Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products.

Silicone oil is a commonly used lubricant in pre-filled syringes (PFSs) and can migrate over time into solution in the form of silicone oil particles (SiOPs). The presence of these SiOPs can result in elevated subvisible particle counts in PFS drug products compared to other drug presentations such as vials or cartridges. Their presence in products presents analytical challenges as they complicate quantitation and characterization of other types of subvisible particles in solution. Previous studies have suggested that they can potentially act as adjuvant resulting in potential safety risks for patients. In this paper we present several analytical case studies describing the impact of the presence of SiOPs in biotherapeutics on the analysis of the drug as well as clinical case studies examining the effect of SiOPs on patient safety. The analytical case studies demonstrate that orthogonal techniques, especially flow imaging, can help differentiate SiOPs from other types of particulate matter. The clinical case studies showed no difference in the observed patient safety profile across multiple drugs, patient populations, and routes of administration, indicating that the presence of SiOPs does not impact patient safety.

Long-term anatomical and functional outcomes of surgical treatment of retinal complications in children and adolescents with Stickler syndrome between 2004 and 2021.

BACKGROUND: Stickler syndrome (STL) is an inherited progressive connective tissue collagen disorder. STL is the most common hereditary cause of retinal complications, retinal tears, and the development of retinal detachment (RD) in childhood. The aim of the study was to evaluate the long-term anatomical and functional results of surgical treatment of retinal complications in children and adolescents affected by STL. METHODS: A retrospective, single-center study was performed a cohort of children with STL who underwent retinal surgery between 2004 and 2021. RESULTS: The study group consisted of nine children; the mean age at the time of the retinal tear with/without retinal detachment was 7.2 (2-10) years, and the mean follow-up period was 9.6 (5-16) years. Pathogenic variants COL2A1 (5 children) and COL11A1 (3 children) were confirmed in our cohort. In total, we operated on 13 eyes, 11 eyes with complicated RD and two eyes with multiple retinal defects, but without RD. At the end of the follow-up period, an attached retina was achieved 77% (10 eyes) with or without silicone oil tamponade: cryopexy alone was successful in one eye (10%), scleral buckling (EB) in five eyes (50%), and vitrectomy with silicone oil tamponade combined with EB in four eyes (40%). The mean number of surgeries was 2.3 per eye. The resulting best corrected visual acuity ranged from 0.03 to 0.1 in one eye, from 0.16 to 0.4 in two eyes, and from 0.5 to 1.0 in 7 eyes. CONCLUSION: Repair of retinal tears with/without retinal detachment in patients with Stickler syndrome often requires multiple surgeries with combinations of cryopexy, scleral buckling, and/or vitrectomy with silicone oil tamponade. Treatment of the ocular complications arising from STL requires long-term comprehensive care.

The study on the feasibility of dietary supplementation with dimethyl silicone oil to prevent frothy rumen bloat in goats fed with high concentrate diets.

The current study was conducted to investigate the feasibility of high concentration diet (HCD) supplementation with Dimethyl Silicone Oil (DSO) to prevent frothy rumen bloat in goats. The treatments were control group (group C, feeding HCD) and test group (group T, feeding HCD supplemented with 0.1%DSO). The results showed that compared with the group C, the ruminal pH value, Microbial Crude Protein content of group T was extremely significantly higher (p < 0.01), the levels of acetic acid and propionic acid were significantly (p < 0.05) and extremely significantly (p < 0.01) lower in group T, respectively. The foam production and foam strength of the rumen fluid in the group T was extremely significantly lower (p < 0.01), the viscosity was extremely significantly (p < 0.01) higher than those of group C. The total gastrointestinal apparent digestibility of various nutrients, the rumen microbial relative abundance at the phylum level and genus level were not significantly different (p > 0.05). The results indicated that the supplementation of 0.1% DSO in HCD can significantly eliminate foam of the rumen fluid, and didn't disturb the ruminal microorganisms, no negatively affect on digestibility of nutrients in goats, thereby has the application prospect of preventing frothy rumen bloat.

The gas produced by rumen fermentation is wrapped in foam and cannot be discharged is the root cause of frothy bloat induced by a high concentration diet. In the present study, the feasibility of dietary supplementation with Dimethyl Silicone Oil (DSO) to prevent frothy bloat was preliminarily evaluated. The results indicated that DSO can significantly eliminate foam of the rumen fluid, and has not negatively effect on the ruminal microorganisms and the digestibility of nutrients in goats, thereby has the application prospect of preventing frothy bloat.

REPAIR OF THE EXIT WOUND OF A PERFORATING GLOBE INJURY WITH THE AMNIOTIC MEMBRANE: A SURGICAL ADJUVANT FOR EARLY VITRECTOMY.

PURPOSE: To describe the use of the amniotic membrane for the repair of the exit wound of a perforating injury involving the retina and the choroid. METHODS: Case report. RESULTS: A 46-year-old man presented one day after a perforating ocular injury with an exit wound close to the inferior temporal retinal vascular arcade. The next day, the patient underwent a combined vitrectomy and phacoemulsification with intraocular lens implantation. During vitrectomy, a retinochoroidectomy was performed at the exit wound and the internal limiting membrane was peeled over the macula and up to the exit wound. Laser retinopexy was followed by plugging of a piece of the amniotic membrane to the exit wound. A second piece of the amniotic membrane was used to cover the bare retinochoroidectomy area. The surgery was concluded with a silicone exchange. Postoperatively, no sign of proliferative vitreoretinopathy was observed, and at 3 months, the silicone oil was removed. The follow-up was uneventful, and the eye achieved a final visual acuity of 20/30. CONCLUSION: The amniotic membrane may offer a simple and safe solution for the repair of the exit wounds of perforating injuries involving the retina and the choroid. The use of the amniotic membrane for this purpose may afford the opportunity for early vitrectomy in the management of perforating ocular injuries.

Effect of different adjuvant formulations on the antibody response of horses to porcine zona pellucida proteins.

Immunization with porcine zona pellucida (PZP) proteins is being used successfully to induce infertility in wildlife including horses. However, widespread adoption of this method to control the growth of horse populations requires further refinement in order to induce long-term infertility, reduce the frequency and severity of injection site reactions, and make the vaccines easier to administer. The next generation of PZP-based vaccines will likely be a controlled-release formulation with different adjuvants from the Freund's adjuvants used in existing vaccines. We evaluated the response of equine peripheral blood mononuclear cells to a cationic nanoparticle adjuvant, Nano-11, alone and with the TLR agonists poly(I:C) and CpG ODN as a screen to develop an adjuvant system suitable for immunization of horses. The secretion of IL-1ß, TNF and CXCL10 were used as readouts. The combination of poly(I:C) with Nano-11 significantly increased the secretion of IL-1ß and TNF in comparison with Nano-11 only, with little effect of further addition of CpG ODN. The efficacy of the Nano-11/poly(I:C) adjuvant to enhance the immune response to native PZP proteins was determined in horses. Horses were immunized twice with the licensed Zonastat-H vaccine or PZP with Nano-11/poly(I:C) emulsified in silicone oil. A third group received PZP with the saponin adjuvant QA-21 emulsified in silicone oil. The horse sera collected monthly after the injections had increased anti-PZP IgG antibodies with the strongest response observed with Zonastat-H. We conclude that Nano-11/poly(I:C) is a potential candidate for the development of a controlled release formulation of a next generation PZP-based immunocontraception.

Surgical management of complicated retinal detachment in a case of retinal hemangioblastoma.

Background: A 40-year-old male presented with a complaint of sudden onset diminution of vision in the left eye for 2 weeks. He was a follow-up case with retinal hemangioblastoma in both eyes. He underwent two sittings of fundus fluorescein angiography-guided trans-pupillary thermotherapy 2 years back. Since then, he was regularly followed up for 2 years with stable vision and stable retinal findings. At present, the best-corrected visual acuity (BCVA) in the right eye is 6/6, and in the left eye, it is counting fingers 2 meters. On fundus examination, he had one active hemangioblastoma in the right eye and total retinal detachment in the left eye with multiple active lesions. The right eye was treated with a single sitting of thermotherapy, and the left eye underwent pars plana vitrectomy and angioma excision, followed by silicone oil tamponade. The immediate and late post-operative periods were uneventful, with successful anatomical and functional outcomes. The left eye BCVA on late follow-up was 6/36, no further treatment was advised, and the patient was kept under follow-up and observed closely. Purpose: : To educate regarding the systemic workup, diagnosis, and surgical management of complicated retinal detachment in retinal hemangioblastoma. Synopsis: : Systemic workup, diagnosis, and surgical steps in the management of complicated retinal detachment in retinal hemangioblastoma were performed. Highlights: : Close follow-up, keen observation, and prompt treatment in the early stages of the disease are indispensable to prevent untoward sequelae of retinal hemangioblastoma. A thorough systemic workup is necessary to diagnose the systemic involvements early. Surgery, if indicated for the retinal hemangioblastoma or its associated sequelae, should be performed diligently and with careful handling of blood vessels and anomalous tissues. Online Video Link: https://youtu.be/CkoqWEnaPB8.

Self-Induced Bilateral Retinal Detachments and Traumatic Cataracts in a Patient With Bohring-Opitz Syndrome.

A 9-year-old female with a history of Bohring-Opitz syndrome (BOS), Down syndrome, and autism initially presented with bilateral cataracts and a total retinal detachment in her left eye secondary to chronic self-injurious behavior. The authors report the first case of self-induced retinal detachment and traumatic cataracts in a patient with BOS. For patients who present with self-injurious behavior, the authors advocate for behavioral modifications at home, including the use of "no-no's," supplemental medication if necessary, and behavioral therapy to reduce the risk of self-induced visual injury. The authors also suggest the use of 25-gauge vitrectomy with silicone oil for retinal detachment repair. Finally, given the high risk of irreversible vision loss from amblyopia and recurrent retinal detachments in children with BOS and self-injurious behavior, the authors recommend regular 2-month interval ophthalmic follow-up. [Ophthalmic Surg Lasers Imaging Retina. 2021;52:400-402.].

Method Comparison Study-One Step Forward toward Robust Silicone Layer Thickness Measurements.

In the past decades, the silicone layer thickness and its distribution on the inner glass barrels of prefilled syringes have been characterized in several studies. However, the limited number of adequate methods to characterize thin baked-on silicone layers and the destructive nature of some analytical techniques suggest challenges to the inter-lab reproducibility of some methods. In this study, the measured silicone layer thickness of baked-on siliconized syringes was compared between two laboratories, both equipped with white light reflectometry coupled to laser interferometry instrumentation (Bouncer, LE UT 1.0, LE UT 2.0). The quantity of silicone oil of a subset of those syringes was measured by Fourier transform infrared spectroscopy. Glide force tests were realized as complementary measurements on both syringes analyzed by white light reflectometry coupled to laser interferometry instrumentation and on non-analyzed identical syringes from the same lot. Silicone profiles of all prefilled syringes including the limit of detection results replaced with 20 nm were comparable, but values were slightly lower when measured with the Bouncer instrument. An increase of the layer thickness from the finger flange to the needle side was found for all syringes with all instruments (20 nm to 130-140 nm). Glide force results were similar except for a difference in peak width in the break loose region between the laboratories. The mean quantities of silicone oil found by both laboratories were similar (64 µg/syringe and 69 µg/syringe). Overall, comparable results between laboratories suggest a good reproducibility of the thickness measurement method as a result of thorough method understanding and defining key method parameters. Hence this study presents a robust inter-lab comparison between silicone layer thickness measurements that has been a lack in the literature up to now.

Intravitreal Conbercept Injection as an Adjuvant in Vitrectomy with Silicone Oil Infusion for Severe Proliferative Diabetic Retinopathy.

Purpose: To assess the clinical effects of preoperative, intraoperative, or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in vitrectomy with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods: Ninety-eight eyes of 98 severe PDR patients undergoing vitrectomy with silicone oil tamponade were randomly assigned to 3 groups: Group 1 (34 eyes) received IVC injections 3 to 5 days before surgery; Group 2 (35 eyes) received IVC injections at the end of surgery; and Group 3 (29 eyes) received IVC injections 3 to 5 days before and at the end of operation. Follow-up examinations were performed for 6 months. Results: The incidence and severity of intraoperative bleeding were not significantly different (P = 0.233). However, the duration of surgery was significantly shorter in Group 1 and Group 3 compared with Group 2 (P < 0.001). The incidences of early and late recurrent vitreous hemorrhage (VH) were 32.35%, 28.57%, and 13.80%, respectively. At 6-month follow-up, mean best-corrected visual acuity had significantly increased to 1.25 ± 0.45 logMAR in Group 1, 1.29 ± 0.46 logMAR in Group 2, 1.16 ± 0.44 logMAR in Group 3 (all P < 0.001). The incidence of postoperative VH, neovascular glaucoma, and retinal detachment in Group 3 was slightly lower, however, no significant differences were observed (all P > 0.05). In young patients, similar results were observed and Group 3 had better visual improvements (P = 0.037). Conclusions: Preoperative IVC injection could be a safe and effective adjunct in pars plana vitrectomy with silicone oil tamponade for severe PDR. Preoperative combined with intraoperative IVC are promising, especially in young patients.

Erosive Retinopathy and Retinal Detachment From Depot Intravitreal Triamcinolone Acetonide Injection at the End of Pars Plana Vitrectomy.

BACKGROUND AND OBJECTIVE: Intravitreal triamcinolone acetonide (IVTA) used as a surgical adjuvant for pars plana vitrectomy (PPV) can stain cortical vitreous, control postoperative inflammation, and reduce retinal edema. Sterile endophthalmitis uncommonly complicates office-based IVTA injection. The authors report a new complication of IVTA depot injection at the end of PPV. PATIENTS AND METHODS: Retrospective records review of all patients treated at the Cincinnati Eye Institute with PPV between January 1, 2011, and December 31, 2017, who developed a triad of sterile endophthalmitis, atrophic retinal breaks under the depot IVTA in the inferior retina, and rhegmatogenous retinal detachment (RRD). Eyes with flap tears, solely superior breaks, or stretch holes from proliferative vitreoretinopathy causing RRD were excluded. RESULTS: Eight eyes of eight patients (four males and four females; mean age: 73.7 years) who received 4 mg or 8 mg IVTA depot at the end of PPV surgery presented at a mean of 23.5 days following PPV with RRD (one macula-involving, seven macula-sparing), requiring treatment with PPV in six eyes and laser retinopexy alone in two eyes. Seven eyes that underwent membrane peeling (MP) received IVT to prevent cystoid macular edema (CME) and one eye with prior MP was treated for CME. Mean vitreous inflammation was 2+ cell at 1 week postoperatively. Two patients had documented sterile endophthalmitis within the first week requiring vitreous cultures and antibiotics injections. Visual acuity (VA) for eyes requiring PPV for RD repair declined from 20/90 preoperatively to 20/212 at 6 months postoperatively. VA for eyes amenable to laser alone improved from 20/53 to 20/35. All eyes remained attached, with the exception of one patient who refused further treatment after developing recurrent detachment from PVR. CONCLUSIONS: Particle-induced sterile endophthalmitis from IVTA depot at the end of PPV surgery resulted in atrophic inferior retinal breaks and RRD as a newly described entity coined "erosive retinopathy." All retinal detachment surgeries required silicone oil tamponade. Poor visual outcome at 6 months was common for eyes requiring PPV for RD repair. The authors recommend avoiding IVTA depot injection at the end of PPV. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:613-619.].

[Treatment of retinal detachment of the pseudophak: vitrectomy without episcleral indentation versus ab externo surgery]. / Le traitement du décollement de rétine du pseudophaque: vitrectomie sans indentation épisclérale VERSUS Chirurgie Ab externo.

Several factors predispose to the occurrence of rhegmatogenous retinal detachment, including cataract surgery, myopia, and degenerative lesions of the peripheral retina as well as eye trauma. This study aims to compare the anatomical and functional outcome of the two surgical techniques (AB interno vs AB externo) in our Hospital. We conducted a descriptive, retrospective study in the Department of Ophthalmology at the University Hospital Mohamed VI in Marrakech, over a period of 3 years, ranging from January 2013 to December 2015. During the study period we compared two groups of people: the first group undergoing surgery by an external approach (cryoapplication of the dehiscences with episcleral indentation) while the second undergoing surgery by endo-ocular approach. Group A or AB externo group included 26 eyes (26 patients) while Group B or vitrectomy with internal tamponade group included 22 eyes (22 patients). In the AB externo group, the average age was 54.92 years against 51.64 years in the AB interno group, with a slight predominance of males in both groups. After the first surgery, retinal reapplication was obtained in both groups with no significant difference, (about 80.76% in Group A versus 81.82% of the second group). In both groups failure was caused advanced vitreoretinal proliferation (4 cases), de novo breaks (3 cases) and breaks which had not been detected on first examinations (2 cases). All these cases underwent reoperation by AB interno approach: patients of group A underwent complete vitrectomy with revision of the indentation +/- internal limiting membrane peeling with internal gas tamponade while patients of group B underwent complementary vitrectomy with dissection of proliferative vitreoretinopathy (PVR) and an internal tamponade with silicone oil. After a mean follow-up period of 12 months, there was no significant difference in visual acuity between the 2 groups, with more than one third of the patients who had regained visual acuity between 1/10 and 5/10 (about 34,61% in AB externo group and 36,36% in AB interno group). Given the technological advances in vitrectomy, the current trend is the endo-ocular surgery however ab-externo surgery is mainly used in the treatment of retinal detachment with visible breaks which can be easily treated with indentation without advanced vitreoretineal proliferation (PVR A-B).

TRActional DIabetic reTInal detachment surgery with co-adjuvant intravitreal dexamethasONe implant: the TRADITION STUDY.

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.

Studies on olive-and silicone-oils-based Janus macroemulsions containing ginger to manage primary dysmenorrheal pain.

Ginger (GIN) powder-loaded oil-in-water (o/w) macroemulsions were prepared based on olive-and silicone-oils. The dispersed oil droplets with paired-beans structure were evident and thus the final emulsion can be termed as Janus macroemulsions. The objectives of the present study are (1) to identify the marker compound present in GIN powder via HPLC analysis, (2) to process the GIN powder via anti-solvent precipitation technique, (3) to see the solubility of GIN powder in various single oils or oil combination, (4) to optimize the GIN-loaded o/w macroemulsions using the central composite design (CCD) with respect to mean particle size of dispersed oil droplets and highest percentage drug entrapment efficiency values (DEE) and (5) to evaluate the pain reducing activity of optimized GIN-loaded macroemulsion via in vivo primary dysmenorrhea (PD) mice model. Both predicted and obtained values of percentage DEE (76.29 Vs.76.09) and mean particle size (245.99 Vs. 272.51 µm) were almost the same indicating the CCD statistical design applicability. The optimized Janus macroemulsion was stable at 4 °C for over a period of 90 days. Using the PD mice model, the counting of writhing reaction produced by the tested GIN-loaded macroemulsions at low and high doses did not reveal significant difference in comparison to the positive control (aspirin treated). Only the high dose of GIN-loaded macroemulsion was able to restore the uterine tissue's normal histomorphological structure after the H & E staining. Nevertheless, the paired beans structure should be tested for entrapping the plant-derived drugs having dissimilar physicochemical characteristics but similar therapeutic activity.

Optic Nerve Sheath Fenestration for Treatment of Retrolaminar Silicone Oil Migration.

The authors report the case of a 75-year-old man with preexisting glaucoma and recurrent retinal detachment who underwent intraocular silicone oil placement OD resulting in subsequent retrolaminar silicone oil migration to the optic chiasm and vision loss OS. MRI showed silicone oil tracking posteriorly along the right optic nerve to the chiasm. He was placed on high-dose corticosteroids and underwent a successful optic nerve sheath fenestration with improvement of vision in the contralateral eye. Clinicians should be cognizant of the potential for translaminar posterior migration of intraocular silicone oil, as well as the utility of optic nerve sheath fenestration to decompress the anterior visual pathways and restore vision.

Conbercept and Ranibizumab Pretreatments in Vitrectomy with Silicone Oil Infusion for Severe Diabetic Retinopathy.

PURPOSE: We compared the efficacies of intravitreal ranibizumab (IVR) and intravitreal conbercept (IVC) as the adjuvant pretreatments for vitrectomy with silicone oil infusion for tractional retinal detachment (TRD) secondary to proliferative diabetic retinopathy. METHODS: This retrospective study comprised 74 patients (79 eyes) who underwent vitrectomy with silicone oil tamponade for diabetic TRD. They received IVC (37 eyes) or IVR (42 eyes) at standard doses 3-5 days preoperatively and were followed up for ∼6 months. Anatomic success rate, intra- and postoperative complications, and visual outcomes were compared between both groups. RESULTS: Initial (IVC vs. IVR: 97% vs. 98%) and final anatomic success rates (100% in each group) and mean visual acuity changes were not significantly different (P = 0.46). Intraoperative complications [iatrogenic retinal breaks (P = 0.58) and intraoperative bleeding (P = 0.66)], postoperative complications [fibrin formation (P = 0.51), postoperative preretinal bleeding (P = 0.88), progressing or persistent neovascular glaucoma (P = 0.63), progressive fibrovascular proliferation (P = 0.93), and recurrent retinal detachment (P = 0.93)], and surgical variables [surgical time (P = 0.53)] were similar between both groups. CONCLUSIONS: Conbercept and ranibizumab are equally effective surgical adjuvants for vitrectomy with silicone oil infusion in patients with diabetic TRD.

Management of Chronic Hypotony Following Bilateral Uveitis in a Patient Treated with Pembrolizumab for Cutaneous Metastatic Melanoma.

Purpose: To describe the presentation and management of severe ocular adverse events following treatment with pembrolizumab for cutaneous metastatic melanoma. Methods: Interventional case report. Results: A 73-year-old Caucasian man receiving pembrolizumab treatment for metastatic melanoma presented with panuveitis and subsequent profound hypotony, choroidal effusions, and optic disk swelling bilaterally. Oral prednisolone controlled intraocular inflammation. However, bilateral hypotony persisted which was managed over a 12-month period with ocular viscoelastic device injections into the anterior chamber of both eyes. There was also phacoemulsification with pars plana vitrectomy (PPV) and silicone oil (SO) tamponade performed on the left eye only. Intraocular pressure (IOP) stabilized (>6 mmHg) with best-corrected visual acuity of 6/60. Conclusion: We report a severe adverse event from pembrolizumab therapy resulting in uveitis and persistent hypotony. Repeat injections of high viscosity OVD achieved an increase in IOP up to 12 months. This technique may be a useful adjuvant or alternative to PPV and SO.

Vitrectomy with silicone oil tamponade for retinal detachment associated with giant retinal tears: Favourable outcomes without adjuvant scleral buckling.

PURPOSE: To evaluate the outcomes of pars plana vitrectomy with silicone oil tamponade in the management of retinal detachment associated with giant retinal tears. METHODS: We reviewed 45 eyes of 42 patients with primary retinal detachment associated with giant retinal tears over 10 years at a tertiary referral centre. Patients underwent 23-gauge vitrectomy without adjuvant scleral buckling by a single surgeon and had follow-up at least 6 months after silicone oil removal. RESULTS: Mean follow-up was 37 ± 35 months. Seven eyes (16%) had grade C proliferative vitreoretinopathy, and 16 (36%) had a giant retinal tear ≥180° at baseline. The primary reattachment rate was 84%, and the overall final anatomical success rate was 98%. The mean Snellen visual acuity equivalent at the final visit was 20/58. Final visual acuity ≥20/40 was achieved in 64%. The mean duration of silicone oil tamponade was 10.5 ± 4 weeks. By the final visit, silicone oil had been removed from 44 eyes (98%). CONCLUSION: The high rates of anatomical and functional success support management of giant retinal tears-associated retinal detachment with vitrectomy without adjuvant scleral buckling. Removal of silicone oil at the earliest possible time helps to avoid complications such as keratopathy, glaucoma and visual loss without apparent reason.

Comparison of topical and retrobulbar anesthesia in terms of pain experience during silicone oil extraction.

PURPOSE: To compare the use of topical anesthesia and retrobulbar anesthesia during silicone oil removal with a mixed pars plana technique, through evaluating the pain experience of patients. METHODS: We selected patients according to their behavior during previous vitreoretinal surgery and ophthalmologic examinations and divided them into two anesthesia groups: topical (n=36) and retrobulbar (n=33). We used a mixed technique for the passive removal of silicone oil in both groups. During each step of the surgery, the patients' pain experience and the surgeon's comfort were scored according to a pain scale. RESULTS: The pain experienced during the application of the anesthesia was significantly greater in the retrobulbar group (p<0.001). The topical group experienced greater pain during trocar insertion (p<0.001). There was no significant difference between the groups regarding the overall pain experience or complications. CONCLUSIONS: The pain experience of the selected patients during silicone oil removal was comparable between the topical and the retrobulbar anesthesia. Topical anesthesia with the mixed pars plana technique is an effective and safe alternative option for silicone oil removal surgery.

Comparison of topical and retrobulbar anesthesia in terms of pain experience during silicone oil extraction / Comparação da sensação de dor durante a extração de óleo de silicone sob anestesia tópica e retrobulbar

ABSTRACT Purpose: To compare the use of topical anesthesia and retrobulbar anesthesia during silicone oil removal with a mixed pars plana technique, through evaluating the pain experience of patients. Methods: We selected patients according to their behavior during previous vitreoretinal surgery and ophthalmologic examinations and divided them into two anesthesia groups: topical (n=36) and retrobulbar (n=33). We used a mixed technique for the passive removal of silicone oil in both groups. During each step of the surgery, the patients' pain experience and the surgeon's comfort were scored according to a pain scale. Results: The pain experienced during the application of the anesthesia was significantly greater in the retrobulbar group (p<0.001). The topical group experienced greater pain during trocar insertion (p<0.001). There was no significant difference between the groups regarding the overall pain experience or complications. Conclusions: The pain experience of the selected patients during silicone oil removal was comparable between the topical and the retrobulbar anesthesia. Topical anesthesia with the mixed pars plana technique is an effective and safe alternative option for silicone oil removal surgery.

RESUMO Objetivo: Comparar a sensação de dor de pacientes durante a remoção do óleo de silicone sob anestesia tópica e retrobulbar, usando uma técnica via pars plana combinada. Métodos: Os pacientes foram selecionados, de acordo com suas atitudes durante cirurgia vitreorretiniana prévia e exames oftalmológicos, e divididos em dois grupos: anestesia tópica e retrobulbar. Para a remoção passiva do óleo de silicone, utilizou-se uma técnica combinada em ambos os grupos. A sensação de dor dos pacientes e o conforto do cirurgião foram classificados através de uma escala de dor durante cada etapa da cirurgia. Resultados: Os grupos anestesia tópica e retrobulbar incluíram 36 e 33 pacientes, respectivamente. A sensação de dor durante a aplicação da anestesia foi significativamente maior no grupo retrobulbar (p<0,001). O grupo anestesia tópica sentiu mais dor durante a inserção do trocarte (p<0,001). Não houve diferença significativa entre os grupos em relação à sensação geral de dor e a complicações. Conclusões: A sensação de dor é comparável entre a anestesia tópica e a retrobulbar durante a remoção de óleo de silicone. A combinação de anestesia tópica e uma técnica via pars plana é uma opção alternativa eficaz e segura para a cirurgia de remoção de óleo de silicone.

A quality of life survey in patients with long-term silicone oil or phthisis bulbi.

AIM: The aim of this study is to determine whether there is any difference in the quality of life of patients with a blind eye with long-term silicone oil compared to without. METHOD: Patients with either long-term silicone oil in situ (N = 17), defined as a period greater than 6 months duration with no plan for future removal, or those with a phthisical, non oil-filled eye were identified (N = 13). Two validated questionnaires (NEI VFQ-25 and the FACE-Q) that cover indicators for visual function, pain and cosmesis were sent to all patients in the two cohorts. RESULTS: There was no significant difference found in quality of life outcomes between the two groups in terms of visual function, pain or cosmesis. CONCLUSION: The results of this study support a holistic approach to the consent process before vitreoretinal surgery. Patients that may need to undergo multiple vitreoretinal procedures, where the endstage result is a long-term silicone oil fill, should be informed that their functional outcome may be similar to having no surgical intervention.