RayOne® Trifocal

RayOne® Trifocal

RayOne® Trifocal is the newest member of the RayOne® family of preloaded IOLs, based on the well-known high performance Rayner platform that performs again and again.

RayOne® Trifocal has a new patented diffractive profile that has been designed in partnership with a leading European technology institute. Over the last four years Rayner has developed the most advanced optic in their history and possibly the most advanced in the industry.

 

Improved visual outcomes designed for less pupil dependency.

 

RayOne® Trifocal has fewer rings on the optic surface than many trifocal IOLs for reduced potential visual disturbances and improved night vision.

Features

  • 16 diffractive rings / steps
  • 4.5 mm diffractive zone
  • >4.5 mm monofocal, distance

Benefits

  • Reduces visual disturbances
  • Developed to be less dependent on pupil size or lighting conditions
  • Improves distance vision in mesopic condition

Optimised patented diffractive design

 

Optimised patented diffractive design is a construct of two profiles to form our patented design:

Graphical representations only of diffractive surface pattern

Exceptional light usage

 
  • 89% of light transmitted to the retina with a pupil of 3 mm
  • Half the light allocated for distance
  • Remaining light divided between near and intermediate vision
  • Light Energy Split at 3.0 mm pupil
  • - 52% Distance
  • - 22% Intermediate
  • - 26% Near

Comfortable transition from near to distance activities

 

RayOne® Trifocal improves intermediate visual acuity enabling patients to feel more comfortable transitioning from near to distance activities.

RayOne® Trifocal is designed with:

+3.50 D near add
37.5 cm reading plane

+1.75 D intermediate add
75.0 cm reading plane

How does RayOne® Trifocal compare?

 

RayOne® RayOne® Trifocal offers excellent performance across Near, Intermediate and Distance vision, and with the retained light energy through the diffractive profile providing excellent contrast sensitivity. In low light conditions when compared to other diffractive trifocal technologies the RayOne® Trifocal maintains its performance across the three foci points. Trifocal offers excellent performance across Near, Intermediate and Distance vision, and with the retained light energy through the diffractive profile providing excellent contrast sensitivity. In low light conditions when compared to other diffractive trifocal technologies the RayOne® Trifocal maintains its performance across the three foci points.

USAF 1951 target charts

 

Rayner model eye bench simulator viewing USAF 1951 target charts. Monocular images that do not take into account the binocular sum that improves the overall view at all distances. A +20.0 D power IOL was used for all IOLs. All trademarks are property of their respective owners. Source: Rayner test data held on file.

30 healthy test persons IOL simulator study

 

Designed as a randomised, observer and subject masked, crossover comparison study using an IOL simulator device.

Conclusions:
  • Visual Acuity of both RayOne® Trifocal and AT LISA Tri are very similar.
  • No significant differences between the lenses in far, near and intermediate position could be defined.

Proven haptic technology for excellent stability

 

Any rotation, tilt or decentration of a multifocal lens could affect patient outcomes and cause phototopic disturbances. Our anti-vaulting haptic technology® gives proven rotational and centrational stability, plus excellent fixation in the capsular bag1:

  • Superb centration - Maximum offset of only 1.0 mm 3 months after surgery2
  • Excellent rotational and torsional stability - 3.1° mean IOL rotation 3 months after surgery2
Outer haptics begin to take up the compression forces of post-operative capsule contraction
Outer haptics engage the inner haptics
Haptic tips gently meet the IOL optic and are effectively locked into position

Vacuole free material for a glistening free IOL

 
  • Single piece IOL created from Rayacryl® a homogeneous material free of microvacuoles, resulting in a glistening free IOL5
  • Compressible material for delivery through a small incision
  • Excellent handling characteristics with controlled unfolding within the capsular bag
  • Low silicone oil adherence6
  • Excellent uveal biocompatibility9
  • Hydrophilic acrylic material with low inflammatory response7

Reducing dysphotopsia by design8

 
  • Rayner’s Enhanced Square Edge Technology shows no general increase in glare from previous models without a square edge4
  • The low refractive index (1.46) of Rayacryl®

360° Optimised Barrier to reduce PCO – Low Nd: YAG capsulotomy rates

 

Rayner's 360° Amon-Apple Enhanced Square Edge creates an optimum barrier to reduce epithelial cell migration including at the haptic-optic junction 4,3

MEAN TIME TO ND:YAG CAPSULOTOMY4 ND:YAG CAPSULOTOMY RATES4
At 12 months 0.6% 9.3 ± 5.5 months (range 2.6 - 22.7 months)
Follow-up period: 5.3 – 29 months
At 24 months 1.7%

Study of 3,461 patients receiving Rayner 570C IOLs over a 24 month period, Nd:YAG capsulotomy rates were extremely low and comparable with hydrophobic acrylic lenses with square-edge optics4

References:

 
  1. Claoué C. Clinical and Surgical Ophthalmology 2008; 26(6): 198-200
  2. Alberdi R et al. J Refract Surg. 2012; 28(10):696-700
  3. Vyas AV et al. J Cataract Refract Surg 2007; 33:81-87
  4. Mathew RG and Coombes AGA. Ophthalmic Surg Lasers Imaging. 2010 Nov-Dec; 41(6):651-5
  5. Rayner. Data on File. White paper
  6. McLoone E et al. Br J Ophthalmol. 2001; 85:543–545
  7. Richter-Mueksch S et al. J Cataract Refract Surg. 2007; 33:1414–1418
  8. Cezón Prieto J and Bautista MJ. J Cataract Refract Surg. 2010; 36:1508-1516
  9. Tomlins PJ et al. J Cataract Refract Surg. 2014; 40:618–625

RayOne® with patented Lock & Roll™ technology for a smoother, more consistent rolling and delivery of the lens via micro incision

Easy to use, true 2-step system

 
  • Simple and intuitive
    • - Minimal learning curve
    • - Minimises error
  • Increase efficiencies
    • - Designed to enable repeatability
    • - Reduces operating time
  • STEP 1. Insert OVD into cartridge via port
  • STEP 2. Lock cartridge ready for implantation

Lock & Roll technology

 
  • Rolls the lens to under half its size before injection
    • - Consistent, smoother delivery
    • - Reduces insertion forces
  • Fully enclosed cartridge with no lens handling
    • - Reduces the risk of lens damage
    • - Minimises chance of contamination

1.65 mm RayOne® nozzle

 
  • Smallest fully preloaded injector nozzle
    • - Ease of insertion
    • - Compatible with MICS
  • Parallel sided for minimal stretch
    • - Sub 2.2 mm wound-in delivery
    • - Maintains incision architecture
Model Name: RayOne® Trifocal
Model Number: RA0603F
Power Range: 0.0 D to +30.0 D (increments 0.5D)
Trifocal, diffractive,
+3.5 D near add and +1.75 D intermediate add at the IOL plane
Delivery System
Injector Type: Single use, fully preloaded IOL injection system
Nozzle Size: 1.65 mm
Bevel Angle: 45°
Lens Delivery: Single handed plunger
Aspheric Monofocal IOL
Material: Single piece Rayacryl® hydrophilic acrylic
Water Content: 26% in equilibrium
UV Protection: Benzophenone UV absorbing agent
UV Light Transmission: UV 10% cut-off is 380 nm
Refractive Index: 1.46
ABBE: 56
Overall Length: 12.50 mm
Optic Diameter: 6.00 mm
Optic Shape: Biconvex (positive powers)
Asphericity: Aberration-neutral technology
Optic Edge Design: Amon-Apple 360° enhanced square edge
Haptic Angulation: 0°, uniplanar
Haptic Style: Closed loop 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

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.

Not all products or offerings are approved or offered in every market and approved labelling and instructions may vary from one country to another. For country specific product information contact your local distributor or email iol_enquires@rayner.com.

This product is not approved by the FDA for use or distribution in the United States of America.

Rayner hold a selection of EC certificates for various products. Please contact the Regulatory Affairs team for the current version.

Scientific Papers and Supporting Materials

RAYTRACE

OVDs