Hudson Henry L, Lane Stephen S, Heier Jeffrey S, Stulting R Doyle, Singerman Lawrence, Lichter Paul R, Sternberg Paul, Chang David F
Retina Centers, Tucson, Arizona, USA.
Ophthalmology. 2006 Nov;113(11):1987-2001. doi: 10.1016/j.ophtha.2006.07.010. Epub 2006 Sep 20.
To evaluate the safety and efficacy of an implantable visual prosthetic device (IMT; VisionCare Ophthalmic Technologies, Saratoga, CA) in patients with bilateral, end-stage age-related macular degeneration (AMD).
Prospective, open-label, multicenter clinical trial with fellow eye controls.
A total of 217 patients (mean age, 76 years) with AMD and moderate to profound bilateral central visual acuity loss (20/80-20/800) resulting from bilateral untreatable geographic atrophy, disciform scars, or both were enrolled.
A visual prosthetic device (implantable telescope), designed to enlarge retinal images of the central visual field, was implanted monocularly in the capsular bag after lens extraction. Fellow eyes were not implanted to provide peripheral vision and served as controls. Study patients participated in 6 visual rehabilitation visits after surgery.
Best-corrected distance visual acuity (BCDVA) and best-corrected near visual acuity (BCNVA), quality-of-life scores from the National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) and the Activities of Daily Life scale, endothelial cell density (ECD), and incidence of complications and adverse events.
At 1 year, 67% of implanted eyes achieved a 3-line or more improvement in BCDVA versus 13% of fellow eye controls (P<0.0001). Fifty-three percent of implanted eyes achieved a 3-line or more improvement in both BCDVA and BCNVA versus 10% of fellow eyes (P<0.0001). Mean BCDVA and BCNVA improved 3.5 lines and 3.2 lines, respectively, in implanted eyes versus 0.8 lines and 1.8 lines, respectively, in fellow eyes (P<0.0001). Change in visual acuity was not related to lesion type. Mean NEI VFQ-25 scores improved by more than 7 points from baseline (P<0.01) on 7 of 8 relevant subscales. Eleven eyes did not receive the device because of an aborted procedure. Endothelial cell density was reduced by 20% at 3 months and 25% at 1 year. The decrease in ECD was correlated with postsurgical edema (P<0.0001), and there was no evidence that endothelial cell loss is accelerated by ongoing endothelial trauma after implantation.
This implantable visual prosthesis can improve visual acuity and quality of life in patients with moderate to profound visual impairment caused by bilateral, end-stage AMD.
评估植入式视觉假体装置（IMT；VisionCare Ophthalmic Technologies，加利福尼亚州萨拉托加）在双侧晚期年龄相关性黄斑变性（AMD）患者中的安全性和有效性。
采用对侧眼对照的前瞻性、开放标签、多中心临床试验。
共纳入217例AMD患者（平均年龄76岁），这些患者因双侧不可治疗的地图状萎缩、盘状瘢痕或两者兼有而导致中度至重度双侧中心视力丧失（20/80 - 20/800）。
一种旨在放大中心视野视网膜图像的视觉假体装置（植入式望远镜）在晶状体摘除后单眼植入囊袋内。对侧眼不植入以提供周边视力并作为对照。研究患者在术后参加6次视觉康复就诊。
最佳矫正远视力（BCDVA）和最佳矫正近视力（BCNVA）、美国国立眼科研究所25项视觉功能问卷（NEI VFQ - 25）和日常生活量表的生活质量评分、内皮细胞密度（ECD）以及并发症和不良事件的发生率。
1年后，植入眼中有67%的BCDVA提高了3行或更多，而对侧眼对照中这一比例为13%（P<0.0001）。植入眼中有53%的BCDVA和BCNVA均提高了3行或更多，而对侧眼中这一比例为10%（P<0.0001）。植入眼的平均BCDVA和BCNVA分别提高了3.5行和3.2行，而对侧眼分别提高了0.8行和1.8行（P<0.0001）。视力变化与病变类型无关。在8个相关子量表中的7个上，平均NEI VFQ - 25评分较基线提高了7分以上（P<0.01）。11只眼因手术中止未接受该装置。3个月时内皮细胞密度降低了20%，1年时降低了25%。ECD的降低与术后水肿相关（P<0.0001），且没有证据表明植入后持续的内皮损伤会加速内皮细胞丢失。
这种植入式视觉假体可改善由双侧晚期AMD引起的中度至重度视力损害患者的视力和生活质量。
