Abstract
Purpose: :
To evaluate the incidence of intravitreal silicone oil (SO) droplets associated with intravitreal injections using syringes with a staked-on versus luer cone needle design in the Standard Care versus COrticosteroid in REtinal Vein Occlusion (SCORE) Study.
Methods: :
The SCORE Study evaluates intravitreal triamcinolone acetonide injection(s) for treatment of vision loss associated with macular edema secondary to central or branch retinal vein occlusion. Injections were given at baseline and 4-month intervals, based on treatment assignment and study-defined re-treatment criteria. Because intravitreal SO following injections was observed in some participants, investigators were instructed on September 22, 2006 to look for intravitreal SO at all study visits. On November 1, 2007, the luer cone needle design replaced the staked-on needle design. Incidence of intravitreal SO was compared among participants exposed to: 1) only staked-on syringes, 2) both staked-on and luer cone syringes, and 3) only luer cone syringes.
Results: :
461 participants received a total of 1153 injections between November 4, 2004 and September 11, 2008. Intravitreal SO was noted in 117/310 (38%) participants exposed only to staked-on syringes, 10/94 (11%) exposed to both staked-on and luer cone syringes, and 0/57 exposed only to luer cone syringes (p<0.0001, log-rank test). Among participants with first injections after September 22, 2006, intravitreal SO was noted in 47/106 injected only with staked-on syringes compared with 0/57 injected only with luer cone syringes.
Conclusions: :
In the SCORE Study, luer cone needle design is associated with a lower frequency of intravitreal SO occurrence compared with the staked-on needle design. This is likely due to increased residual space in the needle hub associated with the luer cone design.
Clinical Trial: :
www.clinicaltrials.gov NCT00105027