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

¹ Ophthalmology, University of Araraquara, Araraquara, Sao Paulo, Brazil
² Ophthalmology, Hospital de Olhos Araraquara, Henrique DallAcqua 45, Araraquara, 14802-530, Brazil
³ Ophthalmology, Federal University of Sao Paulo, Sao Paulo, Sao Paulo, Brazil
⁴ School of Pharmaceutical Sciences-UNESP Araraquara, Araraquara, Brazil
⁵ Ophthalmology, Federal University of Sao Paulo, Sao Paulo, Brazil
⁶ Vitreoretinal Service, Wilmer Eye Institute, Johns Hopkins Hosp, Baltimore, Maryland, United States
⁷ Ophthalmology, University of California, Irvine, Irvine, California, United States
⁸ Department of Ophthalmology, Federal University of Sao Paulo, Sao Paulo, Brazil
⁹ Ophthalmology, University of Araraquara, Araraquara, Brazil

^* To whom correspondence should be addressed. E-mail: hospitaldeolhos{at}uol.com.br.

	Abstract

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 post-operatively with prednisolone 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-Tenons injection of 25-mg triamcinolone and 2-mg ciprofloxacin in biodegradable microspheres. The patients were examined on post-operative days 1, 3, 7, 14, and 28. The main outcome measures were post-operative 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 > 0.14) and flare (P > 0.02) at any post-operative visits. The mean (99% confidence interval) differences in IOP between the prednisolone and triamcinolone groups on days 1, 3, 7, 14, and 28 were -0.4 mmHg (-2.1 to 1.3), 0.0 mmHg (-1.4 to 1.3), 0.0 mmHg (-1.1 to 1.1), -0.2 mmHg (-1.1 to 0.8), and -0.1 mmHg (-1.1 to 0.9), respectively. No patient had a post-operative 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.

Key Words: anti-inflammatory agents, antibiotics, cataract surgery, clinical trial, drug delivery, drug penetration

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