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

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עדשות חניתהHanita Lenses1 of 21Table of Contents:Objectives 2Medical device specification and administration 4Methods 9Results 10a. IOL performance during implantation 10b. IOL position: Centration and Tilt 11c. Post-operative Best Corrected Visual Acuity 11d. Intraocular Pressure Changes 13e. Intra-operative complications 15f. Postoperative Complications 15g. Adverse Events 17h. Clinical evaluation of aspheric optics 18Conclusions 20Signature page 21Hanita 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 Lenses2 of 21Objectives:The objective of this study is to evaluate the safety and efficacy of the SeeLens AF IOL, implantedfollowing cataract removal by phacoemulsification.1. The key efficacy parameters are:- Best Corrected Visual Acuity (BCVA)2. The key safety parameters include:- IOL behavior during implantation and follow-up- IOL related infection and/or inflammatory reactionsEfficacy and Safety AssessmentsThe efficacy and safety assessments were determined as defined by and according to the ISO11979 directive. The following are the demands required by the directive:1. Post Operative BCVA of at least 6/12 (20/40) within 88% of patients' population. For the"best cases" patients, BCVA 6/12 (20/40) or better, for at least 94% of the patients.(Requirements defined by ISO 11979-7 2001 for a sample size of 100 patients).2. IOL related Post Operative complication and Adverse Events equal to or less then theallowed rate defined by ISO 11979-7 2001.3. High order aberrations / Spherical aberrations were evaluated in one medicalcenter (BEAR Institute, Berlin). Total aberrations should be statisticallysignificant lower then reported literature data for spheric lenses.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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