A Single Intraoperative Sub–Tenon’s Capsule Triamcinolone Acetonide and Ciprofloxacin in a Biodegradable Micro–Particule Controlled Release System (Duo–Cat®) Injection for Cataract Surgery. A Minimally Invasive Drop less Cataract Surgical Technique

Abstract

Abstract: : Purpose: To compare the potential of a single intraoperative sub–Tenon’s capsule Duo–Cat^® (25mg triamcinolone acetonide and 1.5mg ciprofloxacin a biodegradable micro–particule controlled release system) injection with dexamethasone–ciprofloxacin drops in the treatment of ocular inflammation after cataract surgery. Methods: A randomized, double–masked controlled trial. A total of 50 patients were prospectively randomized into two groups: 25 patients treated with dexamethasone–ciprofloxacin eye drops (control group A) and 25 patients treated with sub–Tenon’s capsule Duo–Cat^® injection (treatment group B).All patients underwent phacoemulsification and intraocular posterior lens implantation. After surgery, patients were randomized to receive either (B) a Duo–Cat^® sub–Tenon’s injection, (A) dexamethasone–ciprofloxacin drops self–instilled into the treated eye, 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) or (B) one vehicle administered to the eye on a similar schedule, and group A received an intraoperative sub–Tenon’s capsule injection of a 1 ml balanced salt solution. The main outcome measures included inflammation (cell, flare, ciliary flush), intraocular pressure and lack of response. Results: Duo–Cat^® was shown to have anti–inflammatory efficacy clinically equivalent to conventional dexamethasone–ciprofloxacin eye drops in reducing intraocular inflammation, as measured by clinical methods. Duo–Cat^® was found to be as safe as the dexamethasone–ciprofloxacin drops in terms of adverse effects, changes in visual acuity, intraocular pressure, and biomicroscopic and ophthalmoscopic variables. Conclusions: A single intraoperative Duo–Cat^® sub–Tenon’s capsule injection demonstrated a clinically equivalent therapeutic response and ocular tolerance to dexamethasone–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 • corticosteroids • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled