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Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery
This study has been terminated.
( Terminated )
First Received: February 1, 2007   Last Updated: March 6, 2008   History of Changes
Sponsored by: 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

MedlinePlus related topics: Bacterial Infections Cataract Surgery
Drug Information available for: Triamcinolone diacetate Ciprofloxacin Ciprofloxacin hydrochloride Triamcinolone acetonide Ciprofloxacin lactate Triamcinolone Triamcinolone hexacetonide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
colirio: No Intervention
prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops
Device: slow delivery ciprofloxacin + triamcinolone
2 mg ciprofloxacin + 25mg triamcinolone

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

Responsible Party: federal university of sao paulo ( fernando paganelli )
Study ID Numbers: Duocat 001
Study First Received: February 1, 2007
Last Updated: March 6, 2008
ClinicalTrials.gov Identifier: NCT00431028     History of Changes
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

Study placed in the following topic categories:
Bacterial Infections
Anti-Inflammatory Agents
Immunologic Factors
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Prednisolone acetate
Lens Diseases
Tetrahydrozoline
Hormones
Triamcinolone hexacetonide
Anti-Bacterial Agents
Ciprofloxacin
Triamcinolone Acetonide
Cataract
Triamcinolone
Methylprednisolone Hemisuccinate
Eye Diseases
Endophthalmitis
Methylprednisolone acetate
Triamcinolone diacetate
Glucocorticoids
Immunosuppressive Agents
Inflammation
Prednisolone

Additional relevant MeSH terms:
Bacterial Infections
Anti-Inflammatory Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Lens Diseases
Infection
Hormones
Triamcinolone hexacetonide
Ciprofloxacin
Triamcinolone Acetonide
Pathologic Processes
Cataract
Therapeutic Uses
Triamcinolone
Nucleic Acid Synthesis Inhibitors
Eye Diseases
Triamcinolone diacetate
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009