Lytvynchuk Lyubomyr M, Petrovski Goran, Dam Adien, Hiemstra Joep, Wimmer Tobias, Savytska Iryna, Binder Susanne, Stieger Knut
Department of Ophthalmology, Justus-Liebig-University Giessen, Eye Clinic, University Hospital Giessen and Marburg GmbH, Campus Giessen, Giessen, Germany.
Karl Landsteiner Institute for Retinal Research and Imaging, Vienna, Austria.
Clin Ophthalmol. 2021 Feb 19;15:723-734. doi: 10.2147/OPTH.S297139. eCollection 2021.
To study the efficacy of a novel needle for intravitreal injection (IVI) in comparison to the conventional needle under experimental conditions.
The newly designed 30-gauge (G) needle (NDN) (EP 18158 542.3, patent pending) with occluded outer orifice and a side port for drug delivery was compared to the conventional standard hypodermic 30 G needle for IVI (SHN). An animal study to obtain needle tip aspirates was performed on 10 albino rat eyes. During IVIs, cellular content, which was cut by the needle tip, was aspirated. Cellular material was studied in regard to cell types and their quantity. The injection stream was studied using trypan blue dye in vitro and pig cadaver eyes. The penetration force was tested on polyurethane Testing Foil Strips PU 04 (Melab, Leonberg, Germany) by applying a velocity of 100 mm/min. The results were analyzed using descriptive statistics, correlation matrices and -test methods with <0.05 as statistically significant.
Cytological analysis of the needle aspirates showed the presence of cellular content in each case. The amount of conjunctival, ciliary body epithelial cells and granulated basophilic protein sediments (sign of cellular damage) in the case of the NDN tips was significantly lower compared to the SHN. The average penetration force of the NDN was 0.791 N, and in the case of the SHN was 0.566 N. The injection stream study revealed a difference in the initial injection phase between the two needle types, although the diffuse filling of the vitreous area which surrounded the needle tip appeared to be similar.
The NDN demonstrated superior performance with regard to a significantly reduced number of cells being captured by the needle tip. Delivery of the injected fluid into the vitreous cavity was comparable. In order to investigate superior properties of the NDN needle design, further studies with improved prototypes would be necessary.
在实验条件下，研究一种新型玻璃体内注射（IVI）针相较于传统针的疗效。
将新设计的30号（G）针（NDN）（欧洲专利号EP 18158 542.3，正在申请专利）与用于IVI的传统标准皮下30G针（SHN）进行比较。对10只白化大鼠眼进行动物研究以获取针尖吸出物。在IVI过程中，吸出被针尖切断的细胞内容物。对细胞材料进行细胞类型及其数量的研究。在体外和猪尸体眼上使用台盼蓝染料研究注射流。通过以100毫米/分钟的速度施加在聚氨酯测试箔条PU 04（德国莱昂贝格的Melab公司）上测试穿透力。使用描述性统计、相关矩阵和t检验方法分析结果，以P<0.05为具有统计学意义。
对针吸出物的细胞学分析显示每种情况下均存在细胞内容物。与SHN相比，NDN针尖处的结膜、睫状体上皮细胞和嗜碱性颗粒状蛋白质沉积物（细胞损伤迹象）的数量明显更低。NDN的平均穿透力为0.791牛，而SHN的平均穿透力为0.566牛。注射流研究显示两种针类型在初始注射阶段存在差异，尽管围绕针尖的玻璃体区域的弥漫性填充似乎相似。
NDN在针尖捕获的细胞数量显著减少方面表现出卓越性能。注入玻璃体腔的液体输送情况相当。为了研究NDN针设计的卓越特性，有必要对改进的原型进行进一步研究。
