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V. Papa, S. Russo, A. Di Bella, C. Radulescu, O. Gafencu, B. Carstocea, G. Milazzo; A New Topical Antibiotic-cortisonic Combination Containing Netilmicin and Dexamethasone after Cataract Surgery . Invest. Ophthalmol. Vis. Sci. 2003;44(13):195.
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Purpose: To compare the efficacy and safety of a new fixed antibiotic-cortisonic combination containing 0.3% netilmicin and 0.1% dexamethasone (Net-Dex) with that of Tobradex (0.3% tobramycin and 0.1% dexamethasone) following cataract surgery. Methods: This was a randomized, double-masked, active-controlled, parallel-group, multicenter, non-inferiority study. After informed consent, 222 patients undergoing phacoemulsification and IOL implantation were randomly treated (2:1 ratio) with either topical Net-Dex or Tobradex. Treatment started the day of surgery with a single-dose administration and continued q.i.d. for 7 consecutive days. Post-surgical ocular inflammation was measured 1, 8 and 15 days after surgery by biomicroscopy using 0 to 3 categorical scales. The main criterion of efficacy response to treatment was the percentage of patients with absent or mild degree of anterior chamber flare at D8. In addition a patient was considered to have responded to treatment if flare at D8 decreased or remained absent in respect to D1 (baseline). The largest accepted difference between the two groups of treatmentwas 15% (non-inferiority margin). Safety and local tolerance were also evaluated. Results: The percentage of patients with absent or mild degree of anterior chamber flare at D8 in the Net-Dex group was comparable to that of patients treated with Tobradex (96% vs 100%, respectively, p= 0.17, Fisher's test). The percentage of responders in the two groups was also similar (79% vs 78%, p= 0.86, Fisher's test). Concerning safety analysis, both treatments had no remarkable effect on IOP and were well tolerated. No treatment-related adverse events were reported during the study. Conclusions: The overall results of this trial showed that a short-term (8 days) treatment with a topical antibiotic-cortisonic combination containing 0.3% netilmicin plus 0.1% dexamethasone is a suitable post-operative regimen following phacoemulsification. .
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