Three-Year Follow-up of a Novel Aqueous Humor MicroShunt.

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 and IOP reduction >= 20%) was 100%, 91%, and 95%; mean medicated IOP was reduced from 23.8 +/- 5.3 to 10.7 +/- 2.8, 11.9 +/- 3.7, and 10.7 +/- 3.5 mm Hg, and the mean number of glaucoma medications/patient was reduced from 2.4 +/- 0.9 to 0.3 +/- 0.8, 0.4 +/- 1.0, and 0.7 +/- 1.1, respectively. The most common complications were transient hypotony (13%, 3/23) and transient choroidal effusion (8.7%, 2/23), all resolved spontaneously. There were no leaks, infections, migrations, erosions, persistent corneal edema, or serious long-term adverse events. Conclusion: Surgery with the InnFocus MicroShunt transscleral aqueous drainage tube with Mitomycin C achieved IOP control in the low teens in most subjects up to 3 years of follow-up with only transient adverse events occurring within the first 3 months after surgery.