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

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עדשות חניתהHanita Lenses9 of 21Methods:The study is a prospective, open, non-randomized, multi-center study.Sample size: a multi-center study of 129 patients, who meet the inclusion / exclusion criteria for thestudy protocol across 5 centers.Protocol of the study attached as Annex A.The study was carried out starting from December 2008.The Investigative sites were:12345SiteProf. M. TetzATK Spreebogen,Berlin, GermanyDr. V. BarsodevskyNaharia Medical center,Naharia, IsraelDr. Y. TonMeir Medical center,Kfar Saba, IsraelDr. T. LiphshitzSoroka Medical center,Beer-Sheeba, IsraelDr. J. NovakRegional HospitalPradubice,Czech republicNumber ofimplanted eyesNumber of eyes3 months follow up20 1830 2831 31*20 1828 27Total 129 122* Follow up of 2 patients was performed 2 months post-operative instead of 3 months.Patients Enrollment period: up to 9 month.Clinical evaluation of aspheric optics feature was performed by Prof. M. Tetz, ATK Spreebogen, Berlin,Germany. 15 patients were included in the evaluation.Statistical MethodsThe following analyses were used to describe the data in this report:1. Descriptive statistics: continuous variables are described with mean ± standard deviation(SD), median, minimum and maximum. Nominal scale variables are described withabsolute and relative (percents) frequencies. Ordinal variables are described with means ±SD and frequencies of the ordinal grades.2. Comparisons between pre and post operative variables were done with paired-samples t-test. The critical level of significance is α=0.05.3. All analyses were done using Excel 2007 statistics tool package.Hanita Lenses Intraocular & Contact Lenseעדשות 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 •
עדשות חניתהHanita Lenses11 of 21Results:a. IOL performance during implantationImplantation parameters were measured to indicate the performance of the SeeLens AF IOLimplantation during the standard cataract surgery. The implantation parameters that weremeasured during the implantation were SeeLens AF handling, folding, implantation,unfolding, need to manipulate the lens and the final centration and tilt of the lens position atthe end of the procedure.All parameters were graded on a 0 (best) to 4 (worst) scale.See Annex A for more details.The results are presented in Graph 1Graph 1: IOL performance during implantation (implantation parameters):As can be seen in graph 1, all surgeons reported that the SeeLens AF handling, folding andinjection are easy and smooth. IOL unfolded gently and no difficulties in IOL positioning andcentration were reported.Experienced intra-operative complications are listed in section F.Hanita Lenses Intraocular & Contact Lenseעדשות 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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Clinical Evaluation 3-month Follow-up Report SeeLens AF Intraocular Lens

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