Rayner M-flex® Multifocal IOLs

Hydrophilic Acrylic Injectable Multifocal
IOLs with Amon-Apple Enhanced Square Edge

Rayner M-flex® Multifocal IOLs (630F) provide a degree of pseudoaccommodation, lessening the need for additional correction by spectacles or contact lenses.

Rayner M-flex® Multifocal IOLs are the latest generation of refractive IOLs and are based on Rayner’s unique multi-zoned refractive aspheric optic technology with either 4 or 5 annular zones (depending on IOL base power) providing either +3.0D or +4.0D of additional refractive power (equivalent to +2.25 or +3.0D at the spectacle plane).

• Availability of either a +3.0D or a +4.0D addition gives flexibility of choice and enables the ophthalmologist to determine the best option for each individual patient, either bilateral (same power addition), or “mix and match”.
• Unlike “mix and match” with a refractive and a diffractive MIOL, Rayner M-flex® Multifocal IOLs offer this option but with the same IOL design platform and multifocal optic technology.

M-flex® Multifocal IOLs incorporate multi-aspheric aberration-neutral surfaces, with the interface between each annular zone specifically designed to reduce halo and glare.

At each zonal interface, the aspheric correction is uniquely adjusted and the aspheric coefficients are recalculated to ensure that the zonal blend is precise.

With a progressive aspheric correction applied to each individual refractive zone, both near and far, contrast sensitivity and functional visual acuity is equally increased to all refractive zones, irrespective of whether that zone is for near or far focus.

• Superior performance compared with conditions experienced in the phakic eye 1.
• Minimal incidence of halo or glare 3.
• Under normal conditions, provides near diffraction limited performance 1.

Rayner M-flex® Multifocal IOLs for Superior Refractive Outcomes 2, 3, 4

All the advantages of Refractive Aspheric Optic Technology without the disadvantages of Diffractive Optics.

By their very nature, even the best diffractive IOLs are only about 80% to 82% efficient, which results in a significant percentage loss of incident light to higher order aberrations 1.

Some of this lost light will contribute to the distribution or imaging at the fovea which may be visualised by the patient as “ghosting” or “flare”.

M-flex®, having refractive surfaces, does not suffer from this disadvantage – the continuous, aspherically modified surfaces do not have the same optical efficiency issues as that of a diffractive lens.

A diffractive lens has many concentric zones where the light transmission is uncontrolled. These regions can be described as “facet returns” and can result in “spilt” light, which essentially reduces useful light transmission, adding to halo and glare.

Compared with diffractive MIOLs, the refractive aspheric optic technology of M-flex® offers:

• Greater contrast sensitivity (Diffractive IOLs are associated with an 18 – 20% loss in light transmission with a corresponding loss in contrast sensitivity) 1.
• Increased functional visual acuity 1.
• Less susceptibility to the effects of tilt 1.
• Active glare control by design – reduced incidence of halo and glare 1, 3, 4.
• With M-flex® Multifocal IOLs, all the incident light is used in the multi-image formation.

M-flex® has a superior optical transmission efficiency 1.

Graph 1
MTF graph for a refractive lens showing higher contrast sensitivities across the spatial frequency range.

Graph 2
MTF graph for a lens scattering 20% of the light incident on it.
This graph shows the instantaneous collapse of low spatial
frequency contrast sensitivity and this collapse is maintained
across all spatial frequencies. Lenses influenced by this
characteristic include diffractive IOLs.

In addition to multifocality, Rayner M-flex® Multifocal IOLs offer all the additional advantages of C-flex and Superflex®

• Rayner M-flex® Multifocal IOLs are the ONLY multifocal IOLs having the benefit of AVH Technology® for perfect centration, with anterior / posterior, torsional and rotational stability – so important in maintaining a sustained post-operative multifocal performance.
• Unique Amon-Apple Enhanced Square Edge for reduced PCO – again, so important in maintaining a sustained post-operative multifocal performance.
• Manufactured from Rayacryl® hydrophilic acrylic co-polymer for:
  – High biocompatibility
  – Low PCO
  – Optical purity – no vacuoles or glistenings
  – Low silicone oil adherence
  – Superb handling characteristics
• Larger optic diameter (6.25mm) and longer overall length (12.50mm) available
  – Anatomically correct for the larger myopic eye
  – Better visualisation of the retina for the VR patient
  – Provides for a more satisfactory visual outcome in the younger patient with more active pupils
  – Low glare characteristics for better night vision1

Physical parameters

• Optic Diameter: 630F: 6.25mm 580F: 5.75mm
• Overall Length: 630F: 12.50mm 580F: 12.00mm
• Estimated SRK A-Constant: 118.0
• Theoretical ACD: 4.97mm

Power Availability

630F [6.25 / 12.50mm] (+3.0D Far dominant)

• +14.0D to +25.0D in 0.5D increments

630F [6.25 / 12.50mm] (+4.0D Far dominant)

• +10.0D to +25.0D in 0.5D increments

580F [5.75 / 12.00mm] (+4.0D Far dominant)

• +25.5D to +30.0D in 0.5D increments

Presentation

The Rayner M-flex® hydrophilic acrylic injectable IOL is supplied in 0.9% saline solution in a pouched blister pack, sterilised by moist heat and presented in a convenient, ready to use Lens Injection System Pack containing:

• One M-flex® injectable IOL
• One Rayner Single Use Soft-Tipped Injector

References

1. Data on file with Rayner Intraocular Lenses Limited

2. Initial Experience with Rayner’s new M-flex® Multifocal IOL
J. Cezón
Seville, Spain
Presented at the Rayner Symposium, ESCRS, London, 2006

3. Treating Presbyopia
C. Claoué
London, UK
Presented at the Rayner Symposium, ESCRS, Lisbon, 2005

4. M-flex® 630 Study results
B. H. Dick, A. Penja, S. Buchner
Bochum, Germany
Presented at the Rayner Symposium, ESCRS, Stockholm, 2007