Investigative ophthalmology & visual science · 2009
A single intraoperative sub-tenon's capsule injection of triamcinolone and ciprofloxacin in a controlled-release system for cataract surgery.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Paganelli Fernando, Cardillo José A, Melo Luiz A S, Lucena David R, Silva Arnobio A, Oliveira Anselmo G, Höfling-Lima Ana L, Nguyen Quan Dong, Kuppermann Baruch D, Belfort Rubens, Brazilian Ocular Pharmacology and Pharmaceutical Technology Research Group
Аннотация
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 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 > 0.14) and flare (P > 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 -0.4 mm Hg (-2.1 to 1.3), 0.0 mm Hg (-1.4 to 1.3), 0.0 mm Hg (-1.1 to 1.1), -0.2 mm Hg (-1.1 to 0.8), and -0.1 mm Hg (-1.1 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. (ClinicalTrials.gov number, NCT00431028.).
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 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 > 0.14) and flare (P > 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 -0.4 mm Hg (-2.1 to 1.3), 0.0 mm Hg (-1.4 to 1.3), 0.0 mm Hg (-1.1 to 1.1), -0.2 mm Hg (-1.1 to 0.8), and -0.1 mm Hg (-1.1 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. (ClinicalTrials.gov number, NCT00431028.).
Предметные рубрики MeSH
AgedAnterior ChamberAnti-Infective AgentsAnti-Inflammatory AgentsCiprofloxacinConnective TissueDelayed-Action PreparationsDouble-Blind MethodDrug CarriersDrug Therapy, CombinationEye Infections, BacterialFemaleHumansInflammationInjectionsIntraocular PressureIntraoperative CareLactic AcidLens Implantation, IntraocularMaleMicroscopy, AcousticOphthalmoscopyPhacoemulsificationPolyglycolic AcidPolylactic Acid-Polyglycolic Acid CopolymerPostoperative ComplicationsPrednisoloneTriamcinolone AcetonideUveitis, Anterior