Heavy silicone oil versus standard silicone oil as vitreous tamponade in inferior PVR (HSO Study): Design issues and implications

Antonia M. Joussen, Bernd Kirchhof, Norbert Schrage, Christina Ocklenburg, Ralf Dieter Hilgers, Bernd Kirchhof, Antonia M. Joussen, Ralf Dieter Hilgers, Christina Ocklenburg, Bernd Kirchhof, Ralf Dieter Hilgers, Klaus Dieter Lemmen, Antonia M. Joussen, Ralf Dieter Hilgers, Christina Ocklenburg, Ulrich Bartz-Schmidt, Nikolaos Bechrakis, Susanne Binder, Norbert Bornfeld, Arnd BunseJan Olof Carlsson, Sven Crafoord, Claudia Dahlke, Stefan Dithmar, Katrin Engelmann, Nicole Eter, Michael H. Foerster, Salvatore Grisanti, Carl Groenewald, Heinrich Heimann, Hans Hoerauf, Frank G. Holz, Bernd Kirchhof, Xiaoxin Li, Albrecht Lommatzsch, Jerzy Mackiewicz, Angelina Meireles, Maya Müller, Koen van Overdam, Ian Pearce, Ed Peperkamp, Stanislao Rizzo, Johann Roider, György Salacz, Norbert Schrage, Steven Schwartz, Guy Shanks, Ulrike Stolba, Peter Szurman, Marc Veckeneer, Peter Walter, Burkhard Wiechens, David Wong, Katja Höhne, Dominique Ottenberg, Erik Domeier, Daniel Handzel, Carsten Klatt, Beate Prinz, Helene Llacer, Sandra Jöres, Christine Kusserow, Efdal Yörük, P. Jungfermann, Isabel Krömer, Julia Wrede, Maria Herrmann, G. Varapi, Liz Garnett, Gillian Hebbar, Andreas Lipski, Markus Rindsfüser, Laila Eriksson, Claudia Belting

39 Citations (Scopus)

Abstract

Purpose: Proliferative vitreoretinopathy (PVR) is the most important reason for blindness following retinal detachment. Presently, vitreous tamponades such as gas or silicone oil cannot contact the lower part of the retina. A heavier-than-water tamponade displaces the inflammatory and PVR-stimulating environment from the inferior area of the retina. The Heavy Silicone Oil versus Standard Silicone Oil Study (HSO Study) is designed to answer the question of whether a heavier-than-water tamponade improves the prognosis of eyes with PVR of the lower retina. Methods: The HSO Study is a multicentre, randomized, prospective controlled clinical trial comparing two endotamponades within a two-arm parallel group design. Patients with inferiorly and posteriorly located PVR are randomized to either heavy silicone oil or standard silicone oil as a tamponading agent. Three hundred and fifty consecutive patients are recruited per group. After intraoperative re-attachment, patients are randomized to either standard silicone oil (1000 cSt or 5000 cSt) or Densiron® as a tamponading agent. The main endpoint criteria are complete retinal attachment at 12 months and change of visual acuity (VA) 12 months postoperatively compared with the preoperative VA. Secondary endpoints include complete retinal attachment before endotamponade removal, quality of life analysis and the number of retina affecting re-operation within 1 year of follow-up. Results: The design and early recruitment phase of the study are described. Conclusions: The results of this study will uncover whether or not heavy silicone oil improves the prognosis of eyes with PVR.

Original languageEnglish
JournalActa Ophthalmologica Scandinavica
Volume85
Issue number6
Pages (from-to)623-630
Number of pages8
ISSN1395-3907
DOIs
Publication statusPublished - 09.2007

Research Areas and Centers

  • Research Area: Luebeck Integrated Oncology Network (LION)

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