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《人工角膜 Aurolab 与 Boston 型 I 人工角膜:134 例双侧角膜盲的 5 年临床结果》

The Aurolab Keratoprosthesis (KPro) versus the Boston Type I Kpro: 5-year Clinical Outcomes in 134 Cases of Bilateral Corneal Blindness.

机构信息

Tej Kohli Cornea Institute, LV Prasad Eye Institute, Hyderabad, Telangana, India.

Tej Kohli Cornea Institute, LV Prasad Eye Institute, Hyderabad, Telangana, India.

出版信息

Am J Ophthalmol. 2019 Sep;205:175-183. doi: 10.1016/j.ajo.2019.03.016. Epub 2019 Mar 22.

Abstract

PURPOSE

To compare the clinical outcomes of Boston Type I keratoprosthesis (Boston Kpro) with its low-cost version, the Aurolab Kpro (auroKPro).

DESIGN

Retrospective comparative case series.

METHODS

This study included 134 eyes of 130 patients with severe bilateral corneal blindness but with wet ocular surfaces. The patients underwent either Boston Kpro (n = 78) or auroKPro (n = 56) implantation based on the device availability and patient's affordability. The primary outcome measurements were anatomical retention (defined as absence of device extrusion, exchange, or explantation) and functional recovery of 20/200 or better visual acuity at yearly time points until 5-years of follow-up.

RESULTS

Limbal stem cell deficiency was the most common indication (60.5%) for surgery, followed by multiple failed grafts (35%). Both groups were comparable at baseline with respect to indications for surgery and associated ocular co-morbidities (P > 0.05). The overall anatomical retention rates were similar in the Boston Kpro (55 of 78, 70.5%) and auroKPro (35 of 56, 62.5%) groups (P = 0.11). Kaplan-Meier survival rates at 5 years of follow-up were greater for the Boston Kpro with respect to both anatomical retention (63 ± 6% vs. 43.4 ± 10%, respectively; P = 0.057) and functional recovery (42.4 ± 6% vs. 32.2 ± 7%, respectively; P = 0.345), but these differences were not statistically significant. Complications such as intraoperative device breakage (7%) and postoperative extrusions (12.5%) were significantly more common with the auroKPro (P = 0.023).

CONCLUSIONS

Both the auroKPro and the Boston Kpro are effective treatment options for patients with severe bilateral corneal blindness. The auroKPro can be considered an alternative to the Boston Kpro when affordability or availability of the Boston Kpro is a limiting factor.

摘要

目的

比较波士顿 I 型角膜假体(Boston Kpro)与低成本版的 Aurolab Kpro(auroKPro)的临床结果。

设计

回顾性比较病例系列。

方法

本研究纳入了 130 名患者的 134 只眼,这些患者双眼均患有严重的角膜盲,但眼表湿润。根据设备的可用性和患者的经济承受能力,这些患者分别接受了 Boston Kpro(n=78)或 auroKPro(n=56)植入。主要观察指标是解剖学保留(定义为无器械脱出、更换或取出)和功能恢复至 20/200 或更好的视力,每年测量一次,随访时间长达 5 年。

结果

最常见的手术适应证是缘干细胞缺乏症(60.5%),其次是多次移植失败(35%)。两组在手术适应证和相关眼部合并症方面在基线时具有可比性(P>0.05)。Boston Kpro 组(55/78,70.5%)和 auroKPro 组(35/56,62.5%)的总体解剖学保留率相似(P=0.11)。在 5 年的随访中,Boston Kpro 在解剖学保留(63±6% vs. 43.4±10%,分别;P=0.057)和功能恢复(42.4±6% vs. 32.2±7%,分别;P=0.345)方面的 Kaplan-Meier 生存率均较高,但这些差异无统计学意义。术中器械断裂(7%)和术后脱出(12.5%)等并发症在 auroKPro 中更为常见(P=0.023)。

结论

对于严重双侧角膜盲患者,auroKPro 和 Boston Kpro 都是有效的治疗选择。当经济承受能力或 Boston Kpro 的可用性成为限制因素时,auroKPro 可以作为 Boston Kpro 的替代选择。

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