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Nd:YAG 激光玻璃体液化术治疗症状性玻璃体混浊的疗效和安全性:一项随机对照试验。

Efficacy and safety of Nd:YAG laser vitreolysis for symptomatic vitreous floaters: A randomized controlled trial.

机构信息

Ophthalmology Department, Instituto de Assistência Médica ao Servidor Publico Estadual de São Paulo (IAMSPE), São Paulo, SP, Brazil.

出版信息

Eur J Ophthalmol. 2021 May;31(3):909-914. doi: 10.1177/1120672120968762. Epub 2020 Nov 4.

Abstract

BACKGROUND

Vitreous floaters are a common and inconvenient phenomena. This study aims to examine the efficacy and safety in treating vitreous floaters using Nd:YAG laser vitreolysis.

METHODS

In this prospective double-blinded randomized clinical trial 24 eyes of twenty-four patients were randomized into intervention with YAG laser vitreolysis and control groups. Primary outcomes were visual disturbance on a 10-point scale, qualitative changes in a 4-level scale, contrast sensitivity measured with the Pelli-Robson table and the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25). Secondary results included objective change in vitreous opacities, best-corrected visual acuity (BCVA), variation in intraocular pressure (IOP) and other adverse events.

RESULTS

Twenty-one patients (21 eyes; 5 male, 16 female) were enrolled in this study (mean age 62 ± 7.9 years), three were lost during follow-up. In the YAG laser group, the 10-point visual disturbance score improved a mean of 4.7 points ( < 0.001) compared to the control group that improved 2.1 ( = 0.09). The YAG laser group reported greater subjectively symptomatic improvement (77%) than controls (25%). NEI VFQ-25 revealed improved general vision (75.8 versus 59.2;  = 0.037) and in mental health at 6 months (84.3 versus 70.3;  = 0.048). There was no significant difference in contrast sensitivity ( = 0.848) and in IOP ( = 0.505). No differences in adverse events between groups were identified.

CONCLUSION

Vitreolysis with Nd:YAG laser improves visual results in patients with symptomatic vitreous floaters, without adverse events considered clinically relevant. Other trials with a larger number of participants are required to corroborate these results.

摘要

背景

玻璃体混浊是一种常见且令人不适的现象。本研究旨在探讨采用 Nd:YAG 激光玻璃体溶解术治疗玻璃体混浊的疗效和安全性。

方法

在这项前瞻性双盲随机临床试验中,将 24 例患者的 24 只眼随机分为 YAG 激光玻璃体溶解术组和对照组。主要结局指标为 10 分制视觉障碍评分、4 级定性变化、用 Pelli-Robson 表和国家眼科研究所视觉功能问卷 25(NEI VFQ-25)测量的对比敏感度。次要结果包括玻璃体混浊的客观变化、最佳矫正视力(BCVA)、眼内压(IOP)变化和其他不良事件。

结果

本研究纳入了 21 例患者(21 只眼;5 名男性,16 名女性)(平均年龄 62±7.9 岁),3 例在随访过程中失访。YAG 激光组的 10 分视觉障碍评分平均改善 4.7 分( < 0.001),而对照组改善 2.1 分( = 0.09)。YAG 激光组报告的主观症状改善更大(77%比对照组的 25%)。NEI VFQ-25 显示,6 个月时一般视力改善(75.8 比 59.2; = 0.037)和心理健康改善(84.3 比 70.3; = 0.048)。两组之间的对比敏感度差异无统计学意义( = 0.848),IOP 差异也无统计学意义( = 0.505)。两组之间未发现不良反应的差异。

结论

Nd:YAG 激光玻璃体溶解术可改善有症状的玻璃体混浊患者的视力结果,且无临床相关的不良反应。需要更多参与者的其他试验来证实这些结果。

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