Is Loaded Silicone Oil Feasible in the Treatment of Proliferative Vitreoretinopathy? First Results From Austrian Clinical Multicentre Study

Abstract

Purpose:: To evaluate the safety and feasibility of using loaded silicone oil as vitreous tamponade in the treatment of proliferative vitreoretinopathy (PVR).

Methods:: Medical grade silicone oil was loaded with (AS) according to the Austrian Medical Product Guidelines. The AS concentration in the final acetylsalicylic acid - silicone oil suspension (ASA SiO) was 0.4mg/ml. The study was designed as a prospective, randomised, double blind, multi centre study in five opthalmic departements in Austria. In total 32 patients (32 eyes) with PVR (minimum stage C) were treated with vitrectomy in combination with either pure silicone oil (SiO) or with SiO suspended with acetylsalicylic acid (ASA SiO). The most important exclusion criteria included allergies to AS, the presence of vascular retinopathies and the presence of a natural lens.

Results:: No systemic or local adverse events occured in the 18 eyes treated with ASA SiO while in the 14 eyes, treated with pure silicone oil a vitreal haemorrhage and a corneal ulcer were observed. No statistical difference in regard to the number of reoperations due to tracive retinal redetachments was noted.

Conclusions:: The feasibility of loading Si O with an antiproliferative drug could be shown for the ASA SiO. In addition we could also demonstrate the systemic and local safety of this suspension. Transfering antiproliferative drugs via silicone oil may offer novel treatment options for ocular pathologies that are currently treated with pure silicone oil.

Keywords: proliferative vitreoretinopathy • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials