Glistening-Free Hydrophobic Acrylic IOL. Glistening-Free Hydrophobic Acrylic IOL

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Transcription:

Glistening-Free Hydrophobic Acrylic IOL

Proprietary Polymer Composition Packaged Dry UD Aspheric Optic Optimized Refractive Index All SquareTM Enhanced Edge Largest Diopter Range -05.00D to 42.00D Modified C and Plate Haptic Models

The Most Advanced Polymeric Material for IOL Applications Packaged Dry Conventional hydrophobic acrylic IOLs develop various levels of glistening post-implantation due to uncontrolled water sorption into IOL polymers. The first generation hybrid polymers have demonstrated a more controlled water uptake and much improved resistance to glistenings formation. However, IOLs made from these materials have poor mechanical properties and require pre-hydration and storage in saline. Enova is the first glistening-free hydrophobic acrylic IOL that does not require pre-hydration and storage in saline solution. Enova is packaged dry and has excellent optical and mechanical properties for micro incision cataract surgery. Excellent Biomechanical Properties Enova has a unique combination of biomechanical properties making it the perfect choice for micro-incision surgery. An extremely low glass transition temperature (Tg) of -2 C coupled with an optimized modulus of elasticity convey a high level of flexibility and controlled unfolding. An Optimized Refractive Index The refractive index of the Enova material was optimized to produce thinner lenses for smaller incision without the undesirable effects of glare and reflectance observed in IOLs with a higher index of refraction. A Higher Abbe Number for less visible light dispersion Enova has a high Abbe Number value which provides less light dispersion in the visible region and enhance light transmission. Property Refractive Index Abbe Number Tg ( C) Glistenings Packaging Silicone Oil Adhesion ENOVA 1.53 43.0-2.0 No Dry 15% Company A 1.55 37.5 12.0 Yes Dry 35% Company B 1.52 42.7 15.0 Yes Dry 45% Company C 1.54 40.0 22.0 No In saline 31%

Glistening-Free Vision The unique composition of Enova s material shows complete absence of glistenings even under extreme conditions. Glistenings Formation in IOL Water molecules bind to some chemical groups through weak hydrogen bonds. With time, more water molecules diffuse into the polymer network and bind preferably to other water molecules forming clusters - Glistenings ENOVA Glistenings-Free IOL Specific sites for uniform hydration. Eliminate preferential water molecule binding Glistenings-Free Hydrophobic Acrylic IOL What are glistenings? Glistenings are known as fluid-filled micro-vacuoles that are formed within the intraocular lens optic when the IOL is in an aqueous environment. They cause light scattering and may affect the quality of vision by reducing contrast sensitivity and induce undesirable optical artifacts. GLISTENING-FREE Long-Term Clarity and Stability Excellent Elasticity and Mechanical Properties The glass transition temperature (Tg) of a polymer is the temperature above which the polymer becomes soft and pliable. With a Tg of -2 0C, Enova IOL is easily foldable at temperatures well below operating room temperatures and unfolds gently and rapidly. As such, no warming or special conditioning is required.

Cutting Edge Design Aspheric Optic for better contrast sensitivity Largest Diopter Range available on the market The Enova IOL has an aspheric surface with a total residual asphericity of -0.10 µm. This design allows for a balanced control of the spherical aberrations of both the cornea and the actual IOL. This design provides improved contrast sensitivity. With a range of -5.0D to 42.0D (with 0.5D increments) Enova offers the widest available diopter range on the market. All Square Enhanced Edge for lower PCO rate Advanced Haptic Design for better capsular bag stability The Enova IOL is designed with a 3600 enhanced square edge for the prevention of Posterior Capsule Opacification. Extensive compression simulation studies have demonstrated that the haptic design of Enova IOL delivers excellent stability and centration in the capsular bag. Capsular Bag Compression Simulation 13 mm 11 mm 10 mm

GF 1 GF 3 PGF 1 PGF 3 Material Hydrophobic acrylic Material Hydrophobic acrylic Material Hydrophobic acrylic Material Hydrophobic acrylic Optic Size 6.00mm Optic Size 6.00mm Optic Size 6.00mm Optic Size 6.00mm Optic Design Biconvex Aspheric Optic Design Biconvex Aspheric Optic Design Biconvex Aspheric Optic Design Biconvex Aspheric Haptic Size 13.00mm Haptic Size 11.00mm Haptic Size 13.00mm Haptic Size 11.00mm Haptic Design Modified C Haptic Design Plate Haptic Haptic Design Modified C Haptic Design Plate Haptic Haptic Angle 0 Haptic Angle 0 Haptic Angle 0 Haptic Angle 0 Recommended Ac. A Constant 118.0 Recommended Ac. A Constant 118.0 Recommended Ac. A Constant 118.0 Recommended Ac. A Constant 118.0 Recommended Op. A Constant Srk-T: 118.4 - SRK-II: 118.7 Recommended Op. A Constant Srk-T: 118.4 - SRK-II: 118.7 Recommended Op. A Constant Srk-T: 118.4 - SRK-II: 118.7 Recommended Op. A Constant Srk-T: 118.4 - SRK-II: 118.7 Diopter Power Range From -5.00D to +42.00D (0.50D increments) Diopter Power Range From -5.00D to +42.00D (0.50D increments) Diopter Power Range From -5.00D to +42.00D (0.50D increments) Diopter Power Range From -5.00D to +42.00D (0.50D increments) TgC -2.4 C TgC -2.4 C TgC -2.4 C TgC -2.4 C Photoprotection UV Filtration Photoprotection UV Filtration Photoprotection UV Filtration Photoprotection UV Filtration Refractive Index Dry 20 C /35 C 1.531 / 1.533 ± 0.002 Refractive Index Dry 20 C /35 C 1.531 / 1.533 ± 0.002 Refractive Index Dry 20 C /35 C 1.531 / 1.533 ± 0.002 Refractive Index Dry 20 C /35 C 1.531 / 1.533 ± 0.002 Recommended Injector & Cartridge System Acrijet Recommended Injector & Cartridge System Acrijet

History of Foldable Acrylic IOLs Hydrophobic IOLs Hydrophilic IOLs Glistening-Free Hydrophobic IOL in saline Glistening-Free Micro-incision Hydrophobic IOL in dry package The Story of Enova Glistenings were first reported in the early 1990's and have been extensively researched since then. The ophthalmic industry has devoted considerable efforts to develop IOL polymers which do not exhibit glistenings. The first glistening-free HA IOL was developed in 2003 and received FDA and worldwide approvals. Although these lenses are performing well worldwide, they have major handling and incision size limitations. Intense efforts were dedicated to develop a HA IOL that solves all of these problems while preserving their glistening-free quality. Over the past few years, our team of international engineers have strived to develop the most advanced HA IOL technology available to date. The efforts culminated with the introduction of Enova HA IOL, the first and only glistening-free HA IOL designed for micro-incision and packaged dry.

VSY Biotechnology BV Strawinskylaan 1143, 1077 XX Amsterdam - The Netherlands T: +31(0)20 782 00 01 F: +31(0)20 782 00 02 info@vsybiotechnology.com www.vsybiotechnology.com 2015 VSY Biotechnology BV 06/15 MKT Rev-03