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255 - Résultats de la pression intraoculaire après l'implantation du système de drainage du glaucome InnFocus MicroShunt avec 0,2 ou 0,4 mg / ml de mitomycine C: résultats d'une étude monocentrique

The InnFocus MicroShunt Glaucoma Drainage System (MicroShunt) is an 8.5 mm-long (350 μm outer diameter and 70 μm lumen) plateless drainage device made from poly(styrene-block-isobutylene-block-styrene) [SIBS]. This single-centre, single-arm study (NCT01563237) evaluated IOP and medication/patient outcomes using 0.2 and 0.4 mg/mL Mitomycin C (MMC) intraoperatively in patients with primary open-angle glaucoma.

This 24-month study was conducted in France. The MicroShunt was implanted ab externo alone or in combination with cataract surgery. Topical MMC (0.2 or 0.4 mg/mL) was applied using LASIK shields for 2–3 minutes, then rinsed out with saline, in patients inadequately controlled on tolerated medical therapy with IOP ≥18 and ≤40 mmHg. Primary outcomes were reduction in IOP from baseline at Months 12 and 24 and the incidence of all device- and/or procedure‑related adverse events (AEs). IOP was adjusted for those patients who received additional preoperative acetazolamide.

Seventy-two eyes of 67 patients were implanted with the MicroShunt.  Thirty-eight (52.8%) eyes received 0.2 mg/mL MMC and 34 (47.2%) eyes received 0.4 mg/mL MMC. Fifty-nine patients completed the 24-month follow up; one patient died, one patient was excluded because of an AE (pre-procedure), and six were lost to follow up. In the group receiving 0.2 mg/mL MMC, baseline IOP ± SD was 26.8±7.2 mmHg. IOP reduction (percentage reduction from baseline) at 6, 12 and 24 months were; 11.3±6.8 mmHg (40.4±20.1%), 11.1±7.3 mmHg (39.7±21.9%) and 9.9±8.7 mmHg (34.9±29.6%), respectively. Medication/patient at baseline, 6, 12 and 24 months was 3.0±1.6, 0.4±1.0, 0.8±1.3 and 1.8±2.4, respectively. In the group receiving 0.4 mg/mL MMC, baseline IOP was 24.7±6.0 mmHg. IOP reduction ± SD (percentage reduction from baseline) at 6, 12 and 24 months were 9.5±7.2 mmHg (35.2±20.4%), 8.6±7.4 mmHg (31.1±24.5%) and 9.3±7.5 mmHg (33.6±20.4%), respectively. Medication/patient at baseline, 6, 12 and 24 months was 3.6±1.2, 1.0±2.3, 0.9±1.4 and 1.8±2.5, respectively. The device was well tolerated; there were 18 device-related AEs in 14 studied eyes. In studied eyes, there were no reports of endophthalmitis, flat anterior chamber, or hypotony maculopathy. There were two iris adhesions and one bleb leak.  

In this 24-month single-site study, the MicroShunt reduced IOP and number of medications with an acceptable safety profile.

In this study, IOP lowering was comparable between the two MMC groups.