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常用玻璃体腔内注射注射器的准确性、精度和残余容积及其对眼内压的影响。

Accuracy, Precision, and Residual Volume of Commonly Used Syringes for Intravitreal Injections and the Impact on Intraocular Pressure.

机构信息

Hospital de Olhos de Sergipe, Aracaju, Brazil; Department of Ophthalmology, Federal University of São Paulo, São Paulo, Brazil.

Department of Ophthalmology, Oslo University Hospital and Institute for Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.

出版信息

Ophthalmol Retina. 2023 Oct;7(10):892-900. doi: 10.1016/j.oret.2023.06.003. Epub 2023 Jun 9.

Abstract

PURPOSE

To compare accuracy, precision, and residual volume of commonly used syringes for intravitreal injections (IVIs) and to assess the intraocular pressure (IOP) rise by variations in volumes delivered.

DESIGN

Experimental laboratory study.

SUBJECTS

No subjects were involved in this study.

METHODS

We tested 8 syringe models with 2 different needle setups, with 2 different solutions (distilled water or glycerin) and target volumes (50 and 70 μL). To obtain the delivered and residual volumes, we weighed the syringe-needle setups with scale before liquid withdrawal, with liquid, and after liquid release. We also created an experimental eye model to determine the transient rise in IOP following stepwise 10-μL increases in injection volumes.

MAIN OUTCOME MEASURES

Delivered and residual volumes, IOP rise.

RESULTS

We tested a total of 600 syringe-needle setups. Becton Dickinson (BD) Ultra-Fine (0.34 ± 0.28 μL), Zero Residual (1.53 ± 1.15 μL), and Zero Residual Silicone Oil-free (1.40 ± 1.16 μL) syringes showed the lowest residual volume (P < 0.001) in comparison with the others (range: 24.86 ± 1.78 μL for Injekt-F to 51.97 ± 3.37 μL for Omnifix-F). The most accurate setups were (percentage deviation from target volume): Zero Residual Silicone Oil-free (+ 0.70%), Zero Residual 0.3 ml (+ 4.49%), BD Ultra-Fine (+ 7.83%), Injekt-F (9.42%), Norm-Ject (+ 15.88%), Omnifix-F (+ 16.96%), BD Plastipak Brazil (+17.96%), and BD Plastipak Spain syringes (+ 19.41%). There was a statistically significant difference between the Zero Residual Silicone Oil-free syringe and all other syringes (P < 0.0001), except for the Zero Residual 0.3-ml syringe (P = 0.029). The coefficient of variation was low for all syringes. The modeled IOP rise ranged from 32.3 (standard deviation [SD], 1.4) mmHg for 20-μL injection volume to 76.5 (SD, 1.0) mmHg for 80-μL injection volume. For the standard 50-μL injection volume, the peak pressure was 50.7 (SD, 0.1) mmHg, and the pressure rise duration was 28 (SD, 2) minutes.

CONCLUSIONS

There were significant differences in accuracy and residual volume between syringes, whereas they showed a high precision. Volume excess results in a considerable increase in IOP rise after injection. These findings may provide a relevant overview to clinicians and to both device and drug manufacturers regarding pharmacoeconomic, safety, and efficacy issues.

FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

摘要

目的

比较常用于玻璃体腔内注射(IVI)的几种注射器的准确性、精密度和残留量,并评估因注射量变化引起的眼内压(IOP)升高。

设计

实验性实验室研究。

受试者

本研究未涉及受试者。

方法

我们测试了 8 种注射器模型,有 2 种不同的针头设置,使用 2 种不同的溶液(蒸馏水或甘油)和目标体积(50 和 70 μL)。为了获得注射的和残留的体积,我们在液体提取前、液体中和液体释放后用天平称重注射器-针头组件。我们还创建了一个实验性眼模型,以确定随着注射体积每次增加 10 μL,IOP 会发生短暂上升。

主要观察指标

注射的和残留的体积,IOP 升高。

结果

我们总共测试了 600 个注射器-针头组件。BD Ultra-Fine(0.34±0.28 μL)、Zero Residual(1.53±1.15 μL)和 Zero Residual Silicone Oil-free(1.40±1.16 μL)注射器的残留量最低(P<0.001),与其他注射器(Injekt-F 的 24.86±1.78 μL 至 Omnifix-F 的 51.97±3.37 μL)相比。最准确的设置是(与目标体积的百分比偏差):Zero Residual Silicone Oil-free(+0.70%)、Zero Residual 0.3 ml(+4.49%)、BD Ultra-Fine(+7.83%)、Injekt-F(9.42%)、Norm-Ject(+15.88%)、Omnifix-F(+16.96%)、BD Plastipak Brazil(+17.96%)和 BD Plastipak Spain 注射器(+19.41%)。Zero Residual Silicone Oil-free 注射器与所有其他注射器之间存在统计学显著差异(P<0.0001),但与 Zero Residual 0.3-ml 注射器除外(P=0.029)。所有注射器的变异系数均较低。模拟的 IOP 升高范围从 20 μL 注射体积的 32.3(标准差[SD],1.4)mmHg 到 80 μL 注射体积的 76.5(SD,1.0)mmHg。对于标准的 50 μL 注射体积,峰值压力为 50.7(SD,0.1)mmHg,压力升高持续时间为 28(SD,2)分钟。

结论

注射器之间的准确性和残留量存在显著差异,而它们的精密度很高。容量过多会导致注射后 IOP 升高明显。这些发现可能为临床医生以及设备和药物制造商提供有关药代经济学、安全性和疗效问题的相关概述。

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