C-flex® Aspheric

C-flex® Aspheric

Built on the proven Rayner Primary IOL Platform, the C-flex Aspheric is a hydrophilic acrylic aspheric monofocal IOLs with 360° enhanced square edge and true, aberration-neutral optic technology. We believe that every patient’s vision is important and there is no such thing as the “average” cornea. That’s why the Rayner C-flex Aspheric lens is aberration neutral, allowing patients to benefit from the natural residual positive aberration of the cornea.

C-flex Aspheric is the 5.75mm diameter monofocal optic, manufactured in powers from +8.0 to +30.0 D and can be delivered through a 2.2mm wound assisted clear corneal incision.

 

Patients deserve optimal visual quality and functional visual acuity in all light conditions

Aspheric IOL with aberration-neutral technology:

 
  • Offer improved contrast sensitivity compared with spherical IOLs3,4
  • Provide better low light level visual acuity than spherical IOLs18
  • Can offer more depth of field than aberration-negative IOLs by retention of the patient’s natural level of corneal spherical aberration6
  • Are less susceptible to the effects of decentration than aberration-negative IOLs12

Spherical IOL:

 
Spherical IOL
Power increases from centre to edge.

Disadvantages

  • Adds to corneal positive spherical aberration (SA)
  • Degrades image quality and contrast sensitivity

Aberration-neutral aspheric IOL

 
Aberration-neutral aspheric IOL
Prolate anterior surface means uniform power from centre to edge. Aberration-neutral optic retains natural residual positive SA of the cornea.

Advantages

  • High quality vision in all lighting conditions
  • Good contrast sensitivity
  • More depth of field than an aberration-negative aspheric IOL
  • Optimal results for ALL patients; not just for the “average” cornea

Why is it important to retain depth of field?

Patients prefer a lens that retains depth of field6

 
Simulation of retained depth of field
Simulation of retained depth of field
Simulation of reduced depth of field
Simulation of reduced depth of field
  • Retention of some positive SA can provide up to 0.5 D of pseudo-accommodation, offering preferable visual outcomes
  • - In a clinical trial of 80 patients where an aberration-neutral lens was implanted in one eye and an aberration-negative lens was implanted in the other eye:6
2 x as many
patients* preferred the aberration-neutral IOL
* Of those patients who expressed a preference
3 x fewer
reports of visual disturbances with the aberration-neutral IOL

References:

 
  1. Nanavaty MA et al. J Cataract Refract Surg. 2009; 35:663–671
  2. Yagci R et al. Eur J Ophthalmol. 2014 Jul 24; 24(5):688-92
  3. Johansson B et al. J Cataract Refract Surg. 2007; 33:1565–1572
  4. Altmann GE et al. J Cataract Refract Surg. 2005; 31(3): 574-585
  5. Pepose JS et al. Graefes Arch Clin Exp Ophthalmol. 2009 Jul;247(7):965-73
C-flex Aspheric IOLs are supplied with a Rayner injector
  • Uniquely designed loading bay with an extension "lip" to facilitate loading.
  • Soft plunger tip completely fills the nozzle and offers a soft protective interface with the IOL.
  • Reduced nozzle diameter designed to allow delivery of the IOL through a 2.2mm clear cornea wound assisted mini incision.
  • Syringe-style design for single-handed technique for smooth IOL delivery with predictable and efficient insertion, ensuring consistent IOL implantations.
  • Sterile Single-Use, ready to use.
  • RaySert PLUS is supplied in an individual pack.
Model Name: C-flex Aspheric
Model Number: 970C
Power Range:

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

Optic Diameter: 5.75 mm
Haptic Diamter: 12.00 mm
Delivery System
Injector Type: Sterile Single use loadable injector
Nozzle Size: 1.8 mm
Bevel Angle: 35°
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
Optic Shape: Biconvex
Asphericity: Anterior aspheric surface with aberration-neutral technology
Optic Edge Design: Amon-Apple 360° enhanced square edge
Haptic Angulation: 0°, uniplaner
Haptic style: Closed loop with anti-vaulting haptic (AVH) technology
Estimated constants for optical biometry SRK/T: 118.6
Estimated constants for Ultrasound A-constant: 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.

Rayner C-flex® Intraocular Lenses (IOLs)

CAUTION: Federal U.S law restricts this device to the sale by or on the order of a physician.

INDICATIONS: Rayner C-flex® intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsification. The lens is intended to be placed in the capsular bag.

CONTRAINDICATIONS: Apart from non-specific contraindications related to any form of ocular surgery, the following specific contraindications must be respected.

  • Microphthalmia
  • Active ocular disease (e.g. chronic severe uveitis,proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
  • Children under the age of 21 years
  • Corneal decompensation or corneal endothelial cell insufficiency
  • Persons who are pregnant or nursing.

WARNINGS: A risk/benefit ratio must be assessed before confirming a patient as a candidate for a Rayner C-flex® IOL implantation, if they are suffering from any of the following conditions:

  • Recurrent ocular disease (e.g. uveitis, diabetic retinopathy, glaucoma, corneal decompensation)
  • Previous ocular surgery
  • Non-age related cataract
  • Vitreous loss
  • Iris atrophy
  • Severe Aniseikonia
  • Ocular Hemorrhage
  • Macular degeneration
  • Zonular dehiscence
  • Ruptured posterior capsule
  • Patients in whom the intraocular lens may affect the ability toobserve, diagnose, or treat posterior segment diseases.
  • Surgical difficulties at the time of cataract extraction which might increase the potential for complications(e.g. persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss).
  • A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible.
  • Circumstances that would result in damage to the endothelium during implantation.
  • Suspected microbial infection.
  • Children under the age of 2 years are not suitable candidates for intraocular lenses.

Since the Rayner 570C C-flex® IOL clinical study was conducted with lens implantations into the capsular bag only,there are insufficient clinical data to demonstrate the safety and efficacy for ciliary sulcus placement.

ATTENTION: Reference the Instructions for Use labelling for a complete listing of Indications and precautions.

When considering an intraocular lens, what's important to you?

Reliable refractive outcomes and a low rate of post-operative complications

Rayner's Anti-Vaulting Haptic (AVH) Technology provides

  • Excellent refractive outcomes1
  • Stable centration2
Reducing dysphotopsia by design 14
  • Rayner's Enhanced Square Edge Technology shows no general increase in glare from previous models7
  • The low refractive index (1.46) of Rayacryl®
Optimal visual quality in all lighting conditions
  • Aspheric optic technology reduces higher order aberrations when compared with spherical IOLs3,4
  • Excellent contrast sensitivity3,4 and a retained depth of field from aberration-neutral aspheric optic
last_5 1 2 4 5 3
Low Nd: YAG capsulotomy rates

Rayner's 360° Amon-Apple Enhanced Square Edge creates an optimum barrier to reduce epithelial cell migration including the haptic-optic junction6,15

ND:YAG CAPSULOTOMY RATES6 MEAN TIME TO ND:YAG CAPSULOTOMY6
At 12 months 0.6%
At 24 months 1.7%
  9.3 ± 5.5 months
  (range 2.6 - 22.7 months)

  Follow-up period: 5.3 – 29
  months


Study of 3,461 patients receiving Rayner C-flex 570C IOLs over a 24 month period, Nd:YAG capsulotomy rates were extremely low6

An IOL free from vacuoles and glistenings7
  • Single piece IOLs created from Rayacryl® an homogeneous material free of microvacuoles, resulting in a glistening free IOL
  • Compressible material for delivery through a small incision
  • Excellent handling characteristics with controlled unfolding within the capsular bag
  • Low silicone oil adherence8
  • Excellent uveal biocompatibility9
  • Hydrophilic acrylic material with low inflammatory response10

References:

1. Percival SPB et al. Eye 2002 May;16(3):309-315
2. Alberdi R et al. J Refract Surg. 2012;28(10):696-700
3. Nanavaty MA et al. J Cataract Refract Surg. 2009; 35:663-671
4. Yagci R et al. Eur J Ophthalmol. 2014 Jul 24;24(5):688-92
6. Mathew RG and Coombes AGA. Ophthalmic Surg Lasers Imaging. 2010 Nov-Dec;41(6):651-5
7. Rayner data on file
8. McLoone E et al. Br J Ophthalmol. 2001;85:54-545
9. Tomlins PJ et al. J Cataract Refract Surg. 2014; 40:618-625
10. Richter-Mueksch S et al. J Cataract Refract Surg. 2007; 33:1414-1418
14. Vyas A. Clin Exp Ophthalmol 2015, 6(1):391
15. Vyas A et al. J. Cataract Refract Surg 2007, 33:81-87

 

Scientific Papers and Supporting Materials