Bacterial Infections, Inflammation
Conditions
Keywords
Cataract, Endophthalmitis, Antibiotics, Anti-Inflammatory Agents, Drug Delivery Systems
Brief 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.
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
2 mg ciprofloxacin + 25mg triamcinolone
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anterior chamber flare | 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 |
| Anterior chamber cell | Days 1, 3, 7, 14, and 28 after surgery |
| Intraocular pressure | Days 1, 3, 7, 14, and 28 after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Spectacle corrected visual acuity | Day 28 after surgery |
| Conjunctival hyperemia | Days 1, 3, 7, 14, and 28 after surgery |
Countries
Brazil