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EFCLIN 2018
‘IOLs for Better or Worse’
Consultant :Santen/AVSAnewOptic IncOptical ExpressOcular Therapeutix
Previously :AlconNovartisB and LZeissOculentis
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St Thomas’ Hospital 1871
1868
1946
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‘Why don’t you put a new lens in the eye, Sir ? ’
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The story of how the first IOL happened is well known
Ridley’s observation that Perspex did not cause a foreign body reaction
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The first operation
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The first IOL operation was a secondary implant
• Overlooked in the furore that followed
• Extremely fortuitous
• By 3 months the capsule would have thickened and supported the IOL leading to an anatomical success
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Posterior Capsule Opacification
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63.8%
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In 1994 Alcon approached me to see if we could confirm the German observation -
we started a study of PCO in PMMA, Silicone and Acrysof IOLs
Silicone PMMA Acrysof
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0
10
20
30
40
50
60
6m 1yr 2yr 3yr
PMMASiliconeAcrysof
Percentage PCO vs Time
P=0.0001
Hollick Ophthal 1998
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Dr O Nishi showed that a square edge profile prevented PCO
O Nishi et al JCRS 1999
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Bag collapses around
the IOL and the posterior edge
creates a pressure
barrier to LEC migration
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AcrySof SN60 Hoya YA-60BB(now obsolete)
Single piece hydrophobic acrylic, 6mm optic
Both marketed as square edge IOLs
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0
20
40
60
80
100
3m 6m 12m 18m 24m
AcrysofHoya
Area of PCO
Median%
PCO
**
**
*
* P= <0.5
Hancox JCRS 2008
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59 24227 192
395 360
745 710
Hoya Acrysof
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PCO• Not all ‘square edges’ are equal• Hydrophilic IOLs are not so good
19.9µ - bad9.3µ - good
Acrysof Hoya
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Silicone IOLs
Bausch & Lomb Soflex SE Bausch & Lomb SofPort AO
8.3µ 7.6µ
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Hydrophobic Acrylic IOLs
Alcon
AcrySof IQ
Alcon
AcrySof Natural
Alcon
AcrySof MA60AC
8.5µ 9.3µ 9.9µ
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AMO
Sensar
AMO
Tecnis Z9000
AMO
Tecnis ZM9000
9.2µ 9.0µ8.3µ
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Hydrophilic IOLs get more PCO
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Hydrophilic Acrylic IOLs
Bausch & Lomb Akreos
15.9µ
LenstecTetraflex
23.1µ
Rayner Superflex
15.6µ
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• Machined dehydrated• Tumble polished to remove burr• Edge profile lost
• Inter relationship between material and engineering
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What is a ‘square edge’ ?What is the best edge profile ??
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The Lens that failed
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Dreadful PCO
…. re engineer for 1.8mm incisionImprove edge and PCO prevention
B and L MI60MICS IOL
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Accuject 2.2
Viscoject 1.8
Viscoject
1.5mm Internal diameter
MI60
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• Specific injection system
• Material : resist higher compression forces, controlled unfolding
• Design : perfect stability in the bag, prevent PCO, provide excellent optical properties
Challenges
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• Same hydrophilic and hydrophobic polymers but more PMMA and less water
• This makes the polymer stiffer and more resistant to tearingAkreos IOL Material
Hydrophilic HEMA
Hydrophobic PMMA
Water
INCISE IOL Material
31
Material Solution .... new custom designed polymer
• Reduced water content compared 22% versus 26%
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Tensile strength
-Extremely resistant material-Tear strength : +300%
-Allows strong compression forces-Avoid haptic break during injection
Akreos
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Modulus (rigidity)
-Stiffer than Akreos even at body temperature (35°C)-More stable in the capsular bag-More stable if bag compression Akreos
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Elongation
-Strongly improved compared to Akreos (+43%)-Allows injection through very small cartridges
Akreos
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Sharpest 360° Barrier Edge• New sharp edge process on the 360° posterior barrier
16µm
Akreos1 5µm
5µm
INCISE2
“It has a much better profile than previous hydrophilic IOLsand has the best edge of any IOL we have ever imaged”*
Prof. David Spalton2
1. Nanavaty MA et al. J Cataract Refract Surg 2008;34:677–686.2. Imaging & Evaluation of 1.4 IOL St Thomas’ Hospital Anish Dhital, David Spalton, Jimmy Boyce.. 35
*As imaged by David Spalton
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High incidence of decentration - haptics too thin ?? ---- abandoned
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• Hydrophilic IOL calcification – a problem solved
• A lens that died
• A new EDOF concept
• Accommodation – a lens for the future
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Santen ‘Easy Focus’ IOL
A new ‘EDOF’ IOL
Consultant to Santen AVS
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Trifocals
Better near vision
EDOF
Less dysphotopsia
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Design Concept of the xact Mono-EDoF ME4
Visual Range“Depth of Focus”
Mono-FocalIOL
Bifocal+4D
EDoF+1.5D
Trifocal
NearDistance
IntermediateDistance
FarDistance
Minimal optical side effects
Halo /Glare/ Double vision
Reduced Halo / Glare
Xact MonoEDoF
Applicable to wider range of
patients
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Aim of the project
• Hydrophobic diffractive IOLwith 4 rings
Lens performance through
• optical bench testing, • real life simulation• clinical evaluation
To produce a novel and different EDOF IOL
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Lens type Optics Example
Monofocal Refractive Santen Xact W-60R
EDoF Diffractive Tecnis SymfonyZeiss At Lara
Aberration based Sifi Miniwell
Diffractive Santen Xact Mono-EDoF ME4
IOLs tested
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Optical Bench Testing
• Optical Test Equipment : Trioptics OptoSpheric bench
• Model Cornea Used : Corneas matched to IOL asphericity
• Pupil Sizes (at the IOL plane) : 3.0 mm & 4.5 mm
• 550nm wavelength per ISO requirement
• Spatial frequency measured at 15 (50 lp) and 30 cycles / degree (100 lp) per equivalent to 20/40 and 20/20 (per ISO requirement)
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Through Focus MTF Curves
Santen Mono-EDoF IOL has a broad single peak
Other EDoF IOLs have a biphasic curve which are smoothed by white light and corneal aberrations
Optical Bench Testing
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Through Focus Images : 3mm aperture with Corneal asphericity matched to IOL asphericity
Monofocal(W-60R)
Mono-EDoF
Symfony
Miniwell
AT LARA
-0.5D 0.0D 0.5D 1.0D 1.5D
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• Mono-EDoF has crisp emmetropic focus
• Excellent image quality from distance to immediate focus
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4.5 mm pupil
3.0 mm pupilAverage MTF at
100lp/mm (20/20) for 60-70
yrs old
Effect of pupil size on MTF
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Impact of Tilt and Decentration on MTF at 4.5mm pupil
0.5mm decentration
5° TiltMono-EDoF performs as well as normal eyeand is relatively insensitive to decentration and tilt
Average MTF at 50 lp/mm (20/40) eyes between 60 and 70 years old
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• Mono-EDoF has a significantly higher MTF than the average MTF of an age matched phakic eye
• Mono-EDoF has higher MTF than other EDoFIOLs
• Relatively resistant to decentration and tilt in comparison to competitor IOLs
Optical bench testing
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Real Life Vision Simulation Testing
• 3 cameras mounted side by side on car dashboard looking at the same object
• Wet cell system with matching corneas
• Images recorded under identical camera settings
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Polychromatic Images / Photopic Conditions
Monofocal Mono-EDoF Tecnis Symfony
Distance
Decentered by 0.5mm
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Polychromatic Images with Decentration / Mesopic Conditions
Monofocal Mono-EDoF Tecnis Symfony
View of car headlights with IOL off-axis (decentered by 0.5mm)
HeadlightsOff
HeadlightsOn
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Video recording of car headlights with model cornea
Monofocal Mono-EDoF Tecnis Symfony
Night time conditions – 4.5mm at the IOL plane
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Clinical Testing
• Pilot study – Florian Kretz, Rheine, Germany
• Healthy, normal eyes except for cataract– Preoperative keratometric cylinder ≤ 1.0 D
• Three month data– 4 patients, 8 eyes
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1.5 D
3 month post-op Defocus Curve: xact Mono-EDoF
~ 1.80 D
~ 1.5D of Depth of Focus Monocular testing
~ 1.8D of Depth of Focus Binocular testing
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Photopic contrast sensitivity
4 patients, 8 eyes
3 month post-op
There is no statistically significant differences between contrast sensitivity measurements with and without glare
Mesopic Contrast sensitivity
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VISUAL EFFECTS ASSESSMENT
There were no complaints of unwanted visual effects.
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Conclusion
• Higher MTF values and continuous range of vision is expected to result in higher levels of patient satisfaction
• Only 4 rings --- Low incidence of dysphoticsymptoms
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Conclusion• Constant improvement in IOLs
• No such thing as a perfect IOL