Stein Eye Institute, David Geffen School of Medicine, University of California, Los Angeles.
Stein Eye Institute, David Geffen School of Medicine, University of California, Los Angeles; Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles.
Ophthalmology. 2017 Jan;124(1):12-19. doi: 10.1016/j.ophtha.2016.08.003. Epub 2016 Sep 7.
To evaluate the safety of concurrent Boston type I keratoprosthesis (KPro) and glaucoma drainage device (GDD) implantation.
Retrospective comparative study of a consecutive cohort of patients.
Patients who underwent KPro implantation by a single surgeon (A.J.A.) with or without 1 concurrent Ahmed GDD (New World Medical, Inc., Rancho Cucamonga, CA) implantation between January 1, 2005, and January 31, 2015, were included. Patients with fewer than 3 months of follow-up or a history of previous KPro implantation were excluded.
Preoperative, operative, and postoperative data were collected for each procedure. All comparisons were made between KPro procedures performed with or without concurrent GDD implantation. The Fisher exact test (2-tailed) was used to compare proportions, Student t test and Wilcoxon rank-sum test were used to compare means, and the log-rank test was used to compare time-to-outcome events.
The primary outcome was frequency of the composite variable, that is, any serious vision-threatening postoperative complication, which included sterile vitreitis, endophthalmitis, hypotony maculopathy, suprachoroidal hemorrhage, retinal detachment, stromal necrosis, and infectious keratitis. Secondary outcomes included intraocular pressure control, worsening of visual acuity, cystoid macular edema, retroprosthetic membrane formation, persistent epithelial defect formation, GDD exposure, and KPro removal.
One hundred thirty-seven KPro procedures were performed in 129 patients: 91 (66.4%) KPro alone and 46 (33.6%) KPro plus GDD. There were no statistically significant differences between the 2 groups in terms of the incidence of vision-threatening postoperative complications. None of the 46 GDDs placed at the same time as the KPro became exposed during an average follow-up of 44 months.
Compared with KPro alone, GDD placement combined with KPro was not associated with increased postoperative complications.
评估同时行波士顿Ⅰ型角膜假体（KPro）和青光眼引流装置（GDD）植入的安全性。
对一组连续患者进行回顾性比较研究。
纳入 2005 年 1 月 1 日至 2015 年 1 月 31 日期间，由一位外科医生（A.J.A.）进行 KPro 植入手术且同时行或不行 Ahmed GDD（美国新视界医疗器械公司，Rancho Cucamonga，CA）植入术的患者。排除随访时间少于 3 个月或既往有 KPro 植入史的患者。
收集每例手术的术前、术中和术后数据。所有比较均在 KPro 手术中同时行或不行 GDD 植入术之间进行。采用 Fisher 确切概率法（双侧）比较比例，采用 Student t 检验和 Wilcoxon 秩和检验比较均值，采用对数秩检验比较生存时间。
主要结局为复合变量，即任何严重的术后威胁视力的并发症的发生率，包括无菌性玻璃体炎、眼内炎、低眼压性黄斑病变、脉络膜上腔出血、视网膜脱离、基质坏死和感染性角膜炎。次要结局包括眼压控制、视力恶化、黄斑囊样水肿、后弹力层膜形成、持续性上皮缺损形成、GDD 暴露和 KPro 移除。
129 例患者的 137 例 KPro 手术中：91 例（66.4%）单纯 KPro 手术，46 例（33.6%）KPro 联合 GDD。2 组之间在威胁视力的术后并发症发生率方面无统计学差异。在平均 44 个月的随访中，同时放置的 46 个 GDD 中没有一个暴露。
与单纯 KPro 相比，KPro 联合 GDD 植入并不增加术后并发症。
