The Concept of WIOL-CF

Jose L. Guell

Instituto de Microcirugia Ocular de Barcelona Autonoma University of Barcelona

ESASO University of Lugano

Amsterdam, October 2013, ESCRS Annual Meeting

While it is accepted that IOLs enabling vision on different distances represent a solution for presbyopia, existing technologies (esp. multifocal IOLs) face a number of inherent challenges:

High incidence of glare, halos & night driving problems Suboptimal intermediate and distance vision Loss of contrast sensitivity Loss of light that reduces vision, especially at night Explant rate higher than monofocal IOLs

Slight IOL decentration or tilt negatively effects outcomes High PCO incidence

Other: decreasing optical quality over time (glistenings, biofilms, protein deposits, calcifications, capsule fibrosis, cystoid macular edema, retinal detachment, interference with retinal exams and procedures, etc.)

Limitations of Existing Technologies

Technical vs. Bioanalogic

Technical Bioanalogic

1950

1956

1960

1965

1965-70

1990

1992

1996

1999

2004

2013

Biomaterial laboratory of prof. Otto Wichterle founded

First version of pHEMA hydrogels synthesized

Seminal paper on bionanalogic hydrogels published in Nature by prof. Wichterle

First pHEMA hydrogel contact lenses manufactured by spin-casting and clinically tested

Soft hydrogels contact lenses commercialized (license to Bausch+Lomb)

Bioanalogic WIGEL hydrogel, optimized for IOL use, developed

WIOL: 10 mm spherical optics, 10 mm scleral incision

WIOL-C: 9 mm polyfocal optics, fully hydrated, non-foldable, 6-7 mm scleral incision

WIOL-CF, first generation: 9 mm polyfocal optics, fully hydrated, partially foldable, 5.2 mm scleral incision

WIOL-CF, second generation: 9 mm polyfocal optics, semi-hydrated, foldable, 2.5-2.8 mm corneal incision

Available in 13 European countries 30+ patent applications, 60+ scientific publications/presentations 600+ eyes featured in clinical trials with long-term follow-up

History of Bioanalogic IOL Design and Development

Developed specifically for

ophthalmic applications

Long-term biocompatibility

Long-term optical stability

Safety & Reliability

WIGEL

Negative charge due to carboxylate groups

High water content, surface hydration,

smoothness

No foreign body reaction

No biofilm/PCO formation

No glistenings

No protein deposits

No cell attachment and spreading, no

capsule fibrosis

No calcifications

Surface clarity

Excellent shape memory

Water content allowing diffusion of

metabolites and nutrients

Long-term stability of function

Long-term, clinically proven properties

Refractive index matching natural lens

Low reflectivity

Adequate UV absorption

Deformability to allow shape change,

accommodation

Hydrophillicity ensuring compatibility

with silicone oil

Bio

anal

ogi

c p

rop

ert

ies

WIGEL: Material Inspired by Nature

Natural young crystalline lens – the ideal IOL WIOL-CF Bioanalogic IOL

Hydrogel-like tissue with high negative charge (carboxylate and sulphate groups)

High water content (66%), refractive index 1.42

Full size (10.5 mm) lens, smooth, glare-free optics

Hyperbolic surface featuring polyfocal optics enabling large depth of focus and pseudoaccommodation

Accommodation range of up to 10 diopters

(decreasing with age, approx. 2 diopters at the age of 42-50

Hydrogel with high biocompatibility (20+ years of experience) and negative charge (carboxylate groups)

High water content (42%), refractive index 1.43

Full-optics (9 mm) lens, smooth, glare-free optics

Hyperbolic surface featuring polyfocal optics enabling large depth of focus and pseudoaccommodation

Accommodation range exceeding 2 diopters (stable, 12 years data)

Atchison DA.: Accommodation and presbyopia.,Ophthalmic Physiol Opt., Jul 1995;15(4):255-72 Pasta J. et al, Abstract p. 102, ESCRS, Munich, Germany,September, 2003 Fisher RF et al.: J Physiol. (1973),234, 443-7 Kasthurirangan S.:Investigative Ophthalmology & Visual Science, June 2008, Vol. 49, No. 6, 2531-40 Kasthurirangan S. Journal of Vision (2011) 11(3)19, 1–16

Dubbelman M. et al.: Vision Research 41 (2001) 1867–1877 Dubbelman M. et al: Vision Research 43,2003; 2363–2375 Dubbelman M. et al: Vision Research 45 ,2005; 117-132 Manns F. et al: Experimental Eye Research 78, 2004; 39–51 Pasta J. et al: Abstract No 320, ASCRS, San Francisco, CA, April 2006

WIOL-CF: Design Inspired by Nature

Natural Crystalline

Lens

3 modes of action:

1. Polyfocality due to hyperbolic optics

2. Pseudoaccommodation driven by pupil constriction

3. Accommodation driven by the shape change

Relaxed eye

Accommodated eye

Polyfocality leads to the range of focal distances,

corresponding to a range of refractive powers

NCL: MRI measured accommodation

Kasthurirangan S. Journal of Vision (2011) 11(3)19, 1–16

For proper understanding of the function of the human eye, it is important to understand not only the optics, but also the way how retina captures the image and brain transforms it into the cognitive perception. NCL combines 3 key mechanisms of action ensuring vision and continuous focus on different distances

Natural Crystalline Lens: Mechanisms of Action

NCL: Hyperbolic optics featuring polyfocality with refractive power maximum in the center enabling pseudoaccommodation

driven by pupil constriction

WIOL-CF

3 modes of action:

1. Polyfocality due to hyperbolic optics

2. Pseudoaccommodation driven by pupil constriction

3. Accommodation driven by the shape change

Polyfocality leads to the range of focal distances,

corresponding to a range of refractive powers

WIOL-CF combines the same mechanisms of action as the natural crystalline lens and thus provides the retina and brain with the type of „data format“ that they are „used to“ read and translate naturally

Bioanalogic WIOL-CF: Mechanisms of Action

Pasta J. et al: Abstract No 320,ASCRS, San Francisco, April 2006 Pallikaris et al Outcomes after WIOL-CF accommodative intraocular lens implantation. ESCRS, Milan 2012

WIOL-CF: Hyperbolic optics featuring polyfocality with refractive power maximum in the center enabling pseudoaccommodation

driven by pupil constriction

WIOL-CF: iTrace measured accommodation

Note the anterior movement (caused by lens bulging) of the angular structures and change of the corneal angle confirming change of the lens shape

NEAR

FAR

Mean diff.

-1.00D

Max diff

-3.66D

Max

-

4.84

D

Ran

ge

6.55

D

Bioanalogic WIOL-CF: Mechanisms of Action

Glare, halos, night driving issues no worse than monofocal IOLs

No compromises in distance vision

Good intermediate vision

Good near vision

No loss of contrast sensitivity

No loss of light or chromatic aberration

No glistenings, biofilm formation, PCO or other processes underminining long-term function

Long-term stability of optical properties and function

Characteristics Of An Ideal Presbyopia-Correcting IOL

WIOL-CF Delivers Significantly On Characteristics Of An Ideal PC-IOL

Glare, halos, night driving issues no worse than monofocal IOLs

No compromises in distance vision

Good intermediate vision

Good near vision

No loss of contrast sensitivity

No loss of light or chromatic aberration

No glistenings, biofilm formation, PCO or other processes underminining long-term function

Long-term stability of optical properties and function