalmology杂志上。

研究方法

本研究纳入2018年6月至2019年11月接受EVO ICL植入或SMILE手术的患者，平均随访一年。检查项目包括：裸眼远视力(UCVA)、矫正远视力(CDVA)、屈光度、裂隙灯检查、眼压、角膜内皮细胞密度、拱高、对比敏感度、高阶像差（HOA）、调制传递函数（MTF）、点扩散函数（PSF）和患者满意度调查问卷21,22。研究结果

纳入30例患者的60只眼，其中15例（30眼，平均MRSE为-5.4±1.17D）接受双眼EVO ICL植入，15例（30眼，平均MRSE为-5.22±1.05D）接受双眼SMILE手术。术前两组的平均泪膜破裂时间（TBUT）和Schirmer I无显著差异（P=0.29和P=0.17），两组患者均无干眼症。（表1）

视力及眼压结果

两组患者术后的UCVA变化如图1所示。术后一年，EVO ICL组的有效性(UCVA≥20/20)为93.3%(n=28/30)，SMILE组为83.3%(n=25/30)。在随访期间，两组所有眼睛的CDVA均为20/20，两种手术的安全性均为100%。末次随访时两组的可预测性(±0.5D)均为100%。(表3)

对比敏感度

术前两组的对比敏感度无显著性差异。术后一年，与SMILE组(1.70±0.13log CS)相比，EVO ICL组具有更高的对比敏感度(1.82±0.10log CS)(P=0.0002)。(表3)

像差

iTrace对像差的评估表明，术前两组的大多数参数无显著性差异。术后一年SMILE组的所有像差参数均显著增加、MTF显著降低，而EVO ICL组没有观察到显著变化。相较于SMILE组，EVO ICL组的像差更低、MTF值更高。(表2)

视觉质量调查问卷

EVO ICL组的“QoV问卷”平均得分为3.33±3.72，SMILE组为7.20±8.65，表明EVO ICL组的视觉质量比SMILE组更好（P=0.64）。在询问眩光的严重程度时，SMILE组的4名患者都报告眩光中度严重并令人烦扰，但EVO ICL组没有患者报告眩光严重或令人烦扰。

干眼检查参数

术后一年EVO ICL组的TBUT无显著变化（11.6±2.5秒 vs. 11.1±2.7秒；P=0.35），而SMILE组的TBUT显著下降（10.9±1.7秒 vs. 9.3±3.2秒；P=0.02），且两组的TBUT值存在显著差异（11.06±2.65与8.96±1.75；P=0.0006），其中EVO ICL组的值较高。另外，两组间的Schirmer I值也存在显著差异(P=0.0001)。(表3)

（表2）

（表3）

（表4）

讨论

多项研究发现[9,11,12]，与SMILE相比，接受ICL植入的患者有效性指数更高。本研究结果类似，EVO ICL组与SMILE组相比有效性更优（93.3% vs 83.3%）。先前的研究显示[9,11,12]，ICL组与SMILE组的安全性指数相当或更佳。在本研究中，EVO ICL组和SMILE组矫正中度近视显示出相似的安全性。

屈光手术后像差的改变是患者对视觉质量不满意的重要原因。既往研究报道[11,23,24]，因为ICL术后患者的角膜基本保持不变，ICL术后像差优于SMILE术后。本研究结果相似，与SMILE相比，中度近视患者植入EVO ICL后的像差更低、MTF更高。

对比敏感度是影响视觉质量的另一个重要方面。多项研究报告发现[25-27]，中高度近视患者ICL术后的对比敏感度均有所提高，而SMILE术后对比敏感度无明显变化[28,29]。本研究结果类似，对于中度近视患者来说，EVO ICL术眼相较于SMILE术眼，对比敏感度更高。

据报道，相较于其他角膜屈光手术，SMILE术后干眼症的风险更低[30,31]，但在SMILE病例中，仍然观察到干眼检查参数的短暂下降。本研究中，接受EVO ICL植入的病例在末次随访时的干眼检查参数比SMILE更好，主要原因可能是ICL植入不切削角膜。

TAKE HOME MESSAGE

1、EVO ICL植入矫正中度近视安全有效、预测性好。

2、EVO ICL保留了角膜的完整性，其矫正中度近视的对比敏感度以及术后像差更优，患者视觉质量更好。

3、因不切削角膜，EVO ICL术后干眼检查参数更优，干眼发生风险更低。

文献来源

https://pubmed.ncbi.nlm.nih.gov/39257104/

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