Standalone Ab Interno Gelatin Stent versus Trabeculectomy

Schlenker, Matthew B.; Gulamhusein, Husayn; Conrad-Hengerer, Ina; Somers, Alix; Lenzhofer, Markus; Stalmans, Ingeborg; Reitsamer, Herbert A.; Hengerer, Fritz H.; Ahmed, Iqbal Ike K.

doi:10.1016/j.ogla.2018.10.003

Cited by 13 publications

(17 citation statements)

References 10 publications

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“…The usual gold standard in glaucoma surgery is a comparison to trabeculectomy. Such reports on the IOP reducing efficacy rates for adverse effects and visual recovery have been published for XEN45 9 , 10 , 11 and also for the PreserFlo Microshunt 12 . According to the literature, XEN45 was successfully applied to various forms of glaucoma, resulting in IOP readings comparable to ours 13 , 14 , 15 , 16 .…”

Section: Discussionmentioning

confidence: 98%

Retrospective Analysis of 12 Months Glaucoma Implant Efficacy: XEN45 and PreserFlo Microshunt

Saletta

Alexoudis

Gkatzioufas

et al. 2022

Klin Monbl Augenheilkd

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Purpose Several new implant devices have recently been introduced to glaucoma surgery using various techniques for reducing intraocular pressure (IOP). Two implants introduced during the past couple of years, XEN45 and PreserFlo Microshunt, are both designed to control subconjunctival filtration. There are two Swiss multicenter studies that collected the data retrospectively to analyze the efficacy and safety of these two devices separately. In this study, we report the analysis of the combined data subset from the University Hospital of Basel. Subjects and Methods The XEN45 implantation technique was introduced to Basel University Hospital in 2016 and PreserFlo Microshunt in 2018. Sixty operated patients, thirty in each group, were operated on by one surgeon, clinically followed up, and their data retrospectively analyzed from medical records. Only standalone procedures, without combined phacoemulsification, were considered in this analysis; the lens status, however, was neither an inclusion nor an exclusion criterion. Further inclusion criteria were the diagnosis of open-angle glaucoma, no previous glaucoma surgery, other than laser trabeculoplasty, and complete medical records during the 12 months of follow-up. IOP reduction during a 12-month postoperative period was the primary outcome measure as well as the number of IOP reducing drugs. The number of subsequent surgical interventions and complications/adverse events are descriptively reported. Results Patient age, gender, ophthalmological diagnosis, and initial preoperative IOP were well balanced between the two groups. Postoperative IOP course was comparable between the two methods for the first 12 months. IOP measurements were taken preoperatively and then on the first postop day, week 1, month 1, and months 3, 6, and 12 for the PreserFlo Microshunt vs. XEN45 (mmHg): 23.6 vs. 24.9, 9.0 vs. 8.9, 11.4 vs. 10.6, 13.0 vs.18.3, 16.8 vs.15.1, 15.9 vs.15.0, and 15.4 vs.14.5, respectively. IOP reducing medications were also comparable between the two groups. The study showed that subsequent interventions were more frequent in the XEN45 (13) than in the PreserFlo Microshunt group (7). Conclusion Both methods demonstrate satisfactory IOP control within a 12-month postoperative period with practically no serious adverse events/complications, but with relatively high numbers of subsequent interventions (needlings), particularly in the XEN45 group.

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Section: Discussionmentioning

confidence: 98%

Retrospective Analysis of 12 Months Glaucoma Implant Efficacy: XEN45 and PreserFlo Microshunt

Saletta

Alexoudis

Gkatzioufas

et al. 2022

Klin Monbl Augenheilkd

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“…Additional procedures were applied when the following criteria were met: for 5-FU injection (5 mg in 0.2 mL), progressive increase in the IOP greater than 16 mmHg on the consecutive visits and the development of subconjunctival fibrosis (manifested as engorged and tortuous blood vessels above filtering bleb); for needling, diagnosing of fibrosis (based on the abovementioned clinical signs), insufficient subconjunctival outflow, increase in the IOP, or the flattening of the bleb. Injections of 5-FU were administered for 5 consecutive days or until the fibrosis was abated and the IOP stabilized, provided that no antimetabolite-related adverse effects occurred [ 22 , 23 ].…”

Section: Methodsmentioning

confidence: 99%

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications during a Long-Term Follow-Up

Lewczuk

Konopińska

Jabłońska

et al. 2021

Journal of Ophthalmology

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This study aimed to analyze the surgical and refractive outcomes of XEN glaucoma implant (Allergan, an Abbvie company, Irvine, CA, USA), a minimally invasive surgical device for the treatment of operated uncontrolled glaucoma. Eyes that received XEN Gel Stent placement from December 2014 to October 2019 were retrospectively investigated. Intraocular pressure (IOP) change, best-corrected visual acuity (BCVA), change in glaucoma medications, frequency of slit lamp revision procedures, and frequency of secondary glaucoma surgeries were the primary outcomes. Seventy-two eyes of 72 subjects were included in the study: 32 (44%) men and 40 (56%) women. The follow-up period ranged from 1 to 50 months (median, 26.13 months). The mean IOP before surgery was 24.82 ± 8.03 mmHg and decreased to 17.45 ± 5.84 mmHg at the end of the study (mean difference [MD] = −7.48, 95% confidence interval [CI]: −10.04, −4.93; p < 0.001 ). The mean decrease from baseline was 23%. BCVA before surgery was 0.38 ± 0.30, and that at the end of the follow-up period improved to 0.47 ± 0.37, MD = 0.09, 95% CI: 0.04, 0.13; p < 0.001 . Additional procedures (fluorouracil injection and bleb needling) were performed in 11/72 patients (15%). Further glaucoma surgery was necessary for 23.9% of the patients. XEN Gel Stent implantation is both safe and reasonably effective for lowering IOP in operated uncontrolled glaucoma patients.

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“…In two retrospective Xen vs. trabeculectomy studies, the incidence of hypotony was not reported; however, the anterior chamber flattening, a condition commonly related to hypotony, was greatly more frequent in the trabeculectomy compared to the Xen group (19.6% vs. 1.5% and 14.7% vs. 0%, trabeculectomy vs. Xen, respectively) [ 34 , 35 ]. In one study, no late hypotony and hypotony maculopathy occurred after the first month of follow-up [ 36 ], and one study reported a similar incidence of choroidal folds and hypotony maculopathy in the two groups (hypotony maculopathy 1.1% Xen, trabe 0.6%) [ 16 ]. In a large, comparative retrospective study between standalone Xen 45 and standalone trabeculectomy [ 16 ], the authors reported a significantly lower percentage of patients with a vision loss of >2 lines in the Xen group.…”

Section: Discussionmentioning

confidence: 99%

“…In one study, no late hypotony and hypotony maculopathy occurred after the first month of follow-up [ 36 ], and one study reported a similar incidence of choroidal folds and hypotony maculopathy in the two groups (hypotony maculopathy 1.1% Xen, trabe 0.6%) [ 16 ]. In a large, comparative retrospective study between standalone Xen 45 and standalone trabeculectomy [ 16 ], the authors reported a significantly lower percentage of patients with a vision loss of >2 lines in the Xen group.…”

Section: Discussionmentioning

confidence: 99%

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Safety and Efficacy of Ab Interno XEN 45 Gel Stent in Patients with Glaucoma and High Myopia

Sacchi

Fea

Monsellato

et al. 2023

JCM

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This study reports on the safety and efficacy of Xen 45 in patients with glaucoma and high myopia. It was a retrospective study including patients with high myopia (>6D) who underwent Xen implant with 2 years of follow-up. The primary outcome was to report the incidence of hypotony (IOP ≤ 5 mmHg) and hypotony-related complications. Patients with high myopia treated with mitomycin-C-augmented trabeculectomy were included as a control group. We included 14 consecutive patients who underwent Xen implant (seven eyes) and trabeculectomy (seven eyes). The mean myopia was −14.71 ± 5.36 and −15.07 ± 6.11 in the trabeculectomy and Xen groups, respectively (p > 0.05). The success rate and the mean IOP at 1 and 2 years from the intervention were statistically comparable between the two groups. The group undergoing trabeculectomy showed a higher incidence of hypotony (six eyes (85.71%) vs. two eyes (28.57%)) and hypotony maculopathy (three eyes (42.86%) vs. zero eyes (0%)) and required more postoperative procedures. Patients with high myopia were at higher risk of hypotony-related complications after trabeculectomy. The Xen implant can achieve an IOP control comparable to trabeculectomy with a significantly better safety profile and can be considered as an option for the management of patients with high myopia and glaucoma.

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Standalone Ab Interno Gelatin Stent versus Trabeculectomy

Cited by 13 publications

References 10 publications

Retrospective Analysis of 12 Months Glaucoma Implant Efficacy: XEN45 and PreserFlo Microshunt

Retrospective Analysis of 12 Months Glaucoma Implant Efficacy: XEN45 and PreserFlo Microshunt

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications during a Long-Term Follow-Up

Safety and Efficacy of Ab Interno XEN 45 Gel Stent in Patients with Glaucoma and High Myopia

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