Prevalence of silicone oil droplets in eyes treated with intravitreal injection

Melo, Gustavo Barreto; Dias, Celso de Souza; Morais, Fábio Barreto; Cardoso, Alexandre Lima; Figueiredo, Ana Galrão Almeida; Filho, Acácio Alves Souza Lima; Rodrigues, Eduardo Büchele; Emerson, Geoffrey G.; Maia, Maurício

doi:10.1186/s40942-019-0184-9

Cited by 19 publications

(16 citation statements)

References 19 publications

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“…Intolerance of the disinfectant can be attributed to the intravitreal procedure. For intraocular inflammations, on the other hand, it is much more difficult to distinguish between immunogenic inflammatory reactions related to the active substance or silicone oil of the syringe and a carryover of bacteria from the conjunctiva into the eye due to the intravitreal procedure [ 27 ].…”

Section: Introductionmentioning

confidence: 99%

Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial

Ziemssen

Hammer

Grueb

et al. 2020

Journal of Ophthalmology

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Aim. The prospective, noninterventional OCEAN study assessed the safety of intravitreal ranibizumab injections for treatment of neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion under real-world conditions in Germany. Methods. Adults receiving ≥1 ranibizumab (0.5 mg) injections were recruited by 369 ophthalmologists and followed for 24 months. Information on adverse events (AEs) was reported by the treating physician or detected by the data management team. Collected information included observed AE, AE start and end date, intensity, causal relationship, outcome, severity, suspected drug, and actions taken. Results. 2,687 AEs were reported for 1,176 of the 5,781 patients who had received a total of 32,621 injections: 27.4% nonserious AEs, 30.3% serious AEs, 27.3% nonserious adverse drug reactions (ADRs), and 15.0% serious ADRs. Most patients reported no AEs (79.7%) or only 1 AE (10.3%). AEs were most commonly reported in the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) Eye disorders (9.4% of patients) and General disorders and administration site conditions (5.8%). The most frequent AEs by MedDRA preferred term (PT) were visual acuity reduced (3.5% of patients), intraocular pressure increased (2.5%), and drug ineffective (2.1%). AEs occurred most frequently after 3 or 4 injections (1,129 of 2,687 AEs). The proportion of AEs in the SOC Eye disorders decreased slightly with increasing number of injections, from 39.8% of events after 1 or 2 injections to 29.1% after 5 or more injections. Rates of the most frequently reported PTs did not show any consistent increase with increasing number of injections. A decrease in overall AE rates was observed over the study course. Conclusions. The results did not raise any new safety concerns for ranibizumab. The findings allow conclusions to be drawn on how pharmacovigilance data can be collected even more effectively in real-world studies to facilitate discussion on benefit-risk ratio.

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Section: Introductionmentioning

confidence: 99%

Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial

Ziemssen

Hammer

Grueb

et al. 2020

Journal of Ophthalmology

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“…Our investigation of 50 consecutive non-symptomatic patients revealed a very high prevalence (68%) of intravitreal SiO droplets, closely matching a prevalence of 67.57% found in another study. 5 The much lower percentage (1.3%) who spontaneously reported floaters shows that most cases of intravitreal SiO are not reported as floaters. The explanation may be that the patients do not experience floaters, or that they see them but do not report them.…”

Section: Discussionmentioning

confidence: 96%

Cluster of symptomatic silicone oil droplets following intravitreal injections: a 1-year observational study

et al. 2021

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ObjectiveTo describe a cluster of symptomatic intravitreal silicone oil (SiO) droplets following intravitreal injections (IVIs) and assess the effect of switching to a SiO-free syringe.Methods and analysisObservational quality registry study of patients receiving IVI at a large Norwegian ophthalmology centre between April 2018 (start of cluster) and November 2019 (1 year after switching to SiO-free syringes). At onset, anti-vascular endothelial growth factor drugs were administered using SiO-containing insulin syringes. From November 2018, SiO-free syringes were implemented. Spontaneously reported symptomatic SiO cases were confirmed by slit-lamp examination. A follow-up interview was performed after 1 year, assessing visual complaints. The prevalence of non-symptomatic cases was assessed in a sample of 50 eyes from 50 consecutive IVI patients.ResultsAmong 13 429 IVIs, 50 eyes of 46 patients (29 women) with symptomatic intravitreal SiO droplets were identified. Forty-one patients reported floaters at regular appointments, whereas five patients contacted the department regarding symptoms between scheduled appointments. After 1 year, 34 patients (79%) still experienced floaters, 21 (49%) reported reduced symptoms and 3 (7%) reported worsened symptoms. Eighteen patients (42%) reported being bothered, and eight (18.6%) reported that their lives were negatively affected by the floaters. Among 50 non-symptomatic eyes that had received IVI during the same period, intravitreal SiO was found in 34 (68%). No cases of symptomatic intravitreal SiO droplets were identified after switching to SiO-free syringes.ConclusionSymptomatic intravitreal SiO following IVI can cause significant and prolonged distress for affected patients. It can be avoided by using SiO-free syringes.

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“…We reported previously that the needles and syringes tended to be coated with SO, which may ultimately be injected into patients’ eyes 9 – 11 . By studying different syringe and needles samples from the same brand and lot in the current study, we identified great variability in the numbers of particles released.…”

Section: Discussionmentioning

confidence: 99%

High particle variability across siliconized and oil-free syringes and needles from the same lots

Agra

Cruz

Linkuvienė

et al. 2021

Sci Rep

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Previous studies have reported silicone oil (SO) applied to needles and syringes in the vitreous of patients after intravitreal injections. We evaluated four syringes (SR 1-mL insulin, Saldanha-Rodrigues; BD 1-mL Tuberculin Slip Tip, Becton–Dickinson; BD Ultra-Fine 0.3 mL, HSW Norm-Ject Tuberculin, Henke Sass Wolf) and 10 needles (BD PrecisionGlide 27- and 30-gauge (G); BD Eclipse and JBP Nanoneedle 27-, 30-, 33- and 34-G; TSK Invisible Needle and 27 and 30-G Steriject Control Hub). The protein-free buffer samples injected into the syringes and needles under study were collected in an Eppendorf tube and taken to Flow imaging microscopy, that characterized the concentration and morphology of the microsized particles. The number of particles was analyzed. The coefficients of variation (CV) were the primary outcome. The Feltz and Miller test compared the CVs. The significance level was 5%. Numerous particles and high CVs were associated with both devices, needles and syringes; the comparisons among them did not reach significance. The BD Ultrafine 0.3 mL syringe (149.7%) had the highest CV and the SO-free HSW Norm-Ject (66.4%) syringe the lowest, and the TSK Invisible needle (149.5%) had the highest and the BD Precision Glide 30G needle (35.9%) needle the lowest. In conclusion, particle release, including those with SO morphology, varied greatly among instruments, even from the same lots, which is relevant considering that fewer particles are injected into some eyes compared with others.

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Prevalence of silicone oil droplets in eyes treated with intravitreal injection

Cited by 19 publications

References 19 publications

Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial

Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial

Cluster of symptomatic silicone oil droplets following intravitreal injections: a 1-year observational study

High particle variability across siliconized and oil-free syringes and needles from the same lots

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