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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: January 2008

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.

Interventions

  • Device: slow delivery ciprofloxacin + triamcinolone
    • 2 mg ciprofloxacin + 25mg triamcinolone

Arms, Groups and Cohorts

  • No Intervention: colirio
    • prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops

Clinical Trial Outcome Measures

Primary Measures

  • Anterior chamber cell
    • Time Frame: Days 1, 3, 7, 14, and 28 after surgery
  • Anterior chamber flare
    • Time Frame: Days 1, 3, 7, 14, and 28 after surgery
  • Intraocular pressure
    • Time Frame: 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
  • Presence of infection
    • Time Frame: Days 1, 3, 7, 14, and 28 after surgery

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Provider of Information About this Clinical Study
    • fernando paganelli, federal university of sao paulo
  • Overall Official(s)
    • Fernando Paganelli, MD, Principal Investigator, Federal University of Sao Paulo

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