Silicone oil droplets after intravitreal injections: An uncomfortable adverse effect in our consultations

Gómez-Mariscal, M.; Díez-Álvarez, L.

doi:10.1016/j.oftale.2020.01.004

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Gómez-Mariscal, L. Díez-Álvarez" "autores" => array:2 [ 0 => array:4 [ "nombre" => "M." "apellidos" => "Gómez-Mariscal" "email" => array:1 [ 0 => "mgomariscal@gmail.com" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "L." "apellidos" => "Díez-Álvarez" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Oftalmología, Hospital Universitario Ramón y Cajal (Irycis), Madrid, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Las gotas de silicona tras inyecciones intravítreas: un efecto adverso incómodo en nuestras consultas" ] ] "textoCompleto" => "In August 2016 the FDA (Food and Drug Administration) published the first alert about the distribution of silicone oil drops for application on eyes of patients treated with intravitreal injections. The first cases began to be reported 10 years back with a 3-case series by Freund<a class="elsevierStyleCrossRef" href="#bib0005">1</a> who attributed the origin of said drops to the silicone covering the syringe and plunger used for injecting the drug. Since then, reports have been published in relation to various types of intravitreal injections, i.e. triamcinolone acetonide, pegaptanib, bevacizumab, ranibizumab and more recently aflibercept.<a class="elsevierStyleCrossRefs" href="#bib0010">2,3</a>The SCORE study (Standard care versus corticosteroid in retinal vein occlusion) had to modify the study protocol afer finding that silicone drops was an adverse effect to include an active search for these drops as part of the post-injection examination. Halfway into the study, when it became known that 57% of patients exhibited said adverse event, it was decided to replace the standard syringe for glass syringes without silicone coating. This change diminished the number of new cases to zero.<a class="elsevierStyleCrossRef" href="#bib0020">4</a>Polydimethylsiloxane is the most widely used silicone for coating the inner surface of syringes, plungers and needles. It is a transparent, innocuous and nonflammable material that is utilized to facilitate the control movement of the plunger and minimize the absorption of proteins, thus extending the stability of the drug.Said silicone drops entering the vitreous can be observed in funduscopy as small rounded and translucent bubbles that generally float in the intermediate area of the vitreous or migrate towards the upper area due to their lower density than water. In echography, silicone drops can be seen as a hyperechogenic signal and minimum posterior reverberation.<a class="elsevierStyleCrossRef" href="#bib0005">1</a>Silicone drops are generally well tolerated. The only adverse effects associated to date are permanent or temporary myodesopsia, although this effect should not be taken lightly because frequently patients refer visual loss impairment for this reason. Additional potential adverse effects are those associated to the emulsification of the silicone oil used in the vitreoretinal surgery, involving posterior segment inflammation, interaction with intraocular silicone lenses and the passage of said drops to the anterior chamber which could give rise to corneal decompensation or causing glaucoma surgery failure.<a class="elsevierStyleCrossRef" href="#bib0025">5</a> To this date, the latter adverse effects are only potential as the literature does not include reports on cases clearly secondary to syringe silicone drops.Since 2010, 7 years elapsed before the publication of new case series reports related to intravitreal silicone oil drops after injecting antiangiogenic drugs. On this occasion, several authors described largest silicone drops which in mode A echography reached a size of up to 1.300 µm and projected marked reverberation.<a class="elsevierStyleCrossRefs" href="#bib0030">6,7</a> The affected patients referred myodesopsia with bright light in the center. Both authors registered an increase in cases in a short period of time of about 4 months between May and October 2016 and attributed said increase to a possible problem in the production of syringes utilized for injecting bevacizumab, either due to a larger amount of silicone or diminished adherence thereof to the syringe walls. A company that packaged said drug did not comment on this problem. Said increased incidence of silicone drops prompted the FDA to publish the alert described above.In autumn 2018, a new alert was distributed in relation to the dexamethasone Ozurdex implant (Allergan Inc., Irvine, CA, USA).<a class="elsevierStyleCrossRef" href="#bib0040">8</a> A routine inspection identified silicone drops released from the stem of the needle of some product batches attributable to a quality defect.It is necessary to take measures to diminish the incidence of said adverse effect. In the course of the procedure it is advisable to avoid certain maneuvers such as tapping the syringe with a finger to expel air, brusquely pushing the plunger or carrying out multiple forward and backward movements thereof because these contribute to detach the silicone from the syringe wall. These are the most basic measures to reduce the incidence of said problem but are not sufficient to eradicate it. A syringe with an empty space after completing the stroke of the plunger retains the detached silicone instead of injecting it into the eye. However, the most efficient solution is to substitute standard syringes by others manufactured with fluoropolymers instead of silicone.<a class="elsevierStyleCrossRef" href="#bib0045">9</a>Due to the large and increasing number of patients that repeatedly receive intravitreal injections, retina departments have seen the necessity of bringing out the issue. Informed consents must be modified to include the appearance of permanent myodesopsia as an undesired effect. Each department should reconsider the protocols for said procedures and the supply of syringes and needles to halt the appearance of the undesirable silicone drops." "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Gómez-Mariscal M, Díez-Álvarez L. Las gotas de silicona tras inyecciones intravítreas: un efecto adverso incómodo en nuestras consultas. Arch Soc Esp Oftalmol. 2020;95:261–262." ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:9 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Silicone oil droplets following intravitreal injection" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "K.B. Freund" 1 => "K. Laud" 2 => "C.M. Eandi" 3 => "R.F. 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Vol. 95. Issue 6.

Pages 261-262 (June 2020)

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