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

• Published in: Journal of glaucoma Vol. 25; no. 2; p. e58
• Main Authors: Batlle, Juan F, Fantes, Francisco, Riss, Isabelle, Pinchuk, Leonard, Alburquerque, Rachel, Kato, Yasushi P, Arrieta, Esdras, Peralta, Adalgisa Corona, Palmberg, Paul, Parrish, 2nd, Richard K, Weber, Bruce A, Parel, Jean-Marie
• Format: Journal Article
• Language: English
• Published: United States 01.02.2016
• Subjects: Adult; Aged; Aged, 80 and over; Alkylating Agents - administration & dosage; Anterior Chamber - surgery; Aqueous Humor - physiology; Female; Follow-Up Studies; Glaucoma Drainage Implants; Glaucoma, Open-Angle - physiopathology; Glaucoma, Open-Angle - surgery; Humans; Intraocular Pressure - physiology; Lens Implantation, Intraocular; Male; Middle Aged; Mitomycin - administration & dosage; Phacoemulsification; Prospective Studies; Tonometry, Ocular; Visual Acuity - physiology
• ISSN: 1536-481X
• DOI: 10.1097/IJG.0000000000000368

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. 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. 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. 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.