Randomized clinical trial of Surodex steroid drug delivery system for cataract surgery: anterior versus posterior placement of two Surodex in the eye.

OBJECTIVE: To evaluate safety and antiinflammatory efficacy of placing two Surodex (Oculex Pharmaceuticals, Inc., Sunnyvale, CA) in the eye after cataract surgery in comparison with steroid eyedrops and to compare anterior versus posterior chamber placement.
DESIGN: Randomized, masked, controlled trial. PARTICIPANTS: One hundred four eyes of 104 Asian patients undergoing extracapsular cataract extraction with intraocular lens implantation were examined. Of these, 33 eyes of 33 patients served as control eyes (group A). INTERVENTION: Two Surodex pellets were inserted in the anterior chamber (AC) of 35 eyes (group B), and two Surodex pellets were inserted in the ciliary sulcus of 36 eyes (group C) at the conclusion of surgery. Control eyes received neither Surodex nor a placebo implant, but were prescribed conventional 0.1% dexamethasone eyedrops four times daily for 4 weeks. MAIN OUTCOME MEASURES: Anterior chamber flare and cells were graded clinically at the slit lamp. Anterior chamber flare was assessed objectively with the Kowa FC500 Laser Flare Meter (Kowa Co. Ltd, Tokyo, Japan). Intraocular pressure and corneal endothelial specular microscopy with morphometric cell analysis were performed for up to 1 year after surgery.
RESULTS: Lower flare meter readings occurred in both Surodex groups at all postoperative visits, as compared with the dexamethasone eyedrop group, with statistical significance at days 4 (P = 0.001), 8 (P = 0.001), and 15 (P = 0.02). No difference in flare occurred between AC and ciliary sulcus placement. Clinical slit-lamp assessment of anterior chamber flare and cells showed no difference between Surodex-treated eyes and dexamethasone-treated eyes. Nine of 33 eyes (27.3%) in group A required steroid augmentation, as opposed to 4 of 71 eyes (5.6%) in groups B and C. Inflammatory symptoms were reduced in the Surodex-treated eyes, with statistical significance for ocular discomfort (P = 0.001), photophobia (P = 0.04), and lacrimation (P = 0.01). No complications occurred with Surodex-treated eyes, and no significant difference in endothelial cell loss was noted between Surodex-treated eyes and dexamethasone-treated eyes up to 1 year after surgery.
CONCLUSIONS: Intraocular placement of two Surodex is a safe and effective treatment method to reduce intraocular inflammation after cataract surgery and clearly is superior to eyedrops in reducing inflammatory symptoms and aqueous flare as measured with the laser flare meter. No difference in efficacy between AC placement and ciliary sulcus placement of Surodex was detected in this study.

RCT Entities:   Population Interventions Outcomes