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

Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammation; Bacterial Infections

Intervention: slow delivery ciprofloxacin + triamcinolone (Device)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: Federal University of São Paulo

Official(s) and/or principal investigator(s):
Fernando Paganelli, MD, Principal Investigator, Affiliation: Federal University of Sao Paulo

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Anterior chamber cell

Anterior chamber flare

Intraocular pressure

Lack of anti-inflammatory response

Presence of infection

Secondary outcome:

Conjunctival hyperemia

Spectacle corrected visual acuity

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Department of Ophthalmology, Federal University of Sao Paulo, Sao Paulo 04023-062, Brazil
Additional Information

Starting date: September 2005
Last updated: March 6, 2008

Page last updated: August 23, 2015

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