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

This study has been terminated.
(Terminated)
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00431028
First received: February 1, 2007
Last updated: March 6, 2008
Last verified: March 2008
  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 1
Phase 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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:
Inflammation
Cataract
Bacterial Infections
Pathologic Processes
Lens Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Ciprofloxacin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014