Prospective Clinical Trial on the Combined Use of Suroquin Drug Delivery System (DDS) Containing Ciprofloxacin and Surodex DDS Containing Dexamethasone in Phacoemulsification Cataract Surgery Without Need for Eyedrops

Abstract

Abstract: : Purpose: To evaluate the efficacy and long-term safety of combined intra-ocular insertions of a 5-day sustained release Suroquin^TM Drug Delivery System (DDS)^TM (Oculex Pharmaceuticals, Inc.), containing ciprofloxacin and a Surodex^TM DDS^TM containing dexamethasone and to evaluate the novel concept of cataract surgery without postoperative eye drops in patients undergoing elective phacoemulsification with foldable IOL implantation. Methods: Prospective clinical trial involving sixty-four eyes of 64 patients undergoing elective phacoemulsification cataract surgery with foldable acrylic IOL implantation in which one pellet of 30 µg (n=54) Suroquin^TM or 60 µg Suroquin^TM (n=10) and one pellet of Surodex^TM was inserted into the anterior chamber (AC) at the conclusion of surgery. The patients were followed up for 12 months. AC flare was measured with the Kowa FM500 Laser Flare Meter for up to one month, and slit-lamp evaluation, intraocular pressure measurement, gonioscopy, fundoscopy and corneal endothelial cell counts were performed up to 12 months after surgery. Results: Sixty-three of 64 (98.4%) eyes attained 6/12 or better best-corrected visual acuity at 1 month and 60 of 64 (93.8%) at 1 year follow-up. Four eyes did not attain 6/12 vision due to posterior capsular opacity. Average aqueous flare measurements (in photon counts/ms) were 9.2 at day one, 7.6 at day four, 8.2 at day fourteen and 7.6 at day thirty post-operatively. One case of steroid-induced glaucoma was noted. No difference between pre-operative and post-operative endothelial cell counts was noted. At the end of 12 months, no residual DDS was found in 7 cases, while the rest had small remnants of DDS noted in the inferior anterior chamber angle. No other complications relating to surgery or Suroquin^TM insertion were encountered. Based on the study questionnaire, all patients expressed satisfaction with the concept of cataract surgery without eye drops. Conclusions: These results suggest that combined use of Surodex and Suroquin^TM DDS appears to be safe and effective in eliminating the need for eye drops after intraocular surgery and therefore elimination of complications related to eye drop use or abuse. Future studies to ascertain the duration and concentration of ciprofloxacin levels are needed.

Keywords: clinical (human) or epidemiologic studies: tre • drug toxicity/drug effects • cataract