XEN Implantation Research Articles

Clinical effect of XEN gel stent implantation or combined with phacoemusification and intraocular lens implantation on glaucoma

Objective: To evaluate the efficacy and safety of internal XEN gel stent implantation or combined with phacoemusification and intraocular lens (IOL) implantation in the treatment of glaucoma. Methods: It was a retrospective case series study. Forty-five patients (28 males and 17 females; 52 eyes) who had different types of glaucoma treated at the Shenzhen Eye Hospital from December 2021 to June 2023 were included. XEN gel stent implantation (the XEN group) or XEN implantation combined with phacoemusification and IOL implantation (the combined group) were performed in these patients. The postoperative follow-up was 18 months. The observational indexes included the best corrected visual acuity (recorded as the logarithm of the minimum angle of resolution), intraocular pressure (IOP), XEN implantation quadrant, number of IOP-lowering medications, corneal endothelial cell count, operation success rate and surgical complications. The one-way repeated measures of variance, LSD-t test, and rank sum test were used for statistical analysis. Results: There were 28 patients (33 eyes) in the XEN group and 17 patients (19 eyes) in the combined group. The postoperative best corrected visual acuity had no significant change in the XEN group, but improved significantly (0.21±0.30 at 6 months; P<0.05) in the combined group, compared with the preoperative value. The IOP of the two groups at 18 months after surgery [(12.2±3.1) and (11.9±3.9) mmHg (1 mmHg=0.133 kPa)] was significantly lower than that before surgery [(22.1±8.5) and (19.4±10.2) mmHg; P<0.05]. The average number of IOP-lowering medications in all patients was 3 (2, 3) before surgery and 0 (0, 0) at 18 months after surgery. The difference was statistically significant (P<0.05). In the XEN group, the corneal endothelial cell count was (2 387.37±478.22) cells/mm² preoperatively and (2 193.89±311.96) cells/mm² at 12 months. The decrease showed no statistical significance. The XEN gel stent was implanted in the supranasal quadrant in 8 eyes (15.4%), in the inferonasal quadrant in 36 eyes (69.2%), and in the infratemporal quadrant in 8 eyes (15.4%). The operation success rate [complete success rate, 86.5% (45/52); conditional success rate, 9.6% (5/52)] was 96.2% (50/52). The filtering bleb scarring occurred in 9.6% (5/52) of eyes. A small amount of hyphema, postoperative shallow anterior chamber, transient hypertension, and intraoperative drain breakage were found in 7.7% (4/52) of eyes, respectively. A small amount of subconjunctival bleeding was observed in 5.8%(3/52) of eyes. Re-implantation of an XEN gel stent was performed in 5.8% (3/52) of eyes. The intraoperative conjunctival tissue rupture, hypotony macular edema, and drain exposure were observed in 1.9% (1/52) of eyes, respectively. Conclusion: The XEN gel stent implantation or combined with phacoemusification and IOL implantation was effective and safe in treating different types of glaucoma, but its long-term clinical efficacy needs further follow-up observations in multi-center, larger-scale research.

Ab-Externo XEN Gel stent implantation effectively treated refractory glaucoma with prior failed shunt tube

PurposeTo assess the efficacy of a gelatin stent (XEN 45 Gel Stent; Allergan) implant in advanced glaucoma eyes that have failed prior aqueous shunt implantation.MethodsWe retrospectively reviewed 6 patients with refractory glaucoma, defined as persistently high IOP (> 21 mmHg) despite taking at least 3 IOP-lowering medications subsequent to undergoing a glaucoma drainage device (GDD) with or without a second GDD or cilioablative procedure. Eyes with previous failed GDD underwent subconjunctival 0.3 cc (0.4 mg/ml) mitomycin C, tenonectomy, and placement of an ab- externo XEN stent. The outcome measures included change in IOP and the number of glaucoma medications. Success was defined as patients achieving an IOP ≤ 18 mmHg with a percentage reduction of 25% or 15 mmHg and 40% mean IOP reduction from baseline while taking the same number or fewer medications.ResultsAll six eyes with age of 77.6 ± 7.82 years who underwent XEN implantation following previous GDD surgery had primary open-angle glaucoma. The IOP decreased significantly from 32.33 ± 5.99 to 12.67 ± 3.27 mmHg (p < 0.001) with a follow-up of 13.9 ± 2 (11.7–16.7) months. Visual acuity and visual field remained stable after XEN placement. Compared to the baseline number of medications of 4.2 ± 0.8, all medication was discontinued except in one eye on two drops at the end of the follow-up. The overall surgical success rate was 100%. No complications, needling, or additional procedures were required.ConclusionThis study described successful implantation of the XEN stent following failed GDD. XEN Gel stent implantation associated with mitomycin C and tenonectomy can be considered a viable surgical option for patients with a history of previously failed tube shunt requiring further IOP lowering.

Complications Following XEN45 Gel Stent and Glaucoma Drainage Device Implantation During Glaucoma Fellowship.

Purpose XEN45 Gel Stent and glaucoma drainage device (GDD) implantation is safe and effective for glaucoma treatment and should be taught during glaucoma fellowship training. However, complications may still occur, with potentially sight-threatening consequences. The purpose of this study is to describe the management of complications following a series of XEN45 Gel Stent and GDDsurgeries performed over the course of glaucoma fellowship training. Methods This is a retrospective case series of XEN45 Gel Stent surgeries performed on 16 eyes and GDD surgeries performed on seven eyes. Patient demographics, disease characteristics, and complications are reviewed. The intra- and postoperative course of five select cases with complications are described in detail. Results The most frequent complications following XEN45 implantation were transient hypotony (10 eyes, 63%), reduced visual acuity (VA) (five eyes, 31%), choroidal effusion (three eyes, 19%), hyphema (two eyes, 13%), and intraocular pressure (IOP) spike (two eyes, 13%). Thirteen eyes (81%) required bleb needling, and three eyes (19%) required XEN45 replacement. Complications following GDD implantation included hypotony (three eyes, 43%), reduced VA (two eyes, 29%), choroidal effusion (two eyes, 29%), IOP spike (two eyes, 29%), implant exposure (two eyes, 29%), and shallow anterior chamber (one eye, 14%). Three eyes (43%) required revision or explantation with a secondary glaucoma surgery. One choroidal effusion following XEN45 surgery and one following GDD surgery were hemorrhagic choroidal effusions requiring surgical drainage. Conclusion Significant and potentially sight-threatening complications may occur following XEN45 Gel Stent and GDD implantation performed over the course of fellowship training. Glaucoma fellows should be ably equipped to recognize, diagnose, and manage these complications both intra- and postoperatively.

Surgical outcomes of XEN45 implantation, trabeculectomy vs . penetrating canaloplasty in open-angle glaucoma: A non-randomized comparative study.

Surgical outcomes of XEN45 implantation, trabeculectomy vs . penetrating canaloplasty in open-angle glaucoma: A non-randomized comparative study.

Double implantation of Xen 45 gel stent in primary open-angle glaucoma: a pilot study.

To describe the outcomes of double implantation of Xen 45 Gel Stent (Xen) using an ab externo approach with closed conjunctiva. Retrospective single-centre case series of primary open-angle glaucoma patients with at least six months of follow-up after implantation of a second Xen in the same eye via ab externo technique without conjunctival opening. Eight pseudophakic eyes of 8 patients were included. Intraocular pressure (IOP) dropped from 30 ± 2.6mmHg pre-operatively to 22.4 ± 2.3mmHg one month after the first Xen implant (mean difference: -7.6mmHg [95% confidence interval: -9.4, -5.9mmHg], p = 0.0092). A second Xen was then implanted to achieve the target IOP. The procedure showed no significant intraoperative or postoperative complications. The IOP dropped to 16.1 ± 2.7mmHg six months following this second implant (mean difference: -6.3mmHg [95% confidence interval: -7.2, -5.3mmHg], p = 0.0183); however, 3 patients needed medical therapy to further reduce the IOP towards the target value. Sequential implantation of two Xen 45 Gel Stents using an ab externo approach with closed conjunctiva appears a promising procedure that showed a favorable safety and efficacy profile in this small case series. This pilot data might pave the way for further studies to evaluate the safety and efficacy of the procedure.

Xen-DS: a novel technique of ab externo Xen implantation augmented with a modified deep sclerectomy for surgical treatment of glaucoma.

The Xen gel stent is a surgical glaucoma device which creates a subconjunctival filtering bleb, which has demonstrated good intraocular pressure (IOP) lowering and safety. Nonetheless, bleb-related problems have been reported. We present a case series of ab externo Xen procedures augmented with a deep intra-scleral lake, aiming to improve both IOP-lowering and post-operative management. A retrospective review of 20 patients who underwent combined Xen gel stent implantation with modified deep sclerectomy at our institution from June to November 2022, with a 6-month follow-up period. We reviewed demographics, past ocular history, visual acuity (VA), IOP, visual fields, glaucoma medication use, complications, and perioperative information. 20 eyes of 20 patients, with a mean age of 67.45 ± 14.38 underwent surgery. Pre-operative initial IOP was 24.5 ± 7.96 mmHg, improving to 11.50 ± 2.96 mmHg at 6 months; a change of -12.89 ± 8.34 mmHg and a mean decrease of 51.13 ± 20.15% (p < 0.0001) Patients were on 3.1 ± 0.72 glaucoma medications pre-operatively, improving to 0.72 ± 1.27 at 6 months (p < 0.0001). Visual field mean deviation was -13.99 ± 9.98 dB pre-operatively and -10.27 ± 9.06 dB at 6 months, with VA of 0.287 ± 0.69 pre-operatively and 0.31 ± 0.76 LogMAR post-operatively. No patients required bleb needling. 2 patients underwent subsequent bleb revision surgery. 2 patients developed choroidal effusions, which were managed conservatively with good visual outcomes. In this preliminary study, we have found the modification of Xen gel stent implant surgery with a modified deep sclerectomy to offer good IOP lowering, with low rates of bleb needling and a good safety profile.

No Changes in Keratometry Readings and Anterior Chamber Depth after XEN Gel Implantation in Patients with Glaucoma.

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.

Histopathological findings of failed blebs after microinvasive bleb surgery with the XEN Gel Stent and Preserflo MicroShunt

PurposeThe success of XEN Gel Stent (XEN) and Preserflo MicroShunt (Preserflo) implantation depends mainly on the development of bleb fibrosis. This study aimed to describe the histological findings of bleb fibrosis after XEN and Preserflo surgery.MethodsThis retrospective study included patients with different types of glaucoma who underwent revision surgery after XEN or Preserflo implantation. The available clinical information and histological samples of removed fibrotic tissue were analyzed.ResultsThirty-six patients were included. Revision surgery was performed at a median of 195 (range = 31–1264) days after primary surgery. The mean intraocular pressure changed from 29.1 (± 10.3) mmHg at baseline to 18.3 (± 8.7) mmHg (− 37%; p < 0.0001) and 16.2 (± 4.2) mmHg (− 45%; p < 0.0001) after 6 and 12 months, respectively. Histological analysis revealed an increase in activated fibroblasts and macrophages in all specimens and a parallel orientation of fibroblasts in a minor part of the probe in 60% of the specimens. No pronounced inflammatory reaction in the form of lymphocytic or granulocytic infiltration was observed. The comparison of specimens from uveitic glaucoma and primary open-angle glaucoma patients revealed no significant differences.ConclusionsThe histological analysis of fibrotic blebs from the XEN and Preserflo implants did not show any pronounced immune or foreign-body reaction and revealed a similar histological pattern of failed blebs after trabeculectomy.

Mid-term surgical success after transscleral ab interno glaucoma gel stent implantation.

To investigate the surgical success and efficacy of XEN45 implantation (XEN45 μm, AbbVie Inc., USA) with and without combined cataract surgery up to the first 5 years. In a prospective observational monocentric trial, 192 eyes of 157 patients with open-angle glaucoma received either XEN45 implants only (solo surgery group) or combined surgery/cataract surgeries (combined surgery group). Surgical success (qualified and full success; IOP-limit: ≤12, 15, 18, 21 mmHg), time to secondary IOP-lowering procedure, IOP and number of IOP-lowering medications were analysed for 1, 2, 3, 4 and 5 years. Compared to baseline, IOP (24.1 ± 8.1 to 12.6 ± 2.8 mmHg, -48%, p < 0.001) and the number of IOP-lowering medications (3.0 ± 1.0 to 1.5 ± 1.2, -50%, p < 0.001) decreased significantly at 5 years. Although no differences between IOP and the number of IOP-lowering medication courses between the groups were detected at 5 years (p > 0.11), the combined procedure (63%, 37%) showed better success rates compared to the solo procedure (36%, 13%) in the definition IOP ≤18 and ≤12 mmHg (p = 0.035, 0.028). Solo XEN45 procedures had a higher rate of secondary IOP-lowering procedures compared to combined XEN45 cataract procedures (hazard ratio: 2.02, 95%CI: 1.03-3.97, p = 0.04). Twenty per cent of the eyes, including both procedures, required a secondary IOP-lowering procedure within 5 years. The XEN45 implant is effective in lowering IOP and the number of IOP-lowering medications in patients with open-angle glaucoma in the mid-term. Comparing XEN45 implant results with the results of trabeculectomy available in current literature, we speculate that there might be a higher surgical success rate without medications in favour of trabeculectomy.

Factors Associated with the Efficacy of XEN Gel Implant.

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. 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 6months at Hualien Tzu Chi Hospital, Taiwan. If intraocular pressure (IOP) elevated above 20mmHg during the follow-up, needling or open revision was performed. The primary outcome measures included IOP and the number of glaucoma medications. 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 < 18mmHg 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 ≤ 18mmHg 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). 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.

Anterior Segment Optical Coherence Tomography for Cases of High Intraocular Pressure Following XEN Implant for Glaucoma.

This study showed that the XEN patency should be verified by OCT imaging in cases of encapsulated blebs. Although fibrosis plays the principal role, humor aqueous flow reduction could affect the "spacer" effect that inhibits the fibroblast attachments. To evaluate the application of the anterior segment optical coherence tomography (AS-OCT) imaging in studying the relationship between a low flow rate through the XEN63 and the development of a cystic bleb. Retrospective case series of 3 eyes presenting a cystic bleb after an XEN63 implantation for uncontrolled intraocular pressure (IOP). Demographic and clinical data were obtained from medical records. The imaging findings, complications, and managements following the surgery were evaluated. Three patients, with an average age of 67.3 years, initially showed a patent stent lumen and a functional bleb after surgery. The IOP of all eyes increased on average at 28.3 days from the surgery, with a mean value of 39.66mmHg. The slit lamp examination showed a cystic bleb. The AS-OCT imaging confirmed the previous finding and revealed either a partial or total occlusion of the stent internal ostium. A Nd:YAG laser, in proximity to the ostium, was performed to resolve the obstruction. Although the AS-OCT imaging showed the device patency and the IOP immediately decreased, the latter became elevated again. Consequently, in all the cases, a further needling procedure was needed to achieve an adequate IOP reduction. Six months after the two-step procedure, the IOP averaged 13.33mmHg, the XEN63 lumens appeared cleared, and the blebs showed a functional morphology. No adverse events were observed. The development of a cystic bleb may result from an altered balance between the flow rate through the XEN63 and the fibrosis development in the postoperative healing process. A proper follow-up based on slit lamp biomicroscopy, IOP measurement, and AS-OCT imaging is advisable to estimate and manage a cystic bleb following XEN63 implantation.

Bleb Morphology on Anterior-Segment Optical Coherence Tomography after XEN Gel Stent Implantation.

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.

Comparing Outcomes of 45 Xen Implantation Ab Interno With Closed Conjunctiva to Ab Externo With Open Conjunctiva Approaches.

Ab externo with open conjunctiva placement may lead to improved gelatin stent (XEN Gel Stent; Allergan) success rate compared with ab interno with closed conjunctiva because it conferred more favorable intraocular pressure (IOP) and medication burden reduction based on our complete and qualified success criteria. To compare outcomes of a gelatin stent (XEN 45 Gel Stent; Allergan) placed either ab interno with closed conjunctiva (AIC) or ab externo with open conjunctiva (AEO) with or without cataract surgery in patients with glaucoma. Retrospective, nonrandomized comparative study of 85 eyes from 85 glaucoma patients who received XEN 45 Gel Stent placed either AIC (N=32) or AEO (N=53) with or without cataract surgery between July 2018 and January 2022 at Massachusetts Eye and Ear. Patients were included if they were 18 years of age or above and had at least 30 days of follow-up without any disqualifying event. Baseline demographics were similar between both groups, except for the glaucoma type. Both AIC and AEO procedures resulted in significant patterns of IOP and medication reduction from baseline up to 1 year. At postoperative year (POY)1, mean IOP was reduced to 11.34±4mmHg on 1.29±1.34 medications after AEO and 13.70±3.32mmHg on 2±1.81 medications after AIC. The average IOP reduction was significantly greater in the AEO group at all postoperative time points beyond postoperative week 2. There were significant differences in the survival curves of AEO and AIC groups under both the complete success criteria and the qualified success criteria. Under the complete success criteria, the cumulative probability of survival at POY1 was 28.5% in the AEO group and 3.8% in the AIC group. Under the qualified success criteria, the cumulative probability of survival at POY1 was 60.3% in the AEO group and 21.9% in the AIC group. In our study, we demonstrate that both placements reduce IOP and medication from baseline, with AEO placement having more favorable success rates compared with AIC placement.

A case of mitomycin C toxicity after XEN gel stent implantation with the XEN air technique in a glaucoma patient

BackgroundTo discuss the first case of mitomycin C (MMC) toxicity after XEN® gel stent implantation in a glaucoma patient, conducted using the XEN “air” technique with an ophthalmic viscosurgical device (OVD).Case presentationA 44-year-old Asian male presented with increased intraocular pressure (IOP; 52 mmHg) accompanied by keratic precipitates and an edematous cornea. He was diagnosed with uveitic glaucoma in the left eye, and the IOP was controlled with a topical anti-glaucoma agent. However, glaucoma progression was revealed by Humphrey visual field (HVF) and optical coherence tomography (OCT) examinations. The patient underwent uneventful XEN gel stent implantation using the XEN air technique and an MMC (0.02%, 0.1 mL) injection, with subconjunctival air and OVD injection provided prior to XEN implantation in the left eye. The patient exhibited a decreased IOP (11 mmHg), elevated bleb, and extensive subconjunctival hemorrhage on postoperative day 1. On postoperative day 18, diffuse conjunctival injection and a large avascular bleb was noticed around the XEN gel stent. The patient complained of severe eye pain and discomfort, suggestive of MMC toxicity, and the IOP was 12 mmHg. The patient was treated with a topical steroid and antibiotics tapered over a 6-month period. Finally, the toxicity was successfully controlled, with the IOP stabilizing at around 15 mmHg.ConclusionsAlthough significantly greater lowering of the IOP can be expected with the use of subconjunctival OVD injection and MMC during XEN gel stent implantation, a cautious approach and a longer monitoring period are required.

Interim Analysis of Clinical Outcomes with Open versus Closed Conjunctival Implantation of the XEN45 Gel Stent

/Purpose: To examine the longitudinal postoperative outcomes of open versus closed conjunctiva implantation of the XEN45 gel stent. Retrospective multicenter study. 193 patients with glaucoma underwent XEN45 implantation via an open or closed conjunctiva approach. Patient demographics, diagnoses, preoperative and postoperative clinical data, outcome measures including intraocular pressure (IOP), use of glaucoma medications, visual acuity, and complications were collected. Statistical analyses were performed with P < 0.05 as significant. Failure was defined as less than 20% reduction of IOP from medicated baseline or IOP > 21 mmHg at 2 consecutive visits at postoperative month 1 and beyond, the need for subsequent operative intervention or additional glaucoma surgery, or a catastrophic event such as loss of light perception. Eyes that had not failed by these criteria and were not on glaucoma medications were considered complete successes. Overall success was defined as those who achieved success either with or without topical medications. Patients were followed for an average of 17 months. Complete success was achieved in 42.5% and 24.7% of the open and closed groups, respectively (P = 0.01). Overall success was achieved in 64.2% and 37.0% of the open and closed groups, respectively (P < 0.001) at the last follow up. Bleb needling was performed in 12.4% of eyes in the open group compared to 40% in the closed group. An IOP spike of 10 mmHg or greater was twice as likely to occur in the closed compared to the open group during the postoperative period (40% vs 18% P = 0.001). Implantation of the XEN45 with opening of the conjunctiva resulted in a lower IOP with greater success and lower needling rate compared with the closed conjunctiva technique. Similar rates of postoperative complications and vision loss were noted in each group. While both procedures provide substantial IOP reduction, the open technique appears to result in higher success rates and fewer postoperative interventions.

Long-term Outcomes of PreserFlo MicroShunt versus XEN45 Gel Stent in Open-Angle Glaucoma.

To compare two glaucoma drainage devices with subconjunctival filtration (MicroShunt and XEN) for open-angle glaucoma (OAG), with respect to effectiveness and safety. This is a single center, retrospective, interventional study. In total, 106 eyes of 95 patients with OAG underwent surgery. Of these patients, 51 eyes of 45 patients received a MicroShunt implantation and 55 eyes of 50patients received an XEN implantation. Failure was defined as an intraocular pressure (IOP) lower than 5 or higher than 17 mmHg at the end of follow-up after 2 years, the need for surgical revision, secondary glaucoma surgery, or loss of light perception. Outcome was rated as complete success or qualified success, depending on whether it was achieved with or without anti-glaucomatous medications. Postoperative complications and interventions were also documented for both groups. In the MicroShunt group, mean IOP decreased from 20.6 ± 7.5 mmHg at baseline to 13.0 ± 3.9 mmHg (p < 0.0001) after 2 years. In the XEN group, mean IOP was lowered from 22.5 ± 7.9 mmHg to 13.5 ± 4.2 mmHg (p < 0.0001). In both groups, the mean number of medications was significantly reduced (MicroShunt 2.7 ± 1.2 to 0.9 ± 2.5; p < 0.0001 vs. XEN 3.2 ± 0.9 to 1.1 ± 1.5; p < 0.0001). In regard to success rates, 37% of MicroShunt patients achieved complete success and 57% qualified success at the end of follow-up. In the XEN group, rates were 25 and 45%, respectively. Patient demographics differed between the two groups with respect to age (MicroShunt 72.8 ± 8.7 vs. XEN 67.7 ± 9.0 years; p = 0.002). Postoperative complications were comparable between the two groups. Both MicroShunt and XEN are effective in significantly reducing IOP and glaucoma medications in OAG, and with a good safety profile.

XEN 45 Gel Stent Implantation In Open Angle Glaucoma: 5-Year Results Of A Prospective Study.

XEN 45 Gel Stent is safe and effective for 3 years. The study results provide useful insight into the outcome of XEN 45 Gel Stent surgery over 5 years in daily clinical practice. To evaluate 5-year outcomes of XEN 45 gel stent implantation (XEN) in patients with open-angle glaucoma. This is a prospective, single-center, interventional study. XEN implantation either alone (XEN) or combined with phacoemulsification (Phaco + XEN) was performed on 170 consecutive eyes (126 patients) with uncontrolled intraocular pressure (IOP) or disease progression despite medical treatment. 'Complete' surgical success at 60 months was defined as unmedicated IOP ≤15mmHg and a relative IOP reduction ≥ 20% from medicated baseline, while 'qualified' success allowed fewer ocular hypotensive medications (OHM) than at baseline. Other definitions of success with various IOP targets were also analyzed. Secondary outcomes included mean IOP and IOP lowering medication changes, and rates of re-operations. Mean age was 78.1±9.2 years and 70.3% were female. Mean medicated IOP decreased from 19.8±7.7mmHg (19.6±7.1 [XEN] vs. 19.8±7.0mmHg [Phaco+XEN]) at baseline to 12.6±3.1mmHg (12.5± 3.1 [XEN] vs. 12.6±3.1 [Phaco+XEN]) at 5 years (-37.0%; P < 0.001). Medications decreased from 2.0±1.3 (2.0±1.3 [XEN] vs. 2.0±1.3 [Phaco+XEN]) to 0.8±1.1 (0.8±1.1 [XEN] vs. 0.8±1.1 [Phaco + XEN]) (-60%; P<0.001). Needling was performed in 84 eyes (49%), and 19.4% underwent a secondary surgical intervention. Complete success at 3 years was a strong predictor of success at 5 years (OR:3.06, P<0.01), while needling was associated with higher rates of failure (OR:3.6, P<0.01). At 5 years, XEN gel stent implantation was a safe procedure and achieved clinically meaningful IOP and medication reduction. Success at 3 years is a predictor of success at 5 years. Needling correlates with higher failure rates.

Efficacy and safety of the XEN45 implant in glaucoma surgery: Retrospective study of our first 73 cases

ObjectiveTo analyze the results of the Xen45 implant in our hospital center, both in terms of efficacy and safety. MethodsObservational, retrospective, single-center study of patients undergoing Xen45 surgery at the University Hospital of Jaén between January 1, 2018 and June 31, 2021. ResultsA total of 73 patients were implanted with the Xen45 device (48 with in combined surgery with phacoemulsification of the crystalline lens and 25 standalone Xen45 surgery). IOP decreased from 19.9 ± 4.9 mmHg at the first visit to a mean of 17.1 ± 5.3 (P = .001) at the sixth month. Drug use required between the first visit and Xen implantation was reduced from 2.1 ± 0.9 to 0.6 (P < .000). A second surgery was necessary in 18 patients (26.6%) in the first 6 months. ConclusionsGlaucoma surgery by Xen45 implant, alone or combined with cataract surgery, is an effective and safe procedure for IOP lowering.

Eficacia y seguridad del implante XEN45 en la cirugía de glaucoma. Estudio retrospectivo de nuestros primeros 73 casos

ObjectiveTo analyze the results of the XEN45 implant in our hospital center, both in terms of efficacy and safety. MethodsObservational, retrospective, single-center study of patients undergoing XEN45 surgery at the University Hospital of Jaén between January 1, 2018 and June 31, 2021. ResultsA total of 73 patients were implanted with the XEN45 device (48 with in combined surgery with phacoemulsification of the crystalline lens and 25 standalone XEN45 surgery). IOP decreased from 19.9±4.9mmHg at the first visit to a mean of 17.1±5.3 (P=.001) at the sixth month. Drug use required between the first visit and XEN implantation was reduced from 2.1±0.9 to 0.6 (P<.000). A second surgery was necessary in 18 patients (26.6%) in the first 6 months. ConclusionsGlaucoma surgery by XEN45 implant, alone or combined with cataract surgery, is an effective and safe procedure for IOP lowering.

Efficacy and Safety Outcomes of XEN Implantation and Gonioscopy-assisted Transluminal Trabeculotomy for the Management of Advanced Open-angle Glaucoma.

Minimally invasive glaucoma surgery (MIGS) is not typically used in patients with advanced-stage glaucoma. This study describes the outcomes and complications of patients with advanced open-angle glaucoma (OAG) who underwent XEN implantation with cataract surgery or gonioscopy-assisted transluminal trabeculotomy (GATT) with cataract surgery. This retrospective study identified patients who had undergone XEN implantation or GATT for the management of advanced OAG. Outcomes included surgical success, intraocular pressure (IOP) reduction, number of topical IOP-lowering drops, visual field mean deviation (MD), best-corrected visual acuity (BCVA), and complications. Surgical success was defined as an IOP of <14 mm Hg and a 20% reduction at 12 months without topical IOP-lowering drops (complete success) or with topical IOP-lowering drops (qualified success). Exactly 70 eyes were enrolled in this study, including 35 who had undergone XEN implantation and 35 who had undergone GATT. The overall surgical success rate was 74.3% (26 of 35) for eyes that underwent XEN implantation and 71.4% (25 of 35) for eyes that underwent GATT. Percent IOP reduction from baseline to 12 months postoperatively was 48% in the XEN cohort and 32% in the GATT cohort. Significant reduction in the use of topical IOP-lowering drops was demonstrated for both XEN (3.26 ± 1.15-1.23 ± 1.28) (p < 0.001) and GATT (2.46 ± 1.12-0.43 ± 0.78) (p < 0.001) cohorts at 12 months postoperatively. The only complication reported was transient hyphema, which occurred in three patients from the XEN group and four from the GATT group, and resolved spontaneously. Both XEN implantation and GATT may be safe and effective management options when treating patients with advanced OAG. However, larger sample sizes are required to make direct statistical comparisons between these techniques. In this study, XEN implantation and GATT combined with cataract surgery were each associated with favorable outcomes in patients with advanced OAG. Ruparelia S, Sharif M, Shoham-Hazon N. Efficacy and Safety Outcomes of XEN Implantation and Gonioscopy-assisted Transluminal Trabeculotomy for the Management of Advanced Open-angle Glaucoma. J Curr Glaucoma Pract 2023;17(2):63-67.