Abstract
Purpose: :
To compare the potential of a single intraoperative sub–Tenon’s capsule DuoCat (25mg triamcinolone acetonide and 2,0mg ciprofloxacin in a biodegradable micro–particule controlled release system) injection with prednisolone and ciprofloxacin drops for the treatment of ocular inflammation and as a prophylactic infection strategy after cataract surgery
Methods: :
A randomized, double–masked controlled trial. A total of 140 patients that underwent phacoemulsification and intraocular posterior lens implantation were randomized prospectively into 2 groups: 70 patients treated with prednisolone eye drops according to the following schedule: 1 drop 4 times daily (week 1), 3 times daily (week 2), 2 times daily (week 3), once daily (week 4) and ciprofloxacin 4 times daily (week 1) (control group A) and 70 patients treated with single intraoperative sub–Tenon’s capsule DuoCat injection (treatment group B). To mask the study, group B received vehicle drops administered on a similar schedule, and group A received a similar injection of the polimer containing no drug. The main outcome measures included inflammation (cell, flare, ciliary flush), intraocular pressure, lack of response and infection
Results: :
DuoCat was shown to have anti–inflammatory efficacy clinically equivalent to conventional prednisolone and ciprofloxacin eye drops in reducing intraocular inflammation, as measured by clinical methods. DuoCat was found to be as safe as the prednisolone and ciprofloxacin drops in terms of adverse effects, changes in visual acuity, intraocular pressure, prevention of internal eye infection and biomicroscopic and ophthalmoscopic variables
Conclusions: :
A single intraoperative DuoCat sub–Tenon’s capsule injection demonstrated a clinically equivalent therapeutic response and ocular tolerance to prednisolone and ciprofloxacin drops in controlling postoperative inflammation following uncomplicated cataract surgery. This new approach may anticipate the reality of no need for postoperative medication in the modern cataract surgery era and merits further evaluation
Keywords: cataract • pharmacology • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials