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Heavy silicone oil versus standard silicone oil in as vitreous tamponade in inferior PVR (HSO Study): interim analysis.
MedLine Citation:
PMID:  21470388     Owner:  NLM     Status:  Publisher    
Purpose:  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 proliferative vitreoretinopathy (PVR) of the lower retina. Methods:  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 with inferiorly and posteriorly located PVR grade C-A6 were randomized to either HSO or standard silicone oil as a tamponading agent. The main end-point criteria are complete retinal attachment at 12 months and change in visual acuity (VA) 12 months postoperatively compared to the preoperative VA. Results:  Forty-six patients treated with HSO 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 five patients in the standard silicone oil group fulfilled intraoperative exclusion criteria. There was no significant difference between both groups regarding anatomical success. Neither noninferiority nor superiority was shown with regard to final acuity. Conclusions:  The HSO Study is the first randomized prospective clinical trial to compare heavy and standard silicone oil in patients with PVR of the lower retina. The intermediate results failed to demonstrate superiority of a heavy tamponade.
Antonia M Joussen; Stanislao Rizzo; Bernd Kirchhof; Norbert Schrage; Xiaoxin Li; Christina Lente; Ralf-Dieter Hilgers;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-4-7
Journal Detail:
Title:  Acta ophthalmologica     Volume:  -     ISSN:  1755-3768     ISO Abbreviation:  -     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-4-7     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101468102     Medline TA:  Acta Ophthalmol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2011 The Authors. Acta Ophthalmologica © 2011 Acta Ophthalmologica Scandinavica Foundation.
Department of Ophthalmology, Charité, University Medicine, Berlin, Germany U.O.Chirurgia Oftalmica, Azienda Ospedaliero, Universitaria Pisana, Pisa, Italy Department of Vitreoretinal Surgery, University of Cologne, Cologne, Germany Augenklinik Köln-Merheim, Cologne, Germany Beijing University, Beijing, China Department of Medical Statistics, RWTH Aachen, Aachen, Germany.
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