title: Long term effect on IOP of a stainless steel glaucoma drainage implant (Ex-PRESS) in combined surgery with phacoemulsification.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of a stainless steel miniature glaucoma drainage device (Ex-PRESS R50) for the surgical treatment of primary open angle glaucoma (POAG) and cataract when combined with phacoemulsification.
  
  
  METHODS
  Clinical, prospective, multicentre, single treatment arm, non-randomised, non-masked study. The Ex-PRESS device was implanted at the limbus under a conjunctival flap. Phacoemulsification cataract extraction and in the bag IOL implantation were performed through clear cornea temporally.
  
  
  METHODS
  IOP change; secondary outcomes: side effects and VA changes.
  
  
  RESULTS
  26 eyes of 25 patients were implanted with the device. The mean (SD) follow up was 23.9 (10.4) months and the mean age was 75.1 (7.1) years. 17/26 eyes have more than 3 years of follow up. One case was discontinued because of device removal, one because of death, and three were lost to follow up.
  
  
  RESULTS
  preoperative IOP was 21 (4) mm Hg; at 1, 2, and 3 years IOP was 15.3 (3.1) mm Hg (35% reduction), 16.6 (2.7) mm Hg (29% reduction), and 16 (2.6) mm Hg (22% reduction) respectively. Kaplan-Meyer determined overall success rate (IOP < or = 21 mm Hg at the last visit with or without medications) as 76.9%. The number of antiglaucoma medications was reduced by 95% at year 1. Only six patients (23%) were taking IOP lowering treatment at their last visit, five with one medication and one with two medications. Side effects: early postoperative complications were clinically mild and included six cases of hypotony (IOP <5 mm Hg), three cases of hyphaema (<2 mm) with no clinically significant further effects. Long term complications were two cases (7.7%) of device rotation (one treated by reposition) and three cases (11.5%) of conjunctival erosion at 2 and 3 years.
  
  
  CONCLUSIONS
  The Ex-PRESS implant, combined with phacoemulsification cataract extraction, is clinically safe and effective, maintaining in the long term a large reduction in IOP and in the number of antiglaucoma medications.
authors.affiliation: DiNOG, Clinica Oculistica, University of Genova, Italy. mc8620@mclink.it
authors.forename: C E
authors.initials: CE
authors.lastname: Traverso
authors.forename: F
authors.initials: F
authors.lastname: De Feo
authors.forename: A
authors.initials: A
authors.lastname: Messas-Kaplan
authors.forename: P
authors.initials: P
authors.lastname: Denis
authors.forename: S
authors.initials: S
authors.lastname: Levartovsky
authors.forename: E
authors.initials: E
authors.lastname: Sellem
authors.forename: F
authors.initials: F
authors.lastname: Badalà
authors.forename: Z
authors.initials: Z
authors.lastname: Zagorski
authors.forename: A
authors.initials: A
authors.lastname: Bron
authors.forename: S
authors.initials: S
authors.lastname: Gandolfi
authors.forename: M
authors.initials: M
authors.lastname: Belkin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage; D002386:Cataract / Q000150:complications*; D004334:Drug Administration Schedule; D018463:Filtering Surgery / Q000009:adverse effects / Q000379:methods; D005500:Follow-Up Studies; D020327:Glaucoma Drainage Implants; D005902:Glaucoma, Open-Angle / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure; D018918:Phacoemulsification; D011182:Postoperative Care / Q000379:methods; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D013193:Stainless Steel; D014792:Visual Acuity
chemical_list: D000959:Antihypertensive Agents; D013193:Stainless Steel