Posters

Two-year results of a multicentre study assessing the MicroShunt in patients with primary open-angle glaucoma: 0.4 mg/ml mitomycin C outcomes

Poster Details

First Author: H.Beckers NETHERLANDS

Co Author(s):    F. Aptel   C. Webers   E. Bluwol   J. Martinez-de-la-Casa   J. Garcia-Feijoó   Y. Lachkar   C. Méndez-Hernández   I. Riss

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). In a pooled analysis of three studies, in which the MicroShunt was implanted with either 0.2 mg/mL or 0.4 mg/mL Mitomycin C (MMC), the 0.4 mg/mL concentration resulted in greater reductions in intraocular pressure (IOP) and glaucoma medications per patient than the 0.2 mg/mL concentration. Here we present the 2-year results from a European multicentre study of patients who received 0.4 mg/mL topical MMC.

Setting:

A multicentre, prospective, open-label study (NCT02177123) was carried out to assess the efficacy and safety of the MicroShunt in patients with POAG. Six sites in Europe were involved including France (three sites), Spain, Switzerland and The Netherlands (one site each).

Methods:

The MicroShunt was implanted ab externo with topical MMC (0.4 mg/mL) applied via LASIK sponges for 2–3 minutes. Patients included in this study were aged between 18 and 85 years with POAG not controlled on maximum tolerated medical therapy, with IOP between 18 and 35 mmHg. Primary outcomes included reduction in IOP, reduction in glaucoma medication and adverse events. Success rate was defined as patients, with or without medication, who were not pressure failures and did not undergo a reoperation within the operating room. Data collected after reoperation were excluded from the efficacy and safety analyses.

Results:

In the 43 patients who received 0.4 mg/mL MMC, mean ± standard deviation (SD) IOP was reduced from 21.9±3.7 mmHg at baseline to 13.5±3.1 mmHg at Year 2 (37.6% reduction). Mean ± SD number of glaucoma medications/patient decreased from 2.0±1.3 to 0.1±0.4 and 90.6% of patients were medication free. The success rate was 74.4%. The most common procedure- and device-related AEs were keratitis (18.6%) and numerical hypotony (16.3%). One patient had increased IOP requiring needling, and eight patients required a reoperation, of which five were bleb revisions. No long-term sight-threatening AEs were reported.

Conclusions:

In this analysis of 43 patients, MicroShunt implantation with 0.4 mg/mL MMC resulted in a 37.6% mean decrease in IOP to 13.5±3.1 mmHg at Year 2, and glaucoma medications were reduced from 2.0±1.3 to 0.1±0.4 (90.6% of patients were medication free at Year 2). Adverse events were transient, and no long-term sight-threatening AEs were reported.

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