Kang Kai B, Karas Faris I, Rai Ruju, Hallak Joelle A, Kang Joann J, de la Cruz Jose, Cortina Maria S
Illinois Eye and Ear Infirmary, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, IL, United States of America.
PLoS One. 2018 Feb 6;13(2):e0192381. doi: 10.1371/journal.pone.0192381. eCollection 2018.
Despite improved retention and reduced complication rates paving the way for the current expansion of applications and surge in prevalence for the Boston type I Keratoprosthesis (KPro), the most frequent indication for its implantation today remains prior graft failure. The purpose of this study is to evaluate the long-term outcomes of primary KPro and compare to secondary implantation in a matched cohort study. This study included patients who underwent KPro implantation in a single center by two surgeons between July 2008 and October 2014. All eyes with KPro implantation as the primary procedure with a minimum follow up of 12 months were matched with eyes with same preoperative diagnoses that underwent secondary KPro implantation. Main outcomes included visual acuity and device retention. A total of 56 eyes were included with 28 eyes in each group. Mean follow up was 5.0 years for both groups. Twenty-nine percent (8) of the eyes in the primary group had a diagnosis of chemical or thermal injuries, 25% (7) aniridia, 18% (5) autoimmune disease, 4% (1) infectious keratitis/neurotrophic cornea, 7% (2) gelatinous corneal dystrophy, 7% (2) ectrodactyly ectodermal dysplasia/limbal stem cell deficiency, and 11% (3) uveitis/hypotony. Sixty-one percent (17) of the eyes in the primary group and 39% (11) in the secondary group maintained a final best-corrected visual acuity of 20/200 or better at a mean follow up of 5.0 years; the probability of maintaining best-corrected vision is 0.83 and 0.49 for primary and secondary groups at 5.0 years (p = 0.02). There is no statistically significant difference between groups in device retention (p = 0.22) or postoperative complication rates (p >0.05). This study demonstrates that Boston KPro implantation may be successful as a primary procedure in patients at high risk of failure with traditional penetrating keratoplasty. The device has a good long-term retention rate and visual outcomes are promising however a larger study is needed for more definitive results.
尽管保留率提高和并发症发生率降低为目前波士顿I型人工角膜（KPro）应用的扩展和患病率的激增铺平了道路，但目前其植入最常见的指征仍是先前的移植失败。本研究的目的是在一项匹配队列研究中评估初次KPro植入的长期结果，并与二次植入进行比较。本研究纳入了2008年7月至2014年10月期间由两位外科医生在单一中心进行KPro植入的患者。所有以KPro植入作为初次手术且至少随访12个月的眼睛，与接受二次KPro植入且术前诊断相同的眼睛进行匹配。主要结局包括视力和装置保留情况。共纳入56只眼睛，每组28只。两组的平均随访时间均为5.0年。初次植入组中29%（8只）眼睛诊断为化学或热烧伤，25%（7只）无虹膜，18%（5只）自身免疫性疾病，4%（1只）感染性角膜炎/神经营养性角膜，7%（2只）胶冻状角膜营养不良，7%（2只）缺指（趾）外胚层发育不良/角膜缘干细胞缺乏，11%（3只）葡萄膜炎/低眼压。初次植入组61%（17只）眼睛和二次植入组39%（11只）眼睛在平均随访5.0年时最终最佳矫正视力维持在20/200或更好；初次植入组和二次植入组在5.0年时维持最佳矫正视力的概率分别为0.83和0.49（p = 0.02）。两组在装置保留率（p = 0.22）或术后并发症发生率（p >0.05）方面无统计学显著差异。本研究表明，对于传统穿透性角膜移植术失败风险高的患者，波士顿KPro植入作为初次手术可能是成功的。该装置具有良好的长期保留率，视力结果也很有前景，然而需要更大规模的研究以获得更确切的结果。
