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

Abstract

Purpose To compare two glaucoma drainage devices with subconjunctival filtration (MicroShunt and XEN) for open-angle glaucoma (OAG), with respect to effectiveness and safety.

Patients and Methods 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 50 patients 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.

Results 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.

Conclusion Both MicroShunt and XEN are effective in significantly reducing IOP and glaucoma medications in OAG, and with a good safety profile.

Zusammenfassung

Hintergrund Vergleich von 2 Implantaten mit subkonjunktivaler Filtration (MicroShunt und XEN) beim Offenwinkelglaukom hinsichtlich Wirksamkeit und Sicherheit.

Patienten und Methoden Es handelte sich um eine retrospektive, interventionelle Studie. Insgesamt wurden 106 Augen von 95 Patienten mit Offenwinkelglaukom operiert. 51 Augen von 45 Patienten erhielten eine MicroShunt-Implantation und 55 Augen von 50 Patienten eine XEN-Implantation. Misserfolg wurde definiert als ein Augeninnendruck (IOD) von weniger als 5 oder mehr als 17 mmHg nach 2 Jahren, die Notwendigkeit einer chirurgischen Revision, eine sekundäre Glaukomoperation oder der Verlust von Lichtwahrnehmung. Das Ergebnis wurde als vollständiger oder eingeschränkter Erfolg gewertet, je nachdem, ob es mit oder ohne antiglaukomatöse Therapie erreicht wurde. Auch postoperative Komplikationen und Interventionen wurden für beide Gruppen dokumentiert.

Ergebnisse In der MicroShunt-Gruppe sank der mittlere IOD von 20,6 ± 7,5 mmHg bei Studienbeginn auf 13,0 ± 3,9 mmHg (p < 0,0001) nach 2 Jahren. In der XEN-Gruppe sank der mittlere Augeninnendruck von 22,5 ± 7,9 mmHg auf 13,5 ± 4,2 mmHg (p < 0,0001). In beiden Gruppen wurde die durchschnittliche Anzahl der Medikamente signifikant reduziert (MicroShunt 2,7 ± 1,2 auf 0,9 ± 2,5; p < 0,0001 vs. XEN 3,2 ± 0,9 auf 1,1 ± 1,5; p < 0,0001). 37% der MicroShunt-Patienten erzielten einen vollständigen Erfolg und 57% einen qualifizierten Erfolg nach 2 Jahren. In der XEN-Gruppe lagen die Raten bei 25% bzw. 45%. Die beiden Gruppen unterschieden sich hinsichtlich des Alters (MicroShunt 72,8 ± 8,7 vs. XEN 67,7 ± 9,0; p = 0,002). Die postoperativen Komplikationen waren in beiden Gruppen vergleichbar.

Schlussfolgerung Sowohl MicroShunt als auch XEN senken IOD und Anzahl an Medikamenten beim Offenwinkelglaukom nach 2 Jahren signifikant und weisen ein gutes Sicherheitsprofil auf.

Key words

choroid - conjunctiva - glaucoma

Schlüsselwörter

Glaukom - Bindehaut - Chorioidea

Publication History

Received: 27 May 2023

Accepted: 04 August 2023

Article published online:
06 September 2023

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