gms | German Medical Science

23rd Annual Meeting of the German Retina Society

German Retina Society

24.09. - 25.09.2010, Freiburg

Heavy Silicone Oil versus Standard Silicone Oil in as vitreous tamponade in Inferior PVR (HSO Study): Interim Analysis

Meeting Abstract

  • Antonia M. Joussen - Charité, University School of Medicine Berlin, University Eye Clinic, Campus Virchow Clinic and Campus Benjamin Franklin, Berlin
  • C. Ocklenburg - Department of Medical Statistics, RWTH Aachen University
  • B. Kirchhof - Department of Vitreoretinal Surgery, University of Cologne
  • N. Schrage - Eye Clinic Cologne-Merheim, Cologne
  • R.-D. Hilgers - Department of Medical Statistics, RWTH Aachen University
  • HSO-Studiengruppe

German Retina Society. 23rd Annual Conference of the German Retina Society. Freiburg i. Br., 24.-25.09.2010. Düsseldorf: German Medical Science GMS Publishing House; 2010. Doc10rg63

doi: 10.3205/10rg63, urn:nbn:de:0183-10rg630

This is the translated version of the article.
The original version can be found at: http://www.egms.de/de/meetings/rg2010/10rg63.shtml

Published: September 21, 2010

© 2010 Joussen et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

Text

Objective: The Heavy Silicone Oil versus Standard Silicone Oil Study (HSO-study) is designed to answer the question, whether a heavier than water tamponade improves the prognosis of eyes with PVR of the lower retina.

Design: The HSO Study is a multicentre, randomized, prospective controlled clinical trial stratified by surgeon comparing two endotamponades within a two arm parallel group design.

Patients: Patients with inferiorly and posteriorly located PVR grade C-A6 were randomized to either heavy silicone oil or standard silicone oil as a tamponading agent.

Main Outcome Measures: The main endpoint criteria are complete retinal attachment at twelve months and change of VA twelve months postoperatively as compared to the preoperative VA.

Results: 46 patients treated with heavy silicone oil were compared to 47 patients treated with standard silicone oil. There was no difference among the groups regarding baseline data. Three patients in the HSO and 5 patients in the standard silicone oil group fulfilled intraoperative exclusion criteria. There was no significant difference between both groups regarding anatomical success. Neither non-inferiority nor superiority was shown with regard to final acuity.

Conclusions: The HSO Study is the first randomised prospective clinical trial to compare heavy and standard silicone oil in patients with PVR of the lower retina. The intermediate results failed to demonstrate a superiority of a heavy tamponade.

EudraCT 2005-004 154-27