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Aims:

An observational study to determine the safety and efficacy of filtering surgery employing a microlumen aqueous drainage device (InnFocus MicroShunt), used intraoperatively with Mitomycin C, implanted alone or in combination with phacoemulsification.

Materials and Methods:

Single-site, prospective, nonrandomized study of 23 eyes that had failed maximum tolerated glaucoma medication, followed for 3 years. A MicroShunt was implanted ab externo through a needle tract under the limbus, draining aqueous from the anterior chamber to the scleral surface. Prespecified outcome measures include: intraocular pressure (IOP) control, with and without supplemental medication, success rate, medication use, and adverse events.

Results:

Fourteen patients received the MicroShunt alone and 9 with cataract surgery. At 1 (n= 23), 2 (n= 22), and 3 (n= 22) years of follow-up; the qualified success rate (IOP≤ 14 mm Hg …