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
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Department of Ophthalmology, Federal University of Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
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 |
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