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

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Page 1 of 11Ver. 1Table of Contents1 OBJECTIVES ..................................................................................................................... 22 EFFICACY AND SAFETY ASSESSMENTS ................................................................. 23 MEDICAL DEVICE SPECIFICATION AND ADMINISTRATION .......................... 23.1 SPECIFICATIONS............................................................................................................ 23.1.1 Device description .................................................................................................... 23.1.2 SeeLens HP design ................................................................................................... 43.1.3 Surgical Procedure ................................................................................................... 64 METHODS .......................................................................................................................... 74.1 SAMPLE SIZE ................................................................................................................. 74.2 STATISTICAL METHODS ................................................................................................ 75 RESULTS ............................................................................................................................ 85.1 POST-OPERATIVE UNCORRECTED VISUAL ACUITY (UCVA)........................................ 85.2 POST-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA).................................... 85.3 REFRACTION PREDICTABILITY ...................................................................................... 95.4 IOL PERFORMANCE .................................................................................................... 105.5 ADVERSE EVENTS AS DEFINED BY ISO 11979-7 2001 ................................................ 106 CONCLUSIONS ............................................................................................................... 117 APPROVALS .................................................................................................................... 11Hanita 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 2 of 11Ver. 11 ObjectivesThe objective of this study is to evaluate the safety and efficacy of the SeeLens HP IOL,implanted following cataract removal by phacoemulsification.a. The key efficacy parameters are:- Best Corrected Visual Acuity (BCVA)- Predictability of refraction.b. The key safety parameters include:- IOL performance during implantation and follow-up.- IOL related infection and/or inflammatory reactions.2 Efficacy 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).2. IOL related Post Operative complication and Adverse Events equal to or less then theallowed rate defined by ISO 11979-7 2001.3. Refraction deviations criteria were established according to literature. The standard foraccuracy for normal eyes was addressed in study "Benchmark standards for refractiveoutcomes after NHS cataract surgery." The authors concluded that the "benchmark"standard for refractive outcomes for normal eyes after cataract surgery should be within±0.50 D for 55% of cases and within ±1.00 D for 85% of cases (Gale RP, Saldana M,Johnston RL, Zuberbuhler B, McKibbin M. Benchmark standards for refractive outcomesafter NHS cataract surgery. Published on-line in Eye, 24 August 2007)3 Medical Device Specification and Administration3.1 Specifications3.1.1 Device descriptionSeeLens HP is a single-piece hydrophobic acrylic, aspheric, posterior chamber intraocularlens. The SeeLens HP is CE marked since 2009 and being sold in many countriesworldwide. SeeLens HP is an important member in the SeeLens family which is knownfor its leading design, safety, stability and vision predictability.The SeeLens HP is made of hydrophobic acrylic material, which is known to be superiorin postponing the posterior capsular opacification (PCO).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 •
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Clinical Evaluation 1 to 3 months Follow Up Report SeeLens HP Intraocular Lens

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