Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery
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Purpose
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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Anterior chamber cell [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ] [ Designated as safety issue: No ]
- Anterior chamber flare [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ] [ Designated as safety issue: No ]
- Intraocular pressure [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ] [ Designated as safety issue: Yes ]
- Lack of anti-inflammatory response [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ] [ Designated as safety issue: Yes ]
- Presence of infection [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ] [ Designated as safety issue: Yes ]
- Conjunctival hyperemia [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ] [ Designated as safety issue: No ]
- Spectacle corrected visual acuity [ Time Frame: Day 28 after surgery ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
No Intervention: colirio
prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops
|
Device: slow delivery ciprofloxacin + triamcinolone
2 mg ciprofloxacin + 25mg triamcinolone
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with uncomplicated, senile cataract
- Best-corrected visual acuity (VA) of 20/100 or better in the fellow eye
Exclusion Criteria:
- Patients in use of oral or topical anti-inflammatory agents
- History of steroid-induced ocular hypertension
- Hypermature cataracts
- Previous ocular surgery
- Preexisting uveitis
- Diabetic retinopathy
- Glaucoma
- Corneal disease
Contacts and Locations| Brazil | |
| Department of Ophthalmology, Federal University of Sao Paulo | |
| Sao Paulo, Brazil, 04023-062 | |
| Principal Investigator: | Fernando Paganelli, MD | Federal University of Sao Paulo |
More Information
No publications provided by Federal University of São Paulo
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | fernando paganelli, federal university of sao paulo |
| ClinicalTrials.gov Identifier: | NCT00431028 History of Changes |
| Other Study ID Numbers: | Duocat 001 |
| Study First Received: | February 1, 2007 |
| Last Updated: | March 6, 2008 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
Cataract Endophthalmitis Antibiotics Anti-Inflammatory Agents Drug Delivery Systems |
Additional relevant MeSH terms:
|
Bacterial Infections Inflammation Cataract Pathologic Processes Lens Diseases Eye Diseases Triamcinolone hexacetonide Anti-Inflammatory Agents Prednisolone Triamcinolone Triamcinolone Acetonide Ciprofloxacin Triamcinolone diacetate Therapeutic Uses |
Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013