the international society of presbyopia - time for a ......breyer, kaymak& klabeeye surgery and...

Breyer, Kaymak & Klabe Eye Surgery and Premium Eyes are Consulting, Study Center & MAB for:

Abott, Alcon, AlimeraSciences, Allergan, AMO, Bayer, Carl Zeiss Meditec, Ellex, Fluoron, Geuder, iOptics, LensAR, Medicem,

Novartis, Oculentis, Oertli, Revision Optics, Santen, Staar Surgical,

Sifi Medtech, Thea, Topcon, Visufarma, Ziemer

Time for a Paradigm Shift in Presbyopia Correction

ISOP 2019, Pullmann Paris Tour Eiffel

My feeling

1. In Presbyopia correction we cause to much unhappy patients

by generally implanting MIOL as an only first line therapy

2. Presbyopia surgery should be individualized

Time for a Paradigm Shift? Why?

„It is more important to recognize a problem,

Than to know it´s solution,

Because the precise description of a problem,

Always leads us to the solution.

Time for a Paradigm Shift? Why? Einstein about Problem Solution

To the following world class surgeons: In alphabetical order (in first and family name):

Arthur Cummings, Wellington Eye Clinic

Dan Reinstein, London Vision Clinic

Julian Stevens, Moorfields Eye Hospital

Referral to their ppt. is mentioned lower bar

Grateful to Supporting Presentations at AECOS Meeting 2019 in Sitges

Problem 1

Presbyopia correcting surgery is „cosmetic“ surgery(at least in most cases)

Problem 2

All efforts to restore accomodation failed, resulting (mostly) in photopic phenomena

Identifying the Problems

Solution 1: Ethics / Risk management

choose a well proven method

with lowest complication rates and

least possibility of loss of lines

and easiest to correct/individualize in case of unhappiness

„Close your eyes and imagine a family member sitting in front of you: what procedure would you choose?“

Solution Pathway: Reduce Risks & Maximize / Individualize Outcomes

There can be NO discussion in elective, cosmetic surgery: Ethics first

Solution 2

Reduce optical side effects and neuroadaption


Problem and Problem Solution

• Accomodative Optics and restoring accomodation „failed“ (yet) as a mass market product

• 5 optical principals left (action and side effects in a rising order)

• Monovision

• Blended Vision

• Refractive Optics

• Diffractive Optics

• Pinhole Effect

Problem : Annoying, unavoidable Side Effect in Lens Based Surgery:

Halo and Glare

Refraction less than Diffraction

Halo

+0 +1 +2 +3 +4 +5 +6 Addition

Iris Retina

+1 und +6 OK, Rest schwierig

Problem : Fact: H&G Rise with Higher Near Addition

Solution : Only Way OUT: Spherical Aberrations and Blended Vision

Quelle: Foto-net.de

Spheric Abberation Chromatic Abberation

Solution 1: Ethics / Risk management

choose a well proven method

with lowest complication rates and

least possibility of loss of lines

and easiest to correct/individualize in case of unhappiness

„Close your eyes and imagine a family member sitting in front of you: what procedure would you choose?“


There can be NO discussion in elective, cosmetic surgery: Ethics first

Problem 2: Methods and their Complication Rate

Complication Risk in rising order:

• Presbyond Femto LASIK

• I(P)CL

• Add on (M)IOL

• RLOE

Arguments for Laser Vision Correction

According to AECOS 2019, Session6: A. Cummings, Wellington Eye Clinic

• External versus Internal

• Simultaneous versus Sequential

• One eye versus 2 eyes

• Different risks, gravity of risks

• Anesthetic risk versus eye risk

• Permanence of IOL-based procedures

• Future Inventions with IOLs

The Acid Test?

65% of surgeons had Laser Vision correction


Satisfaction after implantation of trifocal lenses


and all other diffractive MIOL.....

Target Population: Presbyopes


CLE: Risk of Catastrophic Complications


CLE: Higher Risk for Younger Patients


CLE: Visually Significant Complications


CLE: Long Term Consideration


CLE: How permanent is the Lens Replacement?


Classic Monovision Blended Vision

Presbyopic Surgery 1: Presbyond Femto LASIK – Optic Principles



Dan Reinstein (Alistair Stuart), London Vision Clinic




Most patients cannot tolerate monovision

Dominant eye:mainly correctedfor distance

Non-dominant eye:mainly correctedfor near

Evans BJ. Monovision: a review., Ophthalmic Physiol Opt. , 2007;27:417-439. According to AECOS 2019, Session14: Fake News and true stories of corneal presbyopia correction, Alastair Stuart, London Vision Clinic

Monovision Disadvantages: Low Tolerance

Brain mergers two imagesto see near and far

without glasses

59-67%Patients Tolerate

Dominant eye:mainly correctedfor distance

Non-dominant eye:mainly correctedfor near

Reinstein D. et al. Lasik for Hyperopic Astigmatism abd Presbyopia Using Micromonovision With the Carl Zeis Meditec MEL80.JRS. 2009;25(1):87-93, According to AECOS 2019, Session14: Fake News and true stories of corneal presbyopia correction, Alastair Stuart, London Vision Clinic

Brain mergers two imagesto see near and far

without glasses

~97%Patients Tolerate

Correcting Presbyopia: Laser Blended Vision

Corneal treatment options lead to poor contrast sensitivity

Loss of ≥2 lines: 6.5% Loss of ≥2 lines: 4%

Reduced multifocal

Biaspheric Multifocal

+µ-monovision

Ø Target -0.12 DE, -0.88NDE

Ø Add: 1.75D

Ø Same Add both eyes

Extended DoF +µ

Biasheric Multifocal

Hybrid

Ø Target -0.12 DE, -0.88 NDE

Ø Add: 0.88 DE, 1.75 NDE

Ø Half Add in DE

According to AECOS 2019, Session14: Fake News and true stories of corneal presbyopia correction, Alastair Stuart, London Vision Clinic

Laser Blended Vision: Contrast Sensitivity

Statistically significant improvement (p<0.05)


Germany Census: Age Distributation

§ Bevölkerung nach Altersgruppen und Geschlecht Altersgruppen in absoluten Zahlen, Anteile der Geschlechter in Prozent, 31.12.2010


Retreatment


1. Flap related facts:

No eye rubbing 2 wks

Dry Eye up to 6 months

2. Blended Vision related facts:

1-3 months neuroadaption

Car driving glasses

3. Re LASIK: 1 – 5%

Presbyond Femto LASIK – What the Patient HAS to know upfront!

• Simply not available (yet)

• 50 yo. Lifestyle usually different from a 25 yo.

• Safer than wearing CL over 5 Years

• and

Data for the correlation of progressive glasses and hip replacementunfortunately still hold back by the general orthopedic surgeon

Presbyond? Why not SMILE!

Survey: Methods

Complication risk in rising order:


• I(P)CL or SMILE

• Add on (M)IOL

• RLOE

ICL and SMILE - Monovision

May be a good idea in high corneal spherical aberrations after CL trial wear

Staar Surgical ICL Evo with EDoF

According to AECOS 2019, Session6: J. Stevens, Moorfields Eye Hospital, London

C.E. marked, clinical trials

In progress

Aspheric lens with EDoF

Properties

Bilateral implantation

• ICL is removable if doesn´t meet expections

• ICL collamer material long Track record

• ICL has UV blocker to protect the crystalline

lens

• ICL eventually replaced when cataract

surgery is performed

ICL and SMILE- Monovision

• Minimal invasive procedure (SMILE)

• Reversibility (ICL)

• No H&G

• Cataract induction (ICL)

• No small print reading

• Aquaport Halo (ICL)

• Different near additions

• Diffractive blended vision (LARA/LISA)

BUT

• Lack of proof of concept

• Prospective study results in Peer reviewed publication urgently needed!

• More difficult to implant

IPCL

Survey: Methods



• I(P)CL

• Add on (M)IOL

• RLOE

Add on MIOL in Pseudophakia

Add on MIOL Duett Implantation in Cataract Surgery

Simultaneously

or

sequentially

• Driving force: unsecure, „difficult“ patient

• Higher risk in sequential surgery (2 procedures)

• Maybe! Higher risk of glaucoma

• Explantation in Pigment dispersion (Concave Iris?!)

Add on MIOL Duett Implantation

Survey: Methods



• I(P)CL

• Add on (M)IOL

• RLOE

Refractive Lens Exchange

• Excellent for hyperopia – low/very low risk of RD

• Long-term solution, which patients like

• High quality optics with today´s EDoF and near-future lenses

• Increasing precision with capsule fixated IOLs, machine learing ray-tracing biometry

According to AECOS 2019, Session6: J. Stevens, Moorfields Eye Hospital, London

Let´s Take the Chance at ISOP 2019 and Rebrand! RLE to RLOE, PLEASE!

• RLOE instead of RLE

• IT IS IMPORTANT! Why?:

Ø Because incorrect terminology!

Ø Confuses patients

Ø Makes patients frightened

Essential: Patient Education about diffractive/refractive MIOL

First question: How did you perceive Halo and Glare when you were 30yo.?

Our MiLens® System: Individual MIOL Selection

„mild“„none“

„moderate“ „severe“


Second question: „How often do you drive at night time? Long distances?

Third question: If you experience these photopic phenomena, can you still drive safely?


MiLens® System: Clinical EBM Individual MIOL Selection

Solution: Trifocal IOL or Combination of..

First let the patient check his IV at work/home ....

Solution: Trifocal IOL or Combination of..

My Laptop solution number 1 used to be....

Monofokale IOL (mon, cc)Lisa Tri (bin, sc, n=20)

Symfony EV (bin, sc, n=12)Symfony BV (bin, sc, n=22)

Comfort MplusX (bin, sc, n=22)Comfort MF15-MF20 BV (bin, sc, n=30)

Comfort MF15-MF15 EV (bin, sc, n=30)Comfort MF15-MF15 BV (bin, sc, n=44)

Referenzkurve Visus=1,0 (mon, sc)0.00

0.25

0.50

0.75

1.00

1.25

-3.0-2.5

-2.0-1.5

-1.0-0.5

0.0

Decim

alVisus

Defocus [D]

91%

89%

43%

104% 100%

84%

94%

98%

92%

Choose MIOL according to Defocus Curves

Monofocal

Reference curve

Brief Summary for the Patient

• Especially about downsides:

• Worse mesopic vision

• More light for reading

• 1-5% touch up procedure needed (costs!)

• 1% cummulative RD risk in 10 years (PVD protective)/ Endophthalmitis: 0.05%



First question: „ Halo and Glare percetion when 30yo.“

MiLens® System: Individual MIOL Selection

Halo

+0 +1 +2 +3 +4 +5 +6 Addition

Iris Retina

+1 und +6 OK, Rest schwierig

+1.5D

Problem Solution 1: Low Near Addition

Refractive Optic Diffractive Optic

Problem Solution 2: Refractive Optics

Problem Solution 3: Blended Vision

Oculentis Comfort +1.5D

Target refraction:

Emmetropia Oculentis Comfort +1.5D

Target refraction:-1.5D

We started 6 Years Ago





Clinical Study Results of a New Segmental, Refractive EDOF IOL with Hydrophobic Hybrid Material

Elke Taylor, D.R.H. Breyer, H. Kaymak, K. Klabe, M. Kirca

Breyer, Kaymak & Klabe Eye Surgery and Premium Eyes are Consulting, Study Center & MAB for:Abott, Alcon, AlimeraSciences, Allergan, Alkahest, AMO, Bayer, Carl Zeiss Meditec, Ellex, Fluoron,Gesundheitsamt Rhein-Neuss-Kreis, Geuder, Glaukos, Hangzhou Classon Tec, HOYA, iOptics,KangHong Biotec., LensAR, Medicem, Novartis, Oculentis, Oertli, OMNITM, Optos, PharmaStulln,PhysIOL, Revision Optics, Santen, Staar Surgical, Sifi Medtech, Teleon Surgical Optics, Thea,Topcon, Visufarma, Ziemer

Background: New Hydrophobic Refractive Segmental +1.5D Near Add IOL

Material: Acunex Vario - How to Insert into Cartridge

Material: Acunex Vario - Intraoperative Photography

Monofocal IOL (mon, cc)

Acunex (mon, cc, n=33)Reference curve Visus=1,0 (mon, sc)

0.00

0.25

0.50

0.75

1.00

1.25

-3.0-2.5

-2.0-1.5

-1.0-0.5

0.0

Deci

mal

vis

us

Defocus [D]

Results: Defocus curve - Refractive Segmental +1.5D Near ADD IOL: DCVA

n = Nubmer of eyesmon = monocularcc = distance corrected

100%

59%

43%

• Typical EDOF IOL DefocusCurve

• Compareable to OculentisComfort MF15 IOL

Perc

enta

ge

ofE

yes [%

]

none mild moderate severe

§ Phakic Eyes (n=126)

§ Acunex Vario (n=20)

0%

25%

50%

75%

100%

Strength of Halo & Glare

• 1-4 weeks postop.

• Better results after

neuroadaption after

3 months expected

Results: Halo & Glare Simulator Data

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

1.5 3.0 6.0 12.0

Log1

0(C

S)

Spatial frequency [cpd]

Acunex Glare (bin, cc, n=28)

Acunex NO Glare (bin, cc, n=28)

• Within normal limits

• Compareable to Oculentis Comfort MF 15 IOL

Results: Contrast Sensitivity

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

1.5 3.0 6.0 12.0

Log1

0(C

S)

Spatial frequency [cpd]

Acunex Glare (bin, cc, n=28)

Acunex NO Glare (bin, cc, n=28)

• Within usual limits for EDOF IOL

• Typical curve kink at 6 cpd

Photopic Mesopic

Düsseldorf Formula: Video Award ESCRS 2016 – Category Innovations





The Duesseldorf Formula – An Individualized MIOL Approach

Implantes asimetricos de lentes Varifocales: La formula de Dusseldorf

Alicante 2018, Prof. Jorge Alio


Abott, Alcon, AlimeraSciences, Allergan, AMO, Bayer, Carl Zeiss Meditec, Ellex, Fluoron, Geuder,

iOptics, LensAR, Medicem, Novartis, Oculentis, Oertli, Revision Optics, Santen, Staar Surgical,


Detlev R.H. Breyer

0%

25%

50%

75%

100%

"keine" "schwach" "mittel" "stark"

Perc

enta

geof

Eyes

[%]

Strength of Halo & Glare

Halo & Glare Simulator

Phake Augen (n=126)

Comfort EV (n=30)

Comfort BV (n=36)

Comfort Mplus BV (n=30)

Comfort MplusX (n=10)

n = Number of eyes

EV = Emmetropic Vision

BV = Blended Vision

No significant differencesbetween the groups

= Employee (Age: 16-60)

none mild moderate severe

Results: Halo and Glare – Duesseldorf Formula

• 67% of phakic eyes have SA of 1.5 or better(comparable to: "80% have SA of 2.0 or better")

• à SA > VA

• Significant (p<0.05) differences between mediansUnexpected: BV significantly better than EV

Results: Titmus Stereo-Fly-Test

n = Number of Patients

EV = Emmetropic Vision

BV = Blended Vision

Phak = Phakic eyes

Gruppe

SA [logMAS]

Median Mittel SD

EV 0.37 0.34 0.39

BV 0.00 0.12 0.35

Phak -0.18 -0.03 0.30

Monofokale IOL (mon, cc)Lisa Tri (bin, sc, n=20)

Symfony EV (bin, sc, n=12)Symfony BV (bin, sc, n=22)

Comfort MplusX (bin, sc, n=22)Comfort MF15-MF20 BV (bin, sc, n=30)

Comfort MF15-MF15 EV (bin, sc, n=30)Comfort MF15-MF15 BV (bin, sc, n=44)

Referenzkurve Visus=1,0 (mon, sc)0.00

0.25

0.50

0.75

1.00

1.25

-3.0-2.5

-2.0-1.5

-1.0-0.5

0.0

Decim

alvisus

Defocus [dpt]

91%

89%

43%

104% 100%

84%

94%

98%

92%

Monofocal

Reference curve

Compared to Symfony, Trifocal IOL

Brief Summary for the Patient with Düsseldorf Formula

• Especially about downsides:

• No small print reading

• Glasses for driving a car

• 1-5% touch up procedure needed (costs!)

• 1% cummulative RD risk in 10 years (PVD protective)/ Endophthalmitis: 0.05%

Problem Solution 3: IOL Based Blended Vision in the NEAR Future?!

LAST: Pinhole IOL IC 8. A No Brainer?

• Towards low complication first line solutions

• Towards easy to handle complications

• Towards removable solutions

• Towards less side effects

• Towards second chances

• Towards individual MIOL surgery

• Towards “aggressive“ SDM

• Not hiding risks and touch up costs

• Towards underpromising, overdelivering

Time for a Paradigm Shift? YES Definetely!

As much as I Know...Thank You Jorge Alio

REVIEW ARTICLE

www.apjo.org | 1

Multifocal Intraocular Lenses and Extended Depth of Focus Intraocular Lenses

Detlev R.H. Breyer, MD,* Hakan Kaymak, MD,† Timon Ax,† Florian T.A. Kretz, FEBO,‡ Gerd U. Auffarth, MD,§ and Philipp R. Hagen, MD¶

Abstract: Presbyopia and cataract patients’ desire for increased spec-tacle independence after surgery is one of the main drivers for the de-velopment of multifocal intraocular lenses (MIOLs) and extended depth of focus (EDOF) intraocular lenses (IOLs). As education, biometry, di-agnostics, surgical techniques, and MIOL/EDOF IOL designs have im-proved over the past decade, an increasing number of cataract surgeons have become cataract-refractive surgeons to help address this need. There is not 1 single MIOL/EDOF IOL, however, that suits all patients’ needs. The wide variety of MIOLs and EDOF IOLs, their optics, and their re-spective impact on our patients’ quality of vision have to be fully under-stood to choose the appropriate IOL for each individual; MIOL/EDOF IOL surgery has to be customized. This review article looks at the dif-ferent optical aspects and clinical consequences of MIOLs/EDOF IOLs to help surgeons find an appropriate solution for each of their individual patients.

Key Words: MIOL, EDOF, defocus curves, halo, glare

(Asia-Pac J Ophthalmol 2017;6:0–0)

Several review articles and meta-analyses regarding multifocal intraocular lenses (MIOLs) have been published in scientific

journals, most of which investigate postoperative outcomes of vi-sual acuity for far and near distance. The superiority of MIOLs over monofocal intraocular lenses (IOLs) with respect to near vi-sual acuity has been demonstrated for more than a decade through meta-analyses of randomized controlled trials.1,2 It has also been shown that this gain in near vision comes without a relevant de-crease in distance vision. However, de Silva et al2 questioned whether this intended improvement outweighed the possible ad-verse effects of MIOLs, such as halo and glare. This is an indi-vidual question that depends on the patient’s motivation.2

Visual acuity values for MIOLs have also been reported by Agresta et al.3 A systematic review was conducted to identify studies reporting uncorrected distance visual acuity (UDVA) and uncorrected near visual acuity (UNVA) after cataract surgery with different MIOLs in presbyopic patients. Their filtering method yielded 29 studies. Although the results varied, all studies that reported pre- and postoperative values demonstrated statistically

significant improvements in UDVA and UNVA due to MIOL implantation.

Cochener et al4 conducted a meta-analysis of comparative clinical trials published between 2000 and 2009 that included bi-lateral MIOL implantations and control groups with monofocal IOLs. Random effects models were used to obtain pooled esti-mates for binocular UDVA and UNVA. On the basis of the pre-sented results, the authors concluded that the considered MIOLs offered patients significantly better UNVA than monofocal IOLs. The corresponding mean values were 0.14 logarithm of the mini-mum angle of resolution (logMAR) and 0.47 logMAR, resulting in higher spectacle independence for the MIOL group. There were no statistically significant UDVA differences between refractive and diffractive MIOL groups.

De Vries et al5 also systematically collected monocular and binocular UDVA and UNVA outcomes along with spectacle inde-pendence rates from 16 randomized clinical trials and 41 nonran-domized case series. However, one general problem with collect-ing visual acuity data from different publications is the variation in the presentation of outcomes. Some give Jaeger optotypes whereas others give mean logMAR values with or without stan-dard deviation and so on. With respect to measuring techniques, thus far there has been no standardized way of testing near visual acuity.

Rosen et al6 conducted a comprehensive review of peer- reviewed papers published between 2000 and 2015 that com-prises 4- to 6-month results for monocular and binocular UDVA and spectacle independence from a total of 203 studies. Mon-ocular UDVA of 0.03 logMAR and 0.00 logMAR or better was achieved in 95.7% and 58.1% of the eyes, respectively. The mean value was 0.05 logMAR. Binocular UDVA of 0.03 logMAR and 0.00 logMAR or better was achieved in 99.9% and 79.2% of the eyes, respectively, with 0.04 logMAR being the mean value. Standard deviations were only given for a subset of the studies. The authors reported that 80.1% of the patients achieved spec-tacle independence. Although these averages were taken across all MIOL types, the values fall in line with visual outcomes after implantation of present-day MIOLs.

Additionally, stray light occurrence measured with the C-Quant device (Oculus Optikgeräte GmbH, Wetzlar, Germany) has been systematically assessed in a recent review by Łabuz et al.7 The authors showed that hydrophilic MIOLs, on average, showed less postoperative stray light than hydrophobic MIOLs.

A review article by Braga-Mele et al8 provides a compre-hensive overview of best practices regarding MIOL management, including thorough discussions of corneal-, pupil-, retinal-, and optic nerve‒related issues, along with previous refractive surger-ies that contraindicate MIOL implantation. The authors present suggestions for how to deal with intraoperative problems and dissatisfied MIOL patients. Besides this, they present helpful

From the *Premium Eyes Augenlasern, Düsseldorf; †Breyer, Kaymak, Klabe Augenchirurgie, Düsseldorf; ‡Augenärzte Gerl. Kretz & Kollegen, Rheine; §Universitäts-Augenklinik, Heidelberg; and ¶Internationale Innovative Ophthalmochirurgie GbR, Düsseldorf, Germany.

Received for publication May 15, 2017; accepted July 26, 2017.The authors have no funding or conflicts of interest to declare.Reprints: Detlev R.H. Breyer, MD, Premium Eyes Augenlasern, Martin-Luther-

Platz 22, 40212 Düsseldorf, Germany. E-mail: [email protected]. Copyright © 2017 by Asia Pacific Academy of OphthalmologyISSN: 2162-0989DOI: 10.22608/APO.2017186

Asia-Pacific Journal of Ophthalmology • Volume 6, Number 4, July/August 2017

Copyright © 2017 Asia-Pacific Academy of Ophthalmology. Unauthorized reproduction of this article is prohibited.

Paradigm Shift Necessary? YES, Definetely!: AECOS 2019, Sitges

Sir John Marshall

„ PRK is for heroes of the past“

Paradigm Shift Necessary? YES, Definetely!: ISOP 2019, Paris

Detlev Breyer

„ MIOL surgery first in presbyopia correction is for heroes of the past,

it´s time for (ethical) individual presbyopia correction (IPC)“

Partner of

Merci Beaucoup et bon journee de Petite Paris (Düsseldorf)

the international society of presbyopia - time for a ......breyer, kaymak& klabeeye surgery and...

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