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M. Weber, B. Vabres, C. Albouy, A. Oberic, H. Conrath, A. Pechereau, C. Tavera; Control of Inflammation With a Diclofenac Impregnated IOL Following Senile Cataract Surgery : Results of a Pilot Study . Invest. Ophthalmol. Vis. Sci. 2005;46(13):786.
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Purpose:To compare the control of inflammation after phacoemulsification with implantation of an intraocular lens (IOL) impregnated with diclofenac without any anti–inflammatory postoperative eye drop or implantation of normal IOL combined with postoperative treatment with diclofenac eye drop. Methods: This pilot, prospective, randomized, controlled open study, included 34 patients with senile cataract. The patients were randomly assigned to received diclofenac impregnated IOL (Group A) or control IOL and topical treatment with sodium diclofenac 0.1% (1 drop, 3 time daily for 4 weeks) (Group B). The inflammation in the anterior chamber (main criteria of efficacy) was measured with a laser flare meter (LFM Kowa 500) preoperatively and 1, 7, 21, 30 and 90 days postoperatively. Optical coherence tomography (OCT 3 Humphrey–Zeiss) was performed preoperatively and 30 days postoperatively to detect cystoid macular edema. Clinical signs of inflammation and tolerance and best–corrected visual acuity were also registered. Statistical data were analyzed with Student t test. Results: The main criteria of efficacy was analyzed on the flare evolution between the last available value (D21 minimum) and the baseline value. No statistical significant difference was evidenced between groups A and B (p=0.4653). Moreover, the difference of flare measurement between each evaluation time and baseline was always similar between groups (analysis of variance, p=0.8655). The variation (D30 – preoperative) of macular thickness evaluated by OCT was similar between groups (p=0.2128). Postoperative best–corrected visual acuity represented a gain of 4 to 5 lines in both groups when compared with preoperative value. Clinical signs of inflammation and tolerance (local symptoms, corneal edema, eyelid edema, conjunctival redness, SPK) were similarly distributed between groups (number and severity). Conclusions: In this pilot study, the diclofenac impregnated IOL was as efficient as the reference treatment (diclofenac 0.1% eye drops) in controlling post surgical inflammation with good safety. Advantages of such an approach are optimal observance of the NSAI and absence of eye drop medication after cataract surgery.
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