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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inflammation Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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colirio

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

Group Type NO_INTERVENTION

slow delivery ciprofloxacin + triamcinolone

Intervention Type DEVICE

2 mg ciprofloxacin + 25mg triamcinolone

Interventions

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slow delivery ciprofloxacin + triamcinolone

2 mg ciprofloxacin + 25mg triamcinolone

Intervention Type DEVICE

Other Intervention Names

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ciprofloxacin triamcinolona

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No