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

March 6, 2008 updated by: Federal University of São Paulo

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

140

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anterior chamber cell
Time Frame: Days 1, 3, 7, 14, and 28 after surgery
Days 1, 3, 7, 14, and 28 after surgery
Anterior chamber flare
Time Frame: Days 1, 3, 7, 14, and 28 after surgery
Days 1, 3, 7, 14, and 28 after surgery
Intraocular pressure
Time Frame: Days 1, 3, 7, 14, and 28 after surgery
Days 1, 3, 7, 14, and 28 after surgery
Lack of anti-inflammatory response
Time Frame: Days 1, 3, 7, 14, and 28 after surgery
Days 1, 3, 7, 14, and 28 after surgery
Presence of infection
Time Frame: Days 1, 3, 7, 14, and 28 after surgery
Days 1, 3, 7, 14, and 28 after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Conjunctival hyperemia
Time Frame: Days 1, 3, 7, 14, and 28 after surgery
Days 1, 3, 7, 14, and 28 after surgery
Spectacle corrected visual acuity
Time Frame: Day 28 after surgery
Day 28 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Fernando Paganelli, MD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Estimate)

March 7, 2008

Last Update Submitted That Met QC Criteria

March 6, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Duocat 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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