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AIM: To evaluate and compare the quality of life of patients submitted to XEN® implant or trabeculectomy and the relationship with potentially involved variables.
METHODS: A cross-sectional study of patients with advanced open-angle glaucoma who underwent implantation of XEN® (group 1) and trabeculectomy (group 2) between October 2015 and February...
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Aim:
To compare the outcome of an Ex-Press implant and subscleral trabeculectomy (SST) in the management of glaucoma after previous trabeculectomy on a fibrotic bleb.
Methods:
This randomized prospective study included 28 eyes from 28 patients (age range: 42-55y) with primary open angle glaucoma (POAG) presented with elevated intraocular pressur...
Citations
... Topical-hypotensive medication is the classic first-treatment approach to primary open-angle glaucoma (POAG), but long-term topical treatments induce dry eyes and fibrosis, thus reducing the probability of success after glaucoma filtering surgery [1][2][3][4][5][6][7][8][9][10][11]. ...
Background: To assess intraocular pressure (IOP) changes and complications after XEN45 implants in medically controlled eyes (MCE) vs. medically uncontrolled eyes (MUE). Methods: A retrospective study, in a tertiary referral hospital, on mild-to-moderate primary open-angle glaucoma (POAG) cases under topical medication, including 32 eyes with IOP < 21 mmHg (MCE group) and 30 eyes with IOP ≥ 21 mmHg (MUE group). The success criteria using Kaplan–Meier analysis was IOP < 21 mmHg without medications (complete success) or fewer drugs than preoperatively (qualified success) at the last visit, without new surgery or unresolved hypotony. Results: No significant preoperative differences were found between the groups. The mean IOP was 15.6 ± 3.8 mmHg in MCE and 15.1 ± 4.1 mmHg in the MUE group (p > 0.05; Mann–Whitney test) at the end of the follow-up (mean of 26.1 ± 15.6 months and 28.3 ± 15.3 months, respectively) (p = 0.414, Mann–Whitney Test). The device caused a significant IOP reduction at 24 h in both groups. Thereafter, the MCE group significantly tended to increase IOP, recovering baseline values at 1 month and maintaining them until the end of the follow-up. In contrast, in the MUE group, the IOP values tended to be similar after the first reduction. No relevant complications and no significant differences between the groups in the survival analysis were found. Conclusions: XEN45 provided stable IOP control in both the MCE and MUE group without important complications in the medium term. The IOP increasing in the MCE group, after a prior decrease, led to restored baseline values 1 month after surgery. The homeostatic mechanism that causes the rise in the IOP to baseline values and its relationship with failure cases remains to be clarified.
... However, other studies showed that reintervention rate, including both needling and revision surgery with conjunctival dissection, is higher after XEN ® implantation compared to other glaucoma filtering surgery [25,26]. Basílio et al. showed non-inferiority of medium-term quality of life after XEN ® implantation compared to trabeculectomy after median 12 months [27]. ...
Purpose
To evaluate the efficacy of XEN®-45 gel stent ab interno implantation for medically uncontrolled uveitic glaucoma.
Methods
Retrospective 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.
Results
Mean 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.
Conclusion
The 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.
... Eine Fragebogenvergleichsstudie hinsichtlich der Glaucoma Symptom Scale zwischen XEN-Stent-Chirurgie und Trabekulektomie konnte keine signifikanten Unterschiede zwischen den beiden chirurgischen Verfahren zeigen; für beide Gruppen fielen die Angaben günstiger aus, je weniger topische Antiglaukomatosa postoperativ getropft werden mussten [35]. Ebenfalls keine signifikanten Gruppenun-terschiede traten in einer Vergleichsstudie Trabekulektomie vs. Glaukomdrainageimplantat (Baerveldt) auf, die die "patientreported vision-specific quality of life" unter Verwendung des National Eye Institute-Visual Functioning Questionnaire (VFQ-25) untersuchte [36], wobei in einer weiteren Studie das Glaukomdrainageimplantat verglichen mit der Trabekulektomie hinsichtlich des Adult Strabismus-20 Questionnaire schlechter abschnitt [37]. ...
Background
Trabeculectomy (TE) remains one of the most frequently performed glaucoma procedures. This surgery enables sufficient reduction of intraocular pressure (IOP) and freedom from using eye drops; however, complication management and time-consuming postoperative care make many ophthalmic surgeons reluctant to include TE in their treatment regimen.AimThis review presents the value of TE compared to other forms of filtering and nonfiltering glaucoma surgery.Conclusion
The use of TE is still the most effective method for lowering IOP and in comparison to other forms of glaucoma surgery in most cases enables freedom from eye drops with a subsequent high quality of life. Postoperative complications occur more frequently, but usually heal spontaneously or can be treated adequately and safely by surgery; however, TE requires intensive postoperative care, which should not be neglected. Repeated surgery due to insufficient IOP reduction is less frequent compared to other forms of glaucoma surgery.
... 17 Fewer studies comparing XEN45 implantation directly with TRAB have been published. [18][19][20][21][22][23][24][25][26][27][28][29] Our group previously published a 1-year retrospective comparison of the efficacy and safety between the XEN45 implant and TRAB, either alone or in combination with phacoemulsification (PHACO), in patients with OAG [showing a mean IOP decrease of 6.7 (10.4-3.0 mm Hg, P = 0.0013, XEN45 alone); 3.5 (5.0-2.0 mm Hg, P < 0.0001, XEN45 ± PHACO); 8.1 (10.4-5.9 mm Hg, P < 0.0001, TRAB alone); and 7.3 (9.3-5.3 mm Hg, P < 0.0001, TRAB ± PHACO)]. 18 This study aimed to extend our analysis of the XEN45 to 36 months in a University Hospital in Alicante, Spain. ...
... [26][27][28] A study of medium-term quality of life assessment found no significant difference between the 2 groups. 29 The authors observed a strongly negative correlation between the administration of topical antihypertensive drug and the assessment questionnaire result in both study groups, possibly due to the symptomatology of the ocular surface that can develop collaterally. 29 The result agrees with that found in other studies about no difference in the postoperative NOAM between the XEN45 implant and TRAB surgery. ...
... 29 The authors observed a strongly negative correlation between the administration of topical antihypertensive drug and the assessment questionnaire result in both study groups, possibly due to the symptomatology of the ocular surface that can develop collaterally. 29 The result agrees with that found in other studies about no difference in the postoperative NOAM between the XEN45 implant and TRAB surgery. [18][19][20][21][22][23][24] There are more limitations to this study. ...
Purpose: The aim of this study was to compare the differences between the efficacy and safety of the XEN45 implant and trabeculectomy (TRAB), either alone or in combination with phacoemulsification (PHACO), in patients with open-angle glaucoma (OAG) at 36 months.
Methods: A retrospective, single-center and comparative study conducted on OAG patients that underwent XEN45 implantation or trabeculectomy from 2016 to 2018. Patients were divided into four groups: group 1 (XEN45 alone); group 2 (XEN45+PHACO); group 3 (TRAB alone); group 4 (TRAB+PHACO). For statistical purposes, groups 1 and 2 were combined (XEN45 implant), while groups 3 and 4 were also combined (TRAB surgery). Intraocular pressure (IOP), number of antiglaucoma medications (NOAM) and adverse events were evaluated. The main outcome measure was the reduction in IOP at 36 months postoperatively.
Results: One hundred and thirty-four patients (134 eyes; 63 XEN45 and 71 TRAB) were included. The mean (95% CI) IOP reduction at the end of the study follow-up was-6.3 (-11.0 to -1.6 mmHg, P=0.025, XEN45 alone),-8.9 (-11.0 to-6.8 mmHg, P<0.001, TRAB alone),-2.5 (-4.5 to -0.4 mmHg, P=0.019, XEN45+PHACO), and-5.6 (-7.7 to-3.4 mmHg, P<0.001, TRAB±PHACO). The proportion of patients achieving an IOP≥6 and≤16 mmHg without treatment at the end of the 36-month follow-up were 50.8% (32/63) in the XEN45 implant and 49.3% (35/71) in the TRAB surgery group, P=0.863. The mean number of antiglaucoma medications was significantly reduced in all the study groups. The needling rate was 19% in XEN45 versus 5.6% in the TRAB group (P=0.030), and 2.81% and 36.6% of eyes in the TRAB group presented anterior chamber (AC) flattening and hyphema, respectively.
... In line with our findings, a previous study reported that GSS scores were significantly lower in patients requiring two or more eye drops per day [27]. In a study by Basilio et al. [28], GSS scores were compared between patients who underwent minimal invasive glaucoma surgery with Xen ® and trabeculectomy. They did not find a difference between the two groups, but they found a strong negative correlation between the administration of topical anti-hypertensive drugs and GSS scores. ...
Glaucoma has a significant impact on quality of life. Here, we aimed to evaluate the influence of a reduction in glaucoma medications on quality of life and patient satisfaction after phacoemulsification combined with the Xen gel stent. We carried out a cross-sectional survey of patients who underwent phacoemulsification with the Xen gel stent at the Medical University of Graz, Austria. Quality of life was assessed using the German version of the Glaucoma Symptoms Scale (GSS)—questionnaire. Patients were also asked whether the operation reduced glaucoma medications and to indicate their overall satisfaction from 1 (totally discontented) up to 10 (totally contented). Questionnaires of 80 patients were evaluated. A total of 36 patients (45.0%) reported a reduction in glaucoma medications. Three items of the GSS were significantly better in patients who needed fewer glaucoma medications after the operation (“hard to see in daylight”, 75.0 ± 31.1 vs. 57.7 ± 39.1, p = 0.035; “hard to see in dark places”, 81.1 ± 28.7 vs. 54.9 ± 41.2, p = 0.002; and “halos around lights”, 88.3 ± 25.9 vs. 68.8 ± 38.6, p = 0.002). Patient satisfaction was significantly higher when the procedure led to a reduction in glaucoma medication (8.3 ± 2.0 vs. 6.8 ± 3.1; p = 0.034). The reported quality of life and patient satisfaction were significantly better when phacoemulsification with the Xen gel stent reduced the number of glaucoma medications needed.
... MIGS techniques are often marketed as procedures with a higher safety profile than traditional subconjunctival filtration surgery [9][10][11]. However, XEN45 implantation is not without risks. ...
Background:
The XEN45 Gel Stent is a subconjunctival filtering device that has demonstrated promising efficacy. This meta-analysis quantitatively evaluates reported complications and interventions after XEN45 implantation in the treatment of open angle glaucoma (OAG).
Methods:
Pilot, cohort, observational studies, and randomised controlled trials that included at least ten patients undergoing ab interno or externo XEN45 surgery, with or without phacoemulsification were deemed eligible for inclusion. A meta-analysis of proportions with random-effect models was performed using the meta routine in R version 3.2.1. Outcomes included the rate of complications and post-operative interventions.
Results:
One hundred and fifty-two studies were identified on initial literature search and 33 were included in final analysis. Numerical hypotony was the most common post-operative complication, involving 20% of patients (95% CI: 10-31%). Post-operative gross hyphema occurred in 14% (95% CI: 7-22%) and transient intra-ocular pressure (IOP) spikes (>30 mmHg) in 13% (95% CI: 4-27%). Stent exposure occurred in 1% (95% CI: 0-2%). Stent migration occurred in 1% (95% CI: 0-3%). XEN45 revision and/or a second XEN45 implantation was performed in 5% of patients (95% CI: 3-7%). Stent relocation was performed in 3% (95% CI: 1-7%). A second glaucoma procedure was performed in 11% (95% CI: 8-15%). 26% underwent one (95% CI: 17-36%), 13% underwent two (95% CI: 5-24%) while 4% underwent three (95% CI: 2-6%) bleb needling procedures. 35% of patients (95% CI: 29-40%) required at least one needling. The average rate of needling per patient was 0.38 (95% CI: 0.20-0.59). However, there is a lack of high-quality data, with 8 of the 33 studies assessed to have a moderate to high risk of bias.
Conclusions:
While literature suggests that XEN45 Gel Stent implantation is safe in the treatment of OAG, the overall current level of evidence is low and further studies are needed. More than a third of patients require at least one post-operative bleb needling procedure.
... Until today, few studies exist comparing the surgical outcome of trabeculectomy combined with MMC and the implantation of a XEN gelstent (Schlenker et al. 2017;Bas ılio et al. 2018;Marcos Parra et al. 2019;Teus et al. 2019;Theilig et al. 2020 (Wagner et al. 2020). Theilig et al. did not find significant differences in success proportions for TE versus XEN implantation 9 and 12 months postoperatively either (Theilig et al. 2020). ...
Purpose:
To assess surgical success and the post-operative development of intraocular pressure between XEN45® gelstent, Preserflo® MicroShunt and trabeculectomy with mitomycin C.
Methods:
Data from 105 eyes from 105 patients of matched cases with refractory open-angle glaucoma, who underwent surgery between January 2019, and August 2020, were evaluated. Patients underwent either stand-alone XEN gelstent insertion with Mitomycin C, stand-alone Preserflo with Mitomycin C or trabeculectomy with Mitomycin C. The primary outcome was the proportion of complete surgical success at 6 months post-operatively (i.e. intraocular pressure between 5mmHg and 18mmHg, no revision surgery, no loss of light perception and no post-operative pharmaceutical antiglaucomatous treatment). The reduction of intraocular pressure after 6 months, the classes of antiglaucomatous medication used post-operatively, best-corrected visual acuity, spherical refractive errors and astigmatism were assessed as secondary outcomes.
Results:
We included 35 eyes in each group. After 6-month follow-up, complete success was 73.5% [95%-CI: 57.9%-89.2%] in the trabeculectomy group, 51.4% [95%-CI: 34.0%-68.8%] in the XEN group and 74.2% [95%-CI: 57.9%-90.5%] in the Preserflo group (p = 0.08). Regarding secondary outcomes, the reduction of intraocular pressure was 12.1 ± 7.9 mmHg in the trabeculectomy group and was thereby 5.8 [95%-CI: 2.2-9.6] mmHg greater compared with the XEN group (p < 0.001) and 4.8 [95%-CI: 0.9-8.7] mmHg higher than the Preserflo group (p = 0.01).
Conclusions:
No statistically significant differences were found between trabeculectomy, XEN45® gelstent implantation and Preserflo® MicroShunt implantation regarding surgical success after 6 months. Yet reduction in intraocular pressure was significantly higher in the trabeculectomy group. However, all three interventions resulted in sufficiently low post-operative intraocular pressure and may therefore be considered individually for glaucoma treatment.
... It has been shown that XEN implantation goes along with a higher rate of bleb needling or revision surgery and this increase is probably explained by increased usage of these implants. 30,31 Another potential factor that might affect the numbers and rates of procedures performed is the role that advertising has for newer procedures compared to older ones. Latest procedures are well advertised and recommended within the group of ophthalmologists and ophthalmic surgeons but might lose their place in the spotlight to newer procedures after a while and therefore be performed less often. ...
Background/Aims
Surgical procedures in ophthalmology underlie variations over different time periods and are strongly dependent on the technical process and the invention of innovative surgical techniques. Especially, in glaucoma surgery a lot of surgical devices and techniques have been introduced during the last years. Until now, the use of these newer techniques has not been shown on a robust data basis. We herein present the numbers of different types of glaucoma surgeries performed at German hospitals between 2006 and 2018.
Methods and Design
The quality reports of hospitals in Germany from 2006 to 2018 were analyzed concerning all procedural codes for glaucoma surgery and intervention. Especially, the change in usage of “classical” and “modern” surgical techniques (MIGS: “minimally invasive glaucoma surgery”) or devices was compared.
Results
The number of glaucoma procedures performed increased by 75% from 27,811 in 2006 to 48,794 in 2018. Absolute numbers of trabeculectomies, goniotomies, ab externo trabeculotomies and to a certain level cyclodestructive procedures decreased during the examined years while use of MIGS has increased in absolute and relative numbers since 2012. From 2015 a strong increase in the usage of XEN implants could be seen. Drainage implants (such as Baerveldt/Ahmed) showed stable absolute numbers over the time period covered. Absolute numbers of laser trabeculoplasty peaked in 2014 and decreased afterwards. Iridotomies and iridectomies increased by 120%/248% over the whole period.
Conclusion
Our data show a trend towards the modern surgical options and especially MIGS during the recent years. Classical procedures showed a decrease in total numbers emphasized from 2013. These numbers confirm the assumption that modern glaucoma surgery is becoming more and more popular and established in German hospitals.
... Few studies have yet compared both filtering surgeries, XEN gelstent implantation and trabeculectomy. To this date, no prospective randomized clinical trial exists that compares the two procedures [8,9]. Most recently, Schlenker et al. found that there were no detectable evidence of differences in the risk of failure or safety profiles between the two surgical procedures [9]. ...
... Until today, few studies exist comparing the surgical outcome of trabeculectomy combined with MMC and the implantation of a XEN gelstent [8,9,16,17]. Schlenker et al. compared the rate of surgical failure after trabeculectomy and XEN gelstent implantation, which directly corresponds to surgical success. ...
Objective
To compare surgical success, postoperative intraocular pressure and complication rates between trabeculectomy and XEN gelstent surgery in a cohort of glaucoma patients in a typical clinical setting.
Methods
A retrospective cohort study of consecutive patients with refractory open-angle glaucoma including patients who underwent either stand-alone XEN gelstent insertion with Mitomycin C or trabeculectomy with Mitomycin C between 2016 and 2018 at the University Eye Hospital Mainz, Germany. Primary outcome measure was the proportion of surgical success 1 year after surgery. Patients with an IOP ≤18mmHg, an intraocular pressure reduction of >20% and in no need of revision surgery or topical medication were considered a complete surgical success. If topical therapy was necessary, they were considered a qualified success. Multivariable logistic regression analysis was carried out for the primary outcome including gender, age, preoperative intraocular pressure and number of medication classes used preoperatively as adjustment variables.
Results
171 eyes of 144 patients were included, including 82 eyes of 58 patients in the XEN group and 89 eyes of 86 patients in the trabeculectomy group. The primary outcome defined as the proportion of surgical success after 1 year (mean 11.1 months ± 2.2) was similar for both groups. The complete success proportion was 65.5% (95%-CI: 55.6–75.9%) in the trabeculectomy group, and 58.5% (95%-CI: 47.6–69.4%) in the XEN group and not statistically different in our analysis model (crude OR = 0.61; 95%-CI: 0.31–1.22; adjusted OR = 0.66; 95%-CI: 0.32–1.37). The intraocular pressure reduction, as secondary outcome measure, was higher in the trabeculectomy group (10.5 mmHg) compared to the XEN group (7.2 mmHg; p = 0.003) at the 12-month follow-up.
Conclusion
Both XEN gelstent implantation and trabeculectomy show similar proportions of surgical success and of complications and are therefore both recommendable for clinical routine. However, trabeculectomy seems to be more effective in lowering intraocular pressure than the XEN implantation. A prospective randomized clinical trial is necessary to evaluate differences in the long-term clinical outcome.
Purpose:
To compare effectiveness and safety of the gel stent to trabeculectomy in open-angle glaucoma (OAG).
Design:
Prospective, randomized, multicenter, noninferiority study.
Methods:
Patients with OAG and intraocular pressure (IOP) 15-44 mmHg on topical IOP-lowering medication were randomized 2:1 to gel stent implantation or trabeculectomy. Primary endpoint (surgical success): patients (%) at Month 12 (M12) 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 endpoints (M12) included mean IOP and medication count; postoperative intervention rate; visual recovery; and patient-reported outcomes (PROs). Safety endpoints included adverse events (AEs).
Results:
At M12, the gel stent was statistically noninferior to trabeculectomy (between-treatment difference [Δ], -6.1%; 95% confidence interval, -22.9%, 10.8%); 62.1% and 68.2% achieved the primary endpoint, respectively (P=.487); mean IOP and medication count reductions from baseline were significant (P<.001); and the IOP change-related Δ (2.8 mmHg) 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 (PROs; P≤.022). Most common AEs: reduced visual acuity at any time (gel stent, 38.9%; trabeculectomy, 54.5%) and hypotony (IOP <6 mmHg at any time) (gel stent, 23.2%; trabeculectomy, 50.0%).
Conclusions:
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.
