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A. M. Joussen, C. Ocklenburg, R.-D. Hilgers, B. Kirchhof, HSO Study group; Heavy Silicone Oil versus Standard Silicone Oil in as Vitreous Tamponade in Inferior PVR (HSO Study): Interim Analysis of 94 Consecutive Patients. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2960.
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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.
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.
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.
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.
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 interim results failed to demonstrate a superiority of a heavy tamponade.
Clinical Trial: :
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