INTRODUCTION: This study was performed to compare the efficacy and safety of PreserFlo MicroShunt (PMS) implantation with mitomycin C (MMC) applied by sub-tenon injection versus conventional application by MMC-soaked sponges. METHODS: This retrospective, 1-year cohort study included 100 eyes of 100 patients with glaucoma who underwent PMS implantation with MMC (0.4 mg/ml) delivered either by sub-tenon injection (50 eyes) or via soaked sponges (50 eyes). The primary outcome measure at 1 year was intraocular pressure (IOP) reduction, with complete success defined as an IOP reduction of ≥ 20% and achieving a target IOP of ≤ 21 or 18 mmHg without the use of medication. Secondary outcomes, including corneal endothelial cell density (CECD) loss, the number of medications, and complications, were assessed and compared between the groups. RESULTS: Sustained reductions in mean IOP were observed in both groups over the 1-year follow-up, with no significant differences between the groups. The complete success rate, with a target IOP of ≤ 21 mmHg after 1 year, was 19.3% in the sponge group and 26.4% in the injection group. The qualified success rate was 59.0% and 87.4% in the sponge and injection groups, respectively. A longer survival rate was observed in the injection group than in the sponge group when IOP was below 21 mmHg. The mean CECD significantly decreased (P < 0.01) from baseline to each postoperative follow-up time point in both groups. At 1 year postoperatively, the percentage of total CECD loss was 8.1% in the sponge group and 8.0% in the injection group. However, no significant differences in mean CECD values, the number of medications, or adverse events were found between the groups. CONCLUSIONS: PMS implantation with sub-tenon injection of MMC was comparable in terms of efficacy and safety to traditional MMC delivery via soaked sponges. However, the injection group demonstrated a significantly higher success rate than the sponge group.

Department of Microbiology Faculty of Medicine Slovak Medical University 833 03 Bratislava Slovakia

Department of Ophthalmology Faculty of Medicine in Hradec Kralove Charles University and University Hospital Hradec Kralove 500 05 Hradec Kralove Czech Republic

Department of Ophthalmology Slovak Medical University and University Hospital in Bratislava Antolska 11 851 07 Bratislava Slovakia

Institute of Molecular Biology Slovak Academy of Sciences Dubravska Cesta 21 845 51 Bratislava Slovakia

Zobrazit více v PubMed

Vision Loss Expert Group of the Global Burden of Disease Study. Global estimates on the number of people blind or visually impaired by glaucoma: a meta-analysis from 2000 to 2020. Eye. 2024;38:2036. PubMed PMC

Chen W, Xu Y, Liu Z, Zhao J. Global, regional and national burden of Glaucoma: an update analysis from the Global Burden of Disease Study 2019. Int Ophthalmol. 2024;44:234. PubMed

Jayaram H, Kolko M, Friedman DS, Gazzard G. Glaucoma: now and beyond. Lancet. 2023;402:1788–801. PubMed

Chan L, Moster MR, Bicket AK, et al. New devices in glaucoma. Ophthalmol Ther. 2023;12:2381–95. PubMed PMC

Saeed E, Gołaszewska K, Dmuchowska DA, Zalewska R, Konopińska J. The PreserFlo MicroShunt in the context of minimally invasive glaucoma surgery: a narrative review. Int J Env Res Public Health. 2023;20:2904. PubMed PMC

Jabłońska J, Lewczuk K, Konopińska J, Mariak Z, Rękas M. Microinvasive glaucoma surgery: a review and classification of implant-dependent procedures and techniques. Acta Ophthalmol (Copenh). 2022;100:e327–38. PubMed PMC

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;105:211–21. PubMed PMC

Gambini G, Carlà MM, Giannuzzi F, et al. PreserFlo® MicroShunt: an overview of this minimally invasive device for open-angle glaucoma. Vision (Basel). 2022;6:12. PubMed PMC

Pawiroredjo SSM, Bramer WM, Pawiroredjo ND, et al. Efficacy of the PRESERFLO MicroShunt and a meta-analysis of the literature. J Clin Med. 2022;11:7149. PubMed PMC

Pietris J, Casson R. One year outcomes of Preserflo Microshunt for primary open-angle glaucoma: a systematic review and meta-analysis. J Glaucoma. 2024;10:1097. PubMed

Khan A, Khan AU. Comparing the safety and efficacy of Preserflo Microshunt implantation and trabeculectomy for glaucoma: a systematic review and meta-analysis. Acta Ophthalmol (Copenh). 2024;102:e443–51. PubMed

Khawaja AP, Abegão Pinto L, Stalmans I, et al. Additional guidance on the use of the PRESERFLO™ MicroShunt in the treatment of glaucoma: insights from a second Delphi Consensus Panel. Ophthalmol Ther. 2024;13:1569–88. PubMed PMC

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. PubMed

Majtanova N, Keri P, Kriskova P, et al. Surgical outcomes of trabeculectomy augmented with sub-tenon injected mitomycin C. Bratisl Lek Listy. 2023;124:907–14. PubMed

Pantalon A, Feraru C, Tarcoveanu F, Chiselita D. Success of primary trabeculectomy in advanced open angle glaucoma. Clin Ophthalmol. 2021;15:2219–29. PubMed PMC

Bhayani R, Martínez de la Casa JM, Figus M, Klabe K, Rabiolo A, Mercieca K. Short-term safety and efficacy of Preserflo™ Microshunt in glaucoma patients: a multicentre retrospective cohort study. Eye. 2023;37:644–9. PubMed PMC

Schlenker MB, Durr GM, Michaelov E, Ahmed IIK. Intermediate outcomes of a novel standalone ab externo SIBS microshunt with mitomycin C. Am J Ophthalmol. 2020;215:141–5. PubMed

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;107:1104–11. PubMed PMC

Steiner S, Resch H, Kiss B, Vass C. PRESERFLO™ Microshunt: 1-year results of a 25-Gauge vs 27-Gauge needle tract. J Clin Med. 2024;13:1979. PubMed PMC

Tojo N, Hayashi A. The outcomes of Trabectome surgery in patients with low, middle, and high preoperative intraocular pressure. Clin Ophthalmol. 2020;2020:4099–108. PubMed PMC

Batlle JF, Fantes F, Riss I, et al. Three-year follow-up of a novel aqueous humor MicroShunt. J Glaucoma. 2016;25:e58–65. PubMed

Vinod K, Gedde SJ, Feuer WJ, et al. Practice preferences for glaucoma surgery: a survey of the American Glaucoma Society. J Glaucoma. 2017;26:687–93. PubMed PMC

Bell K, Bezerra BD, Mofokeng M, et al. Learning from the past: Mitomycin C use in trabeculectomy and its application in bleb-forming minimally invasive glaucoma surgery. Surv Ophthalmol. 2021;66:109–23. PubMed

Ahmed IIK, Sadruddin O, Panarelli JF. Subconjunctival filtration in evolution: current evidence on MicroShunt implantation for treating patients with glaucoma. Eye Vis (Lond). 2023;10:10. PubMed PMC

Saeed E, Zalewska R, Konopińska J. Early complications and results of Preserflo MicroShunt in the management of uncontrolled open-angle glaucoma: a case series. Int J Env Res Public Health. 2022;19:8679. PubMed PMC

Verma-Fuehring R, Dakroub M, Bamousa A, Kann G, Hillenkamp J, Kampik D. The use of intraluminal PRESERFLO stenting in avoiding early postoperative hypotony. Graefes Arch Clin Exp Ophthalmol. 2024. 10.1007/s00417-00024-06567-x. PubMed PMC

Janson BJ, Alward WL, Kwon YH, et al. Glaucoma-associated corneal endothelial cell damage: a review. Survey in Ophthalmology. 2018;63:500–6. PubMed

Ibarz-Barberá M, Morales-Fernández L, Corroto-Cuadrado A, et al. Corneal endothelial cell loss after PRESERFLO™ MicroShunt implantation in the anterior chamber: anterior segment OCT tube location as a risk factor. Ophthalmol Ther. 2022;11:293–310. PubMed PMC

Ahmed T, Honjo M, Sakata R, Fujishiro T, Shirato S, Aihara M. Long-term results of the safety and effectiveness of a novel microshunt in Japanese patients with primary open-angle glaucoma. Jpn J Ophthalmol. 2022;66:33–40. PubMed

Steindor FA, Trigaux C, Holtmann C, Spaniol K, Geerling G, Borrelli M. PRESERFLO MicroShunt®: efficacy and endothelial cell density. J Glaucoma. 2023. 10.1097/IJG.0000000000002325. PubMed

Gassel CJ, Wenzel DA, Nasyrov E, Strasser T, Voykov B. Intermediate-term impact on corneal endothelial cells and efficacy of Preserflo MicroShunt implantation in patients with open-angle glaucoma - a prospective study over two years. Graefes Arch Clin Exp Ophthalmol. 2024. 10.1007/s00417-00024-06508-00418. PubMed PMC

Chamard C, Hammoud S, Bluwol E, Lachkar Y. Endothelial cell loss 5 years after Preserflo MicroShunt implantation: about two cases. Am J Ophthalmol Case Rep. 2021;25: 101238. PubMed PMC

Jamke M, Herber R, Haase MA, Jasper CS, Pillunat LE, Pillunat KR. PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety. Graefes Arch Clin Exp Ophthalmol. 2023;261:2901–15. PubMed PMC

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;128:1710–21. PubMed

Brooks SE, Laird ML, Marcus DM, Johnson MH, Ramage JI, Green K. Kinetics of fluid delivery from methylcellulose sponges. J Glaucoma. 1998;7:16–21. PubMed