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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00431028
Recruitment Status : Terminated (Terminated)
First Posted : February 2, 2007
Last Update Posted : March 7, 2008
Information provided by:
Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Inflammation Bacterial Infections Device: slow delivery ciprofloxacin + triamcinolone Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2005
Primary Completion Date : January 2008
Study Completion Date : March 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Anterior chamber cell [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ]
  2. Anterior chamber flare [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ]
  3. Intraocular pressure [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ]
  4. Lack of anti-inflammatory response [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ]
  5. Presence of infection [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ]

Secondary Outcome Measures :
  1. Conjunctival hyperemia [ Time Frame: Days 1, 3, 7, 14, and 28 after surgery ]
  2. Spectacle corrected visual acuity [ Time Frame: Day 28 after surgery ]

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00431028

Department of Ophthalmology, Federal University of Sao Paulo
Sao Paulo, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Principal Investigator: Fernando Paganelli, MD Federal University of Sao Paulo

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: fernando paganelli, federal university of sao paulo Identifier: NCT00431028     History of Changes
Other Study ID Numbers: Duocat 001
First Posted: February 2, 2007    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: March 2008

Keywords provided by Federal University of São Paulo:
Anti-Inflammatory Agents
Drug Delivery Systems

Additional relevant MeSH terms:
Bacterial Infections
Pathologic Processes
Lens Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors