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

Primary Purpose

Inflammation, Bacterial Infections

Status

Terminated

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

slow delivery ciprofloxacin + triamcinolone

About this trial

This is an interventional treatment trial for Inflammation focused on measuring Cataract, Endophthalmitis, Antibiotics, Anti-Inflammatory Agents, Drug Delivery Systems

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Ophthalmology, Federal University of Sao Paulo

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

colirio

Arm Description

prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops

Outcomes

Primary Outcome Measures

Anterior chamber cell

Anterior chamber flare

Intraocular pressure

Lack of anti-inflammatory response

Presence of infection

Secondary Outcome Measures

Conjunctival hyperemia

Spectacle corrected visual acuity

Full Information

NCT ID

NCT00431028

First Posted

February 1, 2007

Last Updated

March 6, 2008

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT00431028

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Terminated

Why Stopped

Terminated

Study Start Date

September 2005 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, Bacterial Infections

Keywords

Cataract, Endophthalmitis, Antibiotics, Anti-Inflammatory Agents, Drug Delivery Systems

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

colirio

Arm Type

No Intervention

Arm Description

prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops

Intervention Type

Device

Intervention Name(s)

slow delivery ciprofloxacin + triamcinolone

Other Intervention Name(s)

ciprofloxacin, triamcinolona

Intervention Description

2 mg ciprofloxacin + 25mg triamcinolone

Primary Outcome Measure Information:

Title

Anterior chamber cell

Time Frame