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AimThis study was aimed to summarize the complications and their management associated with XEN gel stent implantation.MethodsA systematic review of literature was conducted using Medline (via PubMed), EMBASE, the Cochrane Library databases, and China National Knowledge Infrastructure, from their inception to February 1, 2024.ResultsA total of 48 studies published between 2017 and 2024 were identified and included in the systematic review, including 16 original studies (retrospective or prospective clinical studies), 28 case reports, and 4 case series, which followed patients for up to 5 years. Early postoperative complications of XEN gel stent implantation include hypotony maculopathy (1.9–4.6%), occlusion (3.9–8.8%), suprachoroidal hemorrhage (SCH), choroidal detachment (0–15%), conjunctival erosion, and exposure of the XEN gel stent (1.1–2.3%), wound and bleb leaks (2.1%) and malignant glaucoma (MG) (2.2%). Mid-postoperative complications of XEN gel stent implantation included migration of XEN (1.5%), ptosis (1.2%), endophthalmitis (0.4–3%), macular edema (1.5–4.3%), hypertrophic bleb (8.8%) and subconjunctival XEN gel stent fragmentation (reported in 2 cases). Late postoperative complications reported in cases included spontaneous dislocation and intraocular degradation.ConclusionXEN gel stent implantation is a minimally invasive glaucoma surgery (MIGS) procedure for glaucoma, known for its potential to minimize tissue damage and reduce surgical duration. However, it is crucial to note that despite these advantages, there remains a risk of severe complications, including endophthalmitis, SCH, and MG. Therefore, postoperative follow-up and early recognition of severe complications are essential for surgical management.

Tobias Busch,1 Dragana Skiljic,1,2 Thiemo Rudolph,1 Anders Bergström,1,3 Madeleine Zetterberg1,2 1Department of Ophthalmology, Sahlgrenska University Hospital, Mölndal, Region Västra Götaland, Sweden; 2Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; 3Department of Ophthalmology, Skåne University Hospital, Lund, SwedenCorrespondence: Madeleine Zetterberg, Department of Clinical Neuroscience/ Ophthalmology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Mölndal, SE-431 80, Sweden, Tel +46 31 342 10 00, Fax +46 31 41 29 04, Email madeleine.zetterberg@gu.sePurpose: To report the long-time success rate of XEN 45 gel stent implantation in a Scandinavian population.Patients and Methods: This was a retrospective single-center analysis of all patients undergoing XEN 45 stent surgery between December 2015 and May 2017. The main outcome was success rate according to several definitions of success. Subgroup analysis was performed. Secondary outcomes were change in intraocular pressure (IOP) and number of IOP-lowering agents. Need for secondary glaucoma surgery, needling rate and complications were recorded.Results: A total of 103 eyes could be evaluated after four years. Mean age was 70.6 years. Primary open-angle glaucoma (POAG) accounted for 46.6% and exfoliative glaucoma (PEXG) for 39.8%. Mean IOP dropped from 24.0 to 15.9 mmHg (p< 0.001) and IOP-lowering agents from 3.5 to 1.5 (p< 0.001). The success rate with individual target pressures after four years was 43.7%. Secondary glaucoma surgery was performed in 45 (43.7%) of cases. Combined cases (n=12) were not statistically different to stand-alone procedures (p=0.28). No difference between PEXG and POAG could be detected (p=0.44). During the learning curve, stent misplacement was common and resulted in worse outcome for less experienced surgeons.Conclusion: The overall success rate of XEN 45 gel stent surgery in the present cohort is relatively low in a long-time follow-up under the given circumstances if all initial patients are included to follow-up. The influence of the surgeon’s learning curve is obvious, and improvement in success can be expected when used by experienced and high-volume surgeons. No significant differences were found in PEXG compared to POAG or in XEN surgery combined with cataract surgery compared to stand-alone.Keywords: ab interno implant, glaucoma, minimal invasive glaucoma surgery, pseudoexfoliative glaucoma, surgical success, XEN 45 gel stent

Purpose: The goal of this study was to assess the efficacy and safety of inferior implantation of the Xen Gel 45® Stent in a cohort of refractory glaucoma patients who had undergone multiple failed procedures and lacked healthy superior conjunctiva., Patients and Methods: We retrospectively included individuals with refractory glaucoma who underwent implantation of a Xen 45® in the inferior quadrants of the conjunctiva. At the 12-month mark, two success criteria were assessed: "Complete" success, defined as an intraocular pressure (IOP)≤21mmHg with a≥20% reduction in IOP without additional IOP-lowering medications, the absence of a requirement for additional filtering surgery, and the absence of chronic hypotony; and "Qualified" success, which consisted of patients meeting the same criteria but requiring glaucoma medications postoperatively. Safety was also monitored throughout the 12-month follow-up., Results: A total of 35 patients who underwent inferior Xen implantation were assessed. After 12months, 20 patients (57.1%) achieved qualified success, with twelve patients (34.3%) attaining complete success. Excluding five patients who underwent additional filtering surgery during follow-up, the mean IOP decreased significantly from 30.73±9.7mmHg to 16.49±7.9mmHg, representing a mean decrease of 14.24±12.13mmHg (46.5%; P<0.0001). The mean number of medications at 12months decreased from 3.43±1.6 to 1.53±1.52 (-55.4%; P<0.0001). The mean number of needlings was 1.29±1.2. Implant exposure was observed in two patients during the first postoperative month., Conclusions: Inferior placement of Xen appears to be a viable treatment option for patients with refractory glaucoma and a history of multiple failed glaucoma procedures. It demonstrates both significant efficacy and acceptable safety., (Copyright © 2024 Elsevier Masson SAS. All rights reserved.)

Objectives:To evaluate the effect on intraocular pressure (IOP) reduction and safety of ab interno gelatin microstent (XEN 45 Gel Stent; Aquesys, Inc, Aliso Viejo, CA, USA) microincisional glaucoma/cataract surgery in open-angle glaucoma (OAG).Materials and Methods:In this retrospective study, 30 eyes of 25 patients with OAG which underwent XEN 45 implantation combined with simultaneous phacoemulsification were clinically evaluated. Clinical outcomes analyzed included IOP, percent of IOP reduction, medication use, complications, best corrected visual acuity, and surgical outcomes at 24-month follow-up.Results:After the XEN 45 combined cataract surgery procedure, IOP dropped from 20.37±4.80 mmHg with a mean of 3.07±1.04 medication classes preoperatively to 14.83±1.91 mmHg with a mean of 0.94±1.11 medication classes at 24 months (p=0.001 for both). At 24 months, 55.6% of patients had IOP ≤18 mmHg without medication, 94.4% of patients had IOP ≤18 mmHg with or without medication, and 61.1% of patients reached ≥20% IOP reduction from baseline.Conclusion:XEN 45 is an effective minimally invasive surgical treatment for OAG with significant reduction in IOP and glaucoma medications and minimal complications in long-term follow-up.

Tobias Busch,1 Dragana Skiljic,1,2 Thiemo Rudolph,1 Anders Bergström,1,3 Madeleine Zetterberg1,2 1Department of Ophthalmology, Region Västra Götaland, Sahlgrenska University Hospital, Mölndal, Sweden; 2Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; 3Department of Ophthalmology, Skåne University Hospital, Lund, SwedenCorrespondence: Tobias BuschDepartment of Ophthalmology, Region Västra Götaland, Sahlgrenska University Hospital, SE-431 80, Mölndal, SwedenTel +46 0 31342 10 00Fax +46 0 31 41 29 04Email tobias.busch@vgregion.sePurpose: Evaluation of 1-year-outcome of XEN 45 gel stent surgery in a Swedish cohort with regard to clinical success, complications, and learning curve.Patients and Methods: This was a retrospective study of glaucoma patients undergoing glaucoma XEN-stent surgery alone or combined with phacoemulsification between December 2015 and May 2017. Intraocular pressure (IOP), number of medical agents, and adverse events were assessed. Clinical success rate was defined as achieving individual target pressure with/without medication.Results: A total of 113 eyes were included in the final statistics. Mean age was 70.8± 11.8 years. Primary open angle glaucoma (POAG) accounted for 46.9% and exfoliative glaucoma (PEXG) for 40.7%. Mean preoperative IOP was 23.8± 6.2 mmHg and mean number of agents 3.4. After 1 year, mean IOP was reduced to 16.1± 4.7 mmHg and medication to 1.34 substances on average. Failure rate at 1-year follow-up was 34% with no significant difference between POAG and PEXG. There was a trend of higher success rate for combined cases (P=0.116). Stents with malpositioned or curved appearance had significantly worse outcome. The failure rate of the most productive surgeon dropped from 33% to 10% from the first implantations. Temporary hypotony (19.5%) and choroidal detachment (9.7%) were the most common complications. Blockage of the inner stent lumen was common (8.8%), with a high proportion of failure.Conclusion: XEN-stent surgery is a surgical option in uncontrolled glaucoma in both POAG and PEXG. A XEN-stent can reduce both IOP and the number of antiglaucoma medications needed. The learning curve is significant and stent positioning is crucial for optimal results. Combined XEN-cataract surgery is not inferior to stand-alone procedures. The long-time effectiveness is still to be proven.Keywords: glaucoma, minimal invasive glaucoma surgery, MIGS, pseudoexfoliative glaucoma, XEN 45 gel stent, Ab interno implant, surgical success

Abstract Purpose Assessing the quality of the ocular surface by in vivo scanning laser confocal microscopy (IVCM) in primary open angle glaucoma (POAG) patients treated by Xen 45 Gel Stent, medical therapy and trabeculectomy. Methods Retrospective, single-center, single-masked, comparative study including 60 eyes of 30 patients (mean age 61.16 ± 10 years) affected by POAG. Eyes were divided into 3 groups: Group 1 eyes underwent the Xen 45 Gel Stent procedure, Group 2 eyes were under medical therapy, Group 3 eyes were surgically treated by trabeculectomy. All patients underwent HRT II IVCM analysis of cornea, limbus, conjunctiva, sub-tenionian space and sclera. Results The Xen 45 Gel stent, if properly positioned in the sub-conjunctival space preserves goblet cells and limits ocular surface inflammation. Regular corneal epithelial cells with micro-cysts, and normo-reflective sub-epithelial nerve plexus are documented by IVCM. In sub Tenon’s implants an alternative lamellar intra-scleral filtration is detectable. Combined surgical procedures show a noticeable number of inflammatory cells with rare micro-cysts. Post-trabeculectomy inflammatory reaction is more evident than Xen 45 Gel Stent associated surgical procedures, but less than medical therapy where a conspicuous presence of Langerhans cells, peri-neural infiltrates, marked loss of goblet cells and fibrosis is visible. Conclusion Ocular surface inflammation was more notable in topical therapy than after trabeculectomy, which itself causes more inflammation than XEN Gel stents.

Aim: This study was aimed to summarize the complications and their management associated with XEN gel stent implantation., Methods: A systematic review of literature was conducted using Medline (via PubMed), EMBASE, the Cochrane Library databases, and China National Knowledge Infrastructure, from their inception to February 1, 2024., Results: A total of 48 studies published between 2017 and 2024 were identified and included in the systematic review, including 16 original studies (retrospective or prospective clinical studies), 28 case reports, and 4 case series, which followed patients for up to 5 years. Early postoperative complications of XEN gel stent implantation include hypotony maculopathy (1.9-4.6%), occlusion (3.9-8.8%), suprachoroidal hemorrhage (SCH), choroidal detachment (0-15%), conjunctival erosion, and exposure of the XEN gel stent (1.1-2.3%), wound and bleb leaks (2.1%) and malignant glaucoma (MG) (2.2%). Mid-postoperative complications of XEN gel stent implantation included migration of XEN (1.5%), ptosis (1.2%), endophthalmitis (0.4-3%), macular edema (1.5-4.3%), hypertrophic bleb (8.8%) and subconjunctival XEN gel stent fragmentation (reported in 2 cases). Late postoperative complications reported in cases included spontaneous dislocation and intraocular degradation., Conclusion: XEN gel stent implantation is a minimally invasive glaucoma surgery (MIGS) procedure for glaucoma, known for its potential to minimize tissue damage and reduce surgical duration. However, it is crucial to note that despite these advantages, there remains a risk of severe complications, including endophthalmitis, SCH, and MG. Therefore, postoperative follow-up and early recognition of severe complications are essential for surgical management., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Gan, Wang, Chen and Tang.)

Objectives: To evaluate the effect on intraocular pressure (IOP) reduction and safety of ab interno gelatin microstent (XEN 45 Gel Stent; Aquesys, Inc, Aliso Viejo, CA, USA) microincisional glaucoma/cataract surgery in open-angle glaucoma (OAG). Materials and Methods: In this retrospective study, 30 eyes of 25 patients with OAG which underwent XEN 45 implantation combined with simultaneous phacoemulsification were clinically evaluated. Clinical outcomes analyzed included IOP, percent of IOP reduction, medication use, complications, best corrected visual acuity, and surgical outcomes at 24-month follow-up. Results: After the XEN 45 combined cataract surgery procedure, IOP dropped from 20.37±4.80 mmHg with a mean of 3.07±1.04 medication classes preoperatively to 14.83±1.91 mmHg with a mean of 0.94±1.11 medication classes at 24 months (p=0.001 for both). At 24 months, 55.6% of patients had IOP ≤18 mmHg without medication, 94.4% of patients had IOP ≤18 mmHg with or without medication, and 61.1% of patients reached ≥20% IOP reduction from baseline. Conclusion: XEN 45 is an effective minimally invasive surgical treatment for OAG with significant reduction in IOP and glaucoma medications and minimal complications in long-term follow-up. [ABSTRACT FROM AUTHOR]

Purpose: To compare the efficacy and safety of the XEN45 Gel Stent surgery between patients with and without severe pseudoexfoliation glaucoma., Methods: In this retrospective, single-center, comparative chart review, records of 24 eyes of 23 patients with pseudoexfoliation glaucoma and 24 eyes of 23 patients with non-pseudoexfoliation glaucoma with severe glaucoma, defined as uncontrolled intraocular pressure on maximally tolerated medical therapy, were reviewed. All patients were treated with XEN45 Gel Stent surgery, in either a standalone procedure (84.8%) or combined with phacoemulsification (15.2%). Mean intraocular pressure, mean number of intraocular pressure-lowering medications, change in best-corrected visual acuity and needling or rescue surgery rates were assessed. Success was defined as at least 20% decrease in baseline intraocular pressure among treatment-free patients., Results: Patient characteristics were similar between the groups. At 6 months, intraocular pressure in the pseudoexfoliation glaucoma group decreased by 32% (24.3 ± 9 mmHg-14.8 ± 7 mmHg, p < 0.001), with comparable decrease in intraocular pressure in the non-pseudoexfoliation glaucoma group (22.6 ± 7 mmHg-16.7 ± 6 mmHg, p = 0.011). Similar rates of patients required topical anti-glaucoma therapy (29% vs 22%, p = 0.559), needling (54% vs 37%, p = 0.247), and rescue trabeculectomy (13% in both, p = 1.00) at the last follow-up. However, intraocular pressure decreased more in the pseudoexfoliation glaucoma group among treatment-free patients (-10.1 ± 8.0 mmHg vs -4.1 ± 8.1 mmHg, p = 0.043), and final intraocular pressure was lower in the pseudoexfoliation glaucoma group (12.2 ± 3.5 mmHg vs 15.8 ± 5.7 mmHg, p = 0.044)., Conclusions: The XEN45 Gel Stent implant demonstrated similar efficacy and safety among severe pseudoexfoliation glaucoma and non-pseudoexfoliation glaucoma patients. Greater magnitude of decreased intraocular pressure occurred among treatment-free pseudoexfoliation glaucoma patients.