ArticleOphthalmology. Glaucoma
Safety and Effectiveness of the PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study.
Article in Ophthalmology. Glaucoma. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 88 papers, 1 of them a synthesis that pooled it.
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Who cites it
88 citing papers in PubMed, 1 synthesis or guideline pooled it, 126 citations in OpenAlex.
- PreserFlo MicroShunt versus trabeculectomy: an updated meta-analysis and systematic review.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025Pooled it
- Minimally invasive micro sclerostomy (MIMS) procedure in the treatment of open-angle glaucoma.BMC ophthalmology · 2024Trial
- Factors Associated with Favorable One-Year Outcomes After PreserFlo MicroShunt Implantation: Insights from Anterior Segment Optical Coherence Tomography.Advances in therapy · 2026Article
- Two-years efficacy and safety of bleb forming devices in uncontrolled glaucoma.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026Article
- Achieving low intraocular pressure in normal-tension glaucoma with the Preserflo MicroShunt: comparison with primary open-angle glaucoma and the XEN-45 Gel Stent.BMC ophthalmology · 2026Article
- Standalone versus combined preserflo MicroShunt surgery: A two-year controlled cohort study.Eye (London, England) · 2026Article
- Longitudinal OCT changes of the peripapillary RNFL after different glaucoma interventions - a comparative study.BMC ophthalmology · 2026Article
- Comparison of surgically induced astigmatism following PreserFlo MicroShunt implantation versus trabeculectomy in Japanese patients with glaucoma.Japanese journal of ophthalmology · 2026Article
- Preclinical assessment of Preserflo MicroShunt implantation using an intraocular endoscope-holding robot.Scientific reports · 2026Article
- Tube obstruction caused by blood clots following PreserFlo MicroShunt surgery.American journal of ophthalmology case reports · 2026Article
- Functional assessment of the Preserflo MicroShunt implant in pigmentary glaucoma: 2 years follow-up.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026Observational
- Immunomodulatory topographies regulate myofibroblast differentiation and influence fibrous encapsulation of glaucoma drainage devices.Bioactive materials · 2026Article
- Enabling adaptability and hydraulic resistance in minimally invasive glaucoma surgery using an architecture-driven approach.iScience · 2026Article
- Incidence and clinical features of malignant glaucoma after Preserflo MicroShunt implantation.Japanese journal of ophthalmology · 2026Article
- Preserflo MicroShunt in refractory glaucoma: multicentre european results with up to three years of follow-up.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026Article
- Petrolatum-based ointment application induces swelling of the PRESERFLO Microshunt.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026Article
- A-stream glaucoma shunt versus trabeculectomy: 1-year results on efficacy and safety.Scientific reports · 2026Article
- Postoperative Corneal Dellen Following PreserFlo MicroShunt: A Case Report.The American journal of case reports · 2026Article
- Preserflo microshunt in a real-life UK tertiary setting: success rates, safety profile, and postoperative management.International ophthalmology · 2026Article
- Two-year outcomes of PRESERFLO MicroShunt implantation in a real-world heterogeneous glaucoma cohort: a retrospective single-center study.Frontiers in ophthalmology · 2026Article
28 more citing papers are in PubMed but not listed here.
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Authors and funding
14 authors at 8 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo assess the safety and effectiveness of the PRESERFLO® MicroShunt (formerly InnFocus MicroShunt) in patients with primary open-angle glaucoma (POAG).
designThe MicroShunt, a controlled ab externo glaucoma filtration surgery device, was investigated in a 2-year, multicenter, single-arm study.
participantsEligible patients were aged 18-85 years with POAG inadequately controlled on maximal tolerated medical therapy with intraocular pressure (IOP) ≥18 and ≤35 mmHg or when glaucoma progression warranted surgery.
methodsThe MicroShunt was implanted as a stand-alone procedure with adjunctive use of topical mitomycin C (MMC; 0.2-0.4 mg/ml) for 2-3 minutes.
main outcome measuresThe primary effectiveness outcome was IOP reduction and success (not requiring reoperation or pressure failures [IOP > 21 mmHg and < 20% reduction in IOP]) at year 1. Additional end points at year 2 included IOP reduction, success, glaucoma medications, adverse events (AEs), and reoperations. Results are reported in the overall population and subgroups of patients receiving 0.2 or 0.4 mg/ml MMC.
resultsIn 81 patients, mean (± standard deviation [SD]) IOP decreased from 21.7 ± 3.4 mmHg at baseline to 14.5 ± 4.6 mmHg at year 1 and 14.1 ± 3.2 mmHg at year 2 (P < 0.0001). Overall success (with and without supplemental glaucoma medication use) at year 1 was 74.1%. Mean (± SD) number of medications decreased from 2.1 ± 1.3 at baseline to 0.5 ± 0.9 at year 2 (P < 0.0001), and 73.8% of patients were medication free. Most common nonserious AEs were increased IOP requiring medication or selective laser trabeculoplasty (25.9%) and mild-to-moderate keratitis (11.1%). There were 6 (7.4%) reoperations and 5 (6.2%) needlings by year 2. In an analysis (post hoc) according to MMC concentration, overall success was 78.1% (0.2 mg/ml) and 74.4% (0.4 mg/ml; P = 0.710). In the 0.2 and 0.4 mg/ml MMC groups, 51.9% and 90.3% of patients were medication free, respectively (P = 0.001). There was a trend toward lower IOP and higher medication reduction in the 0.4 mg/ml MMC subgroup.
conclusionsIn this study, mean IOP and glaucoma medication reductions were significant and sustained over 2 years postsurgery. No long-term, sight-threatening AEs were reported. Further studies may confirm potential risk/benefits of higher MMC concentration.
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