title: Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent.
abstract: OBJECTIVE
  To evaluate safety and clinical outcomes of a novel supraciliary device, the CyPass Micro-Stent, for surgical treatment of open-angle glaucoma when implanted in conjunction with cataract surgery.
  
  
  METHODS
  Subjects (n=142) with open-angle glaucoma and cataract underwent combined phacoemulsification, with intraocular lens insertion, and microstent implantation into the supraciliary space of study eyes (n=167). Two analysis cohorts were prespecified based upon medicated baseline intraocular pressure (IOP): ≥21 mm Hg (cohort 1, n=65) or <21 mm Hg (cohort 2, n=102). Glaucoma medications were discontinued or tapered at surgery, and restarted at investigator discretion. The main postoperative outcome measures were adverse events, IOP changes, and number of IOP-lowering medications.
  
  
  RESULTS
  Mean±SD follow-up was 294±121 days. No major intraoperative or postoperative complications occurred. Preoperative baseline mean IOP was 20.2±6.0 mm Hg and mean number of IOP-lowering medications was 2.0±1.1. Cohort 1 showed a 35% decrease in mean IOP and a 49% reduction in mean glaucoma medication usage; cohort 2 demonstrated a 75% reduction in mean medication usage while maintaining mean IOP<21 mm Hg. For all eyes, mean IOP at 12 months was 15.9±3.1 mm Hg (14% reduction from baseline). Early and late postoperative IOP elevation occurred in 1.2% and 1.8% of eyes, respectively. Two subjects developed mild transient hyphema, and none exhibited prolonged inflammation, persistent hypotony, or hypotony maculopathy.
  
  
  CONCLUSIONS
  CyPass Micro-Stent implantation, combined with cataract surgery, resulted in minimal complications and reduced IOP and IOP-lowering medication use at 12 months postoperatively.
authors.affiliation: *Eye Hospital at the Dietrich-Bonhoeffer-Klinikum, Neubrandenburg †Teaching Hospital of the Ernst-Moritz-Arndt, University Greifswald, Greifswald ¶Eye Clinic, Cham, Germany ‡Vold Vision, Fayetteville, AK §Department of Ophthalmology, University of Toronto, Toronto, ON, Canada ∥Institut Catala de Retina, Universidad Internacional de Cataluña, Barcelona, Spain #Department of Ophthalmology, Stanford University, Palo Alto, CA **Department of Ophthalmology, University of California San Francisco, San Francisco, CA ††Ophthalmic Consultants of Boston, Boston, MA.
authors.forename: Helmut
authors.initials: H
authors.lastname: Hoeh
authors.forename: Steven D
authors.initials: SD
authors.lastname: Vold
authors.forename: Iqbal K
authors.initials: IK
authors.lastname: Ahmed
authors.forename: Alfonso
authors.initials: A
authors.lastname: Anton
authors.forename: Magda
authors.initials: M
authors.lastname: Rau
authors.forename: Kuldev
authors.initials: K
authors.lastname: Singh
authors.forename: David F
authors.initials: DF
authors.lastname: Chang
authors.forename: Bradford J
authors.initials: BJ
authors.lastname: Shingleton
authors.forename: Tsontcho
authors.initials: T
authors.lastname: Ianchulev
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002386:Cataract / Q000150:complications; D005260:Female; D020327:Glaucoma Drainage Implants; D005902:Glaucoma, Open-Angle / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D018918:Phacoemulsification; D011183:Postoperative Complications; D014065:Tonometry, Ocular; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology