title: Early postoperative safety and surgical outcomes after implantation of a suprachoroidal micro-stent for the treatment of open-angle glaucoma concomitant with cataract surgery.
abstract: OBJECTIVE
  To evaluate the safety of a new suprachoroidal device, the Cypass micro-stent, for the surgical treatment of open-angle glaucoma (OAG) implanted in conjunction with cataract surgery.
  
  
  METHODS
  Multicenter clinical study.
  
  
  METHODS
  Prospective interventional case series.
  
  
  METHODS
  This is an interim report of an ongoing safety study. Patients with OAG glaucoma (Shaffer grade 3 and 4) who were also candidates for cataract surgery in the affected eye had standard phacoemulsification followed by micro-stent implantation in the supraciliary space. Included were patients with uncontrolled (≥ 21 mm Hg, Cohort 1) or controlled (<21 mm Hg, Cohort 2) medicated intraocular pressure (IOP) at baseline. Glaucoma medications were discontinued at surgery and resumed at the discretion of each investigator. Measures included adverse events/complications and postoperative changes in IOP or medication.
  
  
  RESULTS
  The mean baseline medicated IOP was 21.1 mm Hg ± 5.91 (SD); the mean number of IOP-lowering medications was 2.1 ± 1.1 (N = 184). There were no major events such as retinal or choroidal detachment or endophthalmitis. The most common complications were transient early hypotony (13.8%) and transient IOP increase (10.5%). Uncontrolled patients (n = 57) had a 37% IOP reduction (P<.001), with more than a 50% reduction in glaucoma medications at 6 months (P<.001). Intraocular pressure-controlled patients (n = 41) had a 71.4% reduction in glaucoma medications (P<.001).
  
  
  CONCLUSIONS
  Initial clinical experience with the new micro-stent showed a low rate of surgical complications with concomitant decreases in IOP and/or glaucoma medications.
authors.affiliation: Eye Hospital at Dietrich-Bonhoeffer-Klinikum, Neubrandenburg, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Hoeh
authors.forename: Iqbal Ike K
authors.initials: II
authors.lastname: Ahmed
authors.forename: Swaantje
authors.initials: S
authors.lastname: Grisanti
authors.forename: Salvatore
authors.initials: S
authors.lastname: Grisanti
authors.forename: Günther
authors.initials: G
authors.lastname: Grabner
authors.forename: Quang H
authors.initials: QH
authors.lastname: Nguyen
authors.forename: Magda
authors.initials: M
authors.lastname: Rau
authors.forename: Sonia
authors.initials: S
authors.lastname: Yoo
authors.forename: Tsontcho
authors.initials: T
authors.lastname: Ianchulev
mesh_terms: D000368:Aged; D002386:Cataract / Q000150:complications / Q000503:physiopathology / Q000628:therapy; D002829:Choroid / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D020327:Glaucoma Drainage Implants; D005902:Glaucoma, Open-Angle / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D007431:Intraoperative Complications; D019654:Lens Implantation, Intraocular; D008297:Male; D018918:Phacoemulsification; D011183:Postoperative Complications; D011184:Postoperative Period; D011446:Prospective Studies; D015607:Stents; D014065:Tonometry, Ocular; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology