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BACKGROUND: Describe complications and clinical outcomes of heavy silicone oil (HSO) Oxane HD® use as an alternative to overcome the challenges of performing vitrectomy to treat tractional and rhegmatogenous retinal detachments with proliferative vitreoretinopathy (PVR). METHODS: A retrospective, observational study was performed on patients from one center from August 2014 to Aug 2023. It was included patients who underwent surgery using HSO Oxane HD® to treat rhegmatogenous retinal detachment with PVR or mixed tractional and rhegmatogenous diabetic retinal detachment. Severely ill patients who could not attend to follow up were excluded. The primary outcome was successful retinal attachment at first postoperative month. A descriptive analysis was performed. RESULTS: Among the 31 patients, 29 (93.5%) underwent surgeries due to rhegmatogenous retinal detachment and two (6.5%) for diabetic retinal detachment. The primary anatomic success was achieved in 27 (87.1%) patients. At the final visit, 17 (56.6%) had vision better than 20/400 (range, 20/30 to light perception). The vision was stable or improved in 22 (76.8%) patients at the end of follow-up. Nineteen (61.3%) patients required hypotensive eye drops after HSO use and twelve (38.7%) still required hypotensive eye drops at the final follow-up; three (9.7%) patients required additional glaucoma surgeries. CONCLUSIONS: HSO is safe and useful for complex retinal detachments cases specially with inferior tears and PVR. Ocular hypertension is frequent and usually clinically controlled with hypotensive eyedrops. Close postoperatively follow-up is advised due to the ocular complications, particularly elevated intraocular pressure and emulsification.
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Intravitreal injections are a common procedure in ophthalmology, often using syringes coated with silicone to aid piston movement and needles coated with silicone oil to facilitate penetration of the sclera. Pegcetacoplan and avacincaptad pegol, recently approved for clinical use by the US Food and Drug Administration, have higher viscosity and seem more susceptible to entrap air bubbles compared to anti-VEGF drugs.It is plausible that both anti-complement drugs could be associated with a higher likelihood of introducing silicone oil in the vitreous because of higher viscosity, with potentially higher friction at the inner surface of syringe barrel, in the vicinity of silicone oil. In addition to this, undesirable agitation might be inadvertently promoted by some retina specialists to remove air bubbles from the drug solution.In conclusion, recent reports of silicone oil droplets in the vitreous of patients receiving pegcetacoplan injection might be related to both its viscosity and to agitation of the syringe to remove air bubbles. Since avacincaptad pegol also is viscous, though with different pH, syringe and filter needle, we might expect similar reports for this agent soon. We also recommend further studies be carried not only to clarify the current matter but also the potential association between the combination of agitation, silicone oil and inflammation or any immune response.
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The main drawback for the use of heavy silicone oil (HSO) Oxane HD is the difficulties it presents during removal. It differs from conventional silicone oil removal because it progressively concentrates in the posterior pole during the removal because of its heavier than water density. We describe a technique to facilitate proper HSO Oxane HD removal and minimize residual posterior bubbles and intraoperative complications. We describe our pearls for removing HSO to obtain the optimal results. A concern associated with HSO is the difficulty it presents when it is removed. However, this can be overcome by appropriate modification of surgical techniques during removal to limit intraoperative complications.
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INTRODUCTION AND IMPORTANCE: Complications related to silicone oil tamponade are frequent. There are reports of events related to silicone oil (SO) injection during Pars Plana Vitrectomy (PPV). This case presents the unexpected injection of SO in the suprachoroidal space. The proper management of this complication along with the preventive measures are discussed. CASE PRESENTATION: A 38-year-old male presented with a one-week history of decreased vision in his right eye (OD). His visual acuity was hand motion (HM). A late-onset retinal detachment recurrence with proliferative vitreoretinopathy (PVR) in his OD was diagnosed. Cataract surgery and PPV were scheduled. During PPV, a choroidal detachment (CD) secondary to the suprachoroidal injection of silicone oil (SO) was noted. Suprachoroidal SO was identified timely and was managed with external drainage through a posterior sclerotomy. CLINICAL DISCUSSION: Suprachoroidal silicone oil injection is a potential complication during PPV. For the management of this complication, the drainage of the silicone oil from the suprachoroidal space through a posterior sclerotomy may be considered as an option. This complication may be avoided by periodically checking the correct position of the infusion cannula during the PPV, by injecting the SO into the vitreous cavity under direct visualization and by using automated injection systems. CONCLUSION: Suprachoroidal silicone oil injection is an intraoperative complication that might be avoided by cross-checking the correct position of the infusion cannula and by injecting SO under direct visualization.
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ABSTRACT Purpose: To compare viscotrabeculotomy with anterior chamber irrigation to Ahmed glaucoma valve implantation for secondary glaucoma following silicone oil removal. Methods: A prospective study was conducted on 43 vitrectomized pseudophakic eyes with persistent glaucoma after silicone oil removal. Patients were randomized to either viscotrabeculotomy with anterior chamber irrigation or Ahmed glaucoma valve implantation. All patients were examined on day 1, week 1, and months 1, 3, 6, 9, 12, 18, and 24 postoperatively. Postoperative complications were noted. Success was defined as an intraocular pressure between 6 and 20 mmHg and with an intraocular pressure reduction of >30% compared with the preoperative intraocular pressure. Results: There were 22 eyes in the viscotrabeculotomy with anterior chamber irrigation and 21 eyes in the Ahmed glaucoma valve implantation group. The mean preoperative and postoperative intraocular pressure in the viscotrabeculotomy with anterior chamber irrigation and Ahmed glaucoma valve implantation groups were 35.5 ± 2.6 mmHg and 35.5 ± 2.4 mmHg and 16.9 ± 0.7 mmHg and 17.9 ± 0.9 mmHg respectively (p˂0.0001). There was a statistically significant intraocular pressure reduction at all follow-up time points compared to preoperative values (p˂0.0001) in both groups. The unqualified success rate in the viscotrabeculotomy with anterior chamber irrigation and Ahmed glaucoma valve implantation groups were 72.73% and 61.9%, respectively. A minimal self-limited hyphema was the most common complication. Conclusions: Both viscotrabeculotomy with anterior chamber irrigation and Ahmed glaucoma valve implantation are effective in lowering the intraocular pressure in glaucoma after silicone oil removal with viscotrabeculotomy with anterior chamber irrigation providing greater reduction, higher success rates, and minimal complications.
RESUMO Objetivo: Comparar a viscotrabeculotomia com irrigação da câmara anterior com o implante de válvula de glaucoma de Ahmed para glaucoma secundário após remoção de óleo de silicone. Métodos: Foi realizado um estudo prospectivo de 43 olhos pseudofácicos vitrectomizados com glaucoma persistente após a remoção de óleo de silicone. Os pacientes foram randomizados para viscotrabeculotomia com irrigação da câmara anterior ou implante de válvula de Ahmed. Todos os pacientes foram examinados no primeiro dia, na primeira semana e 1, 3, 6, 9, 12, 18 e 24 meses após a cirurgia. Observaram-se complicações pós-operatórias. O sucesso foi definido como uma pressão intraocular entre 6 e 20 mmHg e uma redução da pressão intraocular >30% em comparação com a pressão intraocular pré-operatória. Resultados: Foram designados 22 olhos para o grupo da viscotrabeculotomia com irrigação da câmara anterior e 21 olhos para o grupo do implante de válvula de Ahmed. A pressão intraocular média pré-operatória foi de 35,5 ± 2,6 mmHg para o grupo da viscotrabeculotomia com irrigação da câmara anterior e pós- e de 35,5 ± 2,4 mmHg no grupo do implante de válvula de Ahmed. e Os valores pós-operatórios foram de 16,9 ± 0,7 mmHg e 17,9 ± 0,9 mmHg para esses mesmos grupos, respectivamente (p<0,0001). Ambos os grupos tiveram uma redução estatisticamente significativa da pressão intraocular em relação aos valores pré-operatórios (p<0,0001) em todos os momentos do acompanhamento. A taxa de sucesso não qualificado nos grupos da viscotrabeculotomia com irrigação da câmara anterior e do implante de válvula de Ahmed foi de 72,73% e 61,9%, respectivamente. A complicação mais comum foi o hifema, autolimitado e mínimo. Conclusões: Tanto a viscotrabeculotomia com irrigação da câmara anterior quanto o implante de válvula de Ahmed são eficazes na redução da pressão intraocular no glaucoma após injeção de óleo de silicone, mas a viscotrabeculotomia com irrigação em câmara anterior proporcionou maior redução da pressão intraocular e maiores taxas de sucesso, com complicações mínimas.
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La silicona líquida es usada intravítrea cuando se requiere un taponamiento prolongado intraocular para mantener la retina aplicada. A pesar de sus ventajas, su uso se ha asociado a algunas complicaciones como catarata, queratopatía, hipertensión ocular, glaucoma entre otras. La hipertensión ocular secundaria por aceite de silicona aparece por varios mecanismos, la migración de partículas a la malla trabecular junto con el proceso inflamatorio que genera es un reto para los cirujanos, de ahí los diferentes criterios de tratamiento que existen para su completa resolución. A continuación, se presenta un paciente operado de desprendimiento de retina recidivado con hipertensión ocular secundario a aceite de silicona 9 meses después de su primera intervención. Llevó tratamiento con hipotensores oculares tópicos, orales y no resolvió por lo que se decide realizar ciclocrioterapia en dos cuadrantes. A pesar que este tratamiento no es el de elección en estos casos, podemos decir que en este paciente se logra controlar la presión intraocular luego de una sola sesión(AU)
Liquid silicone is used intravitreally when prolonged intraocular insulation is required to keep the retina applied. Despite its advantages, its use has been associated with some complications such as cataract, keratopathy, ocular hypertension, glaucoma, among others. Secondary ocular hypertension due to silicone oil appears by several mechanisms. The migration of particles to the trabecular meshwork, together with the inflammatory process it generates, represents a challenge for surgeons, hence the different treatment criteria that exist for its complete resolution. The following is a patient operated on for recurrent retinal detachment with ocular hypertension secondary to silicone oil 9 months after the first operation. He was treated with topical and oral ocular hypotensors and it did not resolve, so it was decided to perform cyclocriotherapy in two quadrants. Although this treatment is not the treatment of choice in these cases, we can say that in this patient intraocular pressure control was achieved after only one session(AU)
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Humanos , Catarata/complicações , Óleos de Silicone/uso terapêutico , Descolamento Retiniano/etiologia , Hipertensão Ocular , Glaucoma/complicaçõesRESUMO
BACKGROUND: To describe the anatomical and functional outcomes and late complications in patients who developed inferior proliferative vitreoretinopathy (PVR) in silicone oil-filled eyes and who required reoperation with large inferior retinectomy. METHODS: This is a single-center, retrospective, interventional case series analysis. The study involved 18 individuals with tractional retinal re-detachment due to PVR development inferiorly in eyes who had undergone prior pars plana vitrectomy and silicone oil as a tamponade. All patients included in the study underwent secondary surgery with large inferior retinectomy (from 120° to 270°) and silicone oil filling. RESULTS: The mean follow-up period was 44.0 ± 31.5 (± SD) months (range: 4 to 96 months. The anatomical success, defined as the complete reattachment of the retina until the last follow-up, was observed in 88.9% of the cases. The postoperative visual acuity ranged from 20/100 to hand motion at 60 cm. Only two cases (11.1%) did not achieve anatomical success at the last follow-up due to recurrent PVR and retinal re-detachment (one including hypotony). All of the patients were pseudophakic. The PVR grade, as well as the presence of PVR prior to primary surgery, showed no statistical correlation with BCVA, the extent of retinectomies, and final macular status. There was a statistically significant correlation between "Final BCVA" and "Initial BCVA" (r = 0.654) and between "Final BCVA" and "Extent of Retinectomy" (r = 0.615). CONCLUSIONS: Reoperation in eyes filled with silicone oil may be required when PVR is developed. Secondary surgery in these cases with large inferior retinectomy and silicone oil implantation may reach good anatomical success with low rates of late complications, besides improving visual acuity. A better BCVA at the time of re-RD diagnosis and cases of retinectomies with greater extensions showed a positive correlation with better functional outcomes. Trial registration Research Ethics Committee of the Suel Abujamra Institute reviewed and approved this study protocol (approval number, 5.404.961).
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BACKGROUND: Noninfectious endophthalmitis may be misdiagnosed, leading to serious clinical implications. So far, its causative factors remain unknown. Therefore, this study assessed the role of silicone oil and syringe agitation in the development of inflammation after intravitreal injection of aflibercept. METHODS: A randomized, double-blind, controlled clinical trial included subjects with an indication of intravitreal antiangiogenic therapy prior to vitrectomy for proliferative diabetic retinopathy. Aflibercept was injected 48 h before surgery. The control group received the injection without agitation, while the intervention group was injected with a previously agitated syringe by flicking with either a siliconized or silicone oil-free syringe. The primary endpoint was the presence of anterior chamber reaction (ACR) at 48 h. Aqueous samples were collected and underwent cytometric bead array analysis for quantification of interleukins and chemokines. RESULTS: Forty-one individuals were included (21 in the agitation group and 20 in the no-agitation group). None of the included eyes showed baseline signs of AC cells, hyperemia or pain complaint, while 10% of control group and 80% of agitation group showed AC cells 48 h after injection of aflibercept with SR syringe. There were no differences in the mean variations of all cytokines and chemokines by agitation status. However, there was a marginally significant increase between the mean variations of IP-10 (p = 0.057) and IL-8 (p = 0.058) in the siliconized one. CONCLUSION: This clinical trial discloses a potential role of agitation and siliconized syringes in the development of inflammation after an intravitreal injection of aflibercept. These findings have important clinical implications for all healthcare practitioners who perform intravitreal injections. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials, RBR-95ddhp. Registered 12 May 2019, http://www.ensaiosclinicos.gov.br/rg/RBR-95ddhp/.
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Injections are widely performed in the healthcare practice. Silicone has long been thought to be an inert and harmless material. Although used for decades in medical implants, including heart valves, breast implants, and as a tamponade for retinal detachment surgery, silicone oil might have deleterious effects. Agitation of the syringe to expel air at the moment of drug preparation not only leads to silicone oil release but also to therapeutic protein aggregation. Lab studies have shown that silicone oil microdroplets can act as an adjuvant to promote a break in immunological tolerance and induce antibody response. Similarly, recent studies have suggested a causal link between agitation of siliconized syringes and ocular inflammation after intravitreal injection. Systemically, silicone oil has been reported in association with autoimmune diseases and skin granuloma after either direct injection of dermal fillers or secondary leakage from silicone breast implant. However, it has not been established yet a potential link between the silicone oil released by the syringes and such relevant systemic adverse events. Few professionals are aware that agitation of a siliconized syringe might lead to silicone oil release, which, in turn, acts an adjuvant to an increased immunogenicity. We strongly recommend that every healthcare professional be aware of the use of silicone oil in the syringe manufacturing process, the factors that promote its release and the potential complications to the organism. Ultimately, we recommend that safer syringes be widely available.
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Introduction: The indications for pars plana vitrectomy (PPV) have increased over the years. The vitreous is no longer considered an inert ocular structure and it is well known that its removal has anatomical and physiological consequences. The vitreous is no longer considered an inert ocular structure. The vitreous plays a key role as an intraocular physiologic oxygen regulator. In order to maintain its transparency, the crystalline lens needs protection from an excessive oxygen exposure. PPV leads to progression of nuclear sclerosis in most eyes.Methods: A systematic review of the literature was conducted using Embase and Medline databases. Articles studying the physiology, pathogenesis and surgical treatment of cataract after PPV were included in this review.Results: The pathogenesis of cataract formation after PPV remains unclear. Predisposing factors include advanced patient age, preexisting nuclear sclerosis, light toxicity, intraoperative oxidation of lens proteins, use of silicone oil or intravitreal gas, mechanical trauma and the duration of exposure to an irrigating solution.Conclusion: Cataract surgery in vitrectomized eyes presents with more technical difficulties, is more challenging and often has a higher risk of intraoperative and postoperative complications than in non vitrectomized eyes. There is no standardized technique or management in these cases; therefore, it requires more precautions during surgery.
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Extração de Catarata , Catarata , Catarata/etiologia , Humanos , Estudos Retrospectivos , Óleos de Silicone , Acuidade Visual , VitrectomiaRESUMO
PURPOSE: To assess the variability of silicone oil (SO) particles released across syringes from the same lot and the role of different needle gauges. MATERIALS AND METHODS: Four syringe models and six needle models were assessed for SO release. About 50 microliters of a buffer solution were loaded into the syringe, needle or syringe/needle setup. The data were analyzed by imaging flow cytometry with fluorescently labeling for SO. RESULTS: All syringe models had a high coefficient of variation in SO release across syringes from the same lot. The amount of SO was significantly greater in the syringe when the needle was attached. SO particles with the BD 30G needle attached to the syringe were statistically greater than the 27G counterpart (p = 0.005). None of the other comparisons was statistically different. Finally, the number of SO particles was higher in the syringe/needle setup than in needles only (p = 0.0024). CONCLUSION: We found a high variability in SO content across syringes from the same lot. Additionally, there was no clear association between needle gauge and the number of SO particles, as well as their coefficient of variation. Finally, the needles accounted for a small number of SO particles in comparison to the combined syringe-needle setup.
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PURPOSE: This study aimed to quantify the amount of silicone oil (SO) released across a variety of syringe and needle models routinely used for intravitreal injection. METHODS: The release of SO was assessed in eight models of syringes, two of which were reported to be 'SO-free', and eleven models of needles with unknown SO content. To evaluate SO release within the context of anti-VEGF therapeutics, syringes were evaluated using aflibercept, bevacizumab, buffer, ziv-aflibercept and formulation buffer. All syringe tests were performed with or without agitation by flicking for syringes. Needles were evaluated without agitation only. Samples were fluorescently labelled to identify SO, and triplicate measurements were collected using imaging flow cytometry. RESULTS: Seven out of 8 syringe models showed a statistically significant increase in the SO particle count after agitation. The two SO-free syringe models (HSW Norm-Ject, Daikyo Crystal Zenith) released the least SO particles, with or without agitation, whereas the BD Ultra-Fine and Saldanha-Rodrigues syringes released the most. More SO was released when the syringes were prefilled with formulation buffer than with ziv-aflibercept. Syringes filled with aflibercept and bevacizumab had intermediate levels. Agitation increased the release of SO into each of the drug solutions. Silicone oil (SO) was detected in all needles. CONCLUSIONS: Agitation of the syringe by flicking leads to a substantial increase in the number of SO particles. Silicone oil (SO)-free syringes had the best performance, but physicians must also be aware that needles are siliconized and also contribute to the injection of SO into the vitreous.
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Inibidores da Angiogênese/química , Injeções Intravítreas/instrumentação , Agulhas , Silício/análise , Óleos de Silicone/análise , Seringas , Inibidores da Angiogênese/administração & dosagem , Desenho de Equipamento , Humanos , Doenças Retinianas/tratamento farmacológicoRESUMO
PURPOSE: The aim of this article is to report a rare case in which a patient presented symptomatic silicon oil brain migration, documented by MRI, several years after vitreoretinal surgery. METHODS: This is a case report with a prospective literature review. PATIENTS: The patient described in the case report. RESULTS: Case report. DISCUSSION/CONCLUSIONS: For several years, silicone oil (SiO) has been widely used as a long-term intravitreal tamponading agent to treat complex retinal detachments. There are rare reports in the literature demonstrating the migration of SiO into the brain. The aim of this article is to report a rare case in which the patient presented severe headaches several years after vitreoretinal surgery, with migrated SiO appearing in MRI as an oval lesion within the horn of the right lateral ventricle. To the best of our knowledge, there are very few reports of symptomatic SiO brain migration in the literature.
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BACKGROUND/AIMS: To assess silicone oil (SO) release by different brands of syringes used for intravitreal injection under different handling conditions. METHODS: Eight syringes were analysed: from the USA, Terumo 0.5 mL, Becton-Dickinson (BD) Tuberculin 1 mL, BD Luer-lok 1 mL, BD Ultra-Fine 0.3 mL and Exel Insulin 0.3 mL; from Germany, Braun Omnifix-F 1 mL and Braun Injekt-F 1 mL and from Spain, BD Plastipak 1 mL. The impact of air, priming the plunger, agitation by flicking and fluid temperature on SO release were assessed by light microscopy. Fourier transform infrared spectroscopy (FTIR) was performed to identify the molecular compound in each syringe. RESULTS: Five hundred and sixty syringes were analysed. Terumo 0.5 mL and BD Ultra-Fine 0.3 mL released more SO than all others. BD Luer-lok 1 mL, BD Plastipak and Braun Omnifix-F 1 mL released little SO; BD Tuberculin 1 mL, Exel 0.3 mL and Braun Injekt-F 1 mL released the least SO. Priming the syringe and different temperatures did not significantly affect SO release. Agitation by flicking caused a significantly higher proportion of samples to have SO droplets and an increased number of oil droplets. Air had an additive effect on the release of oil in the agitation groups. FTIR identified polysiloxane in all syringes but Injekt-F. CONCLUSION: Syringes commonly used for intravitreal injections frequently release SO droplets, especially when agitated by flicking. To avoid unnecessary ocular risks, syringes should not be agitated before intravitreal injection. It is desirable that syringes be manufactured specifically for ophthalmic use.
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Injeções Intravítreas/métodos , Óleos de Silicone/análise , Seringas/normas , Humanos , Modelos Logísticos , Uso Off-LabelRESUMO
PURPOSE: To report a single case history of scleral rupture (SR) during silicone oil injection in a pars plana vitrectomy. OBSERVATIONS: A 60-year-old woman with a history of pathological myopia presented with acute vision loss in her right eye. A retinal detachment, with multiple tears, was diagnosed, and she underwent vitreoretinal surgery. During silicone oil injection, a SR, with extra ocular oil leakage, was advised. Due to the small extent of the lacerated area, the SR was left to spontaneously resolve and, after three surgeries, the retina remained attached, with no internal tamponade, and the patient had not presented symptoms or signs of intracranial migration or toxicity. CONCLUSIONS AND IMPORTANCE: During silicone oil injection, it is most important to maintain a controlled eyeball pressure, especially in patients with scleral weakness, and to carefully check the drainage of air, due to the risk of SR. When oil leakage is detected in the orbital cavity, an accurate assessment may be required due to the likelihood of progression inside the intracranial structures.
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Silicone oil tamponade is a frequent treatment for retinal detachment. Intraventricular migration of this agent is rare, but was described previously in patients with chronic glaucoma and atrophy of the optic disc. We describe a patient with prior silicone oil tamponade in the left eye with a noncontrast computed tomography demonstrating hyperattenuating material along the course of the left optic nerve and in the frontal horns of the lateral ventricles, and emphasize the use of prone noncontrast computed tomography as an important diagnostic tool in order to confirm the low specific gravity of the oil agent.
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AIM: Main failure of diabetic tractional retinal detachment (TRD) surgery is the development of proliferative vitreoretinopathy (PVR), causing higher re-detachment rates. We investigated whether the use of dexamethasone (DEX) implant at the end of pars plana vitrectomy (PPV) with silicone oil tamponade might have an impact on these outcomes. DESIGN: Comparative, nonrandomized, retrospective study. PARTICIPANTS: A total of 148 eyes from 148 patients that underwent PPV with silicone oil tamponade for diabetic TRD (with DEX implant, n = 52; without DEX implant, n = 96). METHODS: Consecutive patients' records were reviewed for time between TRD diagnosis and surgery; lens status before surgery and after 6, 12, and 24 months; retina attachment rate after primary PPV; change in postoperative PVR severity; rate of re-detachment at 6, 12, and 24 months; use of IOP lowering treatment after 6, 12, and 24 months; surgery details; intra- and postoperative complications. Correlations between outcome measures, postoperative PVR severity, and re-detachment rates were analyzed. MAIN OUTCOME MEASURES: Change in postoperative PVR severity and retinal re-detachment rates with and without the adjuvant use of DEX implant. RESULTS: Retinal re-detachment rates were significantly higher in the group of patients that did not receive DEX implant [11/96 (11.5%) vs. 0/52 (0%), p = 0.049; 11/84 (12.9%) vs. 4/52 (7.7%), p = 0.007; 14/71 (19.7%) vs. 5/52 (10%) p < 0.001 at 6, 12, and 24 months, respectively]. PVR severity correlated with retinal status at 12 and 24 months (p = 0.018 and p = 0.027, respectively). The difference in PVR severity between the two groups was statistically significant at 6, 12, and 24 months (p < 0.001). CONCLUSIONS: DEX implant at the end of PPV in patients with diabetic TRD improves PVR severity and decreases re-detachment rates. This should be considered as an option in the customized treatment of TRD.
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Dexametasona/administração & dosagem , Retinopatia Diabética/tratamento farmacológico , Retinopatia Diabética/cirurgia , Descolamento Retiniano/tratamento farmacológico , Descolamento Retiniano/cirurgia , Vitrectomia/métodos , Adulto , Idoso , Terapia Combinada , Dexametasona/efeitos adversos , Retinopatia Diabética/complicações , Implantes de Medicamento/administração & dosagem , Implantes de Medicamento/efeitos adversos , Feminino , Humanos , Injeções Intravítreas , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Período Pós-Operatório , Retina/efeitos dos fármacos , Retina/fisiopatologia , Estudos Retrospectivos , Óleos de Silicone/administração & dosagem , Óleos de Silicone/efeitos adversos , Acuidade Visual/efeitos dos fármacos , Vitrectomia/efeitos adversos , Vitreorretinopatia Proliferativa/tratamento farmacológico , Vitreorretinopatia Proliferativa/etiologia , Vitreorretinopatia Proliferativa/cirurgiaRESUMO
RESUMEN Objetivo: Evaluar la efectividad de la cirugía de catarata para el control de la presión intraocular en pacientes vitrectomizados con aceite de silicona remitidos de la consulta de Retina al Servicio de Catarata del Instituto Cubano de Oftalmología Ramón Pando Ferrer, en el período comprendido de enero de 2016 a enero de 2017. Métodos: Se realizó un estudio descriptivo prospectivo de series de casos en 20 pacientes. El universo quedó conformado por todos los pacientes vitrectomizados, a quienes se les colocó aceite de silicona como sustituto del vítreo con diagnóstico de catarata e hipertensión ocular. Resultados: Los pacientes vitrectomizados con aceite de silicona, a quienes se les realizó cirugía de catarata, se caracterizaron por un predominio del sexo masculino y la edad menor de 60 años, asociado a enfermedad vitreorretiniana de base. La cirugía de catarata se relacionó con una importante disminución de la presión intraocular en el posoperatorio. Todos los pacientes alcanzaron un ángulo camerular abierto posterior a la cirugía, que favoreció la disminución del uso de tratamiento tópico. No fue necesaria la cirugía filtrante posterior a esta. Conclusiones: En los pacientes vitrectomizados, la cirugía de catarata muestra una mejoría sostenida de las presiones intraoculares hasta el sexto mes del posoperatorio(AU)
ABSTRACT Objective: Evaluate the effectiveness of cataract surgery to control intraocular pressure in patients undergoing vitrectomy with silicone injection referred by retina specialists to the Cataract Service of Ramón Pando Ferrer Cuban Institute of Ophthalmology from January 2016 to January 2017. Methods: A descriptive prospective case-series study was conducted of 20 patients. The universe was all the patients undergoing vitrectomy with administration of silicone oil as a vitreal substitute who were diagnosed with cataract and ocular hypertension. Results: Patients undergoing vitrectomy with silicone oil injection and cataract surgery were mostly male, mean age was under 60 years, and a relationship was found to underlying vitreoretinal disease. Cataract surgery was associated to a considerable reduction in intraocular pressure in the postoperative period. All patients achieved an open chamber angle after surgery, leading to a reduction in the use of topical medication. Eventual filtration surgery was not required. Conclusions: In patients undergoing vitrectomy, cataract surgery leads to sustained intraocular pressure improvement until the sixth month of the postoperative period(AU)
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Humanos , Masculino , Pessoa de Meia-Idade , Óleos de Silicone/efeitos adversos , Hipertensão Ocular/epidemiologia , Facoemulsificação/métodos , Cirurgia Vitreorretiniana/métodos , Epidemiologia Descritiva , Estudos Prospectivos , Estudos LongitudinaisRESUMO
BACKGROUND: To determine the effect of the silicone on the dexamethasone intravitreal implant. METHODS: Basic, experimental, prospective and transversal study performed at the hospital "Nuestra Señora de la Luz" in Mexico City. One dexamethasone implant was placed in a test tube with 4 mL of each tamponade medium: 1000cS, 5000cS and heavy silicone oil; basic saline solution was used as the control medium. Photographs were taken weekly for 12 months. 200 µL samples were taken from each medium at 24 h, 1, 2 weeks and monthly for 12 months. ELISA test was performed to quantify dexamethasone release in every sample. An inflammatory stimulus was created and later exposed it to every sample in order to test their anti-inflammatory capacity by cytokine analysis using cytometric bead array. Statistically significant results were obtained with p < 0.05. RESULTS: Photographic follow-up showed disintegration of the implant in control medium. Implants in silicone oil suffered no changes during follow-up. Dexamethasone levels in control medium showed stability from month 2 to 12. Silicone oil mediums showed irregular dexamethasone release during the 1 year period. Dexamethasone in control medium had inhibitory effects on TNF-α starting at 24 h (p < 0.001) and remained stable. Dexamethasone in 1000cS silicone oil showed inhibitory effects from month 2 (p < 0.001) until month 6 (p < 0.001). Implants in denser silicone oils showed no inhibitory effects in any of the samples. CONCLUSIONS: Denser mediums altered the implant pharmacokinetics and showed no anti-inflammatory effects even when concentrations were quantified at levels similar to control medium in vitro.
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The development of protein therapeutics requires stabilization of these labile molecules during shipment and storage. Biologics, particularly monoclonal antibodies, are frequently packaged at high concentration in prefillable syringes traditionally made of glass. However, some biologics are unstable in glass due to sensitivity to silicone oil, tungsten, glue, or metal ions. Syringes made from the plastic cyclic olefin polymer, Daikyo Crystal Zenith® (CZ), with a Flurotec-laminated piston, have none of these issues. This study compared the stability of several proteins including biotherapeutics when stored up to 14 months at 5 °C and 25 °C in prefillable siliconized syringes made of glass or silicone oil-free CZ syringes, and when subjected to mild agitation by end-over-end rotation at room temperature. At each time point, proteins were analyzed by several techniques including turbidity, size exclusion high-performance liquid chromatography, reversed phase high-performance liquid chromatography, ion-exchange chromatography, electrophoresis, and light scattering to monitor changes in aggregation and degradation. The results show that proteins have comparable stability when stored in glass syringes or in syringes made of CZ sterilized by E-beam or autoclave. In addition, proteins stressed by agitation were generally more stable and aggregated less in syringes made of CZ than in ones made of glass.LAY ABSTRACT: Biotherapeutic protein drugs such as monoclonal antibodies are frequently packaged at high concentration in prefillable syringes, which allows the drug to be directly administered by the patient or caregiver. Protein drugs, or biologics, can be unstable, and may aggregate, particularly when shaken. These aggregates can be immunogenic, stimulating the body's immune system to produce antibodies that can reduce the drug's efficacy. Although prefillable syringes are traditionally made of glass, some biologics are unstable in glass syringes due to the presence of substances used in their manufacture, including silicone oil, which is necessary for lubricity. Syringes made from the plastic cyclic olefin polymer, Daikyo Crystal Zenith® (CZ), have none of these issues. This study compared the stability of several biotherapeutic proteins when stored up to 14 months at 5 °C and 25 °C in prefillable siliconized syringes made of glass or silicone oil-free CZ syringes, and when mildly agitated at room temperature. Proteins were analyzed by several techniques to detect changes in aggregation and degradation. The results show that biotherapeutic proteins have similar stability whether stored in syringes made of glass or CZ. In addition, proteins subjected to agitation were generally more stable and aggregated less in CZ syringes than in glass syringes.