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

Abstract

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.

Zusammenfassung

Hintergrund In den letzten Jahren haben einige neue Glaukomimplantate den Weg auf den Markt und in die Augenkliniken gefunden, mit unterschiedlicher Methodik zur Augendrucksenkung (IOD-Senkung). Zwei dieser Implantate, XEN45 und PreserFlo Microshunt, leiten die Kammerflüssigkeit subkonjunktival ab. Zwei voneinander unabhängige, multizentrische Schweizer Studien befassen sich mit der Effizienz und Sicherheit dieser beiden Methoden. Diese Erhebung berichtet über die Zwischenergebnisse einer retrospektiven Subanalyse, welche die Daten beider Methoden vom Augenspital Basel kombiniert.

Methoden und Probanden XEN45-Implantationstechnik wurde in Basel 2016, PreserFlo Microshunt 2018 eingeführt. 60 Patienten wurden von einem Chirurgen operiert, danach klinisch nachkontrolliert und ihre Daten retrospektiv via Aktenstudium analysiert. Es wurden Patienten mit Glaukomoperationen ohne Kombination mit einer Kataraktoperation berücksichtigt; der Linsenstatus (phak/pseudophak) war weder Einschluss- noch Ausschlusskriterium. Einschlusskriterien waren die Diagnose eines Offenwinkelglaukoms, keine vorausgegangene Glaukomchirurgie, außer der Lasertrabekuloplastik, und vollständige klinische Patientenakten während der ersten 12 postoperativen Monate. In den Subgruppen wurden die konsekutiven Daten von jeweils 30 Patienten, welche die o. g. Kriterien erfüllt hatten, eingeschlossen. Analysiert wurden die postoperativen IOD-Werte, Anzahl der drucksenkenden Medikation und die eventuellen nachfolgenden Interventionen.

Ergebnisse Alter, Geschlechterverteilung, Augendiagnosen und präoperativer IOD waren vergleichbar zwischen den beiden Interventionsgruppen – ebenso wie der postoperative IOD-Verlauf in beiden Gruppen. Die IOD-Werte in mmHg präoperativ/am 1. postoperativen Tag/Woche 1/Monate 1/3/6/12 waren jeweils für PreserFlo Microshunt und XEN45 wie folgt: 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; 15,4 vs. 14,5. Die Anzahl der IOD-senkenden Medikamente war postoperativ zwischen den 2 Gruppen ausbalanciert; die Anzahl der nachträglichen Interventionen war höher in der XEN45- (13) als in der PreserFlo-Microshunt-Gruppe (7).

Schlussfolgerung Beide Methoden haben während des Beobachtungszeitraums von 12 Monaten eine gute Kontrolle des Augendrucks mit wenigen Nebenwirkungen erbracht. Eine Anzahl an kleineren, nachträglichen Interventionen (Needlings) war in beiden Gruppen notwendig, insbesondere in der XEN45-Gruppe.

Key words

glaucoma - XEN45 - PreserFlo

Schlüsselwörter

Glaukom - XEN45 - PreserFlo

Publication History

Received: 25 September 2021

Accepted: 06 February 2022

Article published online:
26 April 2022

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