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

Federal University of São Paulo

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Inflammation; Bacterial Infections

Treatments: Device: slow delivery ciprofloxacin + triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00431028

Duocat 001

Details and patient eligibility

About

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 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.

Enrollment: 140 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 1 patient group

colirio

No Intervention group

Description:

prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops

Treatment:

Device: slow delivery ciprofloxacin + triamcinolone