glistening-free hydrophobic acrylic iol · 0˚ recommended ac. a constant 118.0 recommended op. a...

Glistening-free Hydrophobic Acrylic IOL





Wide Diopter Range (0.00–32.00 D with 0.50 D increments)

360° All Enhanced Square Edge

Proprietary Polymer Composition

Optimized Refractive Index

Packaged Dry

UD Aspheric Optic

Modified C and Plate Haptic Models

The Most Advanced Polymeric Material for IOL Applications

Packaged Dry

Conventional hydrophobic acrylic IOLs develop various levels of glisten post-implantation due to uncontrolled water sorption into the IOL polymers. The first-generation hybrid polymers demonstrate a more controlled water uptake and significantly improved resistance to glistening formation. However, IOLs made from such materials have poor mechanical properties and require both pre-hydration and storage in saline. Enova is the first glistening-free hydrophobic acrylic IOL that requires neither pre-hydration nor storage in saline. 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 that make it the perfect choice for micro-incision surgery; its extremely low glass transition temperature (Tg) of -2°C coupled with its optimised modulus of elasticity provide 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 incisions without the undesirable effects of glare and reflectance as 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 enhanced light transmission.

Property

IOL A

ENOVA

IOL B

IOL C

Refractive Index Abbe Number Tg (˚C) Glistening

Yes

Yes

No

No

Packaging Silicone Oil Adhesion

Dry

Dry

In saline

Dry

37.5

42.7

40.0

43.0

12.0

15.0

22.0

-2.0

1.55

1.52

1.54

1.53

35%

45%

31%

15%


Glistening-free Vision

The unique composition of Enova’s material shows the complete absence of glistening even under extreme conditions.

GLISTENING-FREELong-Term Clarity and Stability

What are glistenings?

Glistenings are fluid-filled micro-vacuoles that form 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 the contrast sensitivity and inducing undesirable optical artefacts.

Excellent Elasticity and Mechanical Properties

The glass transition temperature (Tg) of a polymer is the temperature above which it becomes soft and pliable. Having a Tg of -2°C means that Enova IOL is easily foldable at temperatures well below standard operating room temperatures and unfolds gently and rapidly. Thus, no warming or special conditioning is required.

Glistenings Formation in IOLWater molecules bind to certain chemical groups through weak hydrogen bonds.Over time, more water molecules diffuse into the polymer network and bind preferably to other water molecules, which forms clusters referred to as “glistenings”

ENOVA Glistening-free IOLSpecific sites for uniform hydration; eliminate preferential water molecule binding.



Cutting Edge Design

Aspheric Optic for Better Contrast Sensitivity

The Enova IOL has an aspheric surface with a total residual asphericity of -0.10 μm; this design allows for the balanced control of the spherical aberrations of both the cornea and the actual IOL and provides improved contrast sensitivity.

360° All Enhanced Square Edge for a Lower PCO Rate

The Enova IOL is designed with a 360° All enhanced square edge for the prevention of Posterior Capsule Opacification.

Wide Diopter Range

Enova offers wide diopter range between 0.00–32.00 D (with 0.5 D increments)

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.


GF 1

Material Hydrophobic acrylic

Optic Size 6.00mm

Optic DesignBiconvex Aspheric

Haptic Size11.00mm

Haptic DesignPlate Haptic

Haptic Angle0˚

Recommended Ac. A Constant118.0

Recommended Op. A ConstantSrk-T: 118.4 - SRK-II: 118.7

Diopter Power RangeFrom -5.00D to +42.00D (0.50D increments)

Tg-2.4 °C

PhotoprotectionUV Filtration

Refractive Index Dry20°C /35°C 1.531 / 1.533 ± 0.002

Recommended Injector & Cartridge SystemAcrijet


Optic Size 6.00mm


Haptic Size13.00mm

Haptic DesignModified C

Haptic Angle0˚




Tg-2.4 °C



Recommended Injector & Cartridge SystemAcrijet

GF 3


Technical Features

PGF 1


PGF-1 HYDROPHOBIC PRE-LOADED IOL

1

3

4 5

2

INSTRUCTIONS FOR USE

The injector should be carefully removed from the blister.

A

As shown, part “A” is removed by pulling it upwards (in the direction of the arrow).

BSS is injected from the rear part of the cartridge until BSS drops off of the tip of the cartridge.

B

Part B should be rotated in the direction of the arrow until a “click” sound is heard to ensure that it is locked.

Push the plunger forward (in the direction of the arrow) to advance the lens for implantation.

C


Optic Size 6.00mm


Haptic Size11.00mm

Haptic DesignPlate Haptic

Haptic Angle0˚




Tg-2.4 °C



2018

VSY

Bio

tech

nolo

gy B

V R

ev-0

5


VSY Biotechnology BV Strawinskylaan 1143, 1077 XX Amsterdam, The Netherlands T: +31(0) 62 147 38 46 [email protected]

IOL

VISCOELASTICSCARTRIDGE

&INJECTOR

glistening-free hydrophobic acrylic iol · 0˚ recommended ac. a constant 118.0 recommended op. a...

Documents