Avaliação qualitativa e quantitativa das seringas e agulhas usadas para injeção intravítrea: possíveis aplicações na prática clínica
Arquivos
Data
2024-09-26
Autores
Agra, Lydianne Lumack do Monte 
Orientadores
Maia, Mauricio
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Objetivos: Quantificar a liberação de partículas, incluindo as de óleo de silicone (OS), pelas agulhas e seringas para injeções intravítreas (IIV). Os objetivos específicos foram: analisar a variabilidade na liberação de partículas de OS em seringas do mesmo lote e o impacto dos diferentes calibres das agulhas usadas com essas seringas (estudo 1), avaliar quantitativamente a liberação de partículas após a agitação das seringas utilizadas em IIV testadas em modelo experimental (estudo 2) e comparar acurácia, precisão e volume residual das seringas comumente utilizadas em IIV e avaliar a variação da pressão intraocular (PIO) relacionada aos diferentes volumes injetados (estudo 3). Métodos: No estudo 1, quatro modelos de seringas e seis modelos de agulhas foram avaliados quanto à liberação de OS. Os dados foram analisados por citometria de fluxo com marcação fluorescente para OS. No estudo 2, quatro modelos de seringas foram avaliados com e sem agitação, com diferentes fluidos, com contagem, concentração, morfologia e distribuição do tamanho das partículas liberadas tendo sido avaliadas por Microflow Imaging (MFI) Microscopy. E, no artigo 3, oito modelos de seringas, com dois modelos de agulhas, foram pesados em diferentes situações para se obter o volume ejetado e o volume residual. Também foi utilizado um modelo ocular experimental para a medida do aumento da pressão intraocular. Resultados: No estudo 1, todos os modelos de seringa apresentaram um alto coeficiente de variação na liberação de OS, sendo significativamente maior na seringa quando a agulha foi acoplada. O número de partículas de OS foi maior na configuração seringa/agulha do que apenas em seringas (p = 0,0024). No estudo 2, a contagem média de partículas após agitação foi maior do que no grupo sem agitação usando a seringa BD Ultra-Fine, e diferenças foram observadas usando a seringa SR entre as duas condições estudadas para partículas maiores que 10 µm e 25 µm. Para as demais seringas, não foram observadas diferenças significativas nas médias. No estudo 3, as seringas BD Ultra-Fine, Zero Residual e Zero Residual Silicone Oil-free apresentaram o menor volume residual (p < 0,001) em comparação com as demais e o aumento da PIO variou de 32,3 mmHg (desvio-padrão [DP], 1,4), para volume de injeção de 20 µL, a 76,5 mmHg (DP, 1,0), para volume de injeção de 80 µL. Para a injeção-padrão de 50 µL, o pico de pressão foi de 50,7 mmHg (DP, 0,1) e a duração do aumento da pressão foi de 28 (DP, 2) minutos. Conclusões: (1) Há uma grande variabilidade na quantidade de OS liberada por seringas do mesmo lote, não havendo associação clara entre o calibre da agulha e o número de partículas de OS liberadas; (2) Agitar seringas para remover bolhas de ar resulta em um maior número de partículas liberadas durante injeções no vítreo humano; (3) Há diferenças significativas na acurácia, na precisão e no volume residual entre as seringas estudadas; e (4) O excesso de volume injetado resulta em aumento considerável da PIO após a injeção.
Purpose: To quantify the release of particles, including silicone oil (SO), by syringes and needles used worldwide for intravitreal injections (IVIs). The specific objectives were: to analyze the variability in silicone oil particle release in syringes from the same batch and the impact of different needle gauges used with these syringes (study 1), to quantitatively evaluate particle release after flicking the syringes used in IIV tested in an experimental model (study 2), and to compare the accuracy, precision, and residual volume of commonly used syringes in IIV and assess the intraocular pressure (IOP) variation related to different injected volumes (study 3). Methods: In study 1, four syringe models and six needle models were evaluated for SO release. Data were analyzed by flow cytometry with fluorescent labeling for silicone oil. In study 2, four syringe models were evaluated with and without shaking, with different fluids, and the count, concentration, morphology, and size distribution of released particles were assessed by Microflow Imaging (MFI) Microscopy. In study 3, eight syringe models with two needle models were weighed in different situations to obtain the ejected volume and residual volume. An experimental eye model was also used to measure the increase in intraocular pressure. Results: In study 1, all syringe models showed a high coefficient of variation in SO release among syringes from the same batch, being significantly higher in the syringe when the needle was attached. The number of SO particles released with the BD 30G needle was statistically higher than with the 27G needle (p = 0.005). In study 2, the average particle count after flicking was higher than in the non-flicking group using the BD Ultra-Fine syringe, and differences were observed using the SR syringe between the two conditions studied for particles larger than 10 and 25 µm. For the other syringes, no significant differences in means were observed. In study 3, BD Ultra-Fine, Zero Residual, and Zero Residual Silicone Oil-free syringes had the smallest residual volume (p < 0.001) compared to others, and the increase in IOP varied from 32.3 mmHg (standard deviation [SD], 1.4) for a 20 µm injection volume to 76.5 mmHg (SD, 1.0) for an 80 µm injection volume. For the standard 50 µm injection, the peak pressure was 50.7 mmHg (SD, 0.1), and the duration of the pressure increase was 28 (SD, 2) minutes. Conclusions: 1- There is significant variability in the amount of SO released by syringes from the same batch, with no clear association between needle gauge and the number of SO particles released. 2- Flicking syringes to remove air bubbles results in a higher number of particles released during injections into the human vitreous. 3- There are significant differences in accuracy, precision, and residual volume among the studied syringes. 4- Excess injected volume results in a considerable increase in IOP after injection.
Purpose: To quantify the release of particles, including silicone oil (SO), by syringes and needles used worldwide for intravitreal injections (IVIs). The specific objectives were: to analyze the variability in silicone oil particle release in syringes from the same batch and the impact of different needle gauges used with these syringes (study 1), to quantitatively evaluate particle release after flicking the syringes used in IIV tested in an experimental model (study 2), and to compare the accuracy, precision, and residual volume of commonly used syringes in IIV and assess the intraocular pressure (IOP) variation related to different injected volumes (study 3). Methods: In study 1, four syringe models and six needle models were evaluated for SO release. Data were analyzed by flow cytometry with fluorescent labeling for silicone oil. In study 2, four syringe models were evaluated with and without shaking, with different fluids, and the count, concentration, morphology, and size distribution of released particles were assessed by Microflow Imaging (MFI) Microscopy. In study 3, eight syringe models with two needle models were weighed in different situations to obtain the ejected volume and residual volume. An experimental eye model was also used to measure the increase in intraocular pressure. Results: In study 1, all syringe models showed a high coefficient of variation in SO release among syringes from the same batch, being significantly higher in the syringe when the needle was attached. The number of SO particles released with the BD 30G needle was statistically higher than with the 27G needle (p = 0.005). In study 2, the average particle count after flicking was higher than in the non-flicking group using the BD Ultra-Fine syringe, and differences were observed using the SR syringe between the two conditions studied for particles larger than 10 and 25 µm. For the other syringes, no significant differences in means were observed. In study 3, BD Ultra-Fine, Zero Residual, and Zero Residual Silicone Oil-free syringes had the smallest residual volume (p < 0.001) compared to others, and the increase in IOP varied from 32.3 mmHg (standard deviation [SD], 1.4) for a 20 µm injection volume to 76.5 mmHg (SD, 1.0) for an 80 µm injection volume. For the standard 50 µm injection, the peak pressure was 50.7 mmHg (SD, 0.1), and the duration of the pressure increase was 28 (SD, 2) minutes. Conclusions: 1- There is significant variability in the amount of SO released by syringes from the same batch, with no clear association between needle gauge and the number of SO particles released. 2- Flicking syringes to remove air bubbles results in a higher number of particles released during injections into the human vitreous. 3- There are significant differences in accuracy, precision, and residual volume among the studied syringes. 4- Excess injected volume results in a considerable increase in IOP after injection.
Descrição
Citação
AGRA, Lydianne Lumack do Monte. Avaliação qualitativa e quantitativa das seringas e agulhas usadas para injeção intravítrea: possíveis aplicações na prática clínica. 2024. 87 f. Tese (Doutorado em Oftalmologia) - Escola Paulista de Medicina, Universidade Federal de São Paulo,(UNIFESP). São Paulo, 2024.