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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Anterior chamber cell
  • Time Frame: Days 1, 3, 7, 14, and 28 after surgery
    Safety Issue?: No
• Anterior chamber flare
  • Time Frame: Days 1, 3, 7, 14, and 28 after surgery
    Safety Issue?: No
• Intraocular pressure
  • Time Frame: Days 1, 3, 7, 14, and 28 after surgery
    Safety Issue?: Yes
• Lack of anti-inflammatory response
  • Time Frame: Days 1, 3, 7, 14, and 28 after surgery
    Safety Issue?: Yes
• Presence of infection
  • Time Frame: Days 1, 3, 7, 14, and 28 after surgery
    Safety Issue?: Yes

Secondary Measures

• Conjunctival hyperemia
  • Time Frame: Days 1, 3, 7, 14, and 28 after surgery
    Safety Issue?: No
• Spectacle corrected visual acuity
  • Time Frame: Day 28 after surgery
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Federal University of São Paulo

Overall Clinical Trial Officials and Contacts

Fernando Paganelli, MD Principal Investigator Federal University of Sao Paulo  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00431028

Study ID Number: Duocat 001

ClinicalTrials.gov Identifier: NCT00431028

Health Authority: Brazil: National Committee of Ethics in Research