Endothelial keratoplasty versus penetrating keratoplasty for Fuchs endothelial dystrophy.
Endothelial keratoplasty versus penetrating keratoplasty for Fuchs endothelial dystrophy.
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DOI：
10.1002/14651858.cd008420.pub3
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发表时间：
2014-02-14
影响因子：
8.4
通讯作者：
Shortt, Alex J.
中科院分区：
文献类型：
--
作者：
Nanavaty, Mayank A.;Wang, Xue;Shortt, Alex J.
关键词：
Fuchs内皮营养不良（FED）是一种角膜内皮细胞过早变性的疾病。当内皮细胞的数量显著减少时，液体开始在角膜内积聚。结果，角膜失去其透明度，个体遭受视力下降。唯一成功的手术治疗是用捐献者的健康组织替换部分或全部角膜。穿透性角膜移植术（PKP）已经使用多年，其安全性和有效性是众所周知的。内皮角膜移植术（EK）技术是相对较新的外科手术，其相对于PKP的安全性和有效性尚不确定。本综述的目的是比较两种手术方法（EK和PKP）在FED患者中用健康层替换患病角膜内皮层的受益和并发症。我们检索了CENTRAL（其中包含科克伦眼科和视力组试验注册表）（科克伦图书馆2014年第1期）、MEDLINE（1950年1月至2014年1月）、EMBASE（1980年1月至2014年1月）、拉丁美洲和加勒比健康科学文献数据库（LILACS）（1982年1月至2014年1月）、对照试验荟萃注册表（mRCT）（www.controlled-trials.com）和ClinicalTrials.govwww.clinicaltrials.gov）。审判的电子搜索没有日期或语言限制。最后一次检索电子数据库是在2014年1月27日。我们纳入了所有比较EK与PKP的随机对照试验（RCT），用于临床诊断为FED的患者（任何年龄和性别）。两位作者独立筛选检索结果，评估试验质量，并使用科克伦协作网预期的标准方法学程序提取数据。我们纳入了三项随机对照试验，共纳入了136名参与者的139只眼，并分析了123只眼（88%）。2例随机分配至内皮角膜移植术（EK）组或穿透性角膜移植术（PKP）组的RCT和1例随机分配至飞秒激光辅助内皮角膜移植术（FLEK）组或PKP组的RCT。比较EK与PKP的RCT未显示两种手术在两年时的最佳矫正视力（BCVA）方面存在任何显著差异（平均差异（MD）0.14 logMAR; 95%置信区间（CI）-0.08至0.36; P = 0.23）或1年时（MD 0.09 logMAR; 95% CI-0.05至0.23; P = 0.22），而比较FLEK与PKP的试验显示PKP后BCVA显著更好（MD 0.20 logMAR; 95% CI 0.10至0.30; P = 0.0001）。只有一项RCT报告了不规则散光（高阶像差），EK组的不规则散光小于PKP组（MD −1.20 µm; 95% CI −1.53至−0.87; P < 0.001）。仅1项RCT报告了内皮细胞计数（FLEK后低于PKP：MD −969个细胞/mm²; 95% CI −1161至−777; P < 0.001），原发性移植物衰竭（FLEK后高于PKP：RR 7.76; 95%CI 0.41至145.22; P = 0.10）和移植物排斥反应（FLEK后比PKP后更多：RR 1.11; 95% CI 0.07至17.12; P = 0.94）。只有一项随机对照试验报告称，与PKP组相比，FLEK组有27.8%的参与者发生了移植物脱位，2.8%的参与者发生了上皮长入和术后瞳孔阻滞，13.9%的参与者发生了眼内压（IOP）相关问题，而PKP组有10%的参与者发生了缝线相关问题，5%的参与者发生了伤口裂开，10%的参与者进行了缝线翻修以矫正散光。总体而言，FLEK组的不良事件似乎比PKP组更频繁。没有试验报告有关生活质量或经济数据的信息。三项试验的总体方法学质量不令人满意，因为大多数试验没有对参与者和结局评估者进行分配隐藏或掩蔽，并且所有试验的样本量都很小。内皮角膜移植术作为FED治疗选择的快速增长是基于这样的信念，即EK的视力恢复更快，手术诱导的散光（规则和不规则）更少，移植排斥率更低。实践中的这一变化还假设两种手术的长期移植存活率相等。手术之间的实际差异意味着EK后视力恢复更快，但本综述未发现来自RCT的有力证据表明FED患者EK和PKP之间的最终视力结果存在任何差异。这篇综述还发现，EK后高阶畸变较少，但EK后内皮细胞丢失较多。我们纳入的随机对照试验采用了不同的EK技术，这可能与这些发现有关。EK手术经过多年的发展，可以使用不同的技术进行，例如深板层内皮角膜移植术、后弹力层剥脱内皮角膜移植术（DSEK）、后弹力层剥脱自动内皮角膜移植术（DSAEK）、飞秒激光辅助内皮角膜移植术和后弹力层膜内皮角膜移植术（DMEK）。为了确定两个关键问题的答案，需要更多的随机对照试验来比较PKP与常用的EK手术，如DSEK，DSAEK和DMEK，这些技术之间的最终视力结果是否有任何差异，以及移植物长期存活率是否有差异？
Fuchs endothelial dystrophy (FED) is a condition in which there is premature degeneration of corneal endothelial cells. When the number of endothelial cells is reduced to a significant degree, fluid begins to accumulate within the cornea. As a result, the cornea loses its transparency and the individual suffers a reduction in vision. The only successful surgical treatment for this condition is replacement of part or all of the cornea with healthy tissue from a donor. The established procedure, penetrating keratoplasty (PKP), has been used for many years and its safety and efficacy are well known. Endothelial keratoplasty (EK) techniques are relatively new surgical procedures and their safety and efficacy relative to PKP are uncertain. The objective of this review was to compare the benefits and complications related to two surgical methods (EK and PKP) of replacing the diseased endothelial layer of the cornea with a healthy layer in people with FED. We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2014, Issue 1), MEDLINE (January 1950 to January 2014), EMBASE (January 1980 to January 2014), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to January 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) and ClinicalTrials.gov (www.clinicaltrials.gov). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 27 January 2014. We included all randomised controlled trials (RCTs) comparing EK versus PKP for people (of any age and gender) who had been clinically diagnosed with FED. Two authors independently screened the search results, assessed trial quality and extracted data using the standard methodological procedures expected by The Cochrane Collaboration. We included three RCTs that enrolled a total of 139 eyes of 136 participants and analysed 123 (88%) eyes. Two RCTs randomised eyes into either the endothelial keratoplasty (EK) group or penetrating keratoplasty (PKP) group and one RCT randomised eyes into either the femtosecond laser-assisted endothelial keratoplasty (FLEK) group or PKP group. The RCTs comparing EK with PKP did not show any significant differences between procedures with respect to best corrected visual acuity (BCVA) at two years (mean difference (MD) 0.14 logMAR; 95% confidence interval (CI) −0.08 to 0.36; P = 0.23) or at one year (MD 0.09 logMAR; 95% CI −0.05 to 0.23; P = 0.22), whereas the trial comparing FLEK with PKP showed significantly better BCVA after PKP (MD 0.20 logMAR; 95% CI 0.10 to 0.30; P = 0.0001). Only one RCT reported on irregular astigmatism (higher-order aberration), which was less with EK than PKP (MD −1.20 µm; 95% CI −1.53 to −0.87; P < 0.001). Only one RCT reported on endothelial cell counts (lower after FLEK than PKP: MD −969 cells/mm²; 95% CI −1161 to −777; P < 0.001), primary graft failure (higher after FLEK than PKP: RR 7.76; 95% CI 0.41 to 145.22; P = 0.10), and graft rejection (more after FLEK than PKP: RR 1.11; 95% CI 0.07 to 17.12; P = 0.94). Only one RCT reported that 27.8% of participants had graft dislocation, 2.8% had epithelial ingrowth and postoperative pupillary block, and 13.9% had intraocular pressure (IOP)-related problems in the FLEK group compared with the PKP group, in whom 10% had suture-related problems, 5% had wound dehiscence and 10% had suture revision to correct astigmatism. Overall, the adverse events in the FLEK group appeared to be more frequent than in the PKP group. No trials reported information about quality of life or economic data. The overall methodological quality of the three trials was not satisfactory as most did not perform allocation concealment or masking of participants and outcome assessors, and all trials had a small sample size. The rapid growth of endothelial keratoplasty as the treatment of choice for FED is based upon the belief that visual recovery is more rapid, surgically induced astigmatism (regular and irregular) is less and rates of transplant rejection are lower with EK. This change in practice also assumes that the rates of long term transplant survival are equal for the two procedures. The practical differences between the surgical procedures mean that visual recovery is inherently more rapid following EK, but this review found no strong evidence from RCTs of any difference in the final visual outcome between EK and PKP for people with FED. This review also found that higher order aberrations are fewer following EK but endothelial cell loss is greater following EK. The RCTs that we included employed different EK techniques, which may have a bearing on these findings. EK procedures have evolved over the years and can be performed using different techniques, for example deep lamellar endothelial keratoplasty, Descemets stripping endothelial keratoplasty (DSEK), Descemets stripping automated endothelial keratoplasty (DSAEK), femtosecond laser-assisted endothelial keratoplasty and Descemet membrane endothelial keratoplasty (DMEK). More RCTs are needed to compare PKP with commonly performed EK procedures such as DSEK, DSAEK and DMEK in order to determine the answers to two key questions, whether there is any difference in the final visual outcome between these techniques and whether there are differences in the rates of graft survival in the long term?