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Implantable miniature telescope: Lessons learned

机译:植入式微型望远镜:经验教训

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BACKGROUND: The Implantable Miniature Telescope (IMT~(TM)) 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 (90percent), 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.
机译:背景技术:植入式微型望远镜(IMT_TM)是一种可伸缩的假体,与角膜的光学元件相结合,构成了眼内放大系统。它适用于患有稳定,无凹痕保留,双侧,稳定,与年龄相关的黄斑变性(末期)并伴有子宫肌瘤的患者。望远镜假体仅植入患者的一只眼睛中。以这种方式,植入的眼睛提供了改善的视敏度,而未植入的眼睛继续为移动提供周围的视觉。 2003年开始对217例晚期AMD患者进行了一项前瞻性,多中心,开放标签试验(IMT-002)。根据美国食品与药物管理局制定的选择规则,对于大多数患者而言,植入的眼是最差的和药物管理局(FDA)协议;但是,在大多数情况下(90%),该设备可以达到提高视力的目标。该报告将回顾性研究在亚特兰大的埃默里眼科中心植入的2名选定患者,作为该试验的一部分,以得出有关受试者和眼睛选择标准的课程。病例报告:选择两个病例代表患者的功能成功和满意程度。根据最佳矫正视力和美国国家眼科研究所视觉功能问卷25项生活质量调查确定植入后1年的视力和功能结局。植入后四年,有1名患者继续使用望远镜的假体进行所有视觉活动;另一位患者没有从该装置中受益,因此继续主要使用另一只非植入眼。伸缩式假体的好处最有可能是由于植入后眼睛的视敏度水平和眼睛优势度所致。结论:选择合适的眼球植入物植入望远镜假体似乎是决定患者对视觉处理和功能成功的满意度的重要因素。根据作者在IMT方面的经验,验光师可以通过术前确定哪只眼睛(如果植入)为适当的候选人提供最佳的潜在功能益处,来帮助多学科团队。

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