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Safety and efficacy of a micro-lumen aqueous drainage device made of SIBS, the InnFocus MicroShunt™

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Session Details

Session Title: Glaucoma I

Session Date/Time: Sunday 14/09/2014 | 08:00-09:30

Paper Time: 08:30

Venue: Auditorium

First Author: : I.Riss FRANCE

Co Author(s): :    L. Pinchuk   J. Parel           

Abstract Details

Purpose:

To evaluate the safety and efficacy of a micro-lumen aqueous drainage device made of SIBS, the InnFocus MicroShunt™, used with Mitomycin C (MMC), alone or combined with phacoemulsification.

Setting:

Minimally invasive glaucoma surgery

Methods:

Single site, ongoing, prospective non-randomized study of 52 eyes in 52 Caucasien patients having just the glaucoma procedure (45) and 7 combined with phacoemulsification. A single MicroShunt (70 µm lumen, 8.5 mm long) is implanted ab externo, shunting aqueous humor from the anterior chamber to a flap formed under the conjunctiva and Tenons capsule. MMC is applied either far from the limbus (40) or near the limbus (12) at a concentration of 0.2 (19) or 0.4 (33) mg/mL applied for 2 to 3 minutes. Intraocular pressure (IOP), visual fields, visual acuity, medication use and adverse events measured over the course of one year.

Results:

The overall mean IOP drop at one year was 64% from a baseline of 29.9 ± 8 mmHg to 10.7 ± 5 mmHg (n=47). The concentration of MMC had no significant effect on IOP; however, placement of MMC close to the limbus demonstrated a significant lowering effect of IOP as compared to placement deep in the pocket. The mean number of glaucoma medications was reduced 85% from a pre-operative 3.3 to 0.5 medications per patient at one year. The most common complication was immediate postoperative transient hypotony after Day 1 (IOP < 6 mmHg) which occurred in 6% of the non-combined cases only, all of which resolved spontaneously. There were no long term sight-threatening adverse events.

Conclusions:

Surgery with the InnFocus MicroShunt trans-scleral aqueous drainage tube made of SIBS achieved control of IOP comparable to reported results for trabeculectomy with MMC or aqueous drainage implants with what appears to be a simpler procedure with a better safety profile as there were no vision-affecting complications.

Financial Interest:

NONE

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