Efficacy, Confounders and Safety of the Preserflo Microshunt (2024)

Abstract

Background Glaucoma is a leading cause of blindness worldwide. We evaluated the efficacy, confounders, and safety of the Preserflo Microshunt over a one-year follow-up period.

Methods In this retrospective monocentric study, 111 eyes were evaluated. 83 eyes had primary open angle glaucoma, and 28 eyes secondary open angle glaucoma. Intraocular pressure (IOP), visual acuity, number of glaucoma medications, complications, and reoperations were evaluated postoperatively, at 1, 3, 6, 9, and 12 months. The influence of age, sex, type of glaucoma, previous surgery and lens status was also analysed. Bleb revision was indicated if corrected IOP exceeded 18 mmHg.

Results Intraocular pressure significantly decreased from 24.50 ± 8.94 to 14.62 ± 4.86 mmHg (4 – 32 mmHg; p < 0.001), the number of medications from 3.19 ± 1.14 to 0.98 ± 1.39 (0 – 4; p < 0.001). Confounders of interest did not affect efficacy. Bleb revision was performed in 22.5% of eyes and a cyclophotocoagulation was performed in 9.9% of eyes. Complete surgical success (IOP ≤ 17 mmHg, IOP reduction ≥ 20%, without medication) was achieved in 36.9% (n = 41) and qualified success (with medication) in 51.4% (n = 57) of eyes. Transient hypotension (≤ 5 mmHg) occurred in 19.8% after primary implantation and in 1.8% after bleb revision (duration ≤ 3 months).

Conclusion To date, the Preserflo Microshunt has demonstrated good efficacy and a low risk profile.

Publication History

© 2024. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

• References/Literatur

• 1 Lang GK. Hrsg. Augenheilkunde. 6. überarbeitete Aufl.. Stuttgart: Thieme; 2019

  Google Scholar

• 2 Allison K, Patel D, Alabi O. Epidemiology of Glaucoma: The Past, Present, and Predictions for the Future. Cureus; 12. e11686

  Google Scholar

• 3 [Anonymous] European Glaucoma Society Terminology and Guidelines for Glaucoma, 4th Edition – Chapter 2: Classification and Terminology Supported by the EGS Foundation: Part 1: Foreword; Introduction; Glossary; Chapter 2 Classification and Terminology. Br J Ophthalmol 2017; 101: 73-127 DOI: 10.1136/bjophthalmol-2016-EGSguideline.002.

  CrossrefPubMedGoogle Scholar

• 4 Leydhecker W. Glaukom in der Praxis; ein Leitfaden. 2., völlig neubearbeitete Aufl. Berlin, New York: Springer; 1973

  Google Scholar

• 5 Kanski JJ, Burk A, Burk R. Kapitel 13: Glaukom. In: Klinische Ophthalmologie. 6. Aufl.. München: Urban & Fischer in Elsevier; 2008: 377-449

  Google Scholar

• 6 Krieglstein GK. Hrsg. Glaukom 2007: Die Papille beim Glaukom. Heidelberg: Springer Medizin; 2008

  CrossrefGoogle Scholar

• 7 Cairns JE. Trabeculectomy. Preliminary report of a new method. Am J Ophthalmol 1968; 66: 673-679

  PubMedGoogle Scholar

• 8 Hoskins H, Migliazzo C. Die Argon-Laserbehandlung der Filterkisseninsuffizienz. Klin Monbl Augenheilkd 1989; 195: 328-329 DOI: 10.1055/s-2008-1050049.

  Article in Thieme ConnectPubMedGoogle Scholar

• 9 Pinchuk L, Riss I, Batlle JF. et al. The use of poly(styrene-block-isobutylene-block-styrene) as a microshunt to treat glaucoma. Regen Biomater 2016; 3: 137-142 DOI: 10.1093/rb/rbw005.

  CrossrefPubMedGoogle Scholar

• 10 Sadruddin O, Pinchuk L, Angeles R. et al. Ab externo implantation of the MicroShunt, a poly (styrene-block-isobutylene-block-styrene) surgical device for the treatment of primary open-angle glaucoma: a review. Eye Vis (Lond) 2019; 6: 36 DOI: 10.1186/s40662-019-0162-1.

  CrossrefPubMedGoogle Scholar

• 11 Pinchuk L. A review of the biostability and carcinogenicity of polyurethanes in medicine and the new generation of “biostable” polyurethanes. J Biomater Sci Polym Ed 1994; 6: 225-267 DOI: 10.1163/156856294x00347.

  CrossrefPubMedGoogle Scholar

• 12 Arrieta EA, Aly M, Parrish R. et al. Clinicopathologic Correlations of Poly-(styrene-b-isobutylene-b-styrene) Glaucoma Drainage Devices of Different Internal Diameters in Rabbits. Ophthalmic Surg Lasers Imaging 2011; 42: 338-345 DOI: 10.3928/15428877-20110603-01.

  CrossrefPubMedGoogle Scholar

• 13 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 DOI: 10.3390/jcm11237086.

  CrossrefPubMedGoogle Scholar

• 14 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 DOI: 10.1016/j.ogla.2021.07.008.

  CrossrefPubMedGoogle Scholar

• 15 Bhayani R, Martínez de la Casa JM, Figus M. et al. Short-term safety and efficacy of Preserflo^™ Microshunt in glaucoma patients: a multicentre retrospective cohort study. Eye (Lond) 2023; 37: 644-649 DOI: 10.1038/s41433-022-01995-7.

  CrossrefPubMedGoogle Scholar

• 16 Fili S, Kontopoulou K, Vastardis I. et al. PreserFlo^™ microshunt combined with phacoemulsification versus Preserflo^™ MicroShunt as a standalone procedure in patients with medically resistant open-angle glaucoma. J Curr Ophthalmol 2022; 34: 180-186 DOI: 10.4103/joco.joco_298_21.

  CrossrefPubMedGoogle Scholar

• 17 Ibarz Barberá M, Martínez-Galdón F, Caballero-Magro E. et al. Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma. J Glaucoma 2022; 31: 557-566 DOI: 10.1097/IJG.0000000000002052.

  CrossrefPubMedGoogle Scholar

• 18 Batlle JF, Fantes F, Riss I. et al. Three-Year Follow-up of a Novel Aqueous Humor MicroShunt. J Glaucoma 2016; 25: e58-e65 DOI: 10.1097/IJG.0000000000000368.

  CrossrefPubMedGoogle Scholar

• 19 Durr GM, Schlenker MB, Samet S. et al. One-year outcomes of stand-alone ab externo SIBS microshunt implantation in refractory glaucoma. Br J Ophthalmol 2022; 106: 71-79 DOI: 10.1136/bjophthalmol-2020-317299.

  CrossrefPubMedGoogle Scholar

• 20 Fili S, Kontopoulou K, Vastardis I. et al. PreserFlo^™ MicroShunt Versus Trabeculectomy in Patients With Moderate to Advanced Open-Angle Glaucoma: 12-Month Follow-Up of a Single-Center Prospective Study. Cureus 2022; 14: e28288 DOI: 10.7759/cureus.28288.

  CrossrefPubMedGoogle Scholar

• 21 Quaranta L, Micheletti E, Carassa R. et al. Efficacy and Safety of PreserFlo^® MicroShunt After a Failed Trabeculectomy in Eyes with Primary Open-Angle Glaucoma: A Retrospective Study. Adv Ther 2021; 38: 4403-4412 DOI: 10.1007/s12325-021-01811-w.

  CrossrefPubMedGoogle Scholar

• 22 Baker ND, Barnebey HS, Moster MR. et al. Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology 2021; 128: 1710-1721 DOI: 10.1016/j.ophtha.2021.05.023.

  CrossrefPubMedGoogle Scholar

• 23 Rabiolo A, Toscani R, Sacchi M. et al. Risk Factors for Failure in Glaucoma Patients undergoing Microshunt Implantantion. Am J Ophthalmol 2024; 259: 117-130 DOI: 10.1016/j.ajo.2023.11.011.

  CrossrefPubMedGoogle Scholar

• 24 Schlenker MB, Armstrong JJ, De Francesco T. et al. All Consecutive Ab Externo SIBS Microshunt Implantations With Mitomycin C: One-Year Outcomes and Risk Factors for Failure. Am J Ophthalmol 2023; 255: 125-140 DOI: 10.1016/j.ajo.2023.06.009.

  CrossrefPubMedGoogle Scholar

• 25 Fea AM, Laffi GL, Martini E. et al. Effectiveness of MicroShunt in Patients with Primary Open-Angle and Pseudoexfoliative Glaucoma: A Retrospective European Multicenter Study. Ophthalmol Glaucoma 2022; 5: 210-218 DOI: 10.1016/j.ogla.2021.08.005.

  CrossrefPubMedGoogle Scholar

• 26 Nobl M, Freissinger S, Kassumeh S. et al. One-year outcomes of microshunt implantation in pseudoexfoliation glaucoma. PLoS One 2021; 16: e0256670 Verfügbar unter: DOI: 10.1371/journal.pone.0256670. https://dx.plos.org/10.1371/journal.pone.0256670

  CrossrefPubMedGoogle Scholar

• 27 Engeland CG, Sabzehei B, Marucha PT. Sex hormones and mucosal wound healing. Brain Behav Immun 2009; 23: 629-635 DOI: 10.1016/j.bbi.2008.12.001.

  CrossrefPubMedGoogle Scholar

• 28 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 DOI: 10.1111/aos.14602.

  CrossrefPubMedGoogle Scholar

• 29 Fu MX, Normando EM, Luk SMH. et al. MicroShunt versus Trabeculectomy for Surgical Management of Glaucoma: A Retrospective Analysis. J Clin Med 2022; 11: 5481 DOI: 10.3390/jcm11185481.

  CrossrefPubMedGoogle Scholar

• 30 Trigaux C, Steindor FA, Spaniol K. et al. Iris Obstruction Following PRESERFLO Microshunt Implantation and Surgical Management. J Glaucoma 2022; 31: e72-e74 DOI: 10.1097/IJG.0000000000002049.

  CrossrefPubMedGoogle Scholar