Clinical Evaluation 1 to 3 months Follow Up Report SeeLens HP Intraocular Lens

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Page 9 of 11Ver. 1Graph 2: Post-operative BCVA distributionAs shown in graph 2, 1-3 months postoperative BCVA of 6/9 or better was reported in 81% ofall eyes. Excluding eyes with ocular diseases (not IOL related) 100% of the eyes werereported of 6/9 or better with average BCVA of 0.88(6/6.8) ±0.15.In summary, average BCVA of all eyes was 0.77(6/7.8) ±0.29.5.3 Refraction PredictabilityRefraction data of 21 eyes was reported in order to evaluate the predictability of postoperative refraction using the SeeLens HP IOL. Subtracting the target refraction from thepostoperative refraction results the dSE (delta Spherical Equivalent) which is the mainparameter considering refraction predictability of an IOL.The dSE results are presented on Graph 3.Hanita Lenses Intraocular & Contact Lensesעדשות 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 •
Page 10 of 11Ver. 1Graph 3: Refraction predictability (dSE)As can be seen in graph 3, 100% of the eyes implanted by Dr. Yatziv were found with dSEless than 0.5D. 100% of the eyes implanted by Prof. Assia were found with dSE less than 1D.Table 1 summaries the dSE results:dSE valueDr. Yatziv 0.08±0.28Prof. Assia -0.24±0.68Total -0.08±0.535.4 IOL PerformanceAll implantations were reported successful as the lens handling, folding and implantationwere easy and smooth.Dr. Yatziv reported of a few IOLs with glistening found one week post op, which was foundstable in the later follow ups, with no effect on visual acuity. Prof. Assia had also reported oftwo IOLs with glistening two months post op, again with no effect on the visual acuity.5.5 Adverse Events as defined by ISO 11979-7 2001No adverse events were reported by the surgeons. Thus, it can be concluded that the SeeLensHP safety is fully in accordance to the ISO 11979-7 2001Hanita Lenses Intraocular & Contact Lensesעדשות 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 1 to 3 months Follow Up Report SeeLens HP Intraocular Lens

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