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Abstract Introduction Microinvasive glaucoma surgery (MIGS) is a growing trend, and XEN gel implant is one of the most effective types of MIGS. This study aimed to examine factors associated with the surgical success of XEN gel implants. Methods This retrospective cohort study enrolled patients with glaucoma receiving XEN implantation alone or combined with phacoemulsification (PHACOXEN) with a follow-up period of more than 6 months at Hualien Tzu Chi Hospital, Taiwan. If intraocular pressure (IOP) elevated above 20 mmHg during the follow-up, needling or open revision was performed. The primary outcome measures included IOP and the number of glaucoma medications. Results Male patients had lower postoperative IOP; male patients and higher preoperative IOP were associated with higher IOP change rates, and older patients had a higher chance of achieving IOP

Introduction: Microinvasive glaucoma surgery (MIGS) is a growing trend, and XEN gel implant is one of the most effective types of MIGS. This study aimed to examine factors associated with the surgical success of XEN gel implants. Methods: This retrospective cohort study enrolled patients with glaucoma receiving XEN implantation alone or combined with phacoemulsification (PHACOXEN) with a follow-up period of more than 6 months at Hualien Tzu Chi Hospital, Taiwan. If intraocular pressure (IOP) elevated above 20 mmHg during the follow-up, needling or open revision was performed. The primary outcome measures included IOP and the number of glaucoma medications. Results: Male patients had lower postoperative IOP; male patients and higher preoperative IOP were associated with higher IOP change rates, and older patients had a higher chance of achieving IOP < 18 mmHg and being medication-free at months 12, 24, and 36. The Kaplan–Meier curve showed that the probability of free-of-rescue intervention over the follow-up period was not different between the XEN alone and the PHACOXEN group (P = 0.859). Both needling and open revision were effective rescue interventions, but open revision had a higher chance of achieving IOP ≤ 18 mmHg and being medication-free (P = 0.031) and required less medication afterward (P = 0.044). Older age (P = 0.013) and male patients (P = 0.022) had a lower IOP after rescue interventions. Compared with open revision, needling was associated with higher IOP (P = 0.048) and more required medications (P = 0.048). Conclusions: XEN alone and PHACOXEN had comparable surgical outcomes, whereas open revision had a better IOP lowering effect than needling as a rescue intervention. Male and older patients had better surgical results in primary XEN implantations and rescue interventions. [ABSTRACT FROM AUTHOR]

Purpose: Herein, we report a case of XEN gel stent implantation in a patient with ocular cicatricial pemphigoid that successfully reduced glaucoma topical medication at one year. Observations: A 76-year-old male patient presented with severe ocular cicatricial pemphigoid and advanced glaucoma who required several topical medications to control intraocular pressure. Despite successful reduction of ocular inflammation with immunomodulatory therapy, his topical medication regimen prevented total remission of ocular inflammation. One year after XEN gel stent implantation, his intraocular pressures were controlled without any topical medication, and he had no ocular inflammation off any immunomodulatory therapy. Conclusions and Importance: The XEN gel stent represents a useful intervention for glaucoma treatment even in the setting of severe ocular surface disease and can improve outcomes for concurrent inflammatory and glaucomatous pathology.

Abstract Background The placement of a XEN gel stent is an ab-interno, minimally invasive glaucoma surgery which provides a subconjunctival drainage pathway and decreases intraocular pressure (IOP). Case presentation A 75-year-old male patient who had undergone XEN45 gel implantation after phacoemulsification and intraocular lens implantation appealed to the clinic. A filtration bleb was seen that extended through the nasal 180 degrees of the eye which caused ectropion of the lower eyelid. The value of the IOP was 12 mm Hg (mmHg). By the “Drainage Channel with Sutures” method this complication was effectively treated. As with every new method, there is a lack of knowledge about long-term outcomes in terms of effectiveness, technique and complications. Conclusion The “Drainage Channel with Sutures” method has not been described in the literature yet. By this minimal invasive method, hypertrophic bleb complication of XEN gel implant has been successfully treated.

Purpose: To report on the implantation of a XEN 45 gel implant in a patient with glaucoma associated with congenital aniridia. Observations: A 60-year old man with familial congenital aniridia and glaucoma presented with intraocular pressure of 30 mmHg in his right eye despite maximal topical treatment with four medications. Implantation of a XEN gel stent was performed without complications after subconjunctival injection of mitomycin-C (0.1 mL of 0.02%). At the two-year follow-up, the patient's intraocular pressure was 12 mmHg with one topical medication. No needling of the filtering bleb was required. No excessive fibrosis of the conjunctiva or worsening of the existing keratopathy was noted. Conclusions: The XEN 45 implant could be an option in the treatment of aniridia-associated glaucoma.

Glaucoma and pregnancy is an uncommon combination, but it constitutes a very challenging situation for the treating doctor. The challenge is not only controlling the intraocular pressure and preventing glaucoma progression in the mother, but also having to deal with her mental stress and anxiety regarding the safety of her child. The situation is further worsened by the lack of definite guidelines as to how to deal with such patients. Relative rarity of glaucoma in this population restricts any large prospective randomized clinical trials or any large systematic studies. Moreover, none of the existing anti-glaucoma medications is absolutely safe in pregnancy. Current practice patterns depend on some case reports, a few observational studies and a few animal studies that attempt at determining the safety and efficacy of the available medicines. These are then prescribed on the basis of their relative safety in any particular stage of pregnancy or lactation. Newer medications that were released recently in 2018, such as Vyzulta and Rhopressa, presently have limited data to support their safety for use during pregnancy. Laser trabeculoplasty, conventional filtration surgery (of course without anti-metabolites), and minimally invasive glaucoma surgery represent a few non-pharmacological management options. Surgical procedures such as trabeculectomy and tube-shunts or collagen matrix implants, and newer minimally invasive glaucoma surgery procedures such as the gelatin stents are currently being explored and may prove to be viable solutions for severe glaucoma during pregnancy, although they too have their own inherent drawbacks. Management of glaucoma during pregnancy and lactation requires careful consideration of the disease status, gestational stage, US Food and Drug Administration classification and guidelines, and potential benefits and limitations of the various therapeutic modalities. This review focuses on the importance of a multidisciplinary team approach, starting with preconception planning and counseling, determining the treatment options depending on the stage of glaucoma and of pregnancy, and emphasizes the involvement of the patients, their obstetrician, and pediatrician through active discussion regarding the various medical, laser, or surgical modalities currently available or under exploration for use during pregnancy and lactation. The ultimate aim is to achieve an optimal balance between the risks and benefits of any type of intervention, and to customize treatment on an individual basis in order to achieve the best outcomes for both mother and fetus. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to analyze the postural intraocular pressure (IOP) changes in open-angle glaucoma after ab interno XEN gel implant surgery and to compare them with the changes observed with trabeculectomy and medical treatment.Patients and Methods: The study sample included 18 patients with XEN gel implants, 30 patients who had trabeculectomy, and 30 medically managed glaucoma patients. All patients in XEN gel implant and trabeculectomy groups had at least 11 months of follow-up and had successful surgeries that resulted in medication-free control of IOP. A rebound tonometer (Icare, Finland Oy, Helsinki, Finland) was used to measure the IOP levels at the sitting, supine, and dependent lateral decubitus (DLDP) positions after a 5-minute rest at each position.Results: In all the groups, the mean IOP values in the DLDP and supine positions were significantly higher than the sitting position. The IOP elevation after moving from sitting to supine position was significantly reduced in XEN gel implant and trabeculectomy groups compared to medical treatment group (p = .001 and p = .002, respectively). The IOP elevation after a moving from sitting to DLDP was also significantly reduced in XEN gel implant and trabeculectomy groups compared to the medical treatment group (p = .003 and p = .01, respectively). However, there was no significant difference in IOP change after moving from sitting to supine or DLDP positions between XEN gel implant and trabeculectomy groups (p = .74 and p = .98, respectively).Conclusion: This study demonstrated that XEN gel implant could reduce postural elevations in IOP to the same degree as trabeculectomy and provide significantly better postural IOP control than medical treatment. This surgery can be an effective minimally invasive alternative for patients with significant positional IOP elevations. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate, using optical coherence tomography‐angiography (OCT‐A), the vascular features of good bleb function after XEN gel implantation (XGI) for uncontrolled glaucoma. Methods: Forty‐three patients (43 eyes), who underwent XGI, were enrolled. According to the intraocular pressure (IOP) reduction, patients were classified into Group 1 (21 eyes; success) and Group 2 (22 eyes; failure). Optical coherence tomography‐angiography (OCT‐A) was performed to image the vascularization of the conjunctival bleb‐wall. The main outcomes were as follows: vessel displacement areas (VDAs), major vessel displacement area (MVDA; mm2), non‐flow whole area (NFWA; mm2) and bleb‐wall vessel density (BVD; %). Co‐registered B‐scans were also considered to evaluate the bleb‐wall cyst‐like structure density and area (BCSD, cysts/mm2; BCSA, mm2), and the bleb‐wall thickness (BT, µm). Results: Mean postoperative follow‐up was 7.5 ± 0.14 months; Group 1 and 2 IOP were 14.0 ± 2.5 and 25.3 ± 2.1 mmHg, respectively (p < 0.001). Greater VDA (p < 0.001), MVDA (p = 0.046) and NFWA (p = 0.001) values, and lower BVD (p < 0.001) was found in Group 1 compared to Group 2. Group 1 showed higher BSCD, BSCA and BT values compared to Group 2 (p < 0.001). Postoperative IOP positively correlated with BVD (r = 0.567; p = 0.003), but negatively with VDAs, MVDA (r = −0.581, p = 0.002; r = −0.619, p = 0.001, respectively), BCSD, BCSA (r = −0.580; p = 0.002; r = −0.664; p < 0.001) and BT (r = −0.627, p = 0.001). Conclusion: Successful filtration blebs after XGI present numerous and large areas of vessel displacement within the bleb‐wall, along with a rarefied vascular network. These OCT‐A features can be considered angiographic biomarkers of a good aqueous humour percolation through the bleb‐wall layers. [ABSTRACT FROM AUTHOR]

Background In this study, we aimed to analyze the efficacy and safety of ab interno XEN ® gel stent (Allergan Inc., Dublin, Ireland) implantation in a series of eyes with open-angle glaucoma and a history of previous filtering glaucoma surgeries. Methodology This retrospective, single-center study included all eyes that underwent XEN gel implantation with a minimum follow-up of 18 months that had previously undergone a filtering glaucoma surgery. The main outcomes were intraocular pressure (IOP) variation (baseline, first day, first week, and first, third, sixth, 12th, and 18th months), the number of hypotensive eyedrops at 18 months, intraoperative and postsurgical complications, and the need for subsequent glaucoma surgery. Results A total of 10 eyes from nine patients were enrolled in the study. IOP significantly decreased from 24.0 ± 2.4 mmHg to 7.8 ± 1.6 mmHg on the first day, 9.4 ± 2.2 mmHg in the first week, and 12.3 ± 4.8 mmHg, 14.7 ± 4.3 mmHg, 13.3 ± 3.8 mmHg, 11.7 ± 1.9 mmHg, and 12.3 ± 1.9 at the first, third, sixth, 12th, and 18th month, respectively (p < 0.001), with a 49.5% reduction in IOP at the end of the follow-up. The number of hypotensive eyedrops decreased significantly from 3.5 ± 0.5 (3-4) to 0.7 ± 0.7 (0-2) (p = 0.026). No intraoperative or postsurgical complications were recorded. In total, seven (70%) eyes achieved controlled IOP of <18 mmHg without any anti-glaucomatous medications, and one (10%) eye with the use of topical prostaglandin. One (10%) eye was submitted to a surgical revision, and another needed an additional glaucoma surgery during follow-up, with appropriate IOP control at the last follow-up. Conclusions This case series aims to highlight that the XEN implant can be an option in eyes with IOP levels in the low 20s and previously failed filtering surgeries, with satisfactory efficacy and high safety., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2022, Vieira et al.)

Purpose: To report a case of fully dislocated XEN Gel Implant device into the anterior chamber, 18 months after its implantation and its impact on endothelial cell density., Result: A 75-year-old man with a history of multiple glaucoma surgeries during the last three years presented with an entirely dislocated XEN Gel implant into the anterior chamber. An endothelial cell density reduction was observed over 18 months. Thus, the implant was removed. In the short-term after surgery, the endothelial cell loss rate reduced., Conclusion: XEN Gel Implant can dislocate into the anterior chamber, increasing endothelial cell loss in an eye already underwent multiple surgical procedures with subsequent adverse events. Therefore, if the implant seems displaced, the endothelial cell density should be monitored, and the length of the free-tube segment within the anterior chamber should be measured, during the patient's follow-up.

Purpose: To analyse the long-term efficacy and safety of bleb needling in glaucoma patients previously submitted to XEN implantation., Methods: Retrospective, observational study. Charts from patients who underwent XEN gel implant surgery between October 2015 and December 2017 were reviewed. Needling protocol involves use of Mitomycin C 0.2 mg/mL in an operating room. Primary outcome was defined as intraocular pressure (IOP) lowering efficacy at 12 months post-operative. Complete success was defined as a decrease in IOP > 20% and overall value <18 mmHg. Secondary outcomes included safety parameters (both intra and post-operative). Exploratory analysis of predictive factors for success were performed. Statistical analysis was performed using SPSS version 24., Results: About 94 charts were reviewed, with 18 patients (19%) having undergone needle revision. This salvage procedure was performed after 3.3 ± 3.4 months, achieving a mean IOP reduction of 8.3 ± 8.4 mmHg at 12 months after the procedure (pre-needling: 24.0 ± 5.2 mmHg vs 12th month: 13.5 ± 5.9 mmHg, p  < 0.0001). Accordingly, success was achieved in 72% (complete success in 61% of cases). Among predictive factors, there was a higher tendency for success in patients on two types of medications or fewer pre-operatively, cases of standalone XEN surgery and patients with a higher IOP difference pre-needling - day 1. No vision-threatening complications were recorded., Conclusion: XEN salvage procedure with mitomycin C is a valid option in early bleb failure. This single intervention had a long-lasting effect on bleb survival, with almost two-thirds achieving long term significant drop-free IOP reduction.

Background: XEN gel implant is an alternative method of treating glaucoma by connecting the anterior chamber and the subconjunctival space. The efficacy of the XEN gel implant and whether to combine with phacoemulsification is what most concerned. This review aims to test the efficacy and safety of the XEN gel implant compared with trabeculectomy and to test the efficacy between XEN combined with phacoemulsification and XEN alone., Methods: The PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov were searched through July 8, 2020. Studies comparing XEN and trabeculectomy or comparing XEN + phacoemulsification and XEN alone were included. The standard mean differences (SMD) were calculated to analyze the lowered intraocular pressure (IOP) and the number of anti-glaucoma medications. All data were measured from baseline to endpoint. The I2 statistic quantified heterogeneity ranged from 0% to 100%, and a random effects model was used in this meta-analysis. Review Manager 5.3 performed all analyses. The t -test calculated all P values, and P values were regarded as statistically significant at P<0.05. The methodological index for non-randomized studies was used to find and test bias in the literature., Results: Twelve studies with 1,602 eyes were included. Five studies compared the XEN gel implant with trabeculectomy. Eight compared XEN + phacoemulsification with XEN alone. There was no significant correlation between XEN and trabeculectomy groups in lowering IOP (SMD 0.30, 95% CI, 0.00 to 0.60, I 2 =60%) and reduced the number of IOP lowering drugs (SMD 0.01, 95% CI, -0.16 to 0.17, I 2 =0%). There was a significant difference between XEN + phacoemulsification and XEN alone in lowering IOP (1,034 eyes, SMD 0.22, 95% CI, 0.05 to 0.40, I 2 =38%) and reducing the number of medications (729 eyes, SMD 0.20, 95% CI, -0.06 to 0.46, I 2 =62%)., Conclusions: XEN gel implant, although not effective as trabeculectomy, is a safe operation for open-angle and some other types of glaucoma. Meanwhile, XEN alone is more effective than XEN combined with phacoemulsification within 1 week after operations. After three months, the two groups are similar in lowering IOP. More extensive, better-designed, strictly blinded, multicenter randomized clinical trials are needed to confirm our findings., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/atm-20-6354). The authors have no conflicts of interest to declare., (2020 Annals of Translational Medicine. All rights reserved.)

Purpose: To describe the case and the follow-up of an inadvertently damaged XEN gel implant during needling procedure., Methods: Case report., Results: A 60-year-old African American patient underwent an uncomplicated combined phacoemulsification with the insertion of a XEN gel implant. Two months postoperatively, a needling procedure was required. During the needling procedure, a fragment of the XEN gel implant was inadvertently damaged. One month postoperatively, the intraocular pressure was still controlled and the bleb was functioning well., Conclusion: This case report reveals a previously unreported complication concerning XEN gel implant. It is important for the surgeon to pay attention during needling procedure, especially if there is a subconjunctival hemorrhage impairing the view, to defer the procedure until good visibility exists.