Safety and Effectiveness of the PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma

PreserFlo® MicroShunt: An Overview of This Minimally Invasive Device for Open-Angle Glaucoma

“…A novel study to assess the safety and effectiveness of the PreserFlo MicroShunt was led by Beckers [ 31 ]. This prospective, single-arm, multicenter clinical trial (Identifier: NCT02177123) regarded six European sites with a 2 years follow up.…”

“…Overall success (defined as the absence of two consecutive pressure failures; outside target range or a ≤20% reduction from baseline, with and without supplemental glaucoma medication use) was 74.1% at 1 year. Almost 80% of these patients achieved complete success (intending supplemental glaucoma medications were not required to maintain controlled levels of IOP) [ 31 ]. Similar results were reported at the second year follow-up.…”

“…Similar results were reported at the second year follow-up. At the end of the study period, 73.8% of patients were medication-free (regardless of IOP level), with an average 0.5-per-patient medications overall [ 31 ]. Postoperative IOP was comparable in the 0.2 mg/mL and 0.4 mg/mL subgroups during the follow-up period, in a post hoc analysis.…”

“…However, after month 6, there was a tendency toward larger IOP reduction with 0.4 mg/mL MMC compared with the 0.2 mg/mL MMC group. In addition, 90.3% of patients in the 0.4 mg/mL MMC group were medication free at year 2 compared with just half of the patients in the 0.2 mg/mL group, suggesting that the higher MMC concentration might be more appropriate in the eyes of patients with more severe disease [ 31 ]. Nonserious AEs linked to the device or procedure were recorded in 11 (34.4%) and 32 (74.4%) patients in the 0.2 mg/mL and 0.4 mg/mL MMC categories, respectively.…”

“…PreserFlo MicroShunt may be implanted in conjunction with cataract surgery or as a stand-alone treatment. Everywhere, its minimally invasive approach highlights no need for intraoperative gonioscopy, sclerotomy, or iridectomy [ 29 , 30 , 31 ].…”