Clinical trial NCT00431028: Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Inflammation
Bacterial Infections
Keywords: Cataract
Endophthalmitis
Antibiotics
Anti-Inflammatory Agents
Drug Delivery Systems
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2007-02-02
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Anterior chamber cell
timeFrame: Days 1, 3, 7, 14, and 28 after surgery
measure: Anterior chamber flare
timeFrame: Days 1, 3, 7, 14, and 28 after surgery
measure: Intraocular pressure
timeFrame: Days 1, 3, 7, 14, and 28 after surgery
measure: Lack of anti-inflammatory response
timeFrame: Days 1, 3, 7, 14, and 28 after surgery
measure: Presence of infection
timeFrame: Days 1, 3, 7, 14, and 28 after surgery
Secondary outcomes:
measure: Conjunctival hyperemia
timeFrame: Days 1, 3, 7, 14, and 28 after surgery
measure: Spectacle corrected visual acuity
timeFrame: Day 28 after surgery
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Department of Ophthalmology, Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Fernando Paganelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paganelli F, Cardillo JA, Melo LA Jr, Lucena DR, Silva AA Jr, Oliveira AG, Hofling-Lima AL, Nguyen QD, Kuppermann BD, Belfort R Jr; Brazilian Ocular Pharmacology and Pharmaceutical Technology Research Group. A single intraoperative sub-tenon's capsule injection of triamcinolone and ciprofloxacin in a controlled-release system for cataract surgery. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3041-7. doi: 10.1167/iovs.08-2920. Epub 2009 Feb 21.