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

Phase 1

Terminated

• Conditions: Inflammation; Bacterial Infections
• Interventions: Device: slow delivery ciprofloxacin + triamcinolone

• Registration Number: NCT00431028
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2007-02-01
• Study First Submitted QC: 2007-02-01
• Study First Posted: 2007-02-02
• Primary Completion: 2008-01
• Status Verified: 2008-03
• Study Completion: 2008-03
• Last Update Submitted: 2008-03-06
• Last Update Posted: 2008-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
colirio	slow delivery ciprofloxacin + triamcinolone	prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Conjunctival hyperemia	Days 1, 3, 7, 14, and 28 after surgery
Spectacle corrected visual acuity	Day 28 after surgery

Trial Locations

Locations (1)

Department of Ophthalmology, Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil