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Sponsored by: |
Federal University of São Paulo |
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Information provided by: | Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT00431028 |
The purpose of this study is to compare one intraoperative sub-Tenon's capsule injection of triamcinolone and ciprofloxacin in a biodegradable controlled-release system with conventional prednisolone and ciprofloxacin eye drops to treat ocular inflammation and for infection prophylaxis after cataract surgery.
Condition | Intervention | Phase |
---|---|---|
Inflammation Bacterial Infections |
Device: slow delivery ciprofloxacin + triamcinolone |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Comparative Study of a Single Intraoperative Sub-Tenon's Capsule Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System Versus 1% Prednisolone and 0.3% Ciprofloxacin Eyedrops for Cataract Surgery |
Enrollment: | 140 |
Study Start Date: | September 2005 |
Study Completion Date: | March 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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colirio: No Intervention
prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops
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Device: slow delivery ciprofloxacin + triamcinolone
2 mg ciprofloxacin + 25mg triamcinolone
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Topical steroids effectively control ocular inflammation, but are associated with the well-recognized problems of patient compliance. Injection of depot corticosteroids into sub-Tenon's capsule is an established method of treating various ocular inflammatory diseases. Its prolonged therapeutic effect has provided the ophthalmologist with an alternative tool for the treatment of different diseases that may be extended to the surgical arena to modulate postoperative inflammation. The use of topical antibiotic agents poses unique and challenging hurdles for drug delivery, especially because recent reports have suggested that the incidence of endophthalmitis may be increasing. Exploiting the permeability of the sclera, subconjunctival routes may offer a more promising alternative for enhanced drug delivery and tissue targeting compared with topical routes. In theory, the combination of an antibiotic with a steroid in a controlled-release system delivered transscleral could be feasible after cataract surgery to achieve several clinical objectives, i.e., eliminate topical medications, enhance patient compliance, improve drug bioavailability, and protect the patient from infection.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Department of Ophthalmology, Federal University of Sao Paulo | |
Sao Paulo, Brazil, 04023-062 |
Principal Investigator: | Fernando Paganelli, MD | Federal University of Sao Paulo |
Responsible Party: | federal university of sao paulo ( fernando paganelli ) |
Study ID Numbers: | Duocat 001 |
Study First Received: | February 1, 2007 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00431028 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
Cataract Endophthalmitis Antibiotics Anti-Inflammatory Agents Drug Delivery Systems |
Bacterial Infections Anti-Inflammatory Agents Immunologic Factors Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Prednisolone acetate Lens Diseases Tetrahydrozoline Hormones Triamcinolone hexacetonide Anti-Bacterial Agents Ciprofloxacin |
Triamcinolone Acetonide Cataract Triamcinolone Methylprednisolone Hemisuccinate Eye Diseases Endophthalmitis Methylprednisolone acetate Triamcinolone diacetate Glucocorticoids Immunosuppressive Agents Inflammation Prednisolone |
Bacterial Infections Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Lens Diseases Infection Hormones Triamcinolone hexacetonide Ciprofloxacin Triamcinolone Acetonide |
Pathologic Processes Cataract Therapeutic Uses Triamcinolone Nucleic Acid Synthesis Inhibitors Eye Diseases Triamcinolone diacetate Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Inflammation |