Risk of transient vision loss after intravitreal aflibercept using vial-prepared vs. the novel prefilled syringe formulation

PurposeTo compare the risk of transient vision loss (TVL) probably attributable to a severe intraocular pressure spike after intravitreal aflibercept application using the novel prefilled syringe (PFS) vs. the established vial system (VS).MethodsDatasets of the intravitreal injection service of the...

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Main Authors: Julian E. Klaas, Vinh Bui, Niklas Maierhofer, Benedikt Schworm, Mathias Maier, Siegfried G. Priglinger, Jakob Siedlecki
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-10-01
Series:Frontiers in Medicine
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2023.1295633/full
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author Julian E. Klaas
Vinh Bui
Niklas Maierhofer
Benedikt Schworm
Mathias Maier
Siegfried G. Priglinger
Jakob Siedlecki
author_facet Julian E. Klaas
Vinh Bui
Niklas Maierhofer
Benedikt Schworm
Mathias Maier
Siegfried G. Priglinger
Jakob Siedlecki
author_sort Julian E. Klaas
collection DOAJ
description PurposeTo compare the risk of transient vision loss (TVL) probably attributable to a severe intraocular pressure spike after intravitreal aflibercept application using the novel prefilled syringe (PFS) vs. the established vial system (VS).MethodsDatasets of the intravitreal injection service of the Ludwig Maximilians-University Munich and the Technical University Munich, Germany, were screened for documentation of TVL after intravitreal injection of aflibercept. The observation period included two full months prior to the introduction of the novel PFS and two months afterwards. TVL was defined as loss of perception of hand motion for a duration of >30 s.ResultsOver a period of four months, 1720 intravitreal injections of aflibercept were administered in 672 patients. There were 842 injections with the old VS, and 878 injections using the novel PFS. Using the VS, TVL was noted during two injections (0.24%) in two patients, as compared to 11 cases of TVL (1.25%) in 10 patients with the PFS (p = 0.015). Using the PFS, patients had a 5.3-fold risk of TVL as compared to the VS (OR: 5.33; 95% CI: 1.2–24.1; p = 0.0298).ConclusionThere was a more than five-fold risk of TVL using the novel pre-filled aflibercept syringe as compared to the established vial system. During informed consent, this risk should be discussed.
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spelling doaj.art-396b10aa67e845a598a8ed622bbe90372023-10-26T05:11:18ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-10-011010.3389/fmed.2023.12956331295633Risk of transient vision loss after intravitreal aflibercept using vial-prepared vs. the novel prefilled syringe formulationJulian E. Klaas0Vinh Bui1Niklas Maierhofer2Benedikt Schworm3Mathias Maier4Siegfried G. Priglinger5Jakob Siedlecki6Department of Ophthalmology, Ludwig-Maximilians-University, Munich, GermanyDepartment of Ophthalmology, Ludwig-Maximilians-University, Munich, GermanyDepartment of Ophthalmology, Technical University, Munich, GermanyDepartment of Ophthalmology, Ludwig-Maximilians-University, Munich, GermanyDepartment of Ophthalmology, Technical University, Munich, GermanyDepartment of Ophthalmology, Ludwig-Maximilians-University, Munich, GermanyDepartment of Ophthalmology, Ludwig-Maximilians-University, Munich, GermanyPurposeTo compare the risk of transient vision loss (TVL) probably attributable to a severe intraocular pressure spike after intravitreal aflibercept application using the novel prefilled syringe (PFS) vs. the established vial system (VS).MethodsDatasets of the intravitreal injection service of the Ludwig Maximilians-University Munich and the Technical University Munich, Germany, were screened for documentation of TVL after intravitreal injection of aflibercept. The observation period included two full months prior to the introduction of the novel PFS and two months afterwards. TVL was defined as loss of perception of hand motion for a duration of >30 s.ResultsOver a period of four months, 1720 intravitreal injections of aflibercept were administered in 672 patients. There were 842 injections with the old VS, and 878 injections using the novel PFS. Using the VS, TVL was noted during two injections (0.24%) in two patients, as compared to 11 cases of TVL (1.25%) in 10 patients with the PFS (p = 0.015). Using the PFS, patients had a 5.3-fold risk of TVL as compared to the VS (OR: 5.33; 95% CI: 1.2–24.1; p = 0.0298).ConclusionThere was a more than five-fold risk of TVL using the novel pre-filled aflibercept syringe as compared to the established vial system. During informed consent, this risk should be discussed.https://www.frontiersin.org/articles/10.3389/fmed.2023.1295633/fullEyleaafliberceptprefilled syringechoroidal neovascularizationage related macular degenerationdiabetic macular edema
spellingShingle Julian E. Klaas
Vinh Bui
Niklas Maierhofer
Benedikt Schworm
Mathias Maier
Siegfried G. Priglinger
Jakob Siedlecki
Risk of transient vision loss after intravitreal aflibercept using vial-prepared vs. the novel prefilled syringe formulation
Frontiers in Medicine
Eylea
aflibercept
prefilled syringe
choroidal neovascularization
age related macular degeneration
diabetic macular edema
title Risk of transient vision loss after intravitreal aflibercept using vial-prepared vs. the novel prefilled syringe formulation
title_full Risk of transient vision loss after intravitreal aflibercept using vial-prepared vs. the novel prefilled syringe formulation
title_fullStr Risk of transient vision loss after intravitreal aflibercept using vial-prepared vs. the novel prefilled syringe formulation
title_full_unstemmed Risk of transient vision loss after intravitreal aflibercept using vial-prepared vs. the novel prefilled syringe formulation
title_short Risk of transient vision loss after intravitreal aflibercept using vial-prepared vs. the novel prefilled syringe formulation
title_sort risk of transient vision loss after intravitreal aflibercept using vial prepared vs the novel prefilled syringe formulation
topic Eylea
aflibercept
prefilled syringe
choroidal neovascularization
age related macular degeneration
diabetic macular edema
url https://www.frontiersin.org/articles/10.3389/fmed.2023.1295633/full
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