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首页> 外文期刊>American Journal of Ophthalmology: The International Journal of Ophthalmology >Implantable telescope for end-stage age-related macular degeneration: long-term visual acuity and safety outcomes.
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Implantable telescope for end-stage age-related macular degeneration: long-term visual acuity and safety outcomes.

机译：可植入式望远镜，用于与年龄相关的终末期黄斑变性：长期视力和安全性结果。

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摘要

PURPOSE: To evaluate long-term safety and best-corrected visual acuity (BCVA) results of a telescope prosthesis in patients with end-stage age-related macular degeneration (AMD). DESIGN: Prospective, open-label clinical trial with fellow-eye controls. METHODS: Patients with end-stage AMD (bilateral geographic atrophy or disciform scars; BCVA, 20/80 to 20/800) received the telescope prosthesis at 28 centers. Methods were similar to those described in the one-year results, with follow-up visits continuing at 18 and 24 months. Main outcome measures included BCVA change from baseline, endothelial cell density (ECD) and morphometry, and incidence of complications. RESULTS: At two years, data from 174 (92.6%) of 188 available patients were analyzed. Overall, 103 (59.5%) of 173 telescope-implanted eyes gained three lines or more (doubling of visual angle) of BCVA compared with 18 (10.3%) of 174 fellow control eyes (P < .0001). Mean BCVA improved 3.6 lines (standard deviation [SD], 1.9 lines) and 2.8 lines (SD, 2.3 lines) from baseline in eyes with the 3X and 2.2X device models, respectively. Mean ECD stabilized through two years, with 2.4% mean cell loss occurring from one to two years. There was no significant change in coefficient of variation or percentage of hexagonal endothelial cells from within six months to two years after surgery. The most common complication was inflammatory deposits. CONCLUSIONS: Long-term results of this telescope prosthesis show the substantial BCVA improvement at one year is maintained at two years. Key indicators of corneal health demonstrate ECD change that reflects remodeling of the endothelium associated with the implantation procedure. ECD stabilizes over time, and there is no evidence of any ongoing endothelial trauma.
机译：目的：评估末端假性年龄相关性黄斑变性（AMD）患者的望远镜假体的长期安全性和最佳矫正视力（BCVA）结果。设计：前瞻性开放临床试验，采用双眼对照。方法：患有晚期AMD（双侧地理萎缩或盘状疤痕; BCVA，20/80至20/800）的患者在28个中心接受了望远镜假体。方法与一年结果中描述的方法相似，随访时间分别为18和24个月。主要结局指标包括基线的BCVA变化，内皮细胞密度（ECD）和形态，以及并发症的发生率。结果：在两年的时间里，分析了188名可用患者中的174名（92.6％）的数据。总体而言，在173支望远镜植入的眼睛中，有103支（59.5％）获得了三行或更多的BCVA（视角加倍），而在174副对照眼中有18支（10.3％）（P <.0001）。在使用3X和2​​.2X设备模型的眼中，平均BCVA分别比基线改善了3.6线（标准偏差[SD]，1.9线）和2.8线（SD，2.3线）。平均ECD在两年内稳定下来，一到两年平均细胞流失率为2.4％。术后六个月至两年内，六角形内皮细胞的变异系数或百分比没有显着变化。最常见的并发症是炎症沉积。结论：该望远镜假体的长期结果表明，两年内BCVA的大幅改善。角膜健康的关键指标表明ECD的变化反映了与植入程序相关的内皮重塑。 ECD会随着时间的推移而稳定下来，并且没有任何正在进行的内皮损伤的证据。

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