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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Inflammation, Bacterial Infections

Intervention / Treatment
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* Device: slow delivery ciprofloxacin + triamcinolone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: colirio<br>prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops | Device: slow delivery ciprofloxacin + triamcinolone<br>* 2 mg ciprofloxacin + 25mg triamcinolone<br>* Other names: triamcinolona;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Endophthalmitis, Antibiotics, Anti-Inflammatory Agents, Drug Delivery Systems