Free Papers

One-year safety and effectiveness of MicroShunt implantation vs trabeculectomy across five European sites

Free Paper Details

First Author: N.Strouthidis UK

Co Author(s):    J. García-Feijoó   M. Nardi   I. Riss   H. Beckers           

Abstract Details

Purpose:

The MicroShunt, an ab-externo subconjunctival glaucoma implant device, showed in a multicentre single-arm European study sustained reductions in intraocular pressure (IOP) and glaucoma medications up to 2 years post surgery. The safety and effectiveness of MicroShunt surgery versus trabeculectomy in patients with primary open-angle glaucoma were evaluated in a randomised study conducted in the USA and Europe; Year 1 findings for patients randomised at European sites are reported here.

Setting:

Five European sites participated in this 2-year, randomised, single-masked, multicentre study (one each in France, Italy, Spain, The Netherlands and the UK; NCT01881425).

Methods:

Patients aged 40–85 years with uncontrolled IOP (≥15–≤40 mmHg) on maximum tolerated glaucoma medication were randomised in a 3:1 ratio to MicroShunt or trabeculectomy, both performed with intraoperative Mitomycin C (0.2 mg/mL for 2 minutes). The primary effectiveness endpoint was a ≥20% decrease in diurnal IOP from baseline without increasing the number of glaucoma medications. Additional endpoints included change in IOP, change in the number of glaucoma medications per patient and safety at Year 1.

Results:

Fifty-eight (MicroShunt) and 19 (trabeculectomy) eyes were analysed; of which, 69.0% and 78.9% achieved the primary endpoint, respectively. Mean diurnal IOP (± standard deviation [SD]) reduced from baseline to Year 1 following MicroShunt (20.6±3.4 mmHg to 13.5±4.0 mmHg) and trabeculectomy (20.3±3.7 mmHg to 10.8±3.9 mmHg) surgery. Mean glaucoma medication use reduced from 2.5 to 0.6 (MicroShunt) and 2.9 to 0.6 (trabeculectomy). Adverse events in the MicroShunt and trabeculectomy groups included investigator-reported increased IOP requiring treatment (39.7% versus 33.3%) and numerical hypotony (31.0% versus 27.8%). Endothelial cell density loss (± SD) was similar between MicroShunt (3.2±6.8%) and trabeculectomy (3.5±6.4%) surgery.

Conclusions:

In this analysis of data from European sites, both surgeries resulted in a reduction in mean IOP and use of glaucoma medications at Year 1; overall, safety was similar between both groups.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... 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 non-monetary benefits from a competing company, ... receives non-monetary benefits from a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a competing company