silicone oils

硅油
  • 文章类型: Journal Article
    这项研究的目的是比较填充了轻或重硅油的可折叠囊状玻璃体(FCVB)的临床疗效以及植入后治疗严重眼外伤和硅油依赖性眼睛的并发症发生率。
    在24名患者中植入填充了轻质(n=16)或重(n=8)硅油的FCVB。在12个月的随访期间,眼内压,最终最佳矫正视力,视网膜再附着情况,FCVB的位置,并对并发症进行了评估。
    所有手术均无问题进行。两组术前及术后最佳矫正视力差异无统计学意义。手术后,轻质硅油(P=0.029)和重硅油(P=0.035)组的眼压均有显着改善。没有患者发生FCVB移位或脱垂。术后早期和晚期并发症最常见的是术后出血(33.3%)和角膜混浊(50%),分别。
    填充有重质硅油的FCVB可作为眼前节丧失的患者的补充治疗,下视网膜有病变,或者由于各种原因不能保持俯卧位。
    将FCVB与重硅油混合使用可以弥补轻硅油的缺点,为患者提供更加个性化的治疗。
    UNASSIGNED: The purpose of this study was to compare the clinical efficacy of foldable capsular vitreous body (FCVB) filled with either light or heavy silicone oil and the incidence of complications after their implantation for the treatment of severe ocular trauma and silicone oil-dependent eyes.
    UNASSIGNED: FCVB filled with either light (n = 16) or heavy (n = 8) silicone oil was implanted in 24 patients. During the 12-month follow-up period, the intraocular pressure, final best-corrected visual acuity, retinal reattachment condition, position of the FCVB, and complications were assessed.
    UNASSIGNED: All surgeries were performed without issue. There was no significant difference in preoperative and postoperative best-corrected visual acuity between the two groups. A significant improvement in the intraocular pressure was observed after surgery in both the light silicone oil (P = 0.029) and heavy silicone oil (P = 0.035) groups. None of the patients developed displacement or prolapse of the FCVB. The most common early and late postoperative complications were postoperative hemorrhage (33.3%) and corneal opacification (50%), respectively.
    UNASSIGNED: FCVB filled with heavy silicone oil can be used as a supplemental therapy for patients who have lost the anterior segment of their eye, have lesions of the inferior retina, or cannot maintain the prone position for various reasons.
    UNASSIGNED: Implantation of FCVB combined with heavy silicone oil compensates for the shortcomings of this with light silicone oil, providing patients with more personalized treatment.
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  • 文章类型: Journal Article
    STERIS和W.L.GORE合作进行了一个案例研究,测试了新的预填充注射器柱塞设计与VHP终端灭菌的兼容性。VHP腔室条件需要深真空脉冲,这可能是对预填充注射器容器完整性的挑战。VHP灭菌的日益增长的行业趋势是由FDA对EO的替代灭菌方法的搜索和最近发布的VHP特定工艺标准推动的。本研究的目的是测试和报告新的0.5mLGOREIMPROJECT柱塞的兼容性,用于眼科应用的无硅胶注射器溶液,用VHP灭菌。已经报道了各种挑战,当使用传统的,硅化,用于玻璃体内注射的预填充注射器系统,如可见颗粒,炎症,硅胶漂浮物,和眼内压增加。GORE柱塞消除了硅油作为柱塞和筒上的润滑剂的需要,同时满足严格的容器封闭和眼科应用的终端灭菌要求。本案例研究展示了深度真空VHP终端灭菌工艺与GORE柱塞设计和材料成分的兼容性的成功结果。测试结果包括主容器完整性,塞子放气/进入,和视觉检查。VHP真空灭菌工艺原理,测试周期配置,并给出了其主要参数。
    STERIS and W.L. GORE collaborated on a case study testing the compatibility of a new prefilled syringe plunger design with VHP terminal sterilization. VHP chamber conditions require deep vacuum pulsing, which may represent challenges to prefilled syringe container integrity. The growing industry trend toward VHP sterilization is driven by the FDA search for alternative sterilization methods to EO and the recent publication of a VHP specific process standard. The purpose of the study is to test and report compatibility of the new 0.5 mL GORE IMPROJECT plunger, a silicone free syringe solution for ophthalmic application, with VHP sterilization. Various challenges have been reported when using conventional, siliconized, prefilled syringe systems for intravitreal injections such as subvisible particles, inflammation, silicone floaters, and intraocular pressure increases. The GORE plunger eliminates the need for silicone oil as a lubricant on the plunger and barrel, while meeting strict container closure and terminal sterilization requirements of ophthalmic applications. This case study presents successful results of deep vacuum VHP terminal sterilization process compatibility with the GORE plunger design and material composition. Test results include primary container integrity, stopper off-gassing/ingress, and visual inspection. Principles of VHP vacuum sterilization process, test cycle configuration, and its main parameters are presented.
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  • 文章类型: Journal Article
    在眼科手术领域,硅油通常用作填充剂,用于修复视网膜脱离,但它需要随后的删除。这项研究利用机器学习的力量来分析硅油去除前后的黄斑和视盘灌注变化,使用光学相干断层扫描血管造影(OCTA)数据。在先前研究的基础工作的基础上,我们的调查使用高斯过程回归(GPR)和长短期记忆(LSTM)网络来创建基于OCTA扫描的预测模型.我们进行了一项比较分析,重点是外视网膜的流量和深毛细血管丛(上半和中央凹)中的血管密度,以跟踪不同时间点的灌注变化。我们的发现表明,虽然机器学习模型以合理的精度预测了外视网膜的流量,预测深层毛细血管丛(特别是上半凹和中央凹区域)的血管密度仍然具有挑战性。这些结果强调了机器学习为眼科个性化患者护理做出贡献的潜力。尽管在预测眼灌注变化方面存在固有的复杂性。
    In the realm of ophthalmic surgeries, silicone oil is often utilized as a tamponade agent for repairing retinal detachments, but it necessitates subsequent removal. This study harnesses the power of machine learning to analyze the macular and optic disc perfusion changes pre and post-silicone oil removal, using Optical Coherence Tomography Angiography (OCTA) data. Building upon the foundational work of prior research, our investigation employs Gaussian Process Regression (GPR) and Long Short-Term Memory (LSTM) networks to create predictive models based on OCTA scans. We conducted a comparative analysis focusing on the flow in the outer retina and vessel density in the deep capillary plexus (superior-hemi and perifovea) to track perfusion changes across different time points. Our findings indicate that while machine learning models predict the flow in the outer retina with reasonable accuracy, predicting the vessel density in the deep capillary plexus (particularly in the superior-hemi and perifovea regions) remains challenging. These results underscore the potential of machine learning to contribute to personalized patient care in ophthalmology, despite the inherent complexities in predicting ocular perfusion changes.
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  • 文章类型: Journal Article
    目的:报告孔源性视网膜脱离术后硅油取出后视网膜再脱离的发生率,并确定潜在的危险因素。
    方法:回顾性观察病例系列161只眼接受了孔源性视网膜脱离手术和随后的硅油去除术。使用单变量和多变量逻辑回归评估术前和术中的危险因素。我们还评估了填塞持续时间对解剖学结果的影响。
    结果:填塞持续时间中位数为5.9[4.3;7.6]个月。17只(10.6%)眼睛在手术后3个月内接受了硅油去除,中位延迟2.3[2.0;2.8]个月。硅油取出后视网膜脱离率为14.9%。既往手术失败史是硅油取出后视网膜再脱离的唯一重要危险因素(OR4.8,95CI[1.5;19.0],p=0.02)。在硅油去除过程中,使用360°激光视网膜固定术和伴随的空气或气体填塞不会影响再脱离率。硅油填塞≤3个月的眼睛显示增加,尽管不重要,硅油取出后发生复发性孔源性视网膜脱离的风险(35.3%对12.5%,p=0.06)。
    结论:在孔源性视网膜脱离手术后接受硅油去除的眼睛中,有14.9%发生了视网膜再脱离。先前失败的手术与硅油取出后复发性孔源性视网膜脱离的风险增加4.8倍有关。硅油填塞≤3个月的眼睛有较高的再脱离率。
    背景:IDNCT05647928(2022年4月12日)。
    OBJECTIVE: To report the rate of retinal redetachment after silicone oil removal following rhegmatogenous retinal detachment surgery and to determine potential risk factors.
    METHODS: Retrospective observational case series of 161 eyes who underwent rhegmatogenous retinal detachment surgery and subsequent silicone oil removal. Pre- and intraoperative risk factors were evaluated using univariate and multivariate logistic regression. We also evaluated the effect of tamponade duration on anatomical outcomes.
    RESULTS: The median tamponade duration was 5.9 [4.3;7.6] months. Seventeen (10.6%) eyes underwent silicone oil removal within 3 months of surgery, with a median delay of 2.3 [2.0;2.8] months. The rate of retinal detachment after silicone oil removal was 14.9%. A history of previous unsuccessful surgery was the only significant risk factor for retinal redetachment after silicone oil removal (OR 4.8, 95%CI [1.5;19.0], p = 0.02). The use of 360° laser retinopexy and concomitant air or gas tamponade during silicone oil removal were not found to affect the redetachment rate. Eyes with silicone oil tamponade ≤ 3 months showed an increased, albeit not significant, risk of developing recurrent rhegmatogenous retinal detachment after silicone oil removal (35.3% versus 12.5%, p = 0.06).
    CONCLUSIONS: A retinal redetachment occurred in 14.9% of eyes undergoing silicone oil removal following rhegmatogenous retinal detachment surgery. Previous failed surgery was associated with a 4.8-fold increased risk of developing recurrent rhegmatogenous retinal detachment after silicone oil removal. Eyes with silicone oil tamponade ≤ 3 months tended to have a higher redetachment rate.
    BACKGROUND: ID NCT05647928 (12th April 2022).
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  • 文章类型: Journal Article
    这项研究调查了静脉(IV)输注方案对静脉免疫球蛋白G(IVIG)和利妥昔单抗稳定性的影响,特别关注亚可见粒子的产生。将基于蠕动运动的输注集(MedifusionDI-2000泵)与基于重力的输注系统(Accu-Drip)在不同流速下进行比较。还研究了不同稀释剂(0.9%盐水和5.0%葡萄糖)和具有或不具有硅油(SO)的塑料注射器的影响。上述特殊情况的结果表明,蠕动泵产生了高水平的亚可见颗粒(明显<25µm),流速增加加剧了,特别是在缺乏表面活性剂的配方中。其他因素,如稀释剂类型和注射器成分,也增加了亚可见粒子的数量。可以帮助克服这些并发症的策略包括添加表面活性剂以及使用无SO注射器和重力输注系统,这有助于在施用期间减少颗粒形成和保留抗体单体。总之,这些研究结果强调了谨慎选择制剂和输注方案的重要性,以最大限度地减少静脉输注期间的颗粒产生,这对于患者的安全性和治疗效果都是重要的.
    This study investigates the impact of intravenous (IV) infusion protocols on the stability of Intravenous Immunoglobulin G (IVIG) and Rituximab, with a particular focus on subvisible particle generation. Infusion set based on peristaltic movement (Medifusion DI-2000 pump) was compared to a gravity-based infusion system (Accu-Drip) at different flow rates. The impacts of different diluents (0.9 % saline and 5.0 % dextrose) and plastic syringes with or without silicone oil (SO) were also investigated. The results from the aforementioned particular case demonstrated that peristaltic pumps generated high levels of subvisible particles (prominently < 25 µm), exacerbated by increasing flow rates, specifically in formulations lacking surfactants. Other factors, such as diluent type and syringe composition, also increased the number of subvisible particles. Strategies that can help overcome these complications include surfactant addition as well as the use of SO-free syringes and a gravity infusion system, which aid in reducing particle formation and preserving antibody monomer during administration. Altogether, these findings highlight the importance of the careful selection of formulations and infusion protocols to minimize particle generation during IV infusion both for patients\' safety and treatment efficacy.
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  • 文章类型: Letter
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  • 文章类型: Case Reports
    背景:我们报告了一例眼穿透性损伤,其中玻璃体切除术后硅油大量迁移到患者的结膜下间隙和眼眶。
    方法:2023年12月9日,一名30岁男性患者因指甲伤导致左眼疼痛和视力下降,到赣州市人民医院就诊。左眼磁性异物滞留所致穿透性损伤的诊断及住院治疗。2023年12月9日,对左眼进行了平坦部玻璃体切除术,以去除眼内异物,异常晶体提取,视网膜光凝.由于在手术过程中发现了后极的视网膜脱离,注入硅油填充玻璃体,随后观察到上结膜泡状肿胀。术后眼眶计算机断层扫描(CT)检查显示硅油通过自渗透出口迁移到结膜下空间和眼眶。2023年12月18日,患者在南昌大学第一附属医院寻求治疗,中国。左眼手术后患者出现明显的异物感。2023年12月20日,将异物从左眼架中取出,并进行眼内检查。后巩膜撕裂已经闭合,导致在撕裂周围进行补充激光治疗后终止外科手术。患者在手术后仅一天报告眼表症状显著减轻。此外,在眼眶CT扫描中观察到硅油的迁移显著减少.
    结论:应仔细评估眼部穿透伤的硅油注射时机,以避免硅油迁移的可能性。
    BACKGROUND: We report a case of eye-penetrating injury in which a massive silicone oil migration into the patient\'s subconjunctival space and orbit occurred after vitrectomy.
    METHODS: A 30-year-old male patient sought medical attention at Ganzhou People\'s Hospital after experiencing pain and vision loss in his left eye due to a nail wound on December 9, 2023. Diagnosis of penetrating injury caused by magnetic foreign body retention in the left eye and hospitalization for treatment. On December 9, 2023, pars plana vitrectomy was performed on the left eye for intraocular foreign body removal, abnormal crystal extraction, retinal photocoagulation. Owing to the discovery of retinal detachment at the posterior pole during surgery, silicone oil was injected to fill the vitreous body, following which upper conjunctival bubble-like swelling was observed. Postoperative orbital computed tomography (CT) review indicated migration of silicone oil to the subconjunctival space and orbit through a self-permeable outlet. On December 18, 2023, the patient sought treatment at the First Affiliated Hospital of Nanchang University, China. The patient presented with a pronounced foreign body sensation following left eye surgery. On December 20, 2023, the foreign body was removed from the left eye frame and an intraocular examination was conducted. The posterior scleral tear had closed, leading to termination of the surgical procedure following supplementary laser treatment around the tear. The patient reported a significant reduction in ocular surface symptoms just one day after surgery. Furthermore, a notable decrease in the migration of silicone oil was observed in orbital CT scans.
    CONCLUSIONS: The timing of silicone oil injection for an eye-penetrating injury should be carefully evaluated to avoid the possibility of silicone oil migration.
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  • 文章类型: Journal Article
    第一-(单体),二次(预凝胶),和第三代(注射后原位凝胶化)水凝胶先前被引入以替换玻璃体切除术后的玻璃体。在这项研究中,我们评估了手术,光学,在先前应用于眼内植入物的加速老化方案之前和之后,玻璃体替代水凝胶的粘弹性。
    注射力的测量,使用临床建立的玻璃体切除术设置的移除速度,以及在加速老化方案之前和之后进行正向光散射和粘弹性性能的评估。将结果与猪和人玻璃体进行比较,以及目前临床上应用的轻和重于水的硅油。
    所有测试水凝胶的去除速度均大大低于猪玻璃体的去除速度(0.2g/minvs.2.7g/min对于性能最好的水凝胶和猪玻璃体,分别)。在老化过程后,第二代玻璃体替代水凝胶的前向光散射高于平均70岁玻璃体的杂散光(9.4与5.5deg2/sr,分别)。所有水凝胶的粘弹性特性都没有以临床意义的方式改变;然而,老化后刚度和弹性的趋势明显。
    这项研究表明,在临床使用前需要解决水凝胶的手术弱点,特别是低去除速度。与原位凝胶化水凝胶(第三代)相比,预联水凝胶(第二代)在手术性能方面表现较差。
    本研究强调了在临床上应用玻璃体替代水凝胶时可能存在的关于手术和光学性质的缺陷。
    UNASSIGNED: First- (monomers), second- (pre-gelated), and third- (in situ gelating after injection) generation hydrogels were previously introduced to replace the vitreous body after vitrectomy surgery. In this study, we evaluated the surgical, optical, and viscoelastic properties of vitreous body replacement hydrogels before and after an accelerated aging protocol previously applied to intraocular implants.
    UNASSIGNED: Measurements of injection force, removal speed using a clinically established vitrectomy setup, as well as evaluation of forward light scattering and viscoelastic properties before and after an accelerated aging protocol were conducted. Results were compared to porcine and human vitreous bodies, as well as currently clinically applied lighter- and heavier-than-water silicone oils.
    UNASSIGNED: Removal speed of all tested hydrogels is substantially lower than the removal speed of porcine vitreous body (0.2 g/min vs. 2.7 g/min for the best performing hydrogel and porcine vitreous body, respectively). Forward light scattering in second-generation vitreous body replacement hydrogels was higher after the aging process than the straylight of the average 70-year-old vitreous body (9.4 vs. 5.5 deg2/sr, respectively). The viscoelastic properties of all hydrogels did not change in a clinically meaningful manner; however, trends toward greater stiffness and greater elasticity after aging were apparent.
    UNASSIGNED: This study demonstrates surgical weaknesses of the hydrogels that need to be addressed before clinical use, especially low removal speed. Pre-linked hydrogels (second-generation) showed inferior performance regarding surgical properties compared to in situ gelating hydrogels (third-generation).
    UNASSIGNED: This study highlights possible pitfalls regarding surgical and optical properties when applying vitreous replacement hydrogels clinically.
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  • 文章类型: Case Reports
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  • 文章类型: Journal Article
    研究硅油取出后复发性孔源性视网膜脱离(RRD)的预后因素。
    这项回顾性研究纳入了2012年1月至2022年5月在一家以大批量转诊为基础的三级医院接受硅油填塞治疗的147例连续RRD患者。所有患者在随后的硅油去除后接受至少6个月的随访。主要结果指标是硅油取出后视网膜脱离的复发率,次要结局是硅油去除后的最佳矫正视力。
    平均硅油填充时间为4.75.01个月(范围:1-38个月;中位数:3个月),硅油取出后视网膜脱离的复发率为15.6%。Logistic回归分析显示,硅油去除过程中的氩内激光光凝(比值比[OR]:0.31;95%置信区间[CI]:0.106-0.898;p=0.031)与硅油去除后较低的解剖成功率相关。人口统计,术前眼部特征,增生性玻璃体视网膜病变,先前的巩膜环绕或屈曲,既往视网膜切除术,伴随超声乳化术,硅油填塞的持续时间,硅油取出后的气体填塞与硅油取出后的复发性视网膜再脱离没有显着相关。硅油填塞的持续时间(OR:1.23;95%CI:1.07-1.40;p=0.003)和硅油取出后复发性视网膜脱离(OR,3.40;95%CI,1.31-8.82;p=0.012)与硅油去除后视力不良相关。
    在本研究中检查的所有因素中,包括硅油填塞的持续时间,激光视网膜固定术是硅油取出后复发性视网膜脱离的唯一重要预后因素.硅油填充的持续时间较长与较差的视觉结果和去除硅油后的视觉改善率较低相关。
    OBJECTIVE: To investigate the prognostic factors for recurrent rhegmatogenous retinal detachment following silicone oil removal.
    METHODS: This retrospective review included 147 consecutive patients with rhegmatogenous retinal detachment treated with silicone oil tamponade at a high-volume referral-based tertiary hospital between January 2012 and May 2022. All patients underwent follow-up for a minimum of 6 months after subsequent silicone oil removal. The primary outcome measure was the rate of recurrent retinal detachment following silicone oil removal, and the secondary outcome was best-corrected visual acuity after silicone oil removal.
    RESULTS: The mean silicone oil tamponade duration was 4.7 ± 5.01 months (range, 1-38 months; median, 3 months), and the recurrent retinal detachment rate after silicone oil removal was 15.6%. Logistic regression analysis revealed that argon endolaser photocoagulation during silicone oil removal (odds ratio [OR], 0.309; 95% confidence interval [CI], 0.106-0.898; p = 0.031) was associated with a lower rate of anatomical success after silicone oil removal. Demographics, preoperative ocular characteristics, proliferative vitreoretinopathy, previous scleral encircling or buckling, previous retinectomy, concomitant phacoemulsification, duration of silicone oil tamponade, and gas tamponade after silicone oil removal were not significantly associated with recurrent retinal redetachment after silicone oil removal. Duration of silicone oil tamponade (OR, 1.226; 95% CI, 1.073-1.402; p = 0.003) and recurrent retinal detachment after silicone oil removal (OR, 3.400; 95% CI, 1.311-8.817; p = 0.012) were associated with poor visual outcomes after silicone oil removal.
    CONCLUSIONS: Among all factors examined in this study, including the duration of silicone oil tamponade, laser retinopexy was the only significant prognostic factor for recurrent retinal detachment after silicone oil removal. A longer duration of silicone oil tamponade was associated with worse visual outcomes and a lower rate of visual improvement after silicone oil removal.
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