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.

BACKGROUND

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.

METHODS

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.

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.

CONCLUSIONS

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.