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

Sponsor:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00431028

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 I Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections Cataract

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Triamcinolone diacetate Medrol veriderm Ciprofloxacin Ciprofloxacin hydrochloride Triamcinolone acetonide Methylprednisolone Ciprofloxacin lactate Triamcinolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate Triamcinolone hexacetonide 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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: ciprofloxacin triamcinolona

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431028

Locations

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

Sponsors and Collaborators

Federal University of São Paulo

Investigators

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):

Paganelli F, Cardillo JA, Melo LA Jr, Lucena DR, Silva AA Jr, Oliveira AG, Höfling-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. Epub 2009 Feb 21.

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 February 09, 2012