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 cellAnterior chamber flare Intraocular pressure Lack of anti-inflammatory response Presence of infection
Secondary outcome: Conjunctival hyperemiaSpectacle 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
|