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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00431028
• Other study ID #: Duocat 001
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 1, 2007
• Last updated: March 6, 2008
• Start date: September 2005
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Cataract
• Inflammation

Intervention

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

Locations

Country	Name	City	State
Brazil	Department of Ophthalmology, Federal University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior chamber cell		Days 1, 3, 7, 14, and 28 after surgery	No
Primary	Anterior chamber flare		Days 1, 3, 7, 14, and 28 after surgery	No
Primary	Intraocular pressure		Days 1, 3, 7, 14, and 28 after surgery	Yes
Primary	Lack of anti-inflammatory response		Days 1, 3, 7, 14, and 28 after surgery	Yes
Primary	Presence of infection		Days 1, 3, 7, 14, and 28 after surgery	Yes
Secondary	Conjunctival hyperemia		Days 1, 3, 7, 14, and 28 after surgery	No
Secondary	Spectacle corrected visual acuity		Day 28 after surgery	No