Safety and feasibility of a novel intravitreal tamponade using a silicone oil/acetyl-salicylic acid suspension for proliferative vitreoretinopathy: first results of the Austrian Clinical Multicenter Study
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The safety and efficacy of a new surgical method of intravitreal tamponade using silicone oil suspended with aspirin (acetylsalicylic acid) was investigated for the treatment of proliferative vitreoretinopathy.
The study was designed as a prospective, randomized, controlled, double-blind multicenter study. A total of 29 patients were included; 15 patients were treated with the silicone oil suspended with aspirin, and 14 patients represented the control group receiving only silicone oil. A standard three-port pars plana vitrectomy was performed in 29 eyes of 29 patients. In cases in which the natural lens was present, simultaneous phacoemulsification was required. The control group received as standard therapy a vitreous tamponade with pure 5000 mPas silicone oil and the treatment group received silicone oil containing 0.2 mg/ml aspirin (AS SiO). At 6 months after surgery, the tamponade was removed from all eyes. The main outcome measure was the incidence of retinal redetachment requiring reoperation. Secondary outcome measures were visual acuity and ophthalmic examination results.
The rate of redetachment, defined as the primary outcome parameter, was the same for both groups. The AS SiO was well tolerated and remained clear during the 6-month study period. Clinical examination revealed no signs of local or systemic adverse effects. The visual acuities were well matched before inclusion in the study and there were no significant differences during the follow-up period and in the final visual outcome between the two groups.
Aspirin delivery by intravitreal silicone oil in the human eye is safe and also may provide a delivery vehicle for other antiproliferative agents to the posterior pole.
KeywordsAcetyl-salicylic acid Silicone oil Proliferative vitreoretinopathy
We are very grateful to Dr. Dresp from Bausch&Lomb for financing the production of the AS SiO at Pharm Pur. We also thank Prof. Hanno Ulmer for the statistical analyses. This project was supported by the Adele Rabensteiner Stiftung of the Austrian Society of Ophthalmology.
- 2.Claes C, Freeman HM, Tolentino FI (1988) PVR: an overview. In: Freeman HM, Tolentino FI (eds) Proliferative vitreoretinopathy. Springer, Berlin Heidelberg New York , pp 3–11Google Scholar
- 5.Lean J, Azen SP, Lopez PF, Qian D, Lai MY, McCuen B (1996) The prognostic utility of the Silicone Study Classification System. Silicone Study Report 9. Silicone Study Group. Arch. Ophthalmol 114:286–292Google Scholar
- 7.Silicone Study Group (1985) Proliferative vitreoretinopathy. Am J Ophthalmology 99:593–595Google Scholar
- 10.Silicone Study Group (1992) Vitrectomy with silicone oil or sulfur hexafluoride gas in eyes with severe proliferative vitreoretinopathy: results of a randomized clinical trial. Silicone Study Report 1. Arch Ophthalmol 110:770–779Google Scholar
- 11.Silicone Study Group (1992) Vitrectomy with silicone oil or perfluoropropane gas in eyes with severe proliferative vitreoretinopathy: results of a randomized clinical trial. Silicone Study Report 2. Arch Ophthalmol 110:780–790Google Scholar
- 12.Parel J-M, Villain F (1994) Silicone oils: physicochemical properties. In: Ryan SJ (ed) Retina, vol 3, 2nd edn. Mosby, St. Louis, pp 2131–2149Google Scholar
- 25.Nakagawa M, Refojo MF, Marin JF, Doi M, Tolentino Fl (1995) Retinoic acid in silicone and silicone-fluorosilicone copolymer oils in a rabbit model of proliferative vitreoretinopathy. Invest Ophthalmol Vis Sci 36:2388–2395Google Scholar
- 29.Hegazy HM, Peyman GA, Liang C, Unal MH, Molinari LC, Kazi AA (1998–1999) Use of perfluorocarbon liquids, silicone oil, and 5-fluorouracil in the management of experimental PVR. Int Ophthalmol 22(4):239–246Google Scholar
- 38.Analgesics and antipyretics. In: McEvoy GE, Litvak K, Walsh O (eds) American Hospital Formulary Service Drug Information. Bethesda, MD: American Society of Hospital Pharmacists Inc., 1989;962–966Google Scholar