New design. New standard · New RayOne Hydrophobic 6 mm optic Ultra glistening-free. Ultra smooth...

RayOne Hydrophobic IOLNew design. New standard

MAD E IN U K

Setting new standards since 1949

When Sir Harold Ridley designed the world’s first IOL in 1949, he chose Rayner to manufacture this ground-breaking invention. Rayner has remained at the forefront of innovation for nearly 70 years, focused on providing you and your patients with the best IOLs – always driven by science to improve patient outcomes and safety.

Rayner is the only manufacturer of IOLs in the UK, with its state of the art manufacturing plant and global headquarters on the south coast of England.Supplementing Rayner’s family of IOL systems is a full spectrum of OVDs, the RayPRO patient outcomes app, as well as a range of tear film and pharmaceutical eye care products.

About Rayner

RayOne Hydrophobic was born out of a desire to deliver a better operating room experience for surgeons and better visual outcomes for patients, by challenging the current hydrophobic IOL solutions available to them.

Never a company to follow the crowd, when we developed the high performance RayOne platform, we set a new standard for fully preloaded injection systems with our 1.65 mm nozzle. We have now expanded the potential of this innovative technology with our first hydrophobic IOL made of Rayner’s brand new proprietary material.

RayOne Hydrophobic is designed to eliminate the compromises that surgeons have had to put up with – until now.

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Best of both worldsUsing our high performance hydrophilic RayOne system as a foundation, RayOne Hydrophobic has been designed so that surgeons can offer patients excellent visual outcomes whilst still being user friendly in the operating room.

Ultra glistening-free. Ultra smooth. Ultra stable

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bicPatient outcomes

• Glistening-free material

• Stable positioning

• Aspheric design

• Minimised PCO

• UV protection

Usability• Fully preloaded

• Minimal preparation steps

• Single handed operation

• Sub 2.2 mm incision

• No warming or waiting

• Full power range

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RayOne injector

For predictable and efficient delivery, every time

True 2-step system

• Simple and intuitive

i. Minimal learning curve

ii. Minimises error

• Increase efficiencies

i. Designed for repeatability

ii. Reduces operating time

• Step 1: Insert OVD into cartridge via port

• Step 2: Lock cartridge ready for implantation

Ease of use

• Single handed plunger

i. Minimal force required

• Ergonomic design

i. Ease of handling

Sub 2.2 mm incision

1.65 mm RayOne nozzle for sub 2.2 mm incision

• Smallest fully preloaded injector nozzle

i. Ease of insertion

ii. Enables true micro incision

• Parallel sided for minimal stretch

i. Sub 2.2 mm delivery

ii. Maintains incision architecture

1.65 mm

4.5 mm

450

Supplied in saline

• Special lubricious injector coating - activated when wet

i. Smooth lens delivery

ii. Repeatable performance

• Equilibrated state

i. Dimensionally stable

ii. Reduced chance of lens movement

Unique patented Lock & Roll technology for consistent delivery

• Rolls the lens to under half its size before injection

i. Consistent, smoother delivery

ii. Reduces insertion forces

• Fully enclosed cartridge with no lens handling

i. Reduces the risk of lens damage

ii. Minimises chance of contamination

Consistently locked and rolled to under half its size in one simple action

Lock & Roll technology

New RayOne Hydrophobic 6 mm optic

Ultra glistening-free. Ultra smooth

Full preloaded power range-10.0 D to +32.0 D power range means only one IOL solution is needed for all your monofocal patients.

Always ready to implantOur proprietary material is not dependent on the temperature within the operating theatre, so it arrives ready-to-use with no warming needed.

Improved performance and qualityAll hydrophobic acrylic IOLs absorb water once in situ within the eye, causing expansion in size. Our lens is supplied in 0.9% saline solution so that it is in an equilibrated state and dimensionally stable from manufacture to implantation - reducing the chance of undesirable post-implant lens movement.

Ultra smooth

Our patented Lock & Roll system rolls the lens inside the injector for a single smooth movement into the

eye, with minimal force needed.

Once in the eye, our hydrophobic lens unrolls smoothly at a natural

speed for efficient surgery time.

Suitable for all patients

Aberration-neutral technology for visual quality and acuity in all light conditions.

Ultra glistening-free

Designed to minimise PCO

An independent in-vitro study against four leading hydrophobic IOLs found Rayner’s lens to be glistening-free and equivalent or superior to the other lenses1.

Thanks to our Amon-Apple 360˚ Enhanced Square Edge and its natural bioadhesivity, our hydrophobic lens is designed to minimise the risk of PCO.

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Ultra stable

Our patented Cornerstone lens design ensures the IOL is perfectly balanced as it travels down the injector nozzle. Once in the eye, Rayner’s anti-vaulting haptics lock against the unique Cornerstone tabs for superb stability.

New Cornerstone technology

During lens delivery In the eye

As hydrophobic lenses are made of a naturally stiffer material than their hydrophilic counterparts, they are typically more difficult to compress and fold inside the injector.

If the IOL is not folded symmetrically then it can exit the injector nozzle unpredictably – for example, in the undesired ‘S’ position.

Combining the Cornerstone tabs with our anti-vaulting haptic technology creates superb stability once inside the capsular bag.

Our Cornerstone tabs balance the volume of material on both sides of the lens – resulting in:

1. Balanced weighting inside the injector

2. Controlled haptic orientation

3. Controlled speed of exit

How it works:

Our Lock & Roll system rolls the hydrophobic lens with improved symmetry, meaning that it travels down the injector nozzle in a more stable and predictable manner, with a controlled exit into a ‘Z’ orientation.

Outer haptics begin to take up the compression forces of post-operative capsule contraction

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Haptic tips gently meet the optic corners and are effectively locked into position

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Outer haptics engage the inner haptics

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Traditional lens design RayOne Hydrophobic

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Following an established protocol, RayOne Hydrophobic was tested against four commercially available hydrophobic IOLs. The chart below shows the test results of five IOLs of each model which were subjected to an in-vitro aging procedure designed to simulate clinical conditions over time, and evaluate the resultant level of glistenings in each IOL material. A score below one on the clinical Miyata scale will not produce any significant visible glistenings on a slit lamp examination and is considered ‘glistening-free’.

The independent study report concludes that our ultra glistening-free RayOne Hydrophobic is ‘absolutely equivalent or even superior’ to the best hydrophobic IOLs currently available on the market1.

R1: The Rayner RayOne Hydrophobic lens appears dark with average results of 1.96 ±3.69 MV/mm2 and a Miyata scale value of 0.

A1: The Alcon AcrySof IQ SN6OWF IOL clearly shows an increased number of glistenings, averaging 66.01 ±19.25 MV/mm2 with a Miyata scale value of 1.

R1 R2 R3 R4 R5 A1 A2 A3 A4 A5 T1 T2 T3 T4 T5 V1 V2 V3 V4 V5 L1 L2 L3 L4 L5

RayOne (Rayner) AcrySof IQ (Alcon) Tecnis (J&J) Vivinex (Hoya) Lucia (Zeiss)

0 0

20

40

60

80

100 2

1

120

140

160

0 0.61 1.23

31.29

96.32

0.61 0.23 1.23

42.94

38.65

0 07.36

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0 0.611.84

17.18

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9.21.84 1.84

27.6126.99

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All trademarks are property of their respective owners

The difference with RayOne Hydrophobic

Glistenings are fluid-filled microvacuoles that form within the matrix of the lens when exposed to an aqueous environment1. High levels of glistenings can create disturbances for patients, with the scattering of light impacting their contrast sensitivity and unnecessarily compromising their post-surgery satisfaction.

Independent comparative studyThe images below are from an independent study conducted at the University Hospital Heidelberg in Germany. They show the results after glistening induction at 14x magnification.

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Designed for a better experience than current hydrophobic IOLs

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Patient outcomes

Usability

RayOne HydrophobicUnwilling to accept the compromises inherent with many hydrophobic lenses, RayOne Hydrophobic is designed to provide patients with the visual outcomes they demand in a high performing preloaded system that supports surgeons in the operating room.

RayOne family

RayOne Hydrophobic is the newest member of the RayOne family of IOLs.

Based on the well-known, high performance Rayner platform that performs again and again.

Superb stability in the eye:

Unique lens design combines our Cornerstone shape with anti-vaulting haptics for stability from the nozzle and into the eye

Dimensionally stable

Optimised visual qualities:

Ultra glistening-free

Aspheric, aberration-neutral design

UV protection

Minimised risk of complications:

Sub 2.2 mm incision via 1.65 mm injector nozzle

Designed to minimise PCO due to Amon-Apple 360° Enhanced Square Edge

Easy to use and manage:

Fully preloaded, true 2-step injector system with patented Lock & Roll technology

Proprietary hydrophobic material with no warming or waiting required

Full range of powers -10.0 D to +32.0 D means only one monofocal solution for all your patients

©2019 Rayner. Regulatory restrictions may apply in certain markets.‘RayOne’, the RayOne device, ‘Cornerstone’ and ‘Lock & Roll’ are registered trademarks of Rayner Surgical Group Limited. EC 2018-146 01/19

To find out more about how we’re setting new standards for both surgeons and patients,

visit rayner.com/hydrophobic

For Contact Ultrasound, the estimated A-constant is 118.0

Please note that the constants indicated for all Rayner lenses are estimates and are for guidance purposes only. Surgeons must always expect to personalise their own constants based on initial patient outcomes, with further personalisation as the number of eyes increases.

Delivery System

Injector Type: Single use, fully preloaded IOL injection system

Incision Size: 1.65 mm nozzle for a sub 2.2 mm incision

Bevel Angle: 45°

Model Name: RayOne Hydrophobic Aspheric

Model Number: RA0800C

Power Range: -10.0 D to +7.0 D (1.0 D increments, inc. Plano)

+8.0 D to +30.0 D (0.5 D increments)

+31.0 D to +32.0 D (1.0 D increments)

Aspheric Monofocal IOL

Material: Single piece hydrophobic acrylic

UV Protection: UV absorption 10% cut-off is 385 nm

Refractive Index: 1.51

ABBE: 43

Water content: <3%

Diameter: Optic: 6 mm, Overall: 12.5 mm

Optic Shape: Biconvex (positive powers), Plano, concave (negative powers)

Asphericity: Posterior aspheric surface with aberration-neutral technology

Optic Edge Design: Amon-Apple 360° Enhanced Square Edge

Haptic Angulation: 0°, uniplanar

Haptic Style: Cornerstone lens design with anti-vaulting haptic (AVH) technology

Estimated Constants for Optical Biometry

SRK/T Haigis HofferQ Holladay

A-constant a0 a1 a2 pACD SF

118.6 1.17 0.40 0.10 5.32 1.56

1 Independent in-vitro study, IOL material purity report (University Hospital Heidelberg, Germany)

IOLs OVDs OSDRayPRO

RaynerYour Skill.Our Vision

RayOne Hydrophobic early clinical outcomes

Dr. Kevin Waltz, Dr. Gabriel Quesada and Dr. Marco Robles performed the World’s first RayOne Hydrophobic implantations in El Salvador, Central America, during August 2017

Extract from article in Cataract & Refractive Surgery Today Europe (Nov/Dec 2018 Edition)

Before this series of hydrophobic IOL implantations, all three of us had used the preloaded Rayner RayOne Aspheric hydrophilic IOL and injector to establish a comparative baseline and gain a feel for the system. The hydrophobic IOL and injector system’s performance was similar, if not identical, to that of the hydrophilic platform in terms of ease of insertion and refractive predictability.

A total of 50 eyes were implanted over the course of one week in El Salvador. Average patient age was 73 years. The cataracts we encountered, in general, were quite dense (20/200 or worse preoperative visual acuity), often with small pupils that created a challenging surgical environment. The RayOne Hydrophobic

IOL and injector platform performed well in this environment, achieving reliable insertion of the IOL into the capsular bag, even through small pupils.

The data [collected postoperatively] demonstrated predictable, stable refraction and visual acuity over the first three months after implantation. Four eyes were excluded from final data analysis due to macular pathology that was not identified preoperatively due to dense cataract.

The Cornerstone lens shape was developed to improve the consistency of the planar delivery of the IOL. It improves the stability of the IOL as it transits the injector cartridge, ensuring consistent delivery into the capsular bag.

The RayOne Hydrophobic was safe and reliable in this small series with limited follow up. Refractive outcomes were excellent, reflecting stable and predictable effective lens position. There was no variation of visual acuity over the three months of data collection. All surgeons found the IOL easy to use with good stability and centration in all cases.

Postoperative Manifest Refraction and Visual Acuity

No. Eyes Follow-up visit SE ± SD Sphere ± SD Cylinder ± SD LogMAR VA

46 Month 1 +0.25 ± 0.60 +0.72 ± 0.18 +0.94 ± 0.53 +0.05 ± 0.08

46 Month 3 +0.17 ± 0.55 +0.69 ± 0.53 +1.04 ± 0.53 +0.06 ± 0.10

Abbreviations: No. = number; SE = sherical equivalent; SD = standard deviation; VA = visual acuity

Professor Thomas Kohnen, Chair of the Department of Ophthalmology Goethe University, Frankfurt, Germany implanted the World’s first RayOne Hydrophobic IOL post-CE mark in May 2018

Summary of Professor Kohnen’s presentation at the 2018 ESCRS congress in Vienna

Professor Kohnen commented on the surgery “nice to see in the first implantation there was very smooth delivery of the IOL into the capsular bag” and with regards to the Cornerstone technology he stated this “gives better stability to the IOL. From my perspective, a very nice implantation, very easy to do and very much in the standards of the current monofocals.”

Professor Kohnen described the injector system as “simple and intuitive with minimal learning curve”, and when addressing the complete power range of -10.0 D to +32.0 D he stated “this is a very smart move, because if you go into the myopic range, then you can really cover the whole range, many companies unfortunately stop at +10.0 D or +6.0 D.”

Dr. Cedric Schweitzer, Consultant Ophthalmologist at University Hospital centre in Bordeaux, was one of the first surgeons to implant the RayOne Hydrophobic in France

Summary of Dr. Schweitzer’s presentation at the 2018 ESCRS congress in Vienna

Dr. Schweitzer’s team carried out a prospective pilot study in 11 cataract patients. His patients presented with a wide range of refractive errors (0 D to 8.5 D). Dr. Schweitzer stated “on average the total surgical time was between 7-8 minutes and the total unfolding time of IOL was approximately 25 seconds, there were no complications with IOL folding in the injector nor within the surgery.” He measured the rotational stability between day three and one month, and observed very low rotation of below three degrees so stated it is a very stable IOL in the capsular bag. To conclude, Dr. Schweitzer stated “RayOne Hydrophobic fulfils all current IOL requirements for cataract surgery. The IOL unfolding and delivery time within the capsular bag is very short, there are excellent visual, refractive and aberrometry measurements outcomes and excellent rotational stability and centration within the bag.”

Left: Professor Kohnen implanting the first RayOne Hydrophobic. Right: RayOne Hydrophobic centred in the capsular bag.

Visual and refractive outcomes at Month 1 visit

RayOne population (n=11)

Mean postoperative UCVA (LogMAR) 0.04+/-0.07

Mean postoperative BCVA (LogMAR) 0.05+/-0.08

Mean Absolute error of manifest refraction spherical equivalent - Diopter (SD) (Min-Max)

0.22+/-0.25 (0-0.75)

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New design. New standard · New RayOne Hydrophobic 6 mm optic Ultra glistening-free. Ultra smooth...

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Transcript of New design. New standard · New RayOne Hydrophobic 6 mm optic Ultra glistening-free. Ultra smooth...