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European Multicentre Randomised Controlled Clinical Trial: Heavy Silicone Oil versus Standard Silicone Oil as long Term Vitreous Tamponade (HSO-Study).


- candidate number0
- NTR NumberNTR185
- ISRCTNISRCTN47399029
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR23-aug-2005
- Secondary IDsOZR-2004-06 
- Public TitleEuropean Multicentre Randomised Controlled Clinical Trial: Heavy Silicone Oil versus Standard Silicone Oil as long Term Vitreous Tamponade (HSO-Study).
- Scientific TitleEuropean Multicentre Randomised Controlled Clinical Trial: Heavy Silicone Oil versus Standard Silicone Oil as long Term Vitreous Tamponade (HSO-Study).
- ACRONYMHSO-Study
- hypothesisEfficacies of heavy silicone oil and of standard silicone oil, as long-term vitreous tamponade in patients with complex ablatio retinae, are equivalent.
- Healt Condition(s) or Problem(s) studiedRetinal detachment, Proliferative vitreoretinopathy
- Inclusion criteria1. Ablatio retinae with PVR;
2. Giant tear below 10-12 h.
- Exclusion criteria1. Defects above 10-2 h;
2. Proliferative diabetic retinopathy;
3. Trauma;
4. Uveitis;
5. Glaucoma;
6. Monoculus.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2005
- planned closingdate1-mei-2007
- Target number of participants80
- InterventionsMedical device.
- Primary outcomeComplete retinal reattachment and ETDRS vision after 12 months.
- Secondary outcomeNumber of resurgeries within 12 months.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. J.C. Meurs, van
- CONTACT for SCIENTIFIC QUERIESDr. J.C. Meurs, van
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis
- PublicationsWong D, Van Meurs JC, Stappler T, Groenewald C, Pearce IA, McGalliard JN, Manousakis E, Herbert EN. A pilot study on the use of a perfluorohexyloctane/silicone oil solution as a heavier than water internal tamponade agent. Br J Ophthalmol. 2005; 89(6):662-5. PMID: 15923496
- Brief summaryN/A
- Main changes (audit trail)
- RECORD6-sep-2005 - 12-sep-2014


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