Sulcoflex® Trifocal

Sulcoflex® Trifocal

Rayner’s Most Technologically Advanced IOL

The Sulcoflex Trifocal combines Rayner’s pseudophakic supplementary Sulcoflex platform -- designed to be implanted in the ciliary sulcus and with over 10 years of successful outcomes -- with the patented trifocal optic technology of the recently launched RayOne Trifocal IOL.

The reversibility afforded by the Sulcoflex Trifocal means that surgeons can now treat an even wider range of patients for presbyopia, to meet both their visual and lifestyle needs.

 

Rayner Sulcoflex® Trifocal: An elegant solution for the correction of presbyopia

 

The Situation

As a cataract and refractive surgeon, achieving the best possible visual results for your patients is paramount. However, challenging patients may expect more, and demand a chance of being spectacle free.

The Solution

The Sulcoflex® Trifocal supplementary IOL is an adjustable option which allows you to treat an even wider range of patients for presbyopia, to meet both their visual and lifestyle needs.

 

A proven patented optic design for comfortable transition from near to distant visual ranges

 
Indications1,3
For pseudophakic patients with a primary capsular bag IOL
Presbyopia (DUET procedure) Post-surgical ametropia
Pseuodophakic presbyopia* (secondary enhancement) Patients experiencing a dynamic change of refraction

*Contraindicated for implantation into eyes with multifocal capsular bag IOLs.

 

When considering a solution for presbyopia, what is important to you?

 
Exceptional light usage
Ease of Use2
Efficacy & patient outcomes2
Versatility to treat a wider range of patients3
An adjustable solution for peace of mind Increased accuracy with quarter dioptre steps
Increased accuracy with quarter dioptre steps

 

With the Rayner Sulcoflex platform, you can expect the following:

 

Predictability1,3,5

  • Proven to provide better centration compared to capsular bag multifocal IOLs
  • Predictable refractive outcomes; high visual acuity

High patient satisfaction1,4,6

  • Low complication rate
  • Stable long-term refractive results

Reduced surgical risk associated with IOL exchange1,4,6

  • Less surgical trauma than primary IOL exchange
  • Avoids sometimes difficult removal of fibrosed, fixated primary implant
  • Allows for implantation reversibility

“The world’s first trifocal supplementary IOL may be used in routine cataract-procedures (DUET) or in pseudophakes for presbyopic correction. This IOL-concept allows the surgeon to adjust the optical system to any unpredictable situation in the future.”

Michael Amon MD, Professor and Head of the Department of Ophthalmology at the Academic Teaching Hospital of St John, Vienna, Austria

 

Features and benefits of the Sulcoflex® Trifocal IOL

 

Improved visual outcomes designed for less pupil dependency

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

 

Optimised diffractive design.

Sulcoflex® Trifocal uses the Rayner patented diffractive profile that has been designed in partnership with a leading European technology institute. This new design of diffractive technology is the most advanced optic in our history and possibly the most advanced in the industry.

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

Graphical representations only of diffractive surface pattern

 

Our patented diffractive step Trifocal technology reduces light loss to only 11%.

  • 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

  • Sulcoflex® Trifocal improves intermediate visual acuity enabling patients to feel more comfortable transitioning from near to distance activities
  • Sulcoflex® Trifocal is designed with:
  • + 3.50 D near add
  • 37.5 cm reading plane
  • +1.75 D intermediate add
  • 75.0 cm reading plane

Designed to avoid the potential problems of conventional “piggy-back” IOLs1,6,9

 
  • Unique posterior concave surface minimises the possibility of interaction with the primary IOL
  • Reduced likelihood of unwanted photopic effects
  • Reduced refractive error with hyperopic defocus
Physical contact between the two IOLs minimised.
Iris - Sulcoflex
Sulcoflex - IOL

References:

 
  1. Amon MI. Cataract Refract Surg Today Europe. Correcting refractive surprises following cataract surgery. 2009:56-9.
  2. Khan, M.I. & Muhtaseb, M. Piggybacking with the Sulcoflex. J Cataract Refract Surg. 2010;36:14-6.
  3. Claoué et al. Sulcoflex® Pseudophakic Supplementary IOLs. CRST Euro Supple. 2009.
  4. Amon MI et al. Enhancing pseudophakic vision with the Rayner Sulcoflex lens. ESCRS Euro Times Supple. 2012:2-3.
  5. Prager F et al. Capsular bag-fixated and ciliary sulcus-fixated intraocular lens centration after supplementary intraocular lens implantation in the same eye. J Cataract Refract Surg. 2017;43(5):643-647.
  6. Kahraman G, Amon M, Vienna, Austria. J Cataract Refract Surg. New Supplementary intraocular lens for refractive enhancement in pseudophakic patients. 2010 Jul;36(7):1090-4.
  7. Tomlins PJ et al. Long-term biocompatibility and visual outcomes of a hydrophilic acrylic intraocular lens in patients with uveitis. J Cataract Refract Surg. 2014; 40:618-625.
  8. Rayner data on file.
  9. Manzouri B et al. Supplementary IOLs: Monofocal and Multifocal, Their Applications and Limitations. Asia- Pacific Journal of Ophthalmology. Vol 6, Number 4, July/ August 2017.

Rayner have validated the Medicel Accuject 1.8-1P (LP604540) for use with the Sulcoflex Trifocal.

The Medicel Accuject features:

 
  • Large loading chamber with guarding rails for secure loading
  • Unrestricted access for IOL loading
  • No force required for loading IOL
  • Syringe-style for single handed IOL delivery
  • Soft-tip plunger that offers a soft protective interface with the IOL
  • Incision size of 2.2mm for wound in delivery
Model Name: Sulcoflex® Trifocal
Model Number: IOL703F
Power Range

-3.0 D to +3.0 D (increments 0.5 D). -1.0 D to +1.0 D (increments 0.25 D)
Trifocal, diffractive,
+3.5 D near add and +1.75 D intermediate add at the IOL plane

Aspheric Trifocal 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
Overall Diameter: 14.00 mm
Optic Diameter: 6.50 mm
Optic Shape: Anterior convex, posterior concave
Asphericity: Aberration-neutral technology
Haptic Angulation: 10° Posterior angulation
Haptic Style: Undulating and rounded C-loop haptics
Estimated constant for power calculation Expected lens position = 4.5 mm

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