Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System 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.
|Condition or Disease||Intervention/Treatment||Phase|
||Phase 1/Phase 2|
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.
Arms and Interventions
|No Intervention: colirio
prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops
Device: slow delivery ciprofloxacin + triamcinolone
2 mg ciprofloxacin + 25mg triamcinolone
Primary Outcome Measures
- Anterior chamber cell [Days 1, 3, 7, 14, and 28 after surgery]
- Anterior chamber flare [Days 1, 3, 7, 14, and 28 after surgery]
- Intraocular pressure [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]
Secondary Outcome Measures
- Conjunctival hyperemia [Days 1, 3, 7, 14, and 28 after surgery]
- Spectacle corrected visual acuity [Day 28 after surgery]
Patients with uncomplicated, senile cataract
Best-corrected visual acuity (VA) of 20/100 or better in the fellow eye
Patients in use of oral or topical anti-inflammatory agents
History of steroid-induced ocular hypertension
Previous ocular surgery
Contacts and Locations
|1||Department of Ophthalmology, Federal University of Sao Paulo||Sao Paulo||Brazil||04023-062|
Sponsors and Collaborators
- Federal University of São Paulo
- Principal Investigator: Fernando Paganelli, MD, Federal University of Sao Paulo
Study Documents (Full-Text)None provided.
- Duocat 001