Chen Masako, Ng Sueko M, Akpek Esen K, Ahmad Sumayya
Department of Ophthalmology, Icahn School of Medicine, New York Eye and Ear Infirmary of Mount Sinai, New York, 10003, USA.
Department of Ophthalmology, School of Medicine, University of Colorado, Aurora, CO, USA.
Cochrane Database Syst Rev. 2020 May 13;5(5):CD009561. doi: 10.1002/14651858.CD009561.pub3.
Individuals who have failed one or more full thickness penetrating keratoplasties may be offered repeat corneal surgery using an artificial or donor cornea. An artificial or prosthetic cornea is known as a keratoprosthesis. Both donor and artificial corneal transplantations involve removal of the diseased and opaque recipient cornea (or the previously failed cornea) and replacement with another donor or prosthetic cornea.
To assess the effectiveness of artificial versus donor corneas in individuals who have had one or more failed donor corneal transplantations.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 11); Ovid MEDLINE; Ovid Embase; LILACS (Latin American and Caribbean Health Sciences Literature database); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 4 November 2019.
Two review authors independently assessed reports from the electronic searches to identify randomized controlled trials or controlled clinical trials. Any discrepancies were resolved by discussion or consultation.
We used standard methodological procedures expected by Cochrane. For discussion purposes, we summarized findings from relevant comparative case series. We performed no data synthesis.
We did not identify any randomized controlled trials or controlled clinical trials comparing artificial corneas with donor corneas for repeat corneal transplantations.
AUTHORS' CONCLUSIONS: The optimal management for those individuals who have failed a conventional corneal transplantation is unknown. Currently, in some centers, artificial corneal devices are routinely recommended after just one graft failure, while in other centers, they are not recommended until after multiple graft failures, or not at all. To date, there have been no controlled trials comparing the visual outcomes and complications of artificial corneal devices (particularly the Boston type 1 keratoprosthesis, which is the most commonly implanted artificial corneal device) with repeat donor corneal transplantation, in order to guide surgeons and their patients. Such a trial is needed and would offer significant benefit to an ever-increasing pool of people with visual disability due to corneal opacification, most of whom are still in productive stages of their lives.
经历过一次或多次穿透性全层角膜移植术失败的个体，可考虑使用人工角膜或供体角膜进行再次角膜手术。人工角膜或角膜假体被称为角膜移植片。供体角膜移植和人工角膜移植均需移除病变且混浊的受体角膜（或先前移植失败的角膜），并用另一个供体角膜或人工角膜进行置换。
评估人工角膜与供体角膜在经历过一次或多次供体角膜移植失败的个体中的有效性。
我们检索了Cochrane对照试验中心注册库（CENTRAL）（其中包含Cochrane眼科和视力试验注册库）（2019年第11期）；Ovid MEDLINE；Ovid Embase；LILACS（拉丁美洲和加勒比地区健康科学文献数据库）；ClinicalTrials.gov；以及世界卫生组织（WHO）国际临床试验注册平台（ICTRP）。在电子检索试验时，我们未设置任何日期或语言限制。我们最近一次检索电子数据库的时间为2019年11月4日。
两位综述作者独立评估电子检索得到的报告，以识别随机对照试验或对照临床试验。任何分歧均通过讨论或咨询解决。
我们采用了Cochrane期望的标准方法程序。为便于讨论，我们总结了相关比较病例系列的研究结果。我们未进行数据合成。
我们未识别出任何比较人工角膜与供体角膜用于再次角膜移植的随机对照试验或对照临床试验。
对于传统角膜移植失败的个体，最佳治疗方案尚不清楚。目前，在一些中心，仅一次移植失败后就常规推荐使用人工角膜装置，而在其他中心，直到多次移植失败后才推荐使用，或者根本不推荐。迄今为止，尚无对照试验比较人工角膜装置（特别是最常用的植入式人工角膜装置波士顿1型角膜移植片）与再次供体角膜移植的视觉效果和并发症，以指导外科医生及其患者。需要进行这样一项试验，这将为因角膜混浊而视力残疾的人数不断增加的群体带来显著益处，其中大多数人仍处于人生的生产阶段。
