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Abstract #66571 Published in IGR 17-3
Three-Year Follow-up of a Novel Aqueous Humor MicroShunt
Batlle JF; Fantes F; Riss I; Pinchuk L; Alburquerque R; Kato YP; Arrieta E; Peralta AC; Palmberg P; Parrish RK; Weber BA; Parel JMJournal of Glaucoma 2016; 25: e58-e65
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.
*Centro Laser, Santo Domingo, Dominican Republic †Ophthalmic Biophysics Center Bascom Palmer Eye Institute, University of Miami Miller School of Medicine ‡Anne Bates Leach Eye Hospital, University of Miami ∥InnFocus Inc., Miami, FL §Pôle Ophtalmologique de la Clinique Mutualiste, Pessac, Cedex, France.
Full articleClassification:
12.8.2 With tube implant or other drainage devices (Part of: 12 Surgical treatment > 12.8 Filtering surgery)
