PRESERFLO ™ MicroShunt Versus Trabeculectomy: 1-year Results on Efficacy and Safety

Overview

Journal Graefes Arch Clin Exp Ophthalmol

Specialty Ophthalmology

Date 2023 May 3

PMID 37133501

Authors

Melanie Jamke

Robert Herber

Maike A Haase

Carolin S Jasper

Lutz E Pillunat

Karin R Pillunat

Affiliations

Soon will be listed here.

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.

Citing Articles

Risk factors and protective strategies for hypotony following preserflo microshunt implantation.

Mieno H, Mori K, Yoshii K, Okada Y, Ikeda Y, Ueno M Sci Rep. 2025; 15(1):8344.

PMID: 40069337 PMC: 11897240. DOI: 10.1038/s41598-025-92879-9.

Surgical success 2 years after preserflo microshunt implantation: real world data from a single eye care centre.

Hinterberger S, Schneider S, Kallab M, Murauer O, Reisinger A, Bolz M Graefes Arch Clin Exp Ophthalmol. 2025; .

PMID: 39937232 DOI: 10.1007/s00417-025-06739-3.

Short-term efficacy and safety of PreserFlo MicroShunt in Japanese patients with medically treated primary open-angle glaucoma.

Suzuki H, Sakata R, Yamae T, Ishiyama Y, Sugimoto K, Saito H Jpn J Ophthalmol. 2025; .

PMID: 39826074 DOI: 10.1007/s10384-024-01159-y.

Xen 63 versus Preserflo MicroShunt implant in patients with primary open-angle glaucoma.

Martinez-de-la-Casa J, Pascual-Santiago A, Morales-Fernandez L, Saez-Frances F, Garcia-Saenz S, Guemes-Villahoz N Sci Rep. 2025; 15(1):1634.

PMID: 39794378 PMC: 11723952. DOI: 10.1038/s41598-024-81616-3.

Intraluminal Insertion of 9-0 Nylon for Postoperative Choroidal Detachment After Preserflo MicroShunt Implantation: A Case Report.

Kitamura Y, Ikema S, Tatsumi T, Baba T Cureus. 2024; 16(11):e74560.

PMID: 39735092 PMC: 11676401. DOI: 10.7759/cureus.74560.

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