Search Results (69)

Background/Objectives: This study aims to evaluate the long-term efficacy and safety of ab interno techniques using minimally invasive glaucoma surgery (MIGS), specifically XEN gel stent implantation, by evaluating its 2-year outcomes in patients with primary open-angle glaucoma (POAG) and pseudoexfoliation glaucoma (PXG). Methods: This retrospective single-center study consecutively included 31 eyes of 31 patients with POAG or PXG who underwent XEN gel stent implantation. Patients were followed for 24 months, with assessments at multiple time points. Success was defined as achieving an IOP of less than 14 mmHg and a reduction of more than 20% from preoperative IOP without additional glaucoma surgery. Bleb morphology was evaluated using anterior segment optical coherence tomography (AS-OCT) and slit-lamp photographs. Postoperative interventions and complications were also recorded. Results: At 24 months, complete success and qualified success rates were 35.5% (11/31) and 51.6% (16/31), respectively. There was no difference in surgical success rates at 2 years based on the tip location (intraconjunctiva, intratenon, and uviform) on the 1st postoperative day. Patients with high sparse wall on AS-OCT imaging or avascular bleb morphology via slit-lamp photography at 6 months postoperatively had higher complete success rates at 2 years than those without (p = 0.007, p = 0.009, respectively). Patients with avascular bleb types at 6 months postoperatively had higher qualified success rates at 2 years compared with the vascular types (p = 0.038). Needling was performed in 32.3% of eyes, with secondary surgical procedures required in 16.1% of eyes. The most common adverse event was hypotony, occurring in 67.7% of eyes on the 1st postoperative day but resolving within 6 months. Conclusions: The ab interno XEN gel stent is an effective and minimally invasive option for managing POAG and PXG, with long-term success predicted by the AS-OCT assessment of bleb morphology at 6 months. Proactive postoperative management, emphasizing early intervention and monitoring, is crucial for maintaining optimal outcomes. Full article

Background/Objectives: This study evaluated the efficacy and safety of the ab externo open-conjunctiva (AEO) approach with adjunctive Ologen collagen matrix (OCM) compared to ab interno closed-conjunctiva (AIC) techniques for XEN45 gel stent implantation in patients with refractory open-angle glaucoma. The goal was to determine whether the AEO with OCM approach offers advantages in intraocular pressure (IOP) control and postoperative outcomes. Methods: A retrospective, comparative case series was conducted on 76 eyes from 76 patients with open-angle glaucoma who underwent XEN45 implantation between 2017 and 2022 at a single tertiary center. The patients were divided into Group 1 (AEO with OCM, n = 47) and Group 2 (AIC, n = 29). Postoperative IOP, the number of glaucoma medications, surgical complications, bleb revisions, and failure rates were recorded over 12 months. The AEO technique, supported by OCM, was assessed for its potential to reduce postoperative fibrosis and improve long-term outcomes. Results: Both groups experienced significant IOP reductions over time compared to baseline. However, Group 1 had superior outcomes, requiring fewer glaucoma medications postoperatively (p < 0.05), and demonstrated lower rates of complications (10.6% vs. 31.0%, p = 0.026) and bleb revisions (8.5% vs. 34.5%, p = 0.005). Kaplan–Meier survival analysis showed significantly greater cumulative surgical success in Group 1 compared to Group 2 (p < 0.001). Conclusions: The AEO with OCM approach to XEN45 implantation may provide improved safety and efficacy compared to the AIC approach. It appears to be beneficial in minimizing postoperative fibrosis, reducing the medication burden, and lowering complication and failure rates. Prospective randomized trials are needed to validate these findings. Full article

Background: To compare the efficacy and safety of the XEN^® 63 µm and 45 µm devices with the ab externo open conjunctiva with a 30G needle approach. Methods: A retrospective, non-randomized and single-center study was conducted. Consecutive eyes undergoing a XEN^® 63 µm implant were compared with a matched cohort of cases with a XEN^® 45 µm implant. Standalone and combined procedures with phacoemulsification were included. Results: A total of 28 XEN^® 45 µm and 28 XEN^® 63 µm were included. Complete surgical success was achieved in 17 cases (60.7%) in the 45 µm group and in 20 cases (71.4%) in the 63 µm group, with no statistical differences. One year after the surgery, the mean IOP was 13.8 ± 3.3 mmHg for the 45 µm group and 12.4 ± 4.2 mmHg for the 63 µm group (p-value > 0.05). Likewise, the use of glaucoma medication was lowered in the 63 µm device (0.32 ± 0.87) compared to the 45 µm device (0.39 ± 0.86), with no statistical significance. Postoperative hypotony was more frequent in the 63 µm device (39.3%) than in the 45 µm group (28.6%), with no statistical differences. However, hypotony-associated complications (including choroidal detachment, hypotony keratopathy, and hypotony maculopathy) were significantly higher in the 63 µm group (p = 0.011). Conclusions: Although the XEN^® 63 µm may offer a greater IOP-lowering effect with better complete surgical success, no significant differences were detected compared to the 45 µm device. Hypotony-related complications were higher in the XEN 63 µm, although most of them resolved with conservative management. Full article

Background: In this study, we compare the 12-month results of eyes that underwent ab externo, open-conjunctival XEN45 gel stent placement with mitomycin C (MMC) with and without the intraoperative addition of Ologen collagen matrix (XEN45 and XEN45 + Ologen groups, respectively). Methods: Intraocular pressure (IOP) measurements were recorded postoperation at 1 month, 3 months, 6 months, and 9 months, and 12 months, and IOP reduction, reduction in number of IOP-lowering medications, and success rate were compared between XEN45 and XEN45 + Ologen groups. A complete success was defined as a ≥20% drop from baseline IOP at 12 months without the use of medications and without any of the following: an additional procedure (e.g., needling), a recorded IOP ≥ 21 mm Hg at two consecutive visits, or the occurrence of catastrophic events (e.g., no light perception (NLP)). A qualified success was defined as an IOP reduction of ≥20% from baseline with the use of medications. We included 145 eyes with at least 1 month of follow-up data, 46 in the XEN45 group and 99 in the XEN45 + Ologen group. Of these, 113 eyes had 12 months of follow-up data comprising 41 XEN45 eyes and 72 XEN45 + Ologen eyes. Results: There were no significant differences in the IOP change from baseline between XEN45 and XEN45 + Ologen groups except at the 3-month postop timepoint (p < 0.05). At the 12-month follow-up, 41.5% (17/41) of XEN45 eyes and 52.8% (38/72) of XEN45 + Ologen eyes met complete or qualified success criteria. Conclusions: No significant differences in success rate and decrease in the number of IOP-lowering medications from baseline were identified between XEN45 and XEN45 + Ologen groups. Full article

Background: This study aimed to assess the efficacy and safety of the 30G needle mediated ab externo open conjunctiva approach for the XEN 63 µm implant in primary open-angle glaucoma. Methods: A retrospective and non-randomized study was conducted on consecutive cases of medically refractory primary open-angle glaucoma treated with standalone ab externo open conjunctiva XEN^® 63 µm (North Chicago, Illinois) with one-year follow-up. Results: Twenty-two eyes were included. The mean preoperative intraocular pressure was 21.9 ± 7.2 mmHg, and the mean number of glaucoma medications was 2.4 ± 0.9. All patients underwent mitomycin 0.02% application for 2 min, and Healaflow^® (MedicalMix, Spain), was implanted in 11 cases (50%). Complete surgical success was achieved in 14 cases (63.6%). No statistical differences in complete surgical success were noted based on the use of Healaflow^®. A significant reduction in intraocular pressure (11.8 ± 3.4 mmHg) and in the number of hypotensive medications (0.2 ± 0.5 mmHg) was observed 1 year after the procedure. Transient hypotony was detected in 31.8% of cases. Complications secondary to hypotony included four cases of serous choroidal detachment and one case of localized hemorrhagic choroidal detachment, the latter associated with hypotonic keratopathy and hypotonic maculopathy. All these complications evolved favorably with conservative management and adjusted topical treatment. Conclusions: This study highlights the efficacy and safety of this approach for the XEN 63 µm implant in medically refractory primary open-angle glaucoma. Full article

Background/objectives: The efficacy and safety of the XEN45 gel stent implant in patients with glaucoma have been amply demonstrated. XEN63 is a new device that has been developed with a larger bore. This multicenter, observational, retrospective study assessed the efficacy and safety of XEN63 in patients with glaucoma. Methods: Medical records from six participating centers were screened to identify patients meeting the inclusion criteria. The primary outcome was mean IOP at 6 months after surgery. Results: The study included 114 eyes from 102 patients (XEN63 alone: 68 eyes, and XEN63 + Phaco: 46 eyes); 92% of patients had primary open-angle glaucoma. Baseline IOP for all patients was a median of 23.0 mmHg (IQR: 18.5–27.5 mmHg), which decreased significantly on day one post-surgery to 7.0 mmHg (IQR: 4.5–9.5 mmHg) and gradually stabilized at around 13.5 mmHg (IQR: 10.5–16.5 mmHg) by 6 months with no significant differences between groups at 6 months. The number of ocular hypertensive medications (OHMs) reduced significantly from a baseline median of 2.7 ± 1.1 to 0.5 ± 1.0 at 6 months in the entire cohort. The XEN63 alone group showed a significantly lower need for OHMs at 3 and 6 months. The surgical success rate was comparable between the two groups (54.4% vs. 47.8%, p = 0.05, XEN63 alone and XEN63 + Phaco). There was no statistically significant difference in survival outcomes between the XEN63 (0.59, 95% CI: 0.49–0.73) and XEN63 + Phaco groups (0.55, 95% CI: 0.42–0.72) (p = 0.89). Conclusions: In the largest study with XEN63 to date, the device appears to significantly decrease the IOP and the OHMs. Simultaneous XEN63 implant and phacoemulsification showed similar outcomes compared to XEN63 alone. Full article

Objectives: We evaluated the 3-year effectiveness and safety of XEN45, combined or not with phacoemulsification, in patients from the Italian XEN-Glaucoma Treatment Registry. Methods: Data from glaucoma patients who underwent XEN45 alone or combined with phacoemulsification were analyzed. Changes in intraocular pressure (IOP) and the number of ocular hypotensive medications (OHMs) were tested with repeated measures ANOVA in last observation carried forward (LOCF) and per-protocol (PP) analyses. Complete and qualified success (IOP < 18 mmHg and ≥20% IOP reduction from baseline, without or with OHMs) at 36 months and pre- and intraoperative factors predicting surgery failure were explored using survival analysis and Cox proportional-hazard models. Complications rates were evaluated to assess safety. Results: The analysis included 239 eyes (239 patients): 144 (60.2%) in the XEN alone and 95 (39.8%) in the XEN+Phaco groups. Overall success was achieved in 164 (68.1%) eyes [113 (68.9%) complete and 51 (31.1%) qualified], without significant differences in success (p = 0.07) and survival rates (p = 0.46) between groups. At the 36th month, the baseline IOP decreased from a median (IQR) of 23.0 (20.0–26.0) to 15.0 (12.0–17.5) mmHg (p < 0.01), with an overall 34.1 ± 20.1% IOP reduction. The mean ± SD number of OHMs decreased from the baseline of 2.7 ± 0.9 to 0.9 ± 1.1 at month 36 (p < 0.01). PP and LOCF analyses were comparable. Neither pre- nor intraoperative factors were significantly predictive of surgery failure. In 91 (38.1%) and 57 (23.8%) of the eyes, at least one postoperative complication occurred early (<month 1) and late (≥month 1) during follow-up, respectively, without sequelae. During follow-up, 68 (28.5%) eyes needed at least one needling. Conclusions: At 3 years, XEN45, combined or not with phacoemulsification, effectively and safely reduced IOP and OHMs need. Full article

Prosthetic joint infection (PJI) continues to be a devastating complication following total joint replacement surgeries where Staphylococcus aureus is the main offending organism. To improve our understanding of the disease pathogenesis, a histological analysis of infected peri-implant tissue in a hip PJI rat model was utilized to assess S. aureus spread and tissue reaction at early and late stages of infection. Sprague–Dawley rats were used and received a left cemented hip hemiarthroplasty using a 3D-printed titanium femoral stem. The rats received an intra-articular injection of S. aureus Xen36. These infected rats were sacrificed either at 3 days post-infection (early-stage infection) or at 13-days post-infection (late-stage infection). The femoral and acetabular tissues of all animals were harvested at euthanasia. Histological analysis for the harvested tissue was performed using immunohistochemistry, hematoxylin and eosin, as well as Masson’s trichrome stains. Histological examination revealed significant quantitative and qualitative differences in peri-implant tissue response to infection at early and late stages. This hip PJI rat model identified clear histologic differences between early and late stages of S. aureus infection and how quickly bacterial infiltration could occur. These findings can provide insight into why certain surgical strategies like debridement and antibiotics may be associated with high failure rates. Full article

Objectives: To investigate whether phakia affects the outcome of XEN-45 gel stent implantation in the treatment of pseudoexfoliative glaucoma (PXG). Methods: A retrospective, comparative cohort study of 30 phakic and 55 pseudophakic PXG patients who received the XEN-45 gel stent at a tertiary centre. The primary outcome measure was two-year success defined as a ≥20% lowering of intraocular pressure (IOP) and a target IOP of 6–21 mmHg. Success was complete without and qualified irrespective of antiglaucoma medication use. Further glaucoma surgery other than needling was regarded as a failure. The secondary outcome measures included changes in IOP, revision and complication rates. Results: The complete two-year success rates were 70% and 59% in the phakic and pseudophakic groups, respectively (p = 0.75, log-rank test), and the qualified rates were 80% and 72%, respectively (p = 0.89). The median IOP reduction from baseline was 54% in phakic, and 46% in pseudophakic eyes. While needling rates were similar, the incidence of early incisional bleb revisions was significantly higher in the phakic eyes (13% vs. 0% within 3 months; p = 0.0098, chi-square). Increasing after a year, significantly more pseudophakic eyes failed due to secondary glaucoma surgery (16% vs. 0%; p = 0.0191). Conclusions: The XEN-45 gel stent offers equally effective IOP control for both phakic and pseudophakic patients. However, the onset of bleb revisions and the necessity for secondary glaucoma surgery differed significantly between the groups. Full article

Background: To assess intraocular pressure (IOP) changes and complications after XEN45 implants in medically controlled eyes (MCE) vs. medically uncontrolled eyes (MUE). Methods: A retrospective study, in a tertiary referral hospital, on mild-to-moderate primary open-angle glaucoma (POAG) cases under topical medication, including 32 eyes with IOP < 21 mmHg (MCE group) and 30 eyes with IOP ≥ 21 mmHg (MUE group). The success criteria using Kaplan–Meier analysis was IOP < 21 mmHg without medications (complete success) or fewer drugs than preoperatively (qualified success) at the last visit, without new surgery or unresolved hypotony. Results: No significant preoperative differences were found between the groups. The mean IOP was 15.6 ± 3.8 mmHg in MCE and 15.1 ± 4.1 mmHg in the MUE group (p > 0.05; Mann–Whitney test) at the end of the follow-up (mean of 26.1 ± 15.6 months and 28.3 ± 15.3 months, respectively) (p = 0.414, Mann–Whitney Test). The device caused a significant IOP reduction at 24 h in both groups. Thereafter, the MCE group significantly tended to increase IOP, recovering baseline values at 1 month and maintaining them until the end of the follow-up. In contrast, in the MUE group, the IOP values tended to be similar after the first reduction. No relevant complications and no significant differences between the groups in the survival analysis were found. Conclusions: XEN45 provided stable IOP control in both the MCE and MUE group without important complications in the medium term. The IOP increasing in the MCE group, after a prior decrease, led to restored baseline values 1 month after surgery. The homeostatic mechanism that causes the rise in the IOP to baseline values and its relationship with failure cases remains to be clarified. Full article

Background: This study aimed to compare keratometry and anterior chamber depth (ACD) changes after XEN implantation in primary open-angle glaucoma (POAG) cases over a 3-month follow-up period. Methods: Twenty patients with POAG who underwent XEN63 implantation, either standalone or combined with cataract surgery, were included. Preoperative data, including best-corrected visual acuity (BCVA), refraction, gonioscopy, ophthalmoscopy, intraocular pressure (IOP) evaluation, and axial length, were collected. Corneal topography and ACD measurements were assessed preoperatively and at postoperative days 1, 7, 15, 30, 60, and 90. Each patient’s eye that underwent XEN surgery was included in the study group, with the fellow eye serving as a control. Results: In the study group, there was a significant decrease in IOP after XEN stent implantation at all investigated time intervals (p < 0.05). However, changes in mean ACD did not show statistically significant differences at any follow-up examination in both the study and control groups. Additionally, keratometry readings revealed no significant changes in total astigmatism or steep keratometry values in either group. Conclusions: XEN implantation in POAG cases resulted in a significant decrease in IOP over the 3-month follow-up period. However, there were no significant changes observed in mean ACD or keratometry readings, indicating stability in these parameters post-XEN implantation. These findings suggest that XEN implantation may be an effective option for IOP reduction without affecting corneal curvature or ACD in POAG patients. Full article

Modern multiprocessing embedded applications require, in many cases, two different environments on the same platform: one that meets real-time requirements and another one with a general purpose operating system. Although several technologies can be used, two of the most popular are virtualization based on hypervisors and asymmetric multiprocessing software. However, using these tools introduces latency, which must be measured to verify compliance with real-time requirements. With the aim of facilitating these measurements, this work provides a hardware tool that is more precise and easier to use than other existing software solutions. The paper also studies the interrupt latency generated by different hypervisors and asymmetric multiprocessing frameworks in a Zynq UltraScale+ platform. This research work facilitates the accurate study of the temporal response of multiprocessor embedded systems, which allows for evaluating their suitability for applications with real-time requirements. Full article

Embryonic stem cells (ESCs) favor glycolysis over oxidative phosphorylation for energy production, and glycolytic metabolism is critical for pluripotency establishment, maintenance, and exit. However, an understanding of how glycolysis regulates the self-renewal and differentiation of ESCs remains elusive. Here, we demonstrated that protein lactylation, regulated by intracellular lactate, contributes to the self-renewal of ESCs. We further showed that Esrrb, an orphan nuclear receptor involved in pluripotency maintenance and extraembryonic endoderm stem cell (XEN) differentiation, is lactylated on K228 and K232. The lactylation of Esrrb enhances its activity in promoting ESC self-renewal in the absence of the LIF and XEN differentiation of ESCs by increasing its binding at target genes. Our studies reveal the importance of protein lactylation in the self-renewal and XEN differentiation of ESCs, and the underlying mechanism of glycolytic metabolism regulating cell fate choice. Full article

The XEN45 is a minimally invasive glaucoma surgery device commonly used in clinical practice. This retrospective study included consecutive patients with open-angle glaucoma who underwent a XEN45 implant with mitomycin C, either alone or in combination with phacoemulsification, between June 2015 and March 2021. The primary end point was the mean change in intraocular pressure (IOP) from the baseline to month 6. A total of 677 eyes, 395 (58.3%) in the XEN alone group and 282 (41.7%) in the XEN+Phaco group, were included in this study. The preoperative IOP was significantly lowered from 28.7 ± 8.6 mmHg and 25.4 ± 6.9 mmHg to 13.5 ± 5.0 mmHg and 13.5 ± 4.1 mmHg at month 6 in the XEN solo and XEN+Phaco groups, respectively, with p < 0.0001 each. The mean (95% confidence interval) number of ocular hypotensive medications was significantly reduced from 3.3 (3.2–3.4) to 0.2 (0.1–0.2) and from 3.1 (2.9–3.2) to 0.2 (0.1–0.2) in the XEN solo and XEN+Phaco groups, respectively, with p < 0.0001 each. Needling was performed in 228 (33.7%) eyes. Conclusions: the XEN implant significantly reduces both IOP and the number of ocular hypotensive medications. IOP lowering was higher in the XEN solo group than in the XEN+Phaco one, although such a difference was only evident during the first month after surgery. Full article

We aimed to describe a variation of the surgical technique for the ab interno implantation of the XEN Gel Stent, which, in our experience, is yielding very successful results. The injection of 0.1 mL of air and then of 0.1 mL of a dispersive viscoelastic into the subconjunctival space at the beginning of the surgery allows one to perform a mechanical dissection between the conjunctiva and the Tenon’s capsule, creating a real space. In total, 20 eyes of 16 patients underwent the implantation of a stent gel through the “Air and Visco” technique. We retrospectively analyzed the results. We obtained a reduction in the IOP from an average of 18.3 ± 2.2 mmHg preoperatively to at 13.5 ± 3.5 mmHg at month 12. The needling rate was 20%. We did not register any cases of hypotony (IOP < 6 mmHg), hypotony maculopathy or choroidal detachment. The “Air and Visco” technique allows one to correctly place the device in the subconjunctival space, which the pneumo- and visco-dissection transforms into a real space. This enables an easier surgical performance and more predictable postoperative results, with a low needling rate and reintervention in the follow-up period. It also ensures a greater safety profile because the presence of the OVD on the bleb prevents a sudden lowering of the IOP, eliminating complications such as hypotony, hypotony maculopathy and choroidal detachment in our cohort. Full article