Ocular inflammation after agitation of siliconized and silicone oil-free syringes: a randomized, double-blind, controlled clinical trial

Natasha Ferreira Santos da Cruz; Murilo Ubukata Polizelli; Felipe Picanço Muralha; Clarice Neuenschwander Lins de Morais; Octaviano Magalhães Silva Junior; Mauricio Maia; Gustavo Barreto Melo; Michel Eid Farah

doi:10.1186/s40942-022-00387-z

Ocular inflammation after agitation of siliconized and silicone oil-free syringes: a randomized, double-blind, controlled clinical trial

Int J Retina Vitreous. 2022 Jun 17;8(1):41. doi: 10.1186/s40942-022-00387-z.

Authors

Natasha Ferreira Santos da Cruz¹, Murilo Ubukata Polizelli¹, Felipe Picanço Muralha¹, Clarice Neuenschwander Lins de Morais², Octaviano Magalhães Silva Junior¹, Mauricio Maia¹, Gustavo Barreto Melo^{3

4}, Michel Eid Farah¹

Affiliations

¹ Department of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.
² Department of Virology, Foundation Oswaldo Cruz, Aggeu Magalhães Institute, Recife, PE, Brazil.
³ Department of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil. gustavobmelo@yahoo.com.br.
⁴ Hospital de Olhos de Sergipe, Rua Campo do Brito, 995, São José, Aracaju, SE, 49020-380, Brazil. gustavobmelo@yahoo.com.br.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Trial registration: Brazilian Registry of Clinical Trials, RBR-95ddhp. Registered 12 May 2019, http://www.ensaiosclinicos.gov.br/rg/RBR-95ddhp/.

Keywords: Intravitreal injection; Silicone Oil; Syringe.