title: A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma.
abstract: OBJECTIVE
  To assess the safety and effectiveness of the Hydrus Microstent (Ivantis, Inc, Irvine, CA) with concurrent cataract surgery (CS) for reducing intraocular pressure (IOP) in open-angle glaucoma (OAG).
  
  
  METHODS
  Prospective, multicenter, randomized, single-masked, controlled clinical trial.
  
  
  METHODS
  One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP (DIOP) of 21 to 36 mmHg.
  
  
  METHODS
  On the day of surgery, patients were randomized 1:1 to undergo CS with the microstent or CS alone. Postoperative follow-up was at 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months. Washout of hypotensive medications was repeated at 12 and 24 months.
  
  
  METHODS
  Response to treatment was defined as a 20% or more decrease in washed out DIOP at 12 and 24 months of follow-up compared with baseline. Mean DIOP at 12 and 24 months, the proportion of subjects requiring medications at follow-up, and the mean number of medications were analyzed. Safety measures included change in visual acuity, slit-lamp observations, and adverse events.
  
  
  RESULTS
  The proportion of patients with a 20% reduction in washed out DIOP was significantly higher in the Hydrus plus CS group at 24 months compared with the CS group (80% vs. 46%; P = 0.0008). Washed out mean DIOP in the Hydrus plus CS group was significantly lower at 24 months compared with the CS group (16.9±3.3 mmHg vs. 19.2±4.7 mmHg; P = 0.0093), and the proportion of patients using no hypotensive medications was significantly higher at 24 months in the Hydrus plus CS group (73% vs. 38%; P = 0.0008). There were no differences in follow-up visual acuity between groups. The only notable device-related adverse event was focal peripheral anterior synechiae (1-2 mm in length). Otherwise, adverse event frequency was similar in the 2 groups.
  
  
  CONCLUSIONS
  Intraocular pressure was clinically and statistically significantly lower at 2 years in the Hydrus plus CS group compared with the CS alone group, with no differences in safety.
authors.affiliation: Department of Ophthalmology, Johannes Gutenberg-University, Mainz, Germany. Electronic address: norbert.pfeiffer@unimedizin-mainz.de.
authors.forename: Norbert
authors.initials: N
authors.lastname: Pfeiffer
authors.affiliation: Servicio de Oftalmología, Hospital Clinico San Carlos, Madrid, Spain.
authors.forename: Julian
authors.initials: J
authors.lastname: Garcia-Feijoo
authors.affiliation: Servicio de Oftalmología, Hospital Clinico San Carlos, Madrid, Spain.
authors.forename: Jose M
authors.initials: JM
authors.lastname: Martinez-de-la-Casa
authors.affiliation: Servicio de Oftalmología, University Hospital Miguel Servet, Zaragoza, Spain.
authors.forename: Jose M
authors.initials: JM
authors.lastname: Larrosa
authors.affiliation: Dipartimento di Scienze Chirugia, Clinica Oculistica, University of Torino, Torino, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Fea
authors.affiliation: Glaucoma Service, Rotterdam Eye Hospital, Rotterdam, The Netherlands.
authors.forename: Hans
authors.initials: H
authors.lastname: Lemij
authors.affiliation: Unita di Oftalmologia, Universita Degli Studi die Parma, Dipartimento di Scienze Biomediche, Biotecnologiche e Traslazionali, Clinica Oculistica, University of Parma, Parma, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Gandolfi
authors.affiliation: Bürgerhospital Frankfurt, am Main, Augenklinik, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Schwenn
authors.affiliation: Department of Ophthalmology, Johannes Gutenberg-University, Mainz, Germany.
authors.forename: Katrin
authors.initials: K
authors.lastname: Lorenz
authors.affiliation: Minnesota Eye Consultants, Minneapolis, Minnesota.
authors.forename: Thomas W
authors.initials: TW
authors.lastname: Samuelson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage; 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; D016850:Limbus Corneae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D018918:Phacoemulsification; D011446:Prospective Studies; D019919:Prosthesis Implantation; D016037:Single-Blind Method; D015607:Stents; D014065:Tonometry, Ocular; D014792:Visual Acuity / Q000502:physiology; D014794:Visual Fields; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents