Efficacy and Tolerability of a Combined MoxifloxacinDexamethasone Formulation for Topical Prophylaxis in Phacoemulsification An Open-Label Single-Arm Clinical Trial.pdfVIP

Hindawi Publishing Corporation Journal of Ophthalmology Volume 2011, Article ID 769571, 5 pages doi:10.1155/2011/769571 Clinical Study Efficacy and Tolerability of a Combined Moxifloxacin/Dexamethasone Formulation for Topical Prophylaxis in Phacoemulsification: An Open-Label Single-Arm Clinical Trial Cesar Ramon G. Espiritu, Mary Ellen A. Sy, and Tommee Lynne G. Tayengco American Eye Center, Level 5, Shangri-La Plaza, EDSA, Corner Shaw Boulevard, Ortigas Center, Mandaluyong City 1554, Philippines Correspondence should be addressed to Mary Ellen A. Sy, mesy75@ Received 3 January 2011; Accepted 14 March 2011 Academic Editor: David A. Wilkie Copyright © 2011 Cesar Ramon G. Espiritu et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. The use of a fixed-combination antibiotic corticosteroid for infection prophylaxis in Asian patients undergoing phacoemulsification has not been reported. Methods. A 15-day, open-label, single-arm trial of 64 patients for phacoemulsification with intraocular lens (IOL) implantation is described. Patients applied moxifloxacin 0.5%/dexamethasone 0.1% (Vigadexa) eye drops four times daily before and until 15 days after surgery. Anterior chamber (AC) reaction, visual acuity, ocular pain and signs, and intraocular pressure (IOP) were assessed at baseline and on postoperative days 1, 3, 8, and 15. Results. At day 15, 55 (91.7%) patients scored 0 (5 cells) in AC reaction. No surgery-related infection occurred. Mean best-corrected visual acuity improved 0.5 logMAR from baseline to 0.0 logMAR (P .0001). Mean IOP remained at 12-13 mm Hg over the 15-day treatment. O