title: Three-Year Follow-up of a Novel Aqueous Humor MicroShunt.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: *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.
authors.forename: Juan F
authors.initials: JF
authors.lastname: Batlle
authors.forename: Francisco
authors.initials: F
authors.lastname: Fantes
authors.forename: Isabelle
authors.initials: I
authors.lastname: Riss
authors.forename: Leonard
authors.initials: L
authors.lastname: Pinchuk
authors.forename: Rachel
authors.initials: R
authors.lastname: Alburquerque
authors.forename: Yasushi P
authors.initials: YP
authors.lastname: Kato
authors.forename: Esdras
authors.initials: E
authors.lastname: Arrieta
authors.forename: Adalgisa Corona
authors.initials: AC
authors.lastname: Peralta
authors.forename: Paul
authors.initials: P
authors.lastname: Palmberg
authors.forename: Richard K
authors.initials: RK
authors.lastname: Parrish
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Weber
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Parel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000477:Alkylating Agents / Q000008:administration & dosage; D000867:Anterior Chamber / Q000601:surgery; D001082:Aqueous Humor / Q000502:physiology; D005260:Female; D005500:Follow-Up Studies; D020327:Glaucoma Drainage Implants; D005902:Glaucoma, Open-Angle / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology*; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D018918:Phacoemulsification; D011446:Prospective Studies; D014065:Tonometry, Ocular; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000477:Alkylating Agents; D016685:Mitomycin