Gel Stent Research Articles

Results of XEN45 Gel Stent Implantation in the Treatment of Primary Open‐Angle Glaucoma Using 5, 10 or 20 μg Mitomycin C: A Pilot Study

Background: No consensus has been reached on the adequate dose of mitomycin C (MMC) in XEN45 gel stent implantation. Lower doses have the potential to reduce MMC‐linked side effects. This study aimed to evaluate treatment efficacy of ab interno XEN45 gel stent in primary open‐angle glaucoma (POAG) with three different MMC doses.Methods: This retrospective single‐centre nonrandomised trail included 54 patients (56 eyes) who underwent XEN45 gel stent implantation for POAG with above‐target intraocular pressure (IOP) under medical therapy. Eyes were grouped according to the received MMC dose: Group 1 (20 μg; n = 21), Group 2 (10 μg; n = 14) and Group 3 (5 μg; n = 21). The primary endpoint was the mean IOP change in the three MMC dose groups after 6, 12 and 24 months. Secondary endpoints included the success rate defined as lowering of baseline IOP ≥ 20% and below a cut‐off IOP set at three different levels: ≤ 18, ≤ 16 and ≤ 14 mmHg (Criteriums 1, 2 and 3), the mean number of ocular hypotensive medications and the frequency of needling procedures.Results: After 24 months, the overall mean (standard error) IOP was significantly reduced from 24.7 (0.9) mmHg to 15.2 (0.7) mmHg (p < 0.0001). The average IOP change (standard error) in MMC dose groups 1, 2 and 3 was −8.6 (2) mmHg, −10.1 (2.1) mmHg and −10.4 (2.8) mmHg. Complete success (Criterium 1) was achieved in 50%, 62% and 43% of the eyes in groups 1, 2 and 3. No statistically significant difference was found within the first 24 months between the three MMC dose groups for IOP change, success rate, number of ocular hypotensive medications and the frequency of needling procedures.Conclusions: XE45 was effective in all three dose groups. As the success rate did not significantly differ between the MMC doses, these results may support the use of the lowest dose.Trial Registration: ClinicalTrials.gov identifier: 559/2016BO2

Five-year outcomes of ab interno Xen 45 gel stent implantation.

To assess the safety and 5-year efficacy of ab interno XEN 45 gel stent implantation with phacoemulsification in primary open-angle glaucoma (POAG). Single-centre, single-surgeon, retrospective case note review of consecutive OAG patients who underwent ab-interno gel stent placement combined with phacoemulsification. Surgeries were performed between 2/01/2014 and 2/01/2016. mean reduction in intraocular pressure (IOP) and change in number of ocular hypotensive medications from baseline (follow-up range 1-7 years; mean 54 months). change in visual field mean deviation (VFMD) from baseline. Safety data included intraoperative and post-operative complications and adverse events. Failure was defined by IOP reduction < 20% despite maximum medical therapy, the need for further laser or surgical intervention. At 5 years, 75% of eyes were free from failure (95% CI 64 to 83%). Ninety-one eyes were analysed. Mean (SD) IOP and medications decreased from 20.2 (6.4) mmHg and 2.9 (1.0) at baseline to 15.4 (3.6) mmHg (p < 0.001) and 1.5 (1.4) medications at 5 (p < 0.001) years. Baseline mean VFMD (SD) was - 10.3dB (8.5) reducing to - 10.9(8.2) (p < 0.01) at 5 years. Two (2%) eyes had intraoperative complications, 4 (4.3%) experienced post-operative AEs, and 13 (14%) required secondary surgical intervention (SSI). The gel stent combined with phacoemulsification was effective in reducing IOP and medications over 5 years, with an acceptable safety profile. Visual field change was clinically acceptable through the study period.

Combined versus standalone XEN45 Gel Stent implantation in either phakic or pseudophakic patients: a case-matched study

PurposeTo determine differing outcomes among either phakic or pseudophakic patients who received standalone XEN45 Gel Stent (Allergan, an AbbVie Company, CA, USA) implantation and patients who underwent combined surgery with phacoemulsification.MethodsThis retrospective single-center study involved 180 eyes of 180 participants who underwent XEN45 Gel Stent implantation, of which 60 eyes received combined surgery with phacoemulsification (combined group). Standalone stent implantation was performed on 60 phakic (phakic group) and on 60 pseudophakic eyes (pseudophakic group). The groups were matched in a ratio of 1:1:1 based on multiple criteria. Successful surgery was defined by three scores: IOP at the longest follow-up of < 21 mmHg (Score A) or < 18 mmHg (Score B) and an IOP reduction > 20% or IOP ≤ 15 mmHg and an IOP reduction ≥ 40% (Score C). In all scores, one open conjunctival revision was allowed, and additional repeat surgery was considered a failure.ResultsAfter an average follow-up time interval of 20.6 ± 12.6 months, there was a mean IOP-reduction by 37% among the entire cohort. Comparative analysis between the three groups did not show significant differences regarding postoperative IOP, postoperative medication score, side effects, revision rate, repeat surgery rate or success rate. A dysfunctional stent was detected in eight eyes (4%) during open conjunctival revision in 76 eyes.ConclusionThe clinical endpoints investigated did not differ significantly among either phakic or pseudophakic patients who received standalone stent implantation and patients who underwent combined surgery. However mean latency between primary stent implantation and first revision surgery after combined surgery was markedly shorter.

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.

XEN®-45 implantation for refractory uveitic glaucoma

PurposeTo evaluate the efficacy of XEN®-45 gel stent ab interno implantation for medically uncontrolled uveitic glaucoma.MethodsRetrospective analysis of 25 eyes receiving XEN® gel stent for medically uncontrolled uveitic glaucoma from February 2019 to February 2023 with recording of intraocular pressure (IOP) values, ocular hypotensive medication, requirement for revision or secondary surgery and complications. Prerequisites for XEN® implantation were a clear cornea, an open iridocorneal angle and an unscarred, mobile conjunctiva at the implantation site. Minimum follow-up required for inclusion was 3 months. The primary outcome measure was IOP compared to baseline. Complete and qualified success were defined as final IOP of ≤ 18 mmHg without or with topical antiglaucomatous treatment, respectively. Failure was defined as IOP > 18 mmHg on two consecutive visits, IOP reduction < 20%, persisting complications from hypotony and open conjunctival bleb revision. Further glaucoma surgical intervention was defined as complete failure.ResultsMean preoperative IOP was 35.3 ± 10.9 mmHg on 2.9 ± 0.9 topical antiglaucomatous agents. 19 of 25 patients (76%) received additional oral acetazolamide. 19 eyes were pseudophakic, 5 eyes phakic and 1 aphakic.Early postoperatively, mean IOP reduced to 7.7 ± 3.0 mmHg (75.8% reduction). At final follow-up (mean 17.7 months) mean IOP was 12.0 ± 3.8 mmHg (62.5% reduction) on 0.2 ± 0.6 medications.Six eyes (24%) required bleb revision at mean 28 weeks and therefore were categorized as failure. One eye failed despite bleb revision and restart of topical ocular hypotensive medication. Three other eyes (12%) had IOP spikes with uveitis flare-ups. Transient hypotony complications occurred in 32%. At final follow-up, 18 eyes (72%) achieved complete success and one eye (4%) qualified success.ConclusionThe XEN® gel stent effectively reduced IOP in uncontrolled uveitic glaucoma, with 72% complete success. Bleb revision was required in 24%. IOP spikes occurred in 12% despite functioning blebs. Further follow-up is needed to determine long-term outcomes.

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.

Five-Year Outcomes of Single Trabecular Microbypass Stent (iStent®) Implantation with Phacoemulsification in Korean Patients.

This study reports the long-term intraocular pressure (IOP)-lowering efficacy and safety of a singletrabecular microbypass stent(iStent®; Glaukos Corp., San Clemente, CA, USA) for medically controlled open-angleglaucoma in Korean patients. This retrospective observational study included 42 eyes of 35 patients with primary open-angle glaucoma (POAG). All subjects underwent single first-generation iStent® implantation with phacoemulsification by a single surgeon with 5years follow-up. The primary outcomes were changes in IOP and the number of antiglaucoma medications compared to the preoperative values. The secondary outcome was the proportion of eyes with IOP ≤ 18mmHg without medication, ≤ 15mmHg without medication, and ≤ 18mmHg with or without medication. Adverse events and need for secondary glaucoma surgery were also recorded. The mean IOP decreased from 15.8 ± 2.8 to 13.8 ± 1.7mmHg and the mean number of medications was reduced from 2.24 ± 1.18 to 0.83 ± 1.12, respectively, at year5. At 3 and 5years, 80.6% and 78.6% of eyes, respectively, were receiving fewer medications than preoperative numbers. In contrast, only 50% of eyes on four preoperative medications showed medication reductions at 5years. At years3 and 5, 61.3% and 53.5% of eyes achieved IOP ≤ 18mmHg without medication, whereas 90.3% and 89.3% of eyes achieved ≤ 18mmHg regardless of medication use, respectively. Four eyes required additional glaucoma surgery (two Ahmed glaucoma valve implantations, one trabeculectomy, and one XEN45 Gel Stent implantation), and all were receiving four preoperative antiglaucoma medications. Transient IOP elevation (14.3%) was the most common complication, followed by five hyphema, one stent obstruction, one stent malposition, and one severe anterior chamber reaction. This study demonstrated a good safety profile and sustained IOP reduction after the implantation of a single trabecular microbypass stent (iStent®) with phacoemulsification in Korean patients. The majority of subjects with POAG showed a relatively good response; however, eyes receiving a higher number of medications preoperatively (especially four medications) had difficulty achieving a low target IOP.

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.

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.

Effectiveness and Safety of Xen Gel Stent in Glaucoma Surgery: A Systematic Review of the Literature.

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.

One-Year Outcomes of Ab Externo XEN45 Gel Stent Implantation with an Open Conjunctiva Approach in Patients with Open-Angle Glaucoma.

This study aimed to evaluate the 1-year surgical outcomes of XEN45 gel stent implantation with an open conjunctiva approach in patients with open-angle glaucoma (OAG). This retrospective cohort study included 19 eyes of 19 patients who underwent XEN45 gel stent implantation with an open conjunctival approach. Surgical success was defined by intraocular pressure (IOP) ≤18 mmHg and one of the following: IOP reduction ≥30% or reduction of two glaucoma medications with final IOP if baseline IOP ≤18 mmHg. The cumulative probability of success rate was analyzed using Kaplan-Meier survival analysis. Cox proportional hazard regression analysis was used to assess prognostic factors for surgical failure. IOP reduced from 32.37 ± 12.08 mmHg preoperatively to 15.14 ± 2.25 mmHg at 1 year (p = 0.001). The number of glaucoma medication reduced from 3.89 ± 0.32 preoperatively to 0.86 ± 1.35 at 1 year (p = 0.001). The success rates were 78.9% at 6 months and 73.7% at 1 year. Eyes with bleb horizontal extent ≥2 clock hours at 1 month postoperatively had a significantly higher success rate (log-rank test, p &lt; 0.001). Greater bleb horizontal extent at 2 weeks and 1 month postoperatively was associated with a lower surgical failure rate (2 weeks: hazard ratio, 0.119; p = 0.024; 1 month: hazard ratio, 0.046; p = 0.007). Bleb needling and additional glaucoma surgeries were necessary in 10 (52.6%) and five eyes (26.3%), respectively. XEN45 gel stent implantation with the open conjunctiva approach is effective in reducing IOP and glaucoma medication for over 1 year in patients with OAG.

New XEN63 Gel Stent Implantation in Open-Angle Glaucoma: A Two-Year Follow-Up Pilot Study.

The XEN gel stent was developed to reduce the risks of filtration surgery by standardizing the outflow of aqueous humor into the subconjunctival space. Recently, a modified version of the XEN63 gel stent was introduced. The goal of this study was to assess its efficacy and safety. This is a prospective, nonrandomized, observational, consecutive case series study at a single tertiary centre. Patients with open-angle glaucoma with above target intraocular pressure (IOP) despite maximal tolerated medication were included. The primary outcome was a change of median IOP. Secondary outcomes included a change in the number of medications, complete success, needling and complication rates. Success was defined as a lowering of IOP > 20% from baseline and IOP ≤ 14 mmHg. Complete success indicated that the target IOP was reached without medications. Six patients were included. The median IOP decreased from 35.5 mmHg (25.0-40.0 mmHg) at baseline to 11.5 mmHg (4.0-15.0 mmHg, p = 0.03), and median IOP-lowering medication was reduced from 4.0 (3.0-4.0) at baseline to 0 (0-1.0, p = 0.03) after two years. Five patients (83.0%) had a complete success after two years. Two patients (33.0%) required a needling procedure. Three patients (50.0%) required an intervention due to symptomatic hypotony within the first three weeks postoperatively. Hypotony resolved completely or was asymptomatic after three months. Our study demonstrated a statistically significant reduction in both IOP and number of IOP-lowering medications. Complications were well manageable and had no long-term sequelae.

XEN®-63 Compared to XEN®-45 Gel Stents to Reduce Intraocular Pressure in Glaucoma.

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.

Results of open bleb revision as management of primary bleb failure following XEN 45 gel stent and Preserflo™ Microshunt

PurposeThe success of filtering surgery as in XEN-Gel-Stent (XEN) and Preserflo-Microshunt (PF) depends mainly on a functioning bleb. Primary bleb failure (PBF) is not uncommon and can be treated with needling or open bleb revision (OBR). The aim of the study is to compare surgical outcomes of OBR after XEN and PF.MethodsEyes which received OBR as management of PBF following implantation of XEN or PF were retrospectively included. Intraocular pressure (IOP), number of IOP lowering medications (NoM), and success rates (SR) were compared between groups. Complete and qualified success were defined as IOP ≤18mmHg and a reduction of >20%, without and with medications, respectively.Results29 eyes after XEN and 23 eyes after PF were included. Six months following OBR, IOP reduced from 24.2±4.7 to 13.5±4.6 after XEN and from 27.3±8.7 to 15.9±5.8mmHg after PF (both p<0.001). NoM did not change (0.7±1.3 to 0.4±0.8 after XEN and 1.2±1.3 to 1.0±1.5 after PF, p>0.05 for both). Complete SR were higher after XEN than after PF (58.6% vs. 30.4%, p=0.04). Complications were mild and managed mainly conservatively. Additional glaucoma surgery was needed in 17% and 30% of eyes after XEN and PF, respectively (p=0.26).ConclusionAlthough OBR was effective as management of PBF following XEN and PF, SR were higher after XEN than after PF along with comparable safety profile. The change of the surgical approach from ab interno during XEN-Implantation to ab externo during OBR seems to enhance SR compared to PF, where both interventions are done ab externo.

Four-Year Outcome of XEN 45 Gel Stent Implantation in a Swedish Population.

To report the long-time success rate of XEN 45 gel stent implantation in a Scandinavian population. 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. 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. 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.

XEN Gel Stent for Conjunctiva with Minimal Mobility Caused by Scleral Encircling: A Case Report

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.

Short-term Efficacy and Safety of XEN Stent Implantation with or without a Conjunctival Incision

Purpose: Comparison of the 6-month outcomes of ab externo XEN 45 gel stent implantation with conjunctival resection in Korean glaucoma patients.Methods: From January to May 2021, 43 open-angle glaucoma patients who underwent ab externo XEN stent insertion alone and were followed for more than 6 months were classified into incision (n = 23) and non-incision (n = 20) groups according to the presence or absence of a conjunctival incision and analyzed retrospectively. Qualified or complete success was defined as achieving the personal target intraocular pressure (IOP) with or without medication, respectively.Results: The IOP measured 6 months after surgery decreased significantly in both groups. The number of IOP-lowering drugs required was also reduced. The decrease in IOP after surgery was greater in the non-incision group. Six months after surgery, the qualified success rate was 55% in the non-incision group and 52.2% in the incision group, while the complete success rate was 40% and 8.7%, respectively. During follow-up, 58.1% of the patients underwent bleb needling more than once, and 20.9% underwent additional IOP-lowering surgery, but there was no difference between the two groups.Conclusions: XEN stent insertion helped to reduce IOP and the number of IOP-lowering agents after 6 months regardless of a conjunctival incision. However, to maintain the target IOP, bleb manipulation was required in many cases.

Gel Stent Versus Trabeculectomy: The Randomized, Multicenter, Gold-Standard Pathway Study (GPS) of Effectiveness and Safety at 12 Months

To compare effectiveness and safety of the gel stent to trabeculectomy in open-angle glaucoma (OAG). Prospective, randomized, multicenter, noninferiority study. Patients with OAG and intraocular pressure (IOP) 15 to 44 mm Hg on topical IOP-lowering medication were randomized 2:1 to gel stent implantation or trabeculectomy. Primary end point (surgical success): percentage of patients at month 12 achieving ≥20% IOP reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or secondary surgical intervention (SSI) in a noninferiority test with 24% margins. Secondary end points (month 12) included mean IOP and medication count, postoperative intervention rate, visual recovery, and patient-reported outcomes (PROs). Safety end points included adverse events (AEs). At month 12, the gel stent was statistically noninferior to trabeculectomy (between-treatment difference [Δ], -6.1%; 95% CI, -22.9%, 10.8%); 62.1% and 68.2% achieved the primary end point, respectively (P=.487); mean IOP and medication count reductions from baseline were significant (P<.001); and the IOP change-related Δ (2.8 mm Hg) favored trabeculectomy (P=.024). The gel stent resulted in fewer eyes requiring in-office postoperative interventions (P=.024 after excluding laser suture lysis), faster visual recovery (P≤.048), and greater 6-month improvements in visual function problems (ie, PROs; P≤.022). The most common AEs were reduced visual acuity at any time (gel stent, 38.9%; trabeculectomy, 54.5%) and hypotony (IOP <6 mm Hg at any time) (gel stent, 23.2%; trabeculectomy, 50.0%). At month 12, the gel stent was statistically noninferior to trabeculectomy, per the percentage of patients achieving ≥20% IOP reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or SSI. Trabeculectomy achieved a statistically lower mean IOP, numerically lower failure rate, and numerically lower need for supplemental medications. The gel stent resulted in fewer postoperative interventions, better visual recovery, and fewer AEs.

Short-Term Outcomes of Xen-45 Gel Stent Ab Interno Versus Ab Externo Transconjunctival Approaches.

Ab externo transconjunctival placement of the Xen-45 gel stent offers a faster surgical approach and more rapid visual recovery with similar pressure-lowering and complication rates when compared with implantation by the ab interno approach. Compare outcomes of closed conjunctival Xen-45 implantation techniques: ab interno versus ab externo transconjunctival. Single-center, retrospective study of 70 patients undergoing Xen-45 implantation between 2017 and 2020. Group 1 (n=29) had ab interno placement, Group 2 (n=41) had transconjunctival ab externo placement. Primary outcome measures were intraocular pressure (IOP) and medication use. Secondary measures were bleb revision rates, surgical time, time to return to baseline visual acuity, and complication rates. Group 1, preoperative IOP was 22.8±7.5mmHg on 3.8±0.9 IOP-lowering medications and the postoperative IOP at last follow-up was 11.6±2.8mmHg on 1.6±1.3 medications. Group 2, preoperative IOP was 25.6mmHg±7.8mmHg on 3.7±1.1 medications and the postoperative IOP at last follow-up was 12.4±3.6mmHg on 1.5±1.3 medications. There was no difference in postoperative IOP or medications between the 2 groups ( P <0.05). The average surgical time for Group 2 was 25±6.5 minutes to 37±7.3 minutes for Group 1 ( P <0.001). Group 2 showed 88% of patients returning to baseline visual acuity at week 2 compared with 66% in Group 1 ( P <0.05). Bleb revision rates, failure rates, and complication rates were comparable between both groups ( P >0.05). IOP, medication use, complications, bleb revision rates, and failure rates were similar between ab interno and ab externo transconjunctival approaches. The ab externo group had faster surgical times and postoperative visual recovery despite higher number of patients with previous glaucoma procedures.

XEN Gel Stent Versus Non-penetrating Deep Sclerectomy in Ocular-hypertension and Open-angle Glaucoma Patients.

XEN gel-stent and non-penetrating deep sclerectomy, either alone or in combination with cataract surgery, significantly lowered the intraocular pressure and reduced the number of antiglaucoma medications in open-angle-glaucoma patients; with no significant differences between them. To compare the surgical outcomes of XEN45-implant and non-penetrating deep sclerectomy (NPDS), either alone or in combination with cataract surgery, in patients with ocular-hypertension (OHT) and open-angle glaucoma (OAG). Retrospective and single center cohort study conducted on consecutive patients who underwent a XEN45 implant or a NPDS, either alone or in combination with phacoemulsification. The primary endpoint was the mean change in intraocular pressure (IOP) from baseline to the last follow-up visit. One hundred twenty-eight eyes, 65 (50.8%) eyes in the NPDS-group and 63 (49.2%) eyes in the XEN-group, were included in the study. The mean preoperative IOP was significantly lowered from 17.6±5.3mmHg and 17.8±6.2mmHg to 12.6±2.6mmHg and 13.8±2.8mmHg at month-12, in the XEN and NPDS groups, respectively; P<0.0001 each. At month-12, 70(54.7%) eyes were classified as success, with no significant differences between XEN (57.1%; 36/63 eyes) and NPDS (52.3%; 34/65 eyes) (mean difference: 4.8%; 95% CI: -30.5% to 20.8%; P=0.7115). The number of ocular hypotensive medications was significantly reduced in the XEN (from 2.1±0.7 to 0.2±0.5, P<0.0001) and in the NPDS (from 2.0±0.8 to 0.3±0.6, P<0.0001) groups, with no significant differences between them (P=0.2629). The incidence of postoperative adverse events in the overall study population was 12.5%, with no significant differences between groups (P=0.1275). Seven (11.1%) eyes underwent needling (XEN-group) and 10 (15.4%) goniopuncture (NPDS-group); P=0.4753. XEN45-implant and the NPDS, either alone or in combination with cataract surgery, significantly lowered IOP and reduced the number of ocular hypotensive medications in OHT and OAG patients.