RESUMO
PURPOSE: This study aimed to quantify the amount of silicone oil (SO) released across a variety of syringe and needle models routinely used for intravitreal injection. METHODS: The release of SO was assessed in eight models of syringes, two of which were reported to be 'SO-free', and eleven models of needles with unknown SO content. To evaluate SO release within the context of anti-VEGF therapeutics, syringes were evaluated using aflibercept, bevacizumab, buffer, ziv-aflibercept and formulation buffer. All syringe tests were performed with or without agitation by flicking for syringes. Needles were evaluated without agitation only. Samples were fluorescently labelled to identify SO, and triplicate measurements were collected using imaging flow cytometry. RESULTS: Seven out of 8 syringe models showed a statistically significant increase in the SO particle count after agitation. The two SO-free syringe models (HSW Norm-Ject, Daikyo Crystal Zenith) released the least SO particles, with or without agitation, whereas the BD Ultra-Fine and Saldanha-Rodrigues syringes released the most. More SO was released when the syringes were prefilled with formulation buffer than with ziv-aflibercept. Syringes filled with aflibercept and bevacizumab had intermediate levels. Agitation increased the release of SO into each of the drug solutions. Silicone oil (SO) was detected in all needles. CONCLUSIONS: Agitation of the syringe by flicking leads to a substantial increase in the number of SO particles. Silicone oil (SO)-free syringes had the best performance, but physicians must also be aware that needles are siliconized and also contribute to the injection of SO into the vitreous.
Assuntos
Inibidores da Angiogênese/química , Injeções Intravítreas/instrumentação , Agulhas , Silício/análise , Óleos de Silicone/análise , Seringas , Inibidores da Angiogênese/administração & dosagem , Desenho de Equipamento , Humanos , Doenças Retinianas/tratamento farmacológicoRESUMO
BACKGROUND/AIMS: To assess silicone oil (SO) release by different brands of syringes used for intravitreal injection under different handling conditions. METHODS: Eight syringes were analysed: from the USA, Terumo 0.5 mL, Becton-Dickinson (BD) Tuberculin 1 mL, BD Luer-lok 1 mL, BD Ultra-Fine 0.3 mL and Exel Insulin 0.3 mL; from Germany, Braun Omnifix-F 1 mL and Braun Injekt-F 1 mL and from Spain, BD Plastipak 1 mL. The impact of air, priming the plunger, agitation by flicking and fluid temperature on SO release were assessed by light microscopy. Fourier transform infrared spectroscopy (FTIR) was performed to identify the molecular compound in each syringe. RESULTS: Five hundred and sixty syringes were analysed. Terumo 0.5 mL and BD Ultra-Fine 0.3 mL released more SO than all others. BD Luer-lok 1 mL, BD Plastipak and Braun Omnifix-F 1 mL released little SO; BD Tuberculin 1 mL, Exel 0.3 mL and Braun Injekt-F 1 mL released the least SO. Priming the syringe and different temperatures did not significantly affect SO release. Agitation by flicking caused a significantly higher proportion of samples to have SO droplets and an increased number of oil droplets. Air had an additive effect on the release of oil in the agitation groups. FTIR identified polysiloxane in all syringes but Injekt-F. CONCLUSION: Syringes commonly used for intravitreal injections frequently release SO droplets, especially when agitated by flicking. To avoid unnecessary ocular risks, syringes should not be agitated before intravitreal injection. It is desirable that syringes be manufactured specifically for ophthalmic use.
Assuntos
Injeções Intravítreas/métodos , Óleos de Silicone/análise , Seringas/normas , Humanos , Modelos Logísticos , Uso Off-LabelRESUMO
PURPOSE: To assess the histopathological findings of conjunctival specimens from patients submitted to vitreoretinal surgery with intraocular silicone oil injection. METHODS: Prospective analyses of 30 eyes of 30 patients were evaluated. Before the patients underwent removal of the intraocular silicone oil, conjunctival excision was performed and submitted to histopathologic examination. RESULTS: The presence of empty spaces corresponding to silicone oil location was positive in 10 (33%) specimens. The presence of inflammatory cells, vascular congestion, leukostasis, lymphocyte and monocyte infiltrates were positive in 27 (90%) specimens. The presence of silicone oil was positive in 10 (33%) specimens. Therefore, in those patients who undergo vitreoretinal surgery, silicone oil may be present in the conjunctiva or subconjunctival space, even if biomicroscopic examination seems to be normal. According to our knowledge, this is the first study with the purpose to assess the histopathological findings of conjunctival specimens from patients submitted to vitreoretinal surgery with intraocular silicone oil injection. CONCLUSION: Ophthalmologists should be aware of this possible complication after intraocular use of silicone oil after vitreoretinal surgery.
Assuntos
Túnica Conjuntiva/química , Retina/cirurgia , Óleos de Silicone/análise , Corpo Vítreo/cirurgia , Biópsia , Túnica Conjuntiva/patologia , Hematoxilina , Humanos , Período Pós-Operatório , Estudos ProspectivosRESUMO
OBJETIVO: Comprovar a presença do óleo de silicone no espaço subconjuntival de pacientes submetidos previamente à cirurgia vitreorretiniana por meio de estudo histopatológico das amostras conjuntivais obtidas, nos quais o exame biomicroscópico não foi capaz de comprovar sua presença. Determinar qual a incidência da presença do óleo de silicone no espaço subconjuntival em uma série de casos e quais implicações clínico-patológicas. MÉTODOS: Estudo prospectivo em 30 olhos de 30 pacientes. Foram incluídos no estudo os pacientes que haviam sido submetidos previamente à cirurgia vitreorretiniana com implante intra-ocular de óleo de silicone e que possuíssem indicação para retirada do óleo de silicone e que não apresentassem ao exame biomicroscópico sinais da presença do óleo de silicone no espaço subconjuntival. Após sua retirada, a amostra era encaminhada para análise histopatológica pelo método de hematoxilina-eosina. RESULTADOS: Foi observada a presença de espaços vazios correspondentes às áreas de localização do óleo de silicone, removido durante processamento histológico, em 10 (33 por cento) amostras. Observou-se também a presença de sinais inflamatórios na substância própria caracterizada por congestão vascular, leucostase e infiltrado linfomononuclear em 27 (90 por cento) amostras. CONCLUSÃO: Portanto, em pacientes submetidos ao implante intra-ocular do óleo de silicone, devemos suspeitar que o óleo esteja presente no espaço subconjuntival, mesmo que o exame biomicroscópico pareça normal.
PURPOSE: To assess the histopathological findings of conjunctival specimens from patients submitted to vitreoretinal surgery with intraocular silicone oil injection. METHODOS: Prospective analyses of 30 eyes of 30 patients were evaluated. Before the patients underwent removal of the intraocular silicone oil, conjunctival excision was performed and submitted to histopathologic examination. RESULTS: The presence of empty spaces corresponding to silicone oil location was positive in 10 (33 percent) specimens. The presence of inflammatory cells, vascular congestion, leukostases, lymphocyte and monocyte infiltrates were positive in 27 (90 percent) specimens. The presence of silicone oil was positive in 10 (33 percent) specimens. Therefore, in those patients who undergo vitreoretinal surgery, silicone oil may be present in the conjunctiva or subconjunctival space, even if biomicroscopic examination seems to be normal. According to our knowledge, this is the first study with the purpose to assess the histopathological findings of conjunctival specimens from patients submitted to vitreoretinal surgery with intraocular silicone oil injection. CONCLUSION: Ophthalmologists should be aware of this possible complication after intraocular use of silicone oil after vitreoretinal surgery.