Top

Graefe's Archive for Clinical and Experimental Ophthalmology

Published in:

Open Access 03-05-2023 | Glaucoma | Glaucoma

PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety

Authors: Melanie Jamke, Robert Herber, Maike A. Haase, Carolin S. Jasper, Lutz E. Pillunat, Karin R. Pillunat

Published in: Graefe's Archive for Clinical and Experimental Ophthalmology | Issue 10/2023

Abstract

Purpose

To compare the efficacy and safety of the PRESERFLO™ MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG) after one year.

Patients and methods

Institutional prospective interventional cohort study comparing eyes with POAG, which had received the PRESERFLO™ MicroShunt versus trabeculectomy. The MicroShunt group was matched with the trabeculectomy group for age, known duration of disease, and number and classes of intraocular pressure (IOP) lowering medications to have similar conjunctival conditions. The study is part of the Dresden Glaucoma and Treatment Study, using a uniform study design, with the same inclusion and exclusion criteria, follow-ups and standardized definitions of success and failure for both procedures. Primary outcome measures: mean diurnal IOP (mdIOP, mean of 6 measurements), peak IOP, and IOP fluctuations. Secondary outcome measures: success rates, number of IOP lowering medications, visual acuity, visual fields, complications, surgical interventions, and adverse events.

Results

Sixty eyes of 60 patients, 30 in each group, were analyzed after 1-year follow-ups. Median [Q25, Q75] mdIOP (mmHg) dropped from 16.2 [13.8–21.5] to 10.5 [8.9–13.5] in the MicroShunt and from 17.6 [15.6–24.0] to 11.1 [9.5–12.3] in the trabeculectomy group, both without glaucoma medications. Reduction of mdIOP (P = .596), peak IOP (P = .702), and IOP fluctuations (P = .528) was not statistically significantly different between groups. The rate of interventions was statistically significantly higher in the trabeculectomy group, especially in the early postoperative period (P = .018). None of the patients experienced severe adverse events.

Conclusion

Both procedures are equally effective and safe in lowering mdIOP, peak IOP and IOP fluctuations in patients with POAG, one year after surgery.

Clinical trial registration: NCT02959242.

Pillunat KR, Herber R, Jamke M, Haase M, Pillunat LE (2022) PRESERFLO MicroShunt versus Trabekulektomie bei primärem Offenwinkelglaukom: 1 Jahres-Ergebnisse. Die Ophthalmol Meet Abstr S257:01–01

Baker ND, Barnebey HS, Moster MR, Stiles MC, Vold SD, Khatana AK, Flowers BE, Grover DS, Strouthidis NG, Panarelli JF, Group INNS (2021) Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology 128:1710–1721. https://doi.org/10.1016/j.ophtha.2021.05.023CrossRefPubMed

Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY (2014) Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology 121:2081–2090. https://doi.org/10.1016/j.ophtha.2014.05.013CrossRefPubMed

Cairns JE (1968) Trabeculectomy. Preliminary report of a new method. Am J Ophthalmol 66:673–679CrossRefPubMed

Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC, Tube Versus Trabeculectomy Study G (2012) Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol 153:804–814. https://doi.org/10.1016/j.ajo.2011.10.024CrossRefPubMedPubMedCentral

Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL, Tube versus Trabeculectomy Study G (2012) Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol 153:789–803. https://doi.org/10.1016/j.ajo.2011.10.026CrossRefPubMedPubMedCentral

Caprioli J, Kim JH, Friedman DS, Kiang T, Moster MR, Parrish RK 2nd, Rorer EM, Samuelson T, Tarver ME, Singh K, Eydelman MB (2015) Special Commentary: Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery: Summary of a Joint Meeting of the American Glaucoma Society and the Food and Drug Administration, Washington, DC, February 26, 2014. Ophthalmology 122:1795–1801. https://doi.org/10.1016/j.ophtha.2015.02.029CrossRefPubMed

Manasses DT, Au L (2016) The New Era of Glaucoma Micro-stent Surgery. Ophthalmol Ther 5:135–146. https://doi.org/10.1007/s40123-016-0054-6CrossRefPubMedPubMedCentral

Vinod K, Gedde SJ (2017) Clinical investigation of new glaucoma procedures. Curr Opin Ophthalmol 28:187–193. https://doi.org/10.1097/ICU.0000000000000336CrossRefPubMed

10.

Richter GM, Coleman AL (2016) Minimally invasive glaucoma surgery: current status and future prospects. Clin Ophthalmol 10:189–206. https://doi.org/10.2147/OPTH.S80490CrossRefPubMedPubMedCentral

11.

Pinchuk L, Riss I, Batlle JF, Kato YP, Martin JB, Arrieta E, Palmberg P, Parrish RK, Weber BA, Kwon Y, Parel JM (2016) The use of poly(styrene-block-isobutylene-block-styrene) as a microshunt to treat glaucoma. Regen Biomater 3:137–142. https://doi.org/10.1093/rb/rbw005CrossRefPubMedPubMedCentral

12.

Silber S, Colombo A, Banning AP, Hauptmann K, Drzewiecki J, Grube E, Dudek D, Baim DS (2009) Final 5-year results of the TAXUS II trial: a randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for de novo coronary artery lesions. Circulation 120:1498–1504. https://doi.org/10.1161/CIRCULATIONAHA.109.849877CrossRefPubMed

13.

Acosta AC, Espana EM, Yamamoto H, Davis S, Pinchuk L, Weber BA, Orozco M, Dubovy S, Fantes F, Parel JM (2006) A newly designed glaucoma drainage implant made of poly(styrene-b-isobutylene-b-styrene): biocompatibility and function in normal rabbit eyes. Arch Ophthalmol 124:1742–1749. https://doi.org/10.1001/archopht.124.12.1742CrossRefPubMed

14.

Pinchuk L (2022) The use of polyisobutylene-based polymers in ophthalmology. Bioact Mater 10:185–194. https://doi.org/10.1016/j.bioactmat.2021.09.005CrossRefPubMed

15.

Beckers HJM, Aptel F, Webers CAB, Bluwol E, Martinez-de-la-Casa JM, Garcia-Feijoo J, Lachkar Y, Mendez-Hernandez CD, Riss I, Shao H, Pinchuk L, Angeles R, Sadruddin O, Shaarawy TM (2022) Safety and Effectiveness of the PRESERFLO(R) MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study. Ophthalmol Glaucoma 5:195–209. https://doi.org/10.1016/j.ogla.2021.07.008CrossRefPubMed

16.

Batlle JF, Corona A, Albuquerque R (2021) Long-term Results of the PRESERFLO MicroShunt in Patients With Primary Open-angle Glaucoma From a Single-center Nonrandomized Study. J Glaucoma 30:281–286. https://doi.org/10.1097/IJG.0000000000001734CrossRefPubMed

17.

Pillunat KR, Herber R, Haase MA, Jamke M, Jasper CS, Pillunat LE (2022) PRESERFLO MicroShunt versus trabeculectomy: first results on efficacy and safety. Acta Ophthalmol 100:e779–e790. https://doi.org/10.1111/aos.14968CrossRefPubMed

18.

Fea AM, Laffi GL, Martini E, Economou MA, Caselgrandi P, Sacchi M, Au L (2022) Effectiveness of MicroShunt in Patients with Primary Open-Angle and Pseudoexfoliative Glaucoma: A Retrospective European Multicenter Study. Ophthalmol Glaucoma 5:210–218. https://doi.org/10.1016/j.ogla.2021.08.005CrossRefPubMed

19.

Nobl M, Freissinger S, Kassumeh S, Priglinger S, Mackert MJ (2021) One-year outcomes of microshunt implantation in pseudoexfoliation glaucoma. PLoS One 16:e0256670. https://doi.org/10.1371/journal.pone.0256670CrossRefPubMedPubMedCentral

20.

Durr GM, Schlenker MB, Samet S, Ahmed IIK (2022) One-year outcomes of stand-alone ab externo SIBS microshunt implantation in refractory glaucoma. Br J Ophthalmol 106:71–79. https://doi.org/10.1136/bjophthalmol-2020-317299CrossRefPubMed

21.

Wagner FM, Schuster AK, Munder A, Muehl M, Chronopoulos P, Pfeiffer N, Hoffmann EM (2022) Comparison of subconjunctival microinvasive glaucoma surgery and trabeculectomy. Acta Ophthalmol 100:e1120–e1126. https://doi.org/10.1111/aos.15042CrossRefPubMed

22.

Fujimoto T, Nakashima KI, Watanabe-Kitamura F, Watanabe T, Nakamura K, Maki K, Shimazaki A, Kato M, Tanihara H, Inoue T (2021) Intraocular Pressure-Lowering Effects of Trabeculectomy Versus MicroShunt Insertion in Rabbit Eyes. Transl Vis Sci Technol 10:9. https://doi.org/10.1167/tvst.10.9.9CrossRefPubMedPubMedCentral

23.

Leske MC, Heijl A, Hyman L, Bengtsson B (1999) Early Manifest Glaucoma Trial: design and baseline data. Ophthalmology 106:2144–2153. https://doi.org/10.1016/s0161-6420(99)90497-9CrossRefPubMed

24.

Jose P, Teixeira FJ, Barao R, Sousa DC, Marques RE, Barata ADO, Marques-Neves C, Alves M, Papoila AL, Stalmans I, Silva JP, Abegao Pinto L (2022) Trabeculectomy with mitomycin C alone or coupled with intracamerular bevacizumab? A 2-year comparative study. Br J Ophthalmol 106:1399–1405. https://doi.org/10.1136/bjophthalmol-2021-319039CrossRefPubMed

25.

The Advanced Glaucoma Intervention Study (AGIS) (2000) 7. The relationship between control of intraocular pressure and visual field deterioration. The AGIS Investigators. Am J Ophthalmol 130:429–440. https://doi.org/10.1016/s0002-9394(00)00538-9CrossRef

26.

Schlenker MB, Durr GM, Michaelov E, Ahmed IIK (2020) Intermediate Outcomes of a Novel Standalone Ab Externo SIBS Microshunt With Mitomycin C. Am J Ophthalmol 215:141–153. https://doi.org/10.1016/j.ajo.2020.02.020CrossRefPubMed

27.

Gedde SJ, Feuer WJ, Shi W, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt J, Primary Tube Versus Trabeculectomy Study G (2018) Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up. Ophthalmology 125:650–663. https://doi.org/10.1016/j.ophtha.2018.02.003CrossRefPubMed

28.

Bakir B, Pasquale LR (2014) Causes and treatment of choroidal effusion after glaucoma surgery. Semin Ophthalmol 29:409–413. https://doi.org/10.3109/08820538.2014.959200CrossRefPubMed

29.

Marolo P, Reibaldi M, Fallico M, Maugeri A, Barchitta M, Agodi A, Parisi G, Caselgrandi P, Ventre L, Ahmed IIK (2022) Reintervention rate in glaucoma filtering surgery: A systematic review and meta-analysis. Eur J Ophthalmol 32:2515–2531. https://doi.org/10.1177/11206721221093828CrossRefPubMed

30.

Pillunat KR, Orphal J, Haase M, Pillunat LE, Herber R (2021) Scheimpflug Corneal Densitometry Changes After Trabeculectomy. Cornea 40:408–414. https://doi.org/10.1097/ICO.0000000000002439CrossRefPubMed

31.

The Advanced Glaucoma Intervention Study (AGIS) (2001) 9. Comparison of Glaucoma Outcomes in Black and White Patients Within Treatment Groups. Am J Ophthalmol 132:9. https://doi.org/10.1016/s0002-9394(01)01028-5CrossRef

32.

Bhayani R, Martinez de la Casa JM, Figus M, Klabe K, Rabiolo A, Mercieca K (2022) Short-term safety and efficacy of Preserflo Microshunt in glaucoma patients: a multicentre retrospective cohort study. Eye (Lond). https://doi.org/10.1038/s41433-022-01995-7CrossRefPubMed

33.

Batlle JF, Fantes F, Riss I, Pinchuk L, Alburquerque R, Kato YP, Arrieta E, Peralta AC, Palmberg P, Parrish RK 2nd, Weber BA, Parel JM (2016) Three-Year Follow-up of a Novel Aqueous Humor MicroShunt. J Glaucoma 25:e58-65. https://doi.org/10.1097/IJG.0000000000000368CrossRefPubMed

34.

Tanner A, Haddad F, Fajardo-Sanchez J, Nguyen E, Thong KX, Ah-Moye S, Perl N, Abu-Bakra M, Kulkarni A, Trikha S, Lascaratos G, Parnell M, Kailani O, King AJ, Agrawal P, Stead R, Giannouladis K, Rodrigues I, Goyal S, Hysi PG, Lim S, Yu-Wai-Man C (2022) One-year surgical outcomes of the PreserFlo MicroShunt in glaucoma: a multicentre analysis. Br J Ophthalmol. https://doi.org/10.1136/bjophthalmol-2021-320631CrossRefPubMed

35.

Boimer C, Birt CM (2013) Preservative Exposure and Surgical Outcomes in Glaucoma Patients: The PESO Study. J Glaucoma 22:730–735. https://doi.org/10.1097/IJG.0b013e31825af67dCrossRefPubMed

36.

Holland LJ, Kirwan JF, Mercieca KJ (2021) Effect of COVID-19 pandemic on glaucoma surgical practices in the UK. Br J Ophthalmol. https://doi.org/10.1136/bjophthalmol-2021-319062CrossRefPubMed

Title: PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety
Authors: Melanie Jamke
Robert Herber
Maike A. Haase
Carolin S. Jasper
Lutz E. Pillunat
Karin R. Pillunat
Publication date: 03-05-2023
Publisher: Springer Berlin Heidelberg
Keywords: Glaucoma
Trabeculectomy
Published in: Graefe's Archive for Clinical and Experimental Ophthalmology / Issue 10/2023
Print ISSN: 0721-832X
Electronic ISSN: 1435-702X
DOI: https://doi.org/10.1007/s00417-023-06075-4

Keynote webinar | Spotlight on medication adherence

Springer Medicine

PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety

Abstract

Purpose

Patients and methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Patients and methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 10/2023

Comparative analysis of ultrasonic elastosonography and contrast-enhanced ultrasonography in the diagnosis of benign and malignant intraocular tumors

Fractal analysis of the macular region in healthy eyes using swept-source optical coherence tomography angiography

Curcumin attenuates hydroxychloroquine-mediated apoptosis and oxidative stress via the inhibition of TRPM2 channel signalling pathways in a retinal pigment epithelium cell line

Developing and validating a questionnaire to assess the symptoms of blepharitis accompanied by dry eye disease

Association of autoantibody levels with different stages of age-related macular degeneration (AMD): Results from the population-based Gutenberg Health Study (GHS)

Relationship between the main components of the crystalline lens and the anterior chamber depth after cataract formation