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European Multicentre Randomised Controlled Clinical Trial: Perfluorohexylactane versus Silicone Oil as Long-term Vitreous Tamponade (PST-Study)

Joussen A. M., Kirchhof B.,
Universität zu Köln, Zentrum für Augenheilkunde, Abteilung für Netzhaut- und Glaskörperchirurgie (Köln)

Phase: III
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 PFCL application and silicone oil endotamponadeversus surgery without PFCL application and PERFLUOROHEXYLOCTANE endotamponade
Patients: Aphakic or pseudophakic patients with PVR grade C-A6 Time of the Study: 4 years
Endotamponades: PERFLUOROHEXYLOCTANE, 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; Aphakic/pseudophakic at the end of the initial surgery
Exclusion Criteria: Phakia, no lensectomy planned; 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
Examinations: Preoperative, Initial surgery, Postperative follow-up visits within one week, two months, six months and one year after initial surgery. At every reoperation, unscheduled visits, Measurement of visual acuity and documentation of the retina by video, fundus photo, B-scan and fundusdrawing
Primary Endpoint: Six month attachment; visual acuity
Secondary Endpoint: Two months attachment, number of Re-operations, treatment cost
Study Centers: Aachen, Berlin, Dortmund, Erlangen/Nürnberg, Essen, Frankfurt, Freiburg, Hannover, Heidelberg, Homburg Saar, Köln, Mannheim, München, Münster, Leipzig, Liverpool, Royal Oak, MI, Rotterdam, Sulzbach, Tübingen, Würzburg, Wien,

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