Long-term Results of the PRESERFLO MicroShunt in Patients With Primary Open-angle Glaucoma From a Single-center Nonrandomized Study

Abstract

Precis: The MicroShunt was implanted in 23 patients with primary open-angle glaucoma (POAG) in a feasibility study. Reductions in intraocular pressure (IOP) and medications were sustained for up to 5 years with no long-term sight-threatening adverse events (AEs). Purpose: The purpose of this study was to assess the long-term effectiveness and safety of the PRESERFLO MicroShunt (8.5 mm long, 70 µm lumen surgical device, formerly known as the InnFocus MicroShunt) in POAG. Patients and Methods: In a feasibility study (NCT00772330), patients with POAG inadequately controlled on maximum tolerated therapy with IOP ≥18 to ≤40 mm Hg underwent MicroShunt implantation with adjunctive mitomycin C (0.4 mg/mL), alone or in combination with cataract surgery. Years 1 to 3 findings have previously been reported. Endpoints of this extension study included IOP reduction and success at years 4 and 5 (primary), incidence of AEs, medication use, and reoperations. Results: Mean IOP was reduced from 23.8±5.3 mm Hg at baseline to 12.8±5.6 mm Hg (year 4; n=21) and 12.4±6.5 mm Hg (year 5; n=21). Overall success (with/without medication use) was 87.0% (year 4) and 82.6% (year 5). The mean number of medications reduced from 2.4±1.0 at baseline to 0.8±1.3 (year 5). Common (≥5% of patients) AEs included corneal edema (n=4), transient hypotony (n=4), bleb-related complications (n=3), and device touching the iris (n=3). There were 4 reports of serious AEs and 2 reoperations. Conclusions: In this extension study, sustained reductions in mean IOP and medications were observed up to 5 years post-MicroShunt implantation. There were no reports of long-term sight-threatening AEs and a low rate of postoperative interventions.

Clinical outcomes of combined Preserflo Microshunt implantation and cataract surgery in open-angle glaucoma patients

“…When compare our results with the current evidence, the IOP lowering effect seemed to be slightly lower than that reported by Riss et al 10 , Batlle et al 11 , 13 , or Beckers et al 14 , but similar to that found in the INN-005 study 18 . Differences in study protocols, concentration and placement of MMC, and the fact that the current study was conducted in a real setting, might justify such differences.…”

“…The long-term effectiveness of PMS has been evaluated by Batlle et al in a cohort of POAG patients, who underwent PMS implantation with adjunctive MMC 0.4 mg/ml 13 . Mean IOP reduction from baseline to year-4 was − 11.0 ± 5.6 mmHg; 95% CI − 14.5 to − 7.5 mmHg, p < 0.0001 13 .…”

One-year outcomes of microshunt implantation in pseudoexfoliation glaucoma

“…No case of hypotony maculopathy or lasting visual loss was documented. Hypotony and choroidal detachment in previous studies regarding microshunt implantation were almost exclusively documented in POAG subjects and occurred in 13.0% to 39.0% and 2.0% to 12.9% of cases, respectively [12,13,[19][20][21].…”

Efficacy and Safety of PreserFlo® MicroShunt After a Failed Trabeculectomy in Eyes with Primary Open-Angle Glaucoma: A Retrospective Study

“…Mitomycin C (MMC) is also used during the implantation. The device redirects the aqueous humor posteriorly, and has been found to be effective at reducing IOP in initial non-comparative studies on glaucoma and ocular hypertensive eyes, with a low rate of complications, both in the short and in the long term [11][12][13][14]. As a result of the moderately invasive nature of the procedure compared to a trabeculectomy or a GDI, as well as the benefit of posterior aqueous humor redirection, the PreserFlo Ò MicroShunt may be a viable surgical option in eyes with a failed trabeculectomy.…”