PURPOSE

To assess clinical outcomes of patients with severe, cicatricial ocular surface disease (OSD) implanted with the currently marketed design of the Boston keratoprosthesis type II (BK2).

DESIGN

Retrospective cohort study.

METHODS

Records of consecutive patients undergoing BK2 implantation from June 2009 to March 2021 were assessed for postoperative visual acuity, postoperative complications, device replacement, and additional surgeries.

RESULTS

Fifty-six eyes of 53 patients with a mean follow-up of 45.8 months (range, 0.2-134.7 months) were included. Stevens−Johnson syndrome/toxic epidermal necrolysis was the most common indication (49.1%), followed by mucous membrane pemphigoid (39.6%) and other OSD (11.3%). Visual acuity improved from logMAR 2.2 ± 0.5 preoperatively to 1.5 ± 1.2 at final follow-up. Of 56 eyes, 50 saw ≥20/200 at some point postoperatively. Of the eyes with a follow-up of more than 5 years, 50.0% retained a visual acuity of ≥20/200 at their final follow-up. The most common complications over the entire postoperative course (mean ∼4 years) were de novo or worsening glaucoma (41.1%), choroidal effusions (30.3%), retinal detachment (25.0%), and end-stage glaucoma (25.0%). In a univariate analysis, patients who experienced irreversible loss of ≥20/200 visual acuity were more likely to have been previously implanted with an older design of BK2, less likely to be on preoperative systemic immunosuppressive therapy, and less likely to have undergone concurrent glaucoma tube implantation, compared to patients who retained ≥20/200 acuity (P < .04 for all).

CONCLUSIONS

Advances in device design and postoperative care have made implantation of BK2 a viable option for corneal blindness in the setting of severe cicatricial OSD.

中文翻译：

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使用波士顿人工角膜 II 型修复严重、瘢痕性眼表疾病的视力

目的

评估植入目前市售设计的波士顿 II 型角膜假体 (BK2) 的严重瘢痕性眼表疾病 (OSD) 患者的临床结果。

设计

回顾性队列研究。

方法

评估了 2009 年 6 月至 2021 年 3 月连续接受 BK2 植入的患者的术后视力、术后并发症、装置更换和额外手术的记录。

结果

纳入了 53 名患者的 56 只眼，平均随访时间为 45.8 个月（范围，0.2-134.7 个月）。Stevens-Johnson 综合征/中毒性表皮坏死松解症是最常见的适应症 (49.1%)，其次是粘膜类天疱疮 (39.6%) 和其他 OSD (11.3%)。视力从术前的 logMAR 2.2 ± 0.5 提高到最终随访时的 1.5 ± 1.2。在 56 只眼中，有 50 只眼在术后某个时间点看到 ≥20/200。在随访时间超过 5 年的眼睛中，50.0% 的患者在最后一次随访时视力仍保持在 ≥ 20/200。整个术后过程（平均约 4 年）中最常见的并发症是新发的或恶化的青光眼 (41.1%)、脉络膜积液 (30.3%)、视网膜脱离 (25.0%) 和终末期青光眼 (25.0%)。在单变量分析中，视力不可逆丧失 ≥ 20/200 的患者更有可能之前植入了较旧的 BK2 设计，不太可能接受术前全身免疫抑制治疗，并且不太可能同时发生青光眼与保持 ≥20/200 敏锐度的患者相比，管植入（所有P < .04）。

结论

设备设计和术后护理的进步使 BK2 植入成为严重瘢痕性 OSD 情况下角膜失明的可行选择。