09.08.2015 Views

Clinical Evaluation 3-month Follow-up Report SeeLens AF Intraocular Lens

SeeLens AF - Hanita Lenses

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עדשות חניתהHanita <strong>Lens</strong>es18 of 21i. <strong>Clinical</strong> <strong>Evaluation</strong> of Aspheric OpticsA clinical evaluation of aspheric optics feature was done using functional vision p<strong>up</strong>il. Thisevaluation is more practical than one calculated for 6 mm p<strong>up</strong>il opening described in section"Medical Device Specification and Administration", section 2.d of this report. <strong>Clinical</strong>evaluation of aspheric optics feature was performed by Prof. M. Tetz, ATK Spreebogen,Berlin, Germany. 15 patients were included in 3 <strong>month</strong>s post operative evaluation and 11patients in 6 <strong>month</strong>s post operative evaluation.The functional evaluation of SA was performed in a gro<strong>up</strong> of 15 patients using same lightconditions, 3 <strong>month</strong>s post operatively. Measured p<strong>up</strong>il size ranged from 2.7 to 4.5 withaverage of 3.51. The results are presented below. Total SA (measured using WASCA aberrometer minus): -0.01µm Average Corneal SA (measured using Pentacam): +0.26µmFunctional IOL asphericity (in the functional p<strong>up</strong>il size) was estimated to be: -0.27µm.<strong>Clinical</strong> results of <strong>See<strong>Lens</strong></strong> <strong>AF</strong> Contrast Sensitivity performance are presented in Graphs 6-7.Graphs 6-7: Contrast Sensitivity 3 and 6 <strong>month</strong>s Post OperativelyPelli-Robson Contrast sensitivity distribution between 15 patients 3 <strong>month</strong>s post operativelyis presented in graph 8.Hanita <strong>Lens</strong>es <strong>Intraocular</strong> & Contact <strong>Lens</strong>eעדשות חניתהעדשות מגע ועדשות השתלה תוך-עינית•קיבוץ חניתה • 88222 www.hanitalenses.com Kibbutz Hanita 22885 Israel • Tel. 972-4-9950 700• Fax: 972-4-9950 755 •

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