Summary
BACKGROUND: A new surgical method of intravitreal tamponade with silicone oil suspended with acetylsalicylic acid (AS) was investigated for safety and efficiency in the treatment of proliferative vitreoretinopathie. The study was designed as a prospective randomized, controlled double-blind Multicentre Study. METHODS: A standard three-port pars plana vitrectomy was performed in 29 eyes of 29 patients. In case a natural lens was present simultaneous phacoemulsification was obligatory. The control group received standard therapy vitreous tamponade with pure 5000centistoke silicone oil while the silicone oil was suspended with AS to a concentration of 0.2 mg/ml in the study group. After 6 months follow up the tamponade was removed in all eyes. RESULTS: The safety of AS SiO could be demonstrated: the AS SiO was well tolerated and stayed clear during the study period of 6 months. The clinical examination revealed no signs of local or systemic adverse effects in the study eyes. The visual acuities were well matched before inclusion into the study and there was no evidence of significant differences during the follow up period and in final visual outcome between the two groups. The rate of redetachments defined as the primary outcome parameter was the same for both groups. CONCLUSIONS: Acetylsalicylic acid delivery by intravitreal silicone oil in the human eye was shown a safe method that may offer a delivery route for other antiproliferative agents into the posterior pole.
Zusammenfassung
HINTERGRUND: Eine neue Form der intravitrealen Tamponade mit einer Suspension aus Azetyl-Salizylsäure und Silikonöl (AS SiO) wurde einer klinischen Prüfung unterzogen. Die Studie wurde als doppelt-blinde, randomisierte, multizentrische, prospektive Studie konzipiert, um die Sicherheit und Effektivität von AS SiO als Glaskörpertamponade bei proliferativer Vitreoretinopathie (PVR) zu evaluieren. METHODE UND PATIENTEN: Insgesamt 29 Augen von 29 Patienten mit einer PVR Grad C wurden in der Studie entweder einer Pars-Plana Vitrektomie mit anschließender AS-SiO- oder reiner SiO-Tamponade unterzogen. Die Azetyl-Salizylsäure-Konzentration der Suspension betrug 0,2 mg/ml und es wurde in beiden Gruppen jeweils 5000centistoke Silikonöl verwendet. Bei Phakie war zeitgleich eine Operation der Linse obligatorisch, um eventuell AS-SiO-bedingte Linsentrübungen zu vermeiden. Nach 6 Monaten wurde die Tamponade bei allen Patienten entfernt. Im Fall noch vorliegender Traktionen oder instabiler Verhältnisse war eine Retamponade mit reinem SiO natürlich möglich. ERGEBNISSE: Die Sicherheit von AS SiO konnte nachgewiesen werden. Es wurde in allen Augen gut toleriert und die Suspension blieb transparent innerhalb der Beobachtungszeit von 6 Monaten. Die klinische Untersuchung ergab keine Hinweise einer lokalen oder systemischen Toxizität. Die Visuswerte beider Gruppen unterschieden sich nicht signifikant sowohl präoperativ als auch postoperativ. Auch in Bezug auf die Rate der Reablationes, dem Hauptzielkriterium der Studie, waren beide Gruppen gleichwertig. SCHLUSSFOLGERUNG: Die Azetyl-Salizylsäure- und Silikonöl-Suspension (AS SiO) repräsentiert eine sichere und effektive Tamponade im Rahmen der PVR-Behandlung. Zusätzlich beweist sie, dass es möglich ist, mittels Silikonöl Medikamente in den posterioren Augenabschnitt zu verabreichen, wobei hier vor allem der Transfer antiproliferativer Substanzen interessant ist.
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Kralinger, M., Stolba, U., Velikay, M. et al. Acetylsalicylic acid–silicone oil suspension for proliferative vitreoretinopathie: First results of Austrian clinical multicentre study. Spektrum Augenheilkd. 21, 218–220 (2007). https://doi.org/10.1007/s00717-007-0214-0
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DOI: https://doi.org/10.1007/s00717-007-0214-0