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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
2 mg ciprofloxacin + 25mg triamcinolone
Department of Ophthalmology, Federal University of Sao Paulo
São Paulo, São Paulo, Brazil
Anterior chamber cell
Time frame: Days 1, 3, 7, 14, and 28 after surgery
Anterior chamber flare
Time frame: Days 1, 3, 7, 14, and 28 after surgery
Intraocular pressure
Time frame: Days 1, 3, 7, 14, and 28 after surgery
Lack of anti-inflammatory response
Time frame: Days 1, 3, 7, 14, and 28 after surgery
Presence of infection
Time frame: Days 1, 3, 7, 14, and 28 after surgery
Conjunctival hyperemia
Time frame: Days 1, 3, 7, 14, and 28 after surgery
Spectacle corrected visual acuity
Time frame: Day 28 after surgery
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