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Four and five-year results of a single-center study of the poly (styrene-block-isobutylene-block-styrene) (SIBS) based MicroShunt for the surgical management of patients with uncontrolled glaucoma

Poster Details

First Author: J.Batlle DOMINICAN REPUBLIC

Co Author(s):    R. Alburquerque   A. Corona Peralta                 

Abstract Details

Purpose:

The InnFocus MicroShunt�Â�® aqueous drainage device is made from poly(styrene-block-isobutylene-block-styrene) (SIBS), a highly inert and biocompatible biomaterial. Ab externo implantation of this device allows for precise control of placement and hemostasis without the need for a sophisticated microscope, gonioscope, suture tension control, or suture lysis. Reductions in intraocular pressure (IOP) with few adverse events (AEs) over a three-year follow-up period have previously been reported in patients with primary open-angle glaucoma (POAG) who were implanted with the MicroShunt.1 The 4- and 5-year results for this study are presented herein.

Setting:

Centro Laser, Santo Domingo, Dominican Republic

Methods:

Patients were implanted with the MicroShunt (8.5 mm long, 70 �Â�µm lumen) ab externo as either a stand-alone procedure or in combination with cataract surgery. All patients were treated intraoperatively with topical mitomycin C (0.4 mg/mL) for 3 minutes using the Peng Khaw technique. IOP measurements, qualified success rates, the use of topical glaucoma medications, and AEs were recorded over 5 years for each patient. Qualified success was defined as IOP (with or without medication) �â�‰�¤18 mmHg with �â�‰�¥20% reduction from baseline, and no surgical intervention other than needling.

Results:

Twenty-three patients (baseline IOP: 23.8�Â�±5.3 mmHg) were implanted with the MicroShunt (stand-alone [n=14]; with cataract surgery [n=9]). One patient was lost to follow-up (Year 1) and two patients received new devices to improve IOP control (Years 2 and 3). At Years 4 and 5: mean IOPs were 11.2�Â�±4.2 and 11.4�Â�±4.4 mmHg; qualified success rates were 95.2% and 95.0%; topical glaucoma medications/patient were reduced (2.4�Â�±0.9 to 0.9�Â�±1.4 and 0.8�Â�±1.2); and 61% and 65% of patients were medication-free, respectively. The most common AEs were transient and resolved within 90 days of surgery.1 No additional AEs were reported in Years 4 and 5.

Conclusions:

These 4 and 5-year efficacy and safety results for the MicroShunt in patients with POAG support the previously reported outcomes that were observed over a three-year follow-up period. A qualified success rate of 95% over this five-year period, with no long-term sight threatening AEs, suggest that this device may present an alternative to other aqueous drainage devices as well as the trabeculectomy procedure. Sponsored by InnFocus, a Santen company. 1. Batlle JF, Fantes F, Riss I et al. Three-Year Follow-up of a Novel Aqueous Humor MicroShunt. J Glaucoma. 2016;25(2):e58-65. doi: 10.1097/IJG.0000000000000368.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a competing company, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented

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