PURPOSE: To evaluate posterior and anterior segment safety of an intracameral injection of moxifloxacin 0.5% ophthalmic solution as prophylaxis for endophthalmitis in patients having cataract surgery. SETTING: Three private practices, the University of Minnesota School of Medicine, Stillwater, Minnesota, and the University of Cincinnati, Cincinnati, Ohio, USA. METHODS: In this prospective randomized combined-center open-label trial, 57 eyes of 47 patients were treated with intracameral moxifloxacin (250 mug/0.050 mL) or an equal volume of balanced salt solution at the conclusion of cataract surgery with intraocular lens implantation. Safety parameters, including visual acuity, intraocular pressure, endothelial cell counts, corneal pachymetry, corneal clarity and edema, and anterior chamber cells and flare, were evaluated preoperatively and for 3 months postoperatively. RESULTS: Optical coherence tomography results showed no statistically significant differences between the 2 treatment groups preoperatively or at 3 months. There were also no statistically significant differences between the 2 treatment groups in all other parameters preoperatively or at 1 day, 2 to 4 weeks, or 3 months. No study-related adverse events occurred. CONCLUSION: There was no increased safety risk associated with a 250 mug/0.050 mL intracameral injection of moxifloxacin, which appears to be safe in the prophylaxis of endophthalmitis after cataract surgery.
RCT Entities:
PURPOSE: To evaluate posterior and anterior segment safety of an intracameral injection of moxifloxacin 0.5% ophthalmic solution as prophylaxis for endophthalmitis in patients having cataract surgery. SETTING: Three private practices, the University of Minnesota School of Medicine, Stillwater, Minnesota, and the University of Cincinnati, Cincinnati, Ohio, USA. METHODS: In this prospective randomized combined-center open-label trial, 57 eyes of 47 patients were treated with intracameral moxifloxacin (250 mug/0.050 mL) or an equal volume of balanced salt solution at the conclusion of cataract surgery with intraocular lens implantation. Safety parameters, including visual acuity, intraocular pressure, endothelial cell counts, corneal pachymetry, corneal clarity and edema, and anterior chamber cells and flare, were evaluated preoperatively and for 3 months postoperatively. RESULTS: Optical coherence tomography results showed no statistically significant differences between the 2 treatment groups preoperatively or at 3 months. There were also no statistically significant differences between the 2 treatment groups in all other parameters preoperatively or at 1 day, 2 to 4 weeks, or 3 months. No study-related adverse events occurred. CONCLUSION: There was no increased safety risk associated with a 250 mug/0.050 mL intracameral injection of moxifloxacin, which appears to be safe in the prophylaxis of endophthalmitis after cataract surgery.