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晚期年龄相关性黄斑变性患者在接受小切口新一代可植入式微型望远镜(SING IMT™)植入6个月后的解剖学和功能结果。

Anatomical and functional results of patients with late-stage age-related macular degeneration 6 months after smaller-incision new-generation implantable miniature telescope (SING IMT™) implantation.

作者信息

Adamo Ginevra Giovanna, Pellegrini Marco, Nasini Francesco, Talli Pietro Maria, Sarti Laura, Perri Piera, Parmeggiani Francesco, Mura Marco

机构信息

Department of Translational Medicine, University of Ferrara, Ferrara, Italy.

Sant'Anna University Hospital, Ferrara, Italy.

出版信息

Eye (Lond). 2025 Feb;39(3):544-547. doi: 10.1038/s41433-025-03598-4. Epub 2025 Jan 13.

Abstract

OBJECTIVES

The aim of the study was to evaluate anatomical and functional outcomes of the Smaller-Incision New Generation Implantable Miniature Telescope (SING IMT™) in patients with bilateral advanced age-related macular degeneration (AMD).

METHODS

This non-comparative retrospective single-surgeon interventional case series included patients with bilateral late-stage AMD who underwent cataract surgery and SING IMT™ implantation at the Sant'Anna University Hospital, University of Ferrara, Italy. The main outcome measures included corrected distance (CDVA) and near visual acuity (CNVA), endothelial cell loss (ECL), and incidence of complications.

RESULTS

11 eyes of 11 patients were included. The mean follow-up duration was 6.5 ± 2.4 months. After surgery, CDVA significantly improved (from 17.00 ± 9.74 to 26.00 ± 8.53) letters (P = 0.008). Significant improvement of CNVA was also observed (from 12.27 ± 4.36 to 8 ± 2.61 Jaeger levels; P = 0.004). Mean ECL was 4.8 ± 5.5% at 3 months. No intraoperative complications were observed, while postoperative complications included iris incarceration (9.1%), pigment deposition on the device (9.1%), and transient corneal oedema (27.3%). Nevertheless, 10 of 11 patients (90.9%) began to complain of blurred or hazy vision within 3 months of surgery. The device was ultimately explanted in 3 patients (27.3%) because of this symptom.

CONCLUSIONS

Although SING IMT™ implantation is associated with promising objective results, unexplained blurred or hazy vision represents common postoperative complaints which may lead to patient dissatisfaction. Further studies including patient-reported outcomes are warranted to evaluate the effect of the intervention on patients' visual function and quality of life.

摘要

目的

本研究旨在评估新一代小切口可植入微型望远镜(SING IMT™)在双侧晚期年龄相关性黄斑变性(AMD)患者中的解剖学和功能结局。

方法

本非对照回顾性单术者介入病例系列纳入了在意大利费拉拉大学圣安娜大学医院接受白内障手术并植入SING IMT™的双侧晚期AMD患者。主要结局指标包括矫正远视力(CDVA)和近视力(CNVA)、内皮细胞丢失(ECL)以及并发症发生率。

结果

纳入11例患者的11只眼。平均随访时间为6.5±2.4个月。术后,CDVA显著改善(从17.00±9.74提高到26.00±8.53)个字母(P = 0.008)。CNVA也有显著改善(从12.27±4.36提高到8±2.61 Jaeger等级;P = 0.004)。3个月时平均ECL为4.8±5.5%。未观察到术中并发症,而术后并发症包括虹膜嵌顿(9.1%)、装置上的色素沉着(9.1%)和短暂性角膜水肿(27.3%)。然而,11例患者中有10例(90.9%)在术后3个月内开始抱怨视力模糊或朦胧。由于该症状,最终有3例患者(27.3%)取出了该装置。

结论

尽管植入SING IMT™可带来有前景的客观结果,但无法解释的视力模糊或朦胧是常见的术后主诉,这可能导致患者不满。有必要开展包括患者报告结局的进一步研究,以评估该干预措施对患者视觉功能和生活质量的影响。

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