One-year results from a pooled analysis of three studies assessing the MicroShunt in patients with primary open-angle glaucoma with low or high preoperative intraocular pressure

Session Details

Session Title: Microinvasive Glaucoma Surgery

Session Date/Time: Sunday 15/09/2019 | 14:00-16:00

Paper Time: 14:48

Venue: Free Paper Forum: Podium 4

First Author: : F.Aptel FRANCE

Co Author(s): :    J. Batlle   H. Beckers   J. García-Feijoó   Y. Lachkar   I. Riss   T. Shaarawy              

Abstract Details

Purpose:

The MicroShunt is an 8.5-mm-long glaucoma drainage device indicated for the treatment of patients with primary open-angle glaucoma (POAG). MicroShunt implantation has previously resulted in reductions in both intraocular pressure (IOP) and number of glaucoma medications, with no reports of long-term sight-threatening adverse events (AEs) in patients with mild to severe POAG. Here we present 1-year results from a subanalysis of three pooled studies assessing the efficacy and safety of the MicroShunt in patients with POAG stratified by low (≥18–≤21 mmHg) or high (>21 mmHg) baseline IOP.

Setting:

Three non-randomised, single-arm studies (NCT00772330, NCT01563237 and NCT02177123) were carried out to assess the efficacy of the MicroShunt in patients with POAG. Seven sites were involved (three in France and one in each of The Netherlands, Spain, Switzerland, and the Dominican Republic).

Methods:

The MicroShunt was implanted ab externo with topical Mitomycin C (MMC; 0.2 or 0.4 mg/mL) using LASIK sponges for 2–3 minutes. Patients included in the studies were aged 18–85 years with uncontrolled IOP (18–35 mmHg) on maximum tolerated medical therapy. Patients were stratified according to their baseline preoperative IOP as either low (≥18–≤21 mmHg) or high (>21 mmHg). Primary outcomes included reduction in IOP, reduction in glaucoma medication and AEs at Year 1. Data collected after reoperation were excluded from the efficacy and safety analyses. All data refer to the per-protocol patient populations.

Results:

In patients with low (n=64) and high (n=61) IOP, mean ± standard deviation (SD) IOP was reduced from 19.2±1.0 to 13.8±3.6 mmHg (-28.4%) and 25.8±3.5 to 13.8±5.3 mmHg (-45.6%), respectively. Mean ± SD number of glaucoma medications/patient decreased from 2.3±1.2 to 0.4±0.8 mmHg (low IOP) and 2.1±1.3 to 0.6±1.0 mmHg (high IOP). The percentage of patients that were medication free increased from 9.4% to 76.3% and 13.1% to 73.2% for the low and high IOP subgroups, respectively. The most common procedure- or device-related AE was increased IOP (low IOP; 23.4%) (high IOP; 24.6%).

Conclusions:

In this subanalysis of 125 patients with POAG stratified by low (n=64) and high (n=61) baseline IOP, MicroShunt implantation with MMC resulted in decreases in IOP of 28.4% and 45.6%, respectively, compared with baseline at Year 1. Glaucoma medications were also reduced in each patient subgroup (76.3% and 73.2% of patients were medication free at Year 1 in the low and high IOP subgroups, respectively). AEs were transient, and no long-term sight-threatening AEs were reported.

Financial Disclosure:

has significant investment interest in a competing company, travel has been funded, fully or partially, by a competing company, travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a competing company, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a competing company, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented