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

• References

• 1 Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol 2006; 90: 262-267
• 2 Tham YC, Li X, Wong TY. et al. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology 2014; 121: 2081-2090
• 3 Heijl A, Leske MC, Bengtsson B. et al. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol 2002; 120: 1268-1279
• 4 Gazzard G, Konstantakopoulou E, Garway-Heath D. et al. Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial: Six-Year Results of Primary Selective Laser Trabeculoplasty versus Eye Drops for the Treatment of Glaucoma and Ocular Hypertension. Ophthalmology 2023; 130: 139-151
• 5 Gedde SJ, Feuer WJ, Lim KS. et al. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up. Ophthalmology 2020; 127: 333-345
• 6 Sheybani A, Reitsamer H, Ahmed II. Fluid Dynamics of a Novel Micro-Fistula Implant for the Surgical Treatment of Glaucoma. Invest Ophthalmol Vis Sci 2015; 56: 4789-4795
• 7 Acosta AC, Espana EM, Yamamoto H. et al. A newly designed glaucoma drainage implant made of poly(styrene-b-isobutylene-b-styrene): biocompatibility and function in normal rabbit eyes. Arch Ophthalmol 2006; 124: 1742-1749
• 8 Pinchuk L, Riss I, Batlle JF. et al. The development of a micro-shunt made from poly(styrene-block-isobutylene-block-styrene) to treat glaucoma. J Biomed Mater Res B Appl Biomater 2017; 105: 211-221
• 9 Nobl M, Freissinger S, Kassumeh S. et al. One-year outcomes of microshunt implantation in pseudoexfoliation glaucoma. PLoS One 2021; 16: e0256670
• 10 Reitsamer H, Sng C, Vera V. et al. Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma. Graefes Arch Clin Exp Ophthalmol 2019; 257: 983-996
• 11 Davids AM, Pahlitzsch M, Bertelmann E. et al. XEN implantation: an effective strategy to stop glaucoma progression despite prior minimally invasive glaucoma surgery. Graefes Arch Clin Exp Ophthalmol 2023; 261: 1063-1072
• 12 Marcos-Parra MT, Salinas-López JA, Mateos-Marcos C. et al. Long-Term Effectiveness of XEN 45 Gel-Stent in Open-Angle Glaucoma Patients. Clin Ophthalmol 2023; 17: 1223-1232
• 13 Schlenker MB, Durr GM, Michaelov E. et al. Intermediate Outcomes of a Novel Standalone Ab Externo SIBS Microshunt With Mitomycin C. Am J Ophthalmol 2020; 215: 141-153
• 14 Batlle JF, Fantes F, Riss I. et al. Three-Year Follow-up of a Novel Aqueous Humor MicroShunt. J Glaucoma 2016; 25: e58-e65
• 15 Armstrong JJ, De Francesco T, Ma J. et al. Ab Externo SIBS Microshunt with Mitomycin C for Open-Angle Glaucoma: 3-year results as a primary surgical intervention. Ophthalmol Glaucoma 2023;
• 16 Beckers HJM, Aptel F, Webers CAB. et al. Safety and Effectiveness of the PRESERFLO MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study. Ophthalmol Glaucoma 2022; 5: 195-209
• 17 Majoulet A, Scemla B, Hamard P. et al. Safety and Efficacy of the Preserflo^® Microshunt in Refractory Glaucoma: A One-Year Study. J Clin Med 2022; 11: 7086
• 18 Tanner A, Haddad F, Fajardo-Sanchez J. et al. One-year surgical outcomes of the PreserFlo MicroShunt in glaucoma: a multicentre analysis. Br J Ophthalmol 2023; 107: 1104-1111
• 19 Scheres LMJ, Kujovic-Aleksov S, Ramdas WD. et al. XEN Gel Stent compared to PRESERFLO MicroShunt implantation for primary open-angle glaucoma: two-year results. Acta Ophthalmol 2021; 99: e433-e440
• 20 Wagner FM, Schuster AK, Munder A. et al. Comparison of subconjunctival microinvasive glaucoma surgery and trabeculectomy. Acta Ophthalmol 2022; 100: e1120-e1126
• 21 Saletta G, Alexoudis A, Gatzioufas Z. et al. Retrospective Analysis of 12 Months Glaucoma Implant Efficacy: XEN45 and PreserFlo Microshunt. Klin Monbl Augenheilkd 2022; 239: 429-434
• 22 Marcos-Parra MT, Mendoza-Moreira AL, Moreno-Castro L. et al. 3-Year Outcomes of XEN Implant Compared With Trabeculectomy, With or Without Phacoemulsification for Open Angle Glaucoma. J Glaucoma 2022; 31: 826-833
• 23 Lenzhofer M, Strohmaier C, Sperl P. et al. Effect of the outer stent position on efficacy after minimally invasive transscleral glaucoma gel stent implantation. Acta Ophthalmol 2019; 97: e1105-e1111
• 24 Gupta C, Mathews D. XEN stent complications: a case series. BMC Ophthalmol 2019; 19: 253
• 25 Bustros Y, Chaudhary A, Salinas L. et al. Cutting the subconjunctival fragment of the XEN gel implant during needling procedure. Eur J Ophthalmol 2020; 30: NP11-NP15