Search Results (26)

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/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: 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

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

We investigated the internal morphology of filtration blebs after XEN gel stent implantation using anterior segment optical coherence tomography (AS-OCT) and identified factors related to intraocular pressure (IOP) postoperatively. Eighteen eyes of 18 patients who had undergone XEN gel stent implantation were analyzed. Blebs were imaged using Visante OCT (Carl Zeiss Meditec AG, Germany) at 6 months and 1 year after surgery and evaluated for quantitative parameters including bleb height, maximum height of internal cavity, maximum bleb wall thickness, and maximum bleb epithelial thickness. Subjects were classified into two groups according to the presence or absence of a definite internal cavity between the conjunctiva and sclera using AS-OCT imaging. Nine eyes (50%) were assigned to the internal cavity group and 9 (50%) to the uniform group. Postoperative IOP was significantly lower in the internal cavity group than in the uniform group both at 6 months and 1 year after surgery (p = 0.024 and p = 0.040). Postoperative IOP showed statistically significant negative correlations with bleb height and the height of the internal cavity (Spearman correlation coefficient r = −0.518, p = 0.028 and r = −0.453, p = 0.034, respectively). AS-OCT facilitates analysis of bleb morphology after XEN gel stent implantation. A larger height of the internal cavity of the bleb appeared to correlate with lower IOP after XEN implantation. Full article

Minimally invasive glaucoma surgery (MIGS) has emerged as a novel approach in the glaucoma treatment spectrum, offering a range of diverse procedures and devices aimed at reducing intraocular pressure (IOP). MIGS can be broadly classified into several categories: those that enhance trabecular outflow (Trabectome, iStent, Hydrus Microstent, Kahook Dual Blade, high frequency deep sclerotomy, and gonioscopy-assisted transluminal trabeculotomy), those that augment suprachoroidal outflow (CyPass Microstent and iStent Supra), those that target Schlemm’s canal (TRAB360 and the OMNI Surgical System, Streamline, and Ab Interno Canaloplasty), and conjunctival bleb-forming procedures (EX-PRESS Glaucoma Filtration Device, Xen Gel Stent and PreserFlo MicroShunt). MIGS is considered to have a shorter surgical time and fewer severe complications when compared to traditional glaucoma surgeries such as trabeculectomy and glaucoma drainage device implantation (Ahmed, Baerveldt, and Molteno valves). This literature review comprehensively examines the distinct MIGS devices and procedures, their underlying mechanisms, and clinical outcomes, emphasizing the importance of evaluating the efficacy and complications of each approach individually. As the field of MIGS continues to evolve, it is crucial to prioritize high-quality, long-term studies to better understand the safety and effectiveness of these innovative interventions in glaucoma management. Full article

Although topical medical therapy and selective-laser-trabeculoplasty represent the treatments of choice to reduce intraocular pressure, many patients do not achieve adequate glaucoma control; therefore, they require further options and eventually surgery. Trabeculectomy is still considered the gold standard, but the surgical management of glaucoma has undergone continuous advances in recent years, XEN-gel-stent has been introduced as a safer and less traumatic means of lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG). This study aimed to review the effectiveness and safety of clinical data on XEN-stent in OAG patients with a Synthesis-Without-Meta-analysis (SWiM) methodology. A total of 339 studies were identified following a literature search adhering to PRISMA guidelines and, after evaluation, 96 studies are discussed. XEN63 and XEN45 device data were collected both short and long term. In addition, this document has evaluated different aspects related to the XEN implant, including: its role compared to trabeculectomy; the impact of mitomycin-C dose on clinical outcomes; postoperative management of the device; and the identification of potential factors that might predict its clinical outcomes. Finally, current challenges and future perspectives of XEN stent, such as its use in fragile or high myopia patients, were discussed. Full article

The XEN^® gel stent reduces intraocular pressure (IOP) in glaucoma. XEN^®-45 is widely used; the newer XEN^®-63 has a larger lumen targeting potentially lower IOP outcomes. We retrospectively compared the first 15 XEN^®-63 cases to 15 matched XEN^®-45 controls. With a preoperative IOP of 18.1 ± 3.9 mmHg (mean ± SD) and a final IOP of 9.1 ± 2.0 mmHg, XEN^®-63 implantation resulted in an IOP reduction of 44.6 ± 16.5%. Similarly, with a preoperative IOP of 18.3 ± 4.5 mmHg and a final IOP of 10.3 ± 2.1 mmHg, XEN^®-45 implantation resulted in an IOP reduction of 40.1 ± 17.2%. The median follow-up period was 204 days (range 78–338 days) for the XEN^®-63 group and 386 days (range 99–1688 days) for the XEN^®-45 group. In total, 5/15 eyes of each group underwent open conjunctival bleb revision within the period of observation. Three eyes of the XEN^®-63 group had secondary glaucoma surgery. One eye in the XEN^®-63 group and three eyes in the XEN^®-45 group required a restart of antiglaucomatous medication. In conclusion, both stents effectively lower IOP and medication. XEN^®-63 achieved a slightly lower IOP over a short follow-up. Complication and revision rates were similar. Full article

Evaluation of bleb morphology is a vital part of successful filtration glaucoma surgery. The PRESERFLO-MicroShunt (PRESERFLO) and XEN-Gel-Stent (XEN) are drainage devices implanted using different surgical approaches (ab externo and ab interno, respectively), potentially resulting in distinct bleb morphology. Understanding these morphological differences is essential for postoperative care. In this study, we retrospectively examined functioning blebs following PRESERFLO and XEN implantation using high-resolution anterior segment OCT imaging. Qualitative assessment utilizing the Jenaer Bleb Grading System and quantitative assessment measuring 12 parameters representing bleb dimensions were conducted, and the results were compared between the two groups. A total of 80 eyes from 80 patients were included (41 after PRESERFLO, 39 after XEN). Functioning blebs following PRESERFLO exhibited a higher frequency of hyperreflective tenon changes compared to XEN (31.7% vs. 10.3%, respectively, p = 0.02) and a lower frequency of cavernous changes (17.1% vs. 35.9%, p = 0.05). Additionally, PRESERFLO blebs showed a higher frequency of visible episcleral lakes (92.7% vs. 30.8%, p < 0.001). Furthermore, PRESERFLO blebs demonstrated larger height (2.13 ± 0.5 vs. 1.85 ± 0.6 mm, p = 0.03), width (10.31 ± 2.3 vs. 9.1 ± 2.3 mm, p = 0.02), length (9.13 ± 1.8 vs. 8.24 ± 1.9 mm, p = 0.04), posterior location relative to the limbus (6.21 ± 1.2 vs. 5.21 ± 1.8 mm, p = 0.005), and a thicker bleb wall (1.60 ± 0.5 vs. 1.1 ± 0.4 mm, p = 0.004). Functioning blebs following PRESERFLO and XEN displayed morphological distinctions, likely attributed to variations in surgical techniques (ab externo vs. ab interno) and stent dimensions. These morphological differences should be taken into consideration when evaluating blebs, as they could impact assessments of bleb functionality and influence decisions regarding postoperative interventions. Full article

This case report describes the successful use of a XEN gel stent for controlling intraocular pressure (IOP) in a patient who had previously undergone scleral encircling for rhegmatogenous retinal detachment. The patient had very limited mobile conjunctiva due to scarring caused by the earlier surgery, which limited their options for glaucoma surgery. The XEN gel stent, a minimally invasive glaucoma surgery (MIGS) procedure that does not require opening the conjunctiva, was implanted in the subconjunctival space using an ab interno approach. Postoperative blebs were imaged using anterior segment optical coherence tomography, and IOP was monitored over six months. This study found that the XEN gel stent effectively controlled the IOP, and there were no complications during or after surgery. This case report may expand the indication for the XEN gel stent, which could be considered a viable option for patients who have undergone scleral buckling and have limited mobile conjunctiva. Full article

Pyoderma gangrenosum (PG) is an uncommon inflammatory skin disorder typically presenting as painful skin ulcers, which may also exhibit extracutaneous findings. PG can occur at the site of trauma or surgery, which is known as the pathergic phenomenon. A 36-year-old man developed bilateral steroid-induced glaucoma after prolonged systemic immunosuppressive treatment for cutaneous pyoderma gangrenosum. After successful Ahmed glaucoma valve implantation surgery with donor scleral patch graft in the right eye, the same surgery failed repeatedly in the left eye and complicated with the prolonged conjunctival necrosis and the exposure of the donor scleral patch graft. Under the impression of ocular involvement of PG, microinvasive glaucoma surgery (MIGS) with XEN^® Gel Stent was performed in the left eye; the conjunctival bleb was successfully formed without conjunctival necrosis, and intraocular pressure was well maintained. Ophthalmic surgery can be complicated in patients with PG, and the surgical option should be selected prudently to minimize surgical trauma. MIGS, as a minimally invasive surgical technique, could offer an advantage for patients with PG. Full article

Purpose: This study aimed to describe a rare case of bilateral choroidal effusion following a XEN45 implantation. Case Report: An 84-year-old man with primary open-angle glaucoma underwent uneventful ab interno XEN45 device implantation in the right eye. The immediate postoperative period was complicated by hypotony and serous choroidal detachment, which were treated and resolved using steroids and cycloplegic drops. Eight months later, the fellow eye underwent the same surgery, which was followed by choroidal detachment that required transscleral surgical drainage. Conclusions: This case highlights the importance of a careful postoperative follow-up and a timely intervention in the context of XEN45 implantation, and suggests that choroidal effusion in one eye may be a risk factor for choroidal effusion in the other eye when undergoing the same type of surgery. Full article