Objective: The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs.
Method: A systematic review was performed following the PRISMA 2020 guidelines by searching PubMed with the descriptors: (silicone) AND (syringes) AND ((intraocular) OR (intravitreal)) and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences.
Results: Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone; the administration technique; the physicochemical aspects of silicone release; and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialised syringes, the existing syringes for this use have been collected, finding 2 that will probably be commercialised in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic.
Conclusions: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.
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http://dx.doi.org/10.1016/j.farma.2024.04.011 | DOI Listing |
Introduction: The present study aimed to evaluate the effect of estimated individual vitreous volume on intraocular pressure (IOP) spikes after intravitreal anti-vascular endothelial growth factor (VEGF) injections (IVI).
Methods: Vitreous volumes (VV) of eyes were calculated using an axial length (AL) based formula AL3 x (π/6) x 0.76+0.
Am J Ophthalmol Case Rep
December 2024
Department of Ophthalmology, Saitama Medical University, 38 Morohongo, Moroyama, Saitama, 350-0495, Japan.
Purpose: To report a case of lacrimal drainage pathway disease-associated keratopathy (LDAK) with endophthalmitis.
Observations: An 80-year-old man with diabetic retinopathy and nephropathy was referred to our hospital with endophthalmitis of the left eye. Slit-lamp examination revealed slight eye discharge, peripheral corneal ulcers, diffuse hyperemia of the conjunctiva, iris synechia, and a large amount of fibrin in the anterior chamber of the left eye.
Rom J Ophthalmol
October 2024
Department of Ophthalmology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Objective: To describe ocular hypertension cases after using a new aflibercept prefilled syringe and to assess the main characteristics of these eyes and their possible association with intraocular pressure (IOP) changes.
Methods: Case series. We reported all the cases of ocular hypertension following aflibercept prefilled syringes (PFS) treatment in our department between April 2021 and December 2023.
J Vitreoretin Dis
August 2024
Austin Retina Associates, Austin, TX, USA.
To review the first Research and Safety in Therapeutics (ReST) Committee webinar and summarize the most current recommendations regarding diagnosis and management. The ReST Committee is comprised of members of the American Society of Retina Surgeons (ASRS). At regular internal meetings, safety issue reports from the website are reviewed.
View Article and Find Full Text PDFPDA J Pharm Sci Technol
August 2024
STERIS Life Sciences; and.
STERIS and W.L. GORE collaborated on a case study testing the compatibility of a new prefilled syringe plunger design with VHP terminal sterilization.
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