Artikel
Heavy versus standard silicone Oil as Endotamponade in Pars Plana Vitrectomy (HSO-Study)
Suche in Medline nach
Autoren
Veröffentlicht: | 22. September 2004 |
---|
Gliederung
Text
Aim: Improvement of the surgical therapy outcome for aphakic or pseudophakic patients with PVR grade C-A6 by selection of a more specific endotamponade
Study Design: Parallel group design, two treatments
Treatments: Surgery with standard silicone oil endotamponade versus surgery without heavy silicone oil endotamponade
Patients: Phakic, aphakic or pseudophakic patients with PVR grade C-A6
Time of the Study: 4 years
Endotamponades: Heavy silicone oil, standard silicone oil
Inclusion Criteria:
Inferior and posterior PVR grade C-A6, P12 according to Machemer at 10 over 6 to 2 hours (PVR only as rhegmatogenous retinal detachment or a complication of trauma)
Inferior giant retinal tear retinal detachment at 10 over 6 to 2 hours
Exclusion Criteria:
Diabetic retinopathy
Glaucoma
Retinotomy/holes/tears above 2 and 10 o'clock
Superior anterior PVR grade C A6 between 2, 12 and 10 o'clock
Superior giant retinal tear retinal detachment between 2, 12 and 10 o'clock
No written informed consent
Age below 18 years
Participation at another trial
Pregnancy
Primary Endpoint:
Twelve months attachment
Twelve months visual acuity
Secondary Endpoint:
Three months attachment
Number of Re-operations
Quality of life
Principal Investigator: Prof. Dr. Bernd Kirchhof, Cologne
Koordination: PD Dr. A. Joussen, Cologne
Medical Statistics: Prof. Dr. Ralf-Dieter Hilgers, Aachen
Sponsor:
DFG
Fluoron, Neu Ulm/Geuder Heidelberg
Current status: Ethics comittee approved, recruitment ongoing