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可植入式微型望远镜:经验教训

Implantable miniature telescope: lessons learned.

作者信息

Primo Susan A

机构信息

Emory Eye Center, Atlanta, Georgia 30322, USA.

出版信息

Optometry. 2010 Feb;81(2):86-93. doi: 10.1016/j.optm.2009.08.014.

Abstract

BACKGROUND

The Implantable Miniature Telescope (IMT) is a telescopic prosthesis that, combined with the optics of the cornea, constitutes an intraocular magnifying system. It is indicated for use in patients with stable, nonfoveal sparing, bilateral, stable, age-related macular degeneration (end-stage) with associated scotomas. The telescope prosthesis is implanted in only one of the patient's eyes. In this way, the implanted eye provides improved visual acuity, and the nonimplanted eye continues to provide peripheral vision for ambulation. Two hundred seventeen patients with end-stage AMD were enrolled in a prospective, multicenter, open-label trial (IMT-002) beginning in 2003. The implanted eye was the worse eye for most patients based on a selection rule set by the U.S. Food and Drug Administration (FDA) protocol; however, in most cases (90%), visual acuity improvement goals were met with the device. This report will retrospectively look at 2 selected patients implanted at the Emory Eye Center in Atlanta as part of that trial to derive lessons for subject and eye selection criteria.

CASE REPORTS

Two cases were selected to represent patients' levels of functional success and satisfaction. Determination of their visual and functional outcome at 1-year postimplantation was based on best-corrected visual acuity and the National Eye Institute Visual Functioning Questionnaire 25-Item quality-of-life survey. Four years after implantation, 1 patient continued to use the telescope prosthesis eye for all visual activities; the other patient did not perceive any benefit from the device and continued to primarily use the fellow nonimplanted eye. The benefit of the telescopic prosthesis was most likely accounted for by the level of visual acuity in both eyes postimplantation and eye dominance.

CONCLUSION

Proper eye selection chosen for implantation with the telescope prosthesis appears to be an important if not critical factor in determining patient satisfaction for visual processing and functional success. Based on the author's experience with the IMT, optometrists can aid the multidisciplinary team by preoperatively determining which eye, if implanted, offers the optimal potential functional benefit for appropriate candidates.

摘要

背景

可植入式微型望远镜(IMT)是一种伸缩式假体,与角膜光学系统相结合,构成眼内放大系统。它适用于患有稳定的、非黄斑中心凹保留的、双侧的、稳定的年龄相关性黄斑变性(晚期)并伴有暗点的患者。望远镜假体仅植入患者的一只眼睛。通过这种方式,植入眼可提高视力,未植入眼则继续为行走提供周边视觉。从2003年开始,217名晚期年龄相关性黄斑变性患者参加了一项前瞻性、多中心、开放标签试验(IMT - 002)。根据美国食品药品监督管理局(FDA)方案设定的选择规则,对于大多数患者而言,植入眼是较差的那只眼睛;然而,在大多数情况下(90%),该装置达到了视力改善目标。本报告将回顾性地研究作为该试验一部分在亚特兰大埃默里眼科中心植入的2例选定患者,以总结受试者和眼睛选择标准方面的经验教训。

病例报告

选择了两个病例来代表患者的功能成功水平和满意度。根据最佳矫正视力和美国国立眼科研究所视觉功能问卷25项生活质量调查来确定他们植入后1年的视觉和功能结果。植入四年后,1例患者继续使用植入望远镜假体的眼睛进行所有视觉活动;另1例患者未从该装置中获得任何益处,主要继续使用未植入的对侧眼睛。伸缩式假体的益处很可能由植入后双眼的视力水平和眼优势决定。

结论

选择合适的眼睛植入望远镜假体似乎是决定患者视觉处理满意度和功能成功的一个重要因素,即便不是关键因素。根据作者使用IMT的经验,验光师可以通过术前确定如果植入哪只眼睛能为合适的候选人提供最佳潜在功能益处,来协助多学科团队。

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