da Cruz Natasha Ferreira Santos, Polizelli Murilo Ubukata, Muralha Felipe Picanço, de Morais Clarice Neuenschwander Lins, Junior Octaviano Magalhães Silva, Maia Mauricio, Melo Gustavo Barreto, Farah Michel Eid
Department of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.
Department of Virology, Foundation Oswaldo Cruz, Aggeu Magalhães Institute, Recife, PE, Brazil.
Int J Retina Vitreous. 2022 Jun 17;8(1):41. doi: 10.1186/s40942-022-00387-z.
Noninfectious endophthalmitis may be misdiagnosed, leading to serious clinical implications. So far, its causative factors remain unknown. Therefore, this study assessed the role of silicone oil and syringe agitation in the development of inflammation after intravitreal injection of aflibercept.
A randomized, double-blind, controlled clinical trial included subjects with an indication of intravitreal antiangiogenic therapy prior to vitrectomy for proliferative diabetic retinopathy. Aflibercept was injected 48 h before surgery. The control group received the injection without agitation, while the intervention group was injected with a previously agitated syringe by flicking with either a siliconized or silicone oil-free syringe. The primary endpoint was the presence of anterior chamber reaction (ACR) at 48 h. Aqueous samples were collected and underwent cytometric bead array analysis for quantification of interleukins and chemokines.
Forty-one individuals were included (21 in the agitation group and 20 in the no-agitation group). None of the included eyes showed baseline signs of AC cells, hyperemia or pain complaint, while 10% of control group and 80% of agitation group showed AC cells 48 h after injection of aflibercept with SR syringe. There were no differences in the mean variations of all cytokines and chemokines by agitation status. However, there was a marginally significant increase between the mean variations of IP-10 (p = 0.057) and IL-8 (p = 0.058) in the siliconized one.
This clinical trial discloses a potential role of agitation and siliconized syringes in the development of inflammation after an intravitreal injection of aflibercept. These findings have important clinical implications for all healthcare practitioners who perform intravitreal injections.
Brazilian Registry of Clinical Trials, RBR-95ddhp. Registered 12 May 2019, http://www.ensaiosclinicos.gov.br/rg/RBR-95ddhp/.
非感染性眼内炎可能被误诊，从而导致严重的临床后果。迄今为止，其致病因素尚不清楚。因此，本研究评估了硅油和注射器振荡在玻璃体内注射阿柏西普后炎症发生中的作用。
一项随机、双盲、对照临床试验纳入了在接受玻璃体切除术治疗增生性糖尿病视网膜病变之前有玻璃体内抗血管生成治疗指征的受试者。在手术前48小时注射阿柏西普。对照组注射时不振荡，而干预组使用硅化或无硅油注射器轻弹预先振荡过的注射器进行注射。主要终点是48小时时前房反应（ACR）的存在情况。收集房水样本并进行细胞计数珠阵列分析以定量白细胞介素和趋化因子。
纳入41例个体（振荡组21例，不振荡组20例）。所有纳入的眼睛在基线时均未显示前房细胞、充血或疼痛主诉的迹象，而在使用硅化注射器注射阿柏西普48小时后，对照组有10%的眼睛出现前房细胞，振荡组有80%的眼睛出现前房细胞。按振荡状态分组，所有细胞因子和趋化因子的平均变化无差异。然而，在硅化注射器组中，IP - 10（p = 0.057）和IL - 8（p = 0.058）的平均变化之间有略微显著的增加。
本临床试验揭示了振荡和硅化注射器在玻璃体内注射阿柏西普后炎症发生中的潜在作用。这些发现对所有进行玻璃体内注射的医护人员具有重要的临床意义。
巴西临床试验注册中心，RBR - 95ddhp。2019年5月12日注册，http://www.ensaiosclinicos.gov.br/rg/RBR - 95ddhp/ 。
