Department of Ophthalmology (C.S., T.C.C., L.H.Y., D.G.V.. G.N.P, S.M., D.M.W., D.E., J.B.M., L.Q.S., J.C.), Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, USA.
Biostatistics Center (M.V.), Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Am J Ophthalmol. 2022 Nov;243:42-54. doi: 10.1016/j.ajo.2022.06.022. Epub 2022 Jul 16.
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).
Retrospective cohort study.
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.
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).
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.
评估植入目前市售第二代波士顿角膜镜(BK2)的严重瘢痕性眼表疾病(OSD)患者的临床结果。
回顾性队列研究。
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、器械更换和其他手术的记录。
纳入了 53 例患者的 56 只眼,平均随访 45.8 个月(范围:0.2-134.7 个月)。史蒂文斯-约翰逊综合征/中毒性表皮坏死松解症是最常见的适应证(49.1%),其次是黏膜炎性类天疱疮(39.6%)和其他 OSD(11.3%)。术后视力从术前 logMAR 2.2±0.5 提高到最终随访时的 1.5±1.2。56 只眼中,50 只在术后某个时间点至少能看到 20/200。在随访时间超过 5 年的眼中,50.0%在最终随访时保留了≥20/200 的视力。整个术后过程(平均约 4 年)中最常见的并发症是新发或加重青光眼(41.1%)、脉络膜积液(30.3%)、视网膜脱离(25.0%)和晚期青光眼(25.0%)。在单变量分析中,与保留≥20/200 视力的患者相比,不可逆丧失≥20/200 视力的患者更有可能之前植入过旧设计的 BK2,更不可能在术前接受全身性免疫抑制治疗,也更不可能同时进行青光眼管植入(所有 P<0.04)。
器械设计和术后护理的进步使 BK2 植入成为严重瘢痕性 OSD 角膜盲的可行选择。