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Br J Ophthalmol 2005;89:425-429 doi:10.1136/bjo.2004.058032
  • Clinical science
    • Extended reports

Long term effect on IOP of a stainless steel glaucoma drainage implant (Ex-PRESS) in combined surgery with phacoemulsification

  1. C E Traverso1,
  2. F De Feo1,
  3. A Messas-Kaplan2,
  4. P Denis3,
  5. S Levartovsky4,
  6. E Sellem5,
  7. F Badalà1,
  8. Z Zagorski6,
  9. A Bron7,
  10. M Belkin8
  1. 1DiNOG, Clinica Oculistica, University of Genova, Italy
  2. 2Ophthalmology Department, Assaf Harofe Medical Center, Tsrifin, Israel
  3. 3Hôpital Edouard Herriot, Lyon, France
  4. 4Barzilay Medical Center, Ashkelon, Israel
  5. 5Centre Ophtalmologique Kléber, Lyon, France
  6. 6Ophthalmology Department, Lublin University Medical School, Lublin, Poland
  7. 7Ophthalmology Department, University Hospital CHU Dijon, France
  8. 8Goldschleger Eye Research Institute, Tel Hashomer, Israel
  1. Correspondence to: Professor Carlo E Traverso Department of Neurosciences, Ophthalmology and Genetics, University of Genova, Italy; mc8620mclink.it
  • Accepted 1 December 2004

Abstract

Aim: 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. Primary outcome: 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. Efficacy: 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 ≤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.

Footnotes

  • Competing interests: Professor Carlo E Traverso is also a clinical investigator for other surgical drainage glaucoma devices.

  • Informed consent: Approved by local ethics committees.

  • Declared interests: Carlo E Traverso, Audrey Messas-Kaplan, Philippe Denis, Shmuel Levartovsky, Eric Sellem, Zbigniew Zagorski, and Alain Bron have received funding from Optonol Ltd as clinical investigators for carrying out this study. Michael Belkin has proprietary interest in Optonol Ltd.

  • This work was presented as a poster at the Association for Research in Vision and Ophthalmology Annual Meeting 25–29 April 2004, Ft Lauderdale, FL, USA

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