A Single Intraoperative Sub-Tenon's Capsule Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery

Fernando Paganelli, Jose´ A. Cardillo, Luiz A. S. Melo, David R. Lucena, Arnobio A. Silva, Anselmo G. Oliveira, Ana L. Ho¨fling-Lima, Quan Dong Nguyen, Baruch D. Kuppermann, Rubens Belfort
2009 Investigative Ophthalmology and Visual Science  
and the Brazilian Ocular Pharmacology and Pharmaceutical Technology Research Group (BOPP) 7 PURPOSE. To compare intraoperative injection of triamcinolone and ciprofloxacin in a controlled-release system (DuoCat) with prednisolone and ciprofloxacin eye drops after cataract surgery. METHODS. In this randomized, double-masked, controlled trial, a total of 135 patients undergoing cataract surgery were randomly allocated to two groups: 67 patients treated after surgery with prednisolone 1% and
more » ... solone 1% and ciprofloxacin 3% eye drops four times daily (week 1), three times daily (week 2), twice daily (week 3), and once daily (week 4) and 0.3% ciprofloxacin drops four times daily (weeks 1 and 2), and 68 patients treated at the end of surgery with a sub-Tenon's injection of 25 mg triamcinolone and 2 mg ciprofloxacin in biodegradable microspheres. The patients were examined on postoperative days 1, 3, 7, 14, and 28. The main outcome measures were postoperative anterior chamber cell and flare, intraocular pressure (IOP), lack of anti-inflammatory response, and presence of infection. RESULTS. No significant differences were observed between the groups in anterior chamber cell (P Ͼ 0.14) and flare (P Ͼ 0.02) at any postoperative visits. The mean (99% confidence interval) differences in IOP between the prednisolone and triamcinolone groups on days 1, 3, 7, 14, and 28 were Ϫ0.4 mm Hg (Ϫ2.1 to 1.3), 0.0 mm Hg (Ϫ1.4 to 1.3), 0.0 mm Hg (Ϫ1.1 to 1.1), Ϫ0.2 mm Hg (Ϫ1.1 to 0.8), and Ϫ0.1 mm Hg (Ϫ1.1 to 0.9), respectively. No patient had a postoperative infection. CONCLUSIONS. One injection of DuoCat had a therapeutic response and ocular tolerance that were equivalent to conventional eye drops in controlling inflammation after cataract surgery. (Clinical-Trials.gov number, NCT00431028.) (Invest Ophthalmol Vis Sci.
doi:10.1167/iovs.08-2920 pmid:19234342 fatcat:kwfujek3sjhcjnop7ccjkaicea