20
Corneal Compensation of Presbyopia INSTRUCTIONAL COURSE COURSE DIRECTOR: Jorge L. Alió, Spain COURSE PARTICIPANTS: Dan Reinstein, UK Ioannis Pallikaris, Greece Günther Grabner, Austria Julian Stevens, UK Mike Holzer, Germany ESCRS, VIENNA, 2011 Course schedule Introduction: Is corneal accommodation possible?: Jorge Alio Femtosecond presbyopic correction: Mike Holzer Refractive inlays: Flexivue Presbylens: Ioannis Pallikaris The Presbylens (Revision Optics): Julian Stevens Pinhole inlays: Fundamentals of pinhole inlays. The Kamra Acufocus: Gunther Grabner Excimer laser Presbylasik techniques: Peripheral presbylasik techniques: Daniel Reinstein Central Presbylasik techniques: Jorge Alio Panel discussion: F F’ N N’ PP’ The optical system of the human eye CORNEAL ACCOMODATION How does the cornea focus at different distances 1. MULTIFOCALITY 2. DEPTH OF FIELD NORMAL CORNEA DEPTH OF FOCUS DOF=0,75 D FACTORS THAT INFLUENCE NORMAL CORNEAL ACCOMMODATION Myopic Astigmatism Irregular Cornea: Keratoconus Manipulated corneas: Spherical & Coma aberration Grado I: Grado II: -2 X 90º

CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

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Page 1: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

Corneal Compensation of PresbyopiaINSTRUCTIONAL COURSE

COURSE DIRECTOR:Jorge L. Alió, Spain

COURSE PARTICIPANTS:Dan Reinstein, UK

Ioannis Pallikaris, GreeceGünther Grabner, Austria

Julian Stevens, UKMike Holzer, Germany

ESCRS, VIENNA, 2011

Course scheduleIntroduction: Is corneal accommodation possible?:

Jorge Alio

Femtosecond presbyopic correction: Mike Holzer

Refractive inlays: Flexivue Presbylens: Ioannis Pallikaris The Presbylens (Revision Optics): Julian Stevens

Pinhole inlays: Fundamentals of pinhole inlays. The Kamra Acufocus: Gunther Grabner

Excimer laser Presbylasik techniques: Peripheral presbylasik techniques: Daniel ReinsteinCentral Presbylasik techniques: Jorge Alio

Panel discussion:

FF F’N N’PP’

The optical system of the human eye CORNEAL ACCOMODATIONHow does the cornea focus at

different distances

1. MULTIFOCALITY

2. DEPTH OF FIELD

NORMAL CORNEA DEPTH OF FOCUS

DOF=0,75 D

FACTORS THAT INFLUENCE NORMAL CORNEAL ACCOMMODATION

• Myopic Astigmatism

• Irregular Cornea: Keratoconus

• Manipulated corneas: Spherical & Coma aberration

Grado I: Grado II:

-2 X 90º

Page 2: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

CORNEAL ACCOMODATIONHow does the cornea focus at

different distances?

1. MULTIFOCALITY

2. DEPTH OF FIELD

METHODS TO INDUCE CORNEAL ACCOMMODATION

• CORNEAL LASER SURGERY: Excimer Laser Multifocal Cornea (PresbyLasik techniques):Intrastromal Femtosecond mutifocality

• CORNEAL INLAYS:Refractive InlaysPinhole Inlays

EXCIMER LASER SURGERY:MODERN PRESBYLASIK

1. CENTER FOR NEAR : Central hyperpositive multifocal area(Central Presbylasik).

2. CENTER FOR FAR: Peripheral multifocal area (Peripheral Presbylasik).

MODERN REQUIREMENTS FOR PRESBYLASIK TECHNIQUES

• Bilateral• Should not decrease vision for far• Should improve functional vision to adequate

levels• Should not induce collateral negative

symptoms• Should be stable• Minimally invassive

FAR VISION

CENTRAL PRESBYLASIKCENTER FOR NEAR MIGHT BE

BETTER…• Synergistic with convergence myosis• Synergistic with the line of sight• Minimal tissue ablation added to the

correction of the main defect• Minimal neuroadaptation , immediate

outcome• Focus dominance FAR/NEAR depending on

pupil size• Minimal induction of HOA / minimal or no

degradation of the quality of the retinal image

Page 3: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

0

1

2

3

4

5

0 0,5 1 1,5 2 2,5 3 3,5 4 4,5 5

IOL Rea Power Facto %r

0 0 58,0938

0,5 0,43 87% 58,527

1 0,86 86% 58,9541

1,5 1,28 85% 59,3747

2 1,70 85% 59,7888

2,5 2,10 84% 60,1962

3 2,50 83% 60,5968

3,5 2,90 83% 60,9905

4 3,28 82% 61,3772

4,5 3,66 81% 61,7568

5 4,04 81% 62,1292

EQUIVALENCE BETWEEN CORNEA AND IOL OPTICAL POWER FOR A…

REFRACTIVE INDEX

PERIPHERAL PRESBYLASIK

• Based on the induction of high levels of negative asphericity at the mid –peripheral cornea

• The inducton of high levels of negative spherical aberration increases dept of field

• Requires a period of neuroadaptation

FAR VISION

PERIPHERAL PRESBYLASIK

Visx Aspheric Presby Ablation

CENTRAL Vs PERIPHERAL PRESBYLASIK

Differences in tissue removal :

4 micron more

CENTRAL PERIPHERALHYPEROP +3(+2 near ADD)

150 micron for -0.5 asphericity

MYOP -3(+2 near ADD)

4 micron200 micron for

-0.25 asphericity > 270 micron for -0.5 asphericity

CENTRAL PresbyLasikPresbyMax ®

Page 4: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

Aspheric Visx TreatmentAspheric Visx TreatmentCustomVueCustomVue

Presbyopia AblationPresbyopia Ablation

CustomVue + PresbyCustomVue + Presby

+2.00+0.50x125+2.00+0.50x125

PERIPHERAL PRESBYLASIK PresbyLasik Meta-analysis(only bilateral procedures)

Number of studies:Peripheral: 9Central: 4

Years:2004 to 2009

Number of eyes included: Peripheral: 1072Central: 140

Level of evidence:Peripheral: 1.66Central: 2

PresbyLASIK PresbyLASIK –– Main ReportsMain ReportsInvestigatorInvestigator AliAlióó ** JacksonJackson Jung **Jung ** WilliamsWilliamsLaserLaser H. Eye TechH. Eye Tech AMO/VISX AMO/VISX (software)(software) AMO/VISX AMO/VISX (software)(software) AMO/VISX AMO/VISX (software)(software)

N=eyes/patientsN=eyes/patients 50/25 LASIK50/25 LASIK 56/28 LASIK56/28 LASIK 54/27 LASIK (25) PRK (29)54/27 LASIK (25) PRK (29) 60/30 PRK60/30 PRK

AgeAge 58 (5158 (51--68)68) 56 (4556 (45--65)65) 53 (4553 (45--63)63) 52 (4652 (46--61)61)

Mean SEMean SE +1.69 +1.69 ±± 0.63 D0.63 D(+0.50 to +3.00 D)(+0.50 to +3.00 D)

+1.92 +1.92 ±± 0.56 D0.56 D +1.16 +1.16 ±± 0.82 D0.82 D +1.46 +1.46 ±± 0.55 D0.55 D

FollowFollow--up (mths)up (mths) 66 1212 66 66

Binocular UCDVA Binocular UCDVA 20/25 or better20/25 or better

88%88% 100%100% 93% (monocular)93% (monocular) 86%86%

Binocular UCNVA J3 Binocular UCNVA J3 or betteror better

91%91% 100%100% 64%64% 97%97%

Mean PostMean Post--op SEop SE --0.34 0.34 ±± 0.55 D0.55 D +0.07 +0.07 ±± 0.48 D0.48 D +0.33 +0.33 ±± 0.45 D0.45 D +0.16 +0.16 ±± 0.60 D0.60 D

Simultaneous 20/25 & J3Simultaneous 20/25 & J3 -- 100%100% 64%64% --

Lines Lost Dist & NearLines Lost Dist & Near 14% 2 lines dist 14% 2 lines dist 16% for near16% for near

14% 2 lines dist14% 2 lines dist8.3% near8.3% near

4% 2 lines dist4% 2 lines dist0% near0% near

0% 2 lines dist0% 2 lines dist0% near0% near

Contrast AcuityContrast Acuity DecreasedDecreased Decrease Decrease –– Not SignificantNot Significant Decrease Decrease –– Not SignificantNot Significant --

HOAHOA SA SA ↓↓ Coma Coma ↑↑ SA SA ↓↓ Coma Coma ↑↑ SA SA ↓↓ Coma Coma ↑↑ --

Satisfaction Dist & Satisfaction Dist & NearNear

High, 72% no High, 72% no glassesglasses

High, 49% no glassesHigh, 49% no glasses -- High, 79% satisfiedHigh, 79% satisfied

RetreatmentsRetreatments 12%12% 00 00 00

** AliAlióó et al. Correction of presbyopia by technovision central multifoet al. Correction of presbyopia by technovision central multifocal LASIK (PresbyLASIK). J Refract Surg. 2006;22:453cal LASIK (PresbyLASIK). J Refract Surg. 2006;22:453--460.460.

**** Jung et al. Multifocal Corneal Ablation for Hyperopic PresbyopeJung et al. Multifocal Corneal Ablation for Hyperopic Presbyopes. J Refract Surg. 2008;24:903s. J Refract Surg. 2008;24:903--910. 910.

MONOCULAR BINOCULAR

Type of presbylasik CENTRAL

No. EyesPERIPHERAL

No. EyesCENTRAL

No. PatientsPERIPHERALNo. Patients

UCVADISTANCE≥ 0.8 (20/25)

89 (94.4%) 786 (86.1%) 68 (97.1%) 264 (100%)

UCVANEAR ≥ J3

90 (100%) 975 (90.9%) 70 (100%) 277 (100%)

Last 5 years reports (only binocular procedures)Definition of success:•Far: ≥ 0.8 (20/25)•Near: ≥ J3

* COMMENT: Peripheral presbylasik requires a longer follow-up to achieve success

FEMTOSECONDS MULTIFOCAL CORNEA SURGERY

(Intracore )®

IOP

INTRACOR presbyopia mechanism®

Page 5: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

• J1 post op

• 5min post op

CENTER FOR NEAR CORNEAL LASER PROCEDURES

• Both PresbyMax and Intracore works improving near vision related to pupil size

• Both, confirmed by optical analysis by simulated RayTrace on real case data

• To add central corneal power should have equivalent effects to multifocal pupil dependent IOLs

• Still these techniques require to pass the test of time to confirm stability of the outcomes

CORNEAL INLAYS

• REFRACTIVE :

• PINHOLE :

CrystallineLens

Retina

Pupil

Cornea

• Inlay steepens central cornea– Dilated pupil allows for distance image focus– Pupil constriction during accomodative response

increases near power to create pseudo-accommodation

FLEXIVUE® Optical Design

Model Eye

FLEXIVUE SLIT LAMP APPEARANCE

Page 6: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

Random hole pattern

Solid ID andOD edge

Pores are 5 to 11 microns diameter

CORNEA INLAYS

• PINHOLE EFFECT

Near Object Less Blurred

Image

Lens Cannot Accommodate

Presbyopic Near Vision with a Pinhole Inlay

Focus Behind Retina

Smaller Blur Circle

ACI

Depth of Field with Kamra

Near Vision is Clear

Intermediate Vision is Clear

Distance Vision is Clear

Kamra Slit Lamp appearance

CONCLUSIONS• Corneal compensation of presbyopia can be

accomplished through different mechanisms and surgical techniques

• Such methods are feasible and successful• They will have probably different indications

depending on patient´s profile and corneal anatomy

• They may offer a more attractive option than CLT (Cristaline Lens Mutilation and substitution by an IOL) as they are less invasive and, in some cases, reversible

Page 7: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

Pinhole InlaysFundamentals, Results ,Complications and Outlook of the

AcuFocus™ Kamra Inlay

Pinhole InlaysFundamentals, Results ,Complications and Outlook of the

AcuFocus™ Kamra Inlay

G.Grabner

and co-workersO.Seyeddain, M.Hohensinn, W.Riha, G.Nix, T. Rückl, M.Rasp, A.K.Dexl

G.Grabner

and co-workersO.Seyeddain, M.Hohensinn, W.Riha, G.Nix, T. Rückl, M.Rasp, A.K.Dexl

ESCRS Paris, 2010, Instructional Course ESCRS Paris, 2010, Instructional Course ““Corneal Compensation of Corneal Compensation of PresbyopiaPresbyopia””

Universitätsaugenklinik Salzburg

AcuFocus™ ACI-7000 Corneal InlayAcuFocusAcuFocus™™ ACIACI--7000 Corneal Inlay7000 Corneal Inlay

•• Designed to improve near and intermediate Designed to improve near and intermediate vision invision in presbyopiapresbyopia

•• PolyvinylidenePolyvinylidene fluoridefluoride•• 1600 random nutritional holes 1600 random nutritional holes (25(25µµm m ØØ))

Central aperture:Central aperture: 1.6 mm1.6 mmOverall diameter: 3.8 mmOverall diameter: 3.8 mm

10 microns thin10 microns thin

Blocks Blocks unfocused lightunfocused light

Allows focused Allows focused light into the eyelight into the eye

Universitätsaugenklinik Salzburg

Near Vision Same principle used in camera lenses to increase range of vision

Normal

Presbyopia

With ACI

Increasing DepthIncreasing Depth ofof FieldField !!

Universitätsaugenklinik Salzburg

Surgical ProcedureSurgical ProcedureSurgical Procedure

Non dominant EyeTopical anesthesiaFlap created (Intralase, 170 µm depth)ACI-7000 insertion and centrationClosing of flap< 30 minutes - start to finish

Non dominant EyeNon dominant EyeTopical anesthesiaTopical anesthesiaFlap created (Flap created (IntralaseIntralase, 170 , 170 µµm depth)m depth)ACIACI--7000 insertion and7000 insertion and centrationcentrationClosing of flapClosing of flap< 30< 30 minutes minutes -- start to finishstart to finish

Universitätsaugenklinik Salzburg

Inclusion criteriaInclusion criteria•• naturalnatural presbyopic emmetropespresbyopic emmetropes•• age between 45 age between 45 -- 55 years55 years•• spherical Equivalent of spherical Equivalent of ±± 0.50.5 sphsph•• reading add between +1.0reading add between +1.0 sphsph to +2.5to +2.5 sphsph•• KK--value value ≥≥ 41.00D and 41.00D and ≤≤ 47.00D 47.00D •• UNVA UNVA ≥≥ 20/100 and 20/100 and ≤≤ 20/4020/40•• BCDVA BCDVA ≥≥ 20/20 in both eyes20/20 in both eyes

Exclusion criteriaExclusion criteria•• prior eye surgeryprior eye surgery•• any other eye diseaseany other eye disease•• cycloplegiccycloplegic Refraction > Refraction > ±± 0.50.5 sphsph

StudyStudy Design / Salzburg GroupDesign / Salzburg GroupAs part of a prospective nonrandomizedAs part of a prospective nonrandomizedMulticenterMulticenter FDA Study FDA Study (U.S. & European Sites)(U.S. & European Sites)

Universitätsaugenklinik Salzburg

RE49 year old presbyopeNON-implanted eye

Page 8: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

Universitätsaugenklinik Salzburg

LE49 year old presbyopeIMPLANTED eye

Universitätsaugenklinik Salzburg

Uncorrected Visual Acuity Results (mean)Uncorrected Visual Acuity Results (mean)

SalzburgResults

PreOP

n=321Mon=32

3Mon=32

6Mon=32

9 Mon=32

12Mon=32

24Mon=32

30Mon=31

36Mon=32

NEAR (IE)line change vs base

J-7/J-8

J2+3.6

J2+4.4

J2+4.3

J1+4.7

J2+4.4

J2+4.4

J2+4.4

J1+4.6

Intermediate (IE)* line change vs base

20/40 20/25+1.4

20/25+1.8

20/25+1.7

20/25+1.7

20/25+1.7

20/25+1.6

20/25+1.8

20/25+2.3

Distance (IE)line change vs base

20/16 20/25-0.9

20/20-0.7

20/20-0.8

20/20-1.0

20/20-0.8

20/20-0.7

20/20-0.8

20/20-0.8

Distance (OU)line change vs base

20/16 20/160

20/160

20/16-0.1

20/16-0.1

20/160

20/160

20/16-0.1

20/160

* Letter size seen at 80 cm testing distance

Universitätsaugenklinik Salzburg

Uncorrected Near VA (Implanted Eye)Uncorrected Near VA (Implanted Eye)

FDA: 75% ≥ J5

Optec 6500P Vision tester

Universitätsaugenklinik Salzburg

Uncorrected Intermediate VA (IE)Uncorrected Intermediate VA (IE)

Optec 6500P Vision tester

Universitätsaugenklinik Salzburg

Uncorrected Distance VA (IE)Uncorrected Distance VA (IE)

Optec 6500P Vision tester

Universitätsaugenklinik Salzburg

Uncorrected Distance & Near VAUncorrected Distance & Near VA

20/2020/20

Optec 6500P Vision tester

Page 9: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

Universitätsaugenklinik Salzburg

Complications

0.5 mm recentration after 7 months0.5 mm0.5 mm recentration afterrecentration after 77 monthsmonths

11 case with epithelial ingrowthcase with epithelial ingrowth andand repeated flaprepeated flap lift lift

22 cases with decentered inlayscases with decentered inlaysLow decreaseLow decrease UDVA,UDVA, low increaselow increase in UNVA & UIVA 6in UNVA & UIVA 6 months after implantation months after implantation

Universitätsaugenklinik Salzburg

Visual Acuity after Recentration

4545

4550

44

40

23

41

34

43

30

5147

45

0

10

20

30

40

50

60

preOp 1 Month 3 Month 9 Month 15 Month 21 Month 30 Month

Time

UCN

VA E

DTRS

Patient 1 Patient 2

Visual Acuity after Recentration

39

32

5049

5047

48

5554

5045

49

43

50

0

10

20

30

40

50

60

preOp 1 Month 3 Month 9 Month 15 Month 21 Month 30 Month

Time

UCDV

A E

DTRS

Patient 1 Patient 2

22 cases with decentered inlayscases with decentered inlays

UncorrectedUncorrected distance anddistance and nearnear VA 30VA 30 months after recentrationmonths after recentration

UCNVA UCDVA

20/20

Complications

Universitätsaugenklinik Salzburg

Solution for optimising centration

LineLine--ofof--sightsight (LOS) (LOS) -- DeviceDevice

TheThe KAMRA KAMRA AcuTargetAcuTargetTMTM

Universitätsaugenklinik Salzburg

For the AcuFocus Corneal Inlay (ACI)

Universitätsaugenklinik Salzburg

Future ?

1600 holes1600 holesconstant sizeconstant sizethickness 10 thickness 10 µµ

8400 holes8400 holesvariable sizevariable sizethicknessthickness 5 5 µµ

new Pocket – technique (target depth 200 - 220 µ)

LDVLDV IntraLaseIntraLase

n = 10n = 101 1 yearyear ff--uu

- is here !

newnew implantimplant

Universitätsaugenklinik Salzburg

Effective

Extraocular and minimally invasive

Stable and well toleratedpotentially reversible

Allows for complete ocular exam / Tx postop.Great potential

post-LASIK presbyopiapseudophakia

AcuFocus™ ACI 7000 - ConclusionsAcuFocus™ ACI 7000 - Conclusions

Page 10: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

Universitätsaugenklinik Salzburg

4 years postfs-LASIK

iFS > 220 µ

140 µ

Universitätsaugenklinik Salzburg

Excellent option forExcellent option for presbyopiapresbyopia ! !

Page 11: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

Laser Blended Vision with MEL80

Dan Z Reinstein MD MA(Cantab) FRCSC FRCOphth1,2,3,4

1. London Vision Clinic, London, UK2. St. Thomas’ Hospital - Kings College, London, UK 3. Weill Medical College of Cornell University, New York, USA4. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche), Paris, France

This indication for use is not cleared by the FDA for distribution in the United States

©DZ Reinstein [email protected]

Financial Disclosure

The author (DZ Reinstein) acknowledges a financial interest in Artemis™ VHF digital ultrasound (ArcScan Inc, Morrison, CO)

The author (DZ Reinstein) is a consultant for Carl Zeiss Meditec AG (Jena, Germany)

©DZ Reinstein [email protected]

Laser Blended Vision: 8-in-1 Mechanism5. Retinal image processing

[edge detection]6. Neural summation7. Blur adaptation8. Neural suppression

1. Monovision principle2. Depth of field to reduce anisometropia3. Spherical aberration control

[DOF without decrease quality of vision]

4. Vertex centration of spherical aberration[OSA coma, on-axis symmetry of image blur]

©DZ Reinstein [email protected]

Laser Blended Vision: 8-in-1 Mechanism5. Retinal image processing

[edge detection]6. Neural summation7. Blur adaptation8. Neural suppression

1. Monovision principle2. Depth of field to reduce anisometropia3. Spherical aberration control

[DOF without decrease quality of vision]

4. Vertex centration of spherical aberration[OSA coma, on-axis symmetry of image blur]

©DZ Reinstein [email protected]

Presbyopia: Ideal Solution

Near

Intermediate

Distance

Far Distance

Right Eye Left Eye

3.00 D 3.00 D

©DZ Reinstein [email protected]

Influence of Spherical Aberration on Depth of Field

without spherical aberration

with spherical aberration

Slides courtesy Hartmut Vogelsang, PhD

Page 12: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

©DZ Reinstein [email protected]

Laser Blended Vision: 8-in-1 Mechanism5. Retinal image processing

[edge detection]6. Neural summation7. Blur adaptation8. Neural suppression

1. Monovision principle2. Depth of field to reduce anisometropia3. Spherical aberration control

[DOF without decrease quality of vision]

4. Vertex centration of spherical aberration[OSA coma, on-axis symmetry of image blur]

©DZ Reinstein [email protected]

Control Pre Control Post Pre CRS-M Repair

Post CRSM-Repair

Sph Ab Area 122 276 563 410

0100200300400500600700800900

µm

2

p

3 cpd 6 cpd 12 cpd 18 cpdControl Pre 1.02 1.02 1.03 1.04Control Post 1.04 1.01 1.03 1.01Pre CRSM-Repair 0.85 0.84 0.77 0.75Post CRSM-Repair 1.04 1.02 1.02 1.00

0.5

0.6

0.7

0.8

0.9

1.0

1.1

1.2

Normalized Contrast

Sensitivity Ratio

How much spherical aberration?Spherical Aberration Normalized Contrast

Sensitivity Ratio

27%

• Tolerable level ~0.56 µm @ 6mm

Control WFG Repair

©DZ Reinstein [email protected]

Depth of Field by SA: Myopia

Sphe

rical

Abe

rrat

ion

+ve

-ve

0

Low High High Pre SA

Threshold

©DZ Reinstein [email protected]

Depth of Field by SA: Hyperopia

Sphe

rical

Abe

rrat

ion

+ve

-ve

0

Low High Dist/Near Eye

Threshold

Threshold

©DZ Reinstein [email protected]

Depth of Field by SA: Emmetropia

Sphe

rical

Abe

rrat

ion

+ve

-ve

0

Dist Eye Near Eye

Threshold

Threshold©DZ Reinstein 2010

[email protected]

Laser Blended Vision: 8-in-1 Mechanism5. Retinal image

processing [edge detection]

6. Neural summation7. Blur adaptation8. Neural suppression

1. Monovision principle2. Depth of field to reduce anisometropia3. Spherical aberration control

[DOF without decrease quality of vision]

4. Vertex centration of spherical aberration[OSA coma, on-axis symmetry of image blur]

If we can increase depth of field fully by

spherical aberration, brain can create sharp

perception at all distances

Page 13: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

©DZ Reinstein [email protected]

Simulation for -1.50 D defocus-1.50 D @ 7 mm

Add spherical aberrationReduce pupil size to 4 mm

With spherical aberration and @ 4 mm

Central neural processing©DZ Reinstein 2010

[email protected]

Presbyopia: Ideal Solution

Near

Intermediate

Distance

Far Distance

Right Eye Left Eye

3.00 D 3.00 D

©DZ Reinstein [email protected]

Current Possible Depth of Field Increase

Near

Intermediate

Distance

Far Distance

Right Eye Left Eye

1.50 D 1.50 D

Loss of contrast

©DZ Reinstein [email protected]

Laser Blended Vision: 8-in-1 Mechanism5. Retinal image processing

[edge detection]6. Neural summation7. Blur adaptation8. Neural suppression

1. Monovision principle2. Depth of field to reduce anisometropia3. Spherical aberration control

[DOF without decrease quality of vision]

4. Vertex centration of spherical aberration[OSA coma, on-axis symmetry of image blur]

©DZ Reinstein [email protected]

Laser Blended Vision – Micro-Monovision

Near

Intermediate

Distance

Far Distance

Dominant Eye Non-Dominant Eye

“Blend Zone”

1.50 D 1.50 D

©DZ Reinstein [email protected]

Contact Lens Monovision

Near

Intermediate

Distance

Far Distance

Dominant Eye Non-Dominant Eye

“Blend Zone”“Blur Zone”

1.50 D

1.50 D

Page 14: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

©DZ Reinstein [email protected]

Correcting Presbyopia: Contact Lens Monovision

Dominant eye:mainly corrected for distance

Non-dominant eye:mainly corrected for near

Brain merges two images to see near and

far without glasses

59-67%Patients Tolerate

Evans BJ. Monovision: a review. Ophthalmic Physiol Opt.2007;27:417-439.

©DZ Reinstein [email protected]

Correcting Presbyopia: Laser Blended Vision

Brain merges two images to see near and

far without glasses

Dominant eye:mainly corrected for distance

Non-dominant eye:mainly corrected for near

~97%Patients Tolerate

Reinstein DZ et al. LASIK for Hyperopic Astigmatism and Presbyopia Using Micro-monovision With the Carl Zeiss Meditec MEL80. JRS. 2009;25(1):87-93

©DZ Reinstein [email protected]

Laser Blended Vision: 8-in-1 Mechanism5. Retinal image processing

[edge detection]6. Neural summation7. Blur adaptation8. Neural suppression

1. Monovision principle2. Depth of field to reduce anisometropia3. Spherical aberration control

[DOF without decrease quality of vision]

4. Vertex centration of spherical aberration[OSA coma, on-axis symmetry of image blur]

Online Feb 2010

Laser Blended Vision:Binocular UDVA > Monocular UDVA (distance eye)

Evans BJ. Monovision: a review. Ophthalmic Physiol Opt. 2007;27:417-439.

Traditional Monovision:Binocular UDVA < Monocular UDVA (distance eye)

©DZ Reinstein [email protected]

Binocular Vision: Neural Summation

0%10%

20%30%40%50%60%70%80%

90%100%

Distance UCVA After All Treatments

Cum

ulat

ive

Perc

enta

ge E

yes

Near Eyes 1% 3% 15% 24% 36% 45% 80%

Distance Eyes 9% 45% 92% 98% 99% 100% 100%

Binocular 13% 53% 96% 98% 100% 100% 100%

20/12.5 or better

20/16 or better

20/20 or better

20/25 or better

20/32 or better

20/40 or better

20/63 or better

Distance UCVA After All Treatments

Near Eyes 1% 3% 15% 24% 36% 45% 80%

Distance Eyes 9% 45% 92% 98% 99% 100% 100%

Binocular 13% 53% 96% 98% 100% 100% 100%

©DZ Reinstein [email protected]

Laser Blended Vision: 8-in-1 Mechanism5. Retinal image processing

[edge detection]6. Neural summation7. Blur adaptation8. Neural suppression

1. Monovision principle2. Depth of field to reduce anisometropia3. Spherical aberration control

[DOF without decrease quality of vision]

4. Vertex centration of spherical aberration[OSA coma, on-axis symmetry of image blur]

©DZ Reinstein [email protected]

Blur Adaptation

Wore glasses except for VA measurement

No glasses throughout

Wore glasses throughout

No change in Rx

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©DZ Reinstein [email protected]

Laser Blended Vision: 8-in-1 Mechanism5. Retinal image processing

[edge detection]6. Neural summation7. Blur adaptation8. Neural suppression

1. Monovision principle2. Depth of field to reduce anisometropia3. Spherical aberration control

[DOF without decrease quality of vision]

4. Vertex centration of spherical aberration[OSA coma, on-axis symmetry of image blur]

©DZ Reinstein [email protected]

Ocular Rivalry and Blur Suppression vs Multifocal

• Neuronal gates instantaneously select the better image, or elements of each, to obtain the best image for the task at hand

Awareness OD

Suppression OS

Source: Monovision in name only. William F Maloney. Ocular Surgery News US Edition October 1, 2006

Binocular Mediating Neuron

OD

OS

©DZ Reinstein [email protected]

Brain adaptation

Multi-focality Binocular Fusion

©DZ Reinstein [email protected]

Problem With Multi-focality

ReSTOR ReZoom

Near

Far

Near

Far

Anschütz,Dausch,Klein,Joly

(Meditec group, 1991)

Avalos, Rozakis, Agarwal (PARM-technique, 1998)

G.Tamayo (2000)

Concentric distance near zonesDiffraction design

PROBLEM:Two Images

Multi-focal Ablation Profiles

Multi-focal IOLs

©DZ Reinstein [email protected]

Laser Blended Vision: 8-in-1 Mechanism5. Retinal image processing

[edge detection]6. Neural summation7. Blur adaptation8. Neural suppression

1. Monovision principle2. Depth of field to reduce anisometropia3. Spherical aberration control

[DOF without decrease quality of vision]

4. Vertex centration of spherical aberration[OSA coma, on-axis symmetry of image blur]

©DZ Reinstein [email protected]

Centration: Visual Axis vs Entrance Pupil

Phoroptor Lens

No Angle Kappa

Phoroptor Manifest Refraction Excimer Laser Ablation

Large Angle Kappa

Ablation Profile

Phoroptor Lens

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©DZ Reinstein [email protected]

Centration: Visual axis vs Pupil centre

Higher order

wavefront map

Objective

Point Spread Function

Subjective

Point Spread Function

Vertex centration Pupil centration

Subjective PSF correlates with vertex PSF, NOT pupil PSF

©DZ Reinstein [email protected]

Laser Blended Vision: 8-in-1 Mechanism5. Retinal image processing

[edge detection]6. Neural summation7. Blur adaptation8. Neural suppression

1. Monovision principle2. Depth of field to reduce anisometropia3. Spherical aberration control

[DOF without decrease quality of vision]

4. Vertex centration of spherical aberration[OSA coma, on-axis symmetry of image blur]

Outcomes

Measurement of Effective Depth of Field

Example: Emmetropic Patient

©DZ Reinstein [email protected]

Laser BV Emmetropic LASIK – 56 yo Female

56 yo OD OS Binocular

Pre

Manifest +0.75 -0.75 x 158 +0.50 -0.75 x 170

BSCVA 20/16 20/16

1 Yr Post Op

UCVA 20/16 20/32 20/16 & J2

Manifest +0.25 sph -1.00 -0.50 x 20

BSCVA 20/16 20/16

©DZ Reinstein [email protected]

• Near eye Rx: -1.00 -0.50 x 20– SEQ -1.25 D UCVA 20/63

20253240506380

100125160

-2.50-2.25-2.00-1.75-1.50-1.25-1.00-0.75-0.50-0.250.00

Spherical Equivalent (D)

Dis

tanc

e U

CVA

(log

Mar

)

Expected Distance UCVA

20/20 0.00

20/25 -0.25

20/32 -0.50

20/40 -0.75

20/50 -1.00

20/63 -1.25

20/80 -1.50

©DZ Reinstein [email protected]

20253240506380

100125160

-2.50-2.25-2.00-1.75-1.50-1.25-1.00-0.75-0.50-0.250.00

Spherical Equivalent (D)

Dis

tanc

e U

CVA

(log

Mar

)

Expected Distance UCVA

• Near eye Rx: -1.00 -0.50 x 20– SEQ -1.25 D UCVA 20/63– Actual UCVA 20/32 -0.50 D

20/20 0.00

20/25 -0.25

20/32 -0.50

20/40 -0.75

20/50 -1.00

20/63 -1.25

20/80 -1.50

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©DZ Reinstein [email protected]

20253240506380

100125160

-2.50-2.25-2.00-1.75-1.50-1.25-1.00-0.75-0.50-0.250.00

Spherical Equivalent (D)

Dis

tanc

e U

CVA

(log

Mar

)

Expected Near Addition – 56 yo Female

• Near eye Rx: -1.00 -0.50 x 20– SEQ -1.25 D UCVA 20/63– Actual UCVA 20/32 -0.50 D

Age Add50-52 +1.50 D

52-54 +1.75 D

54-56 +2.00 D

56-58 +2.25 D

Over 58 +2.50 D

Near UCVA: J2

©DZ Reinstein [email protected]

20253240506380

100125160

-2.50-2.25-2.00-1.75-1.50-1.25-1.00-0.75-0.50-0.250.00

Spherical Equivalent (D)

Dis

tanc

e U

CVA

(log

Mar

)

Depth of Field – 56 yo Female

• Near eye Rx: -1.00 -0.50 x 20– SEQ -1.25 D UCVA 20/63– Actual UCVA 20/32 -0.50 D

Age Add50-52 +1.50 D

52-54 +1.75 D

54-56 +2.00 D

56-58 +2.25 D

Over 58 +2.50 D

Near UCVA: J2

Depth of field: 1.50 D

Outcomes of Non-linear Aspheric Presbyopic Micro-monovision LASIK for Myopia, Hyperopia, and Emmetropia

Online Feb 2010

©DZ Reinstein [email protected]

Blended Vision: Methods

Myopia Hyperopia Emmetropia

# Patients 136 111 119

SEQ-3.58 ± 1.80 Dup to -8.50 D

+2.58 ± 1.17 Dup to +5.75 D

+0.35 ± 0.35 D-0.50 to +0.75 D

Cylinder -0.83 ± 0.64 D up to -2.50 D

-0.49 ± 0.50 D up to -3.25 D

-0.39 ± 0.30 D up to -1.00 D

Agemedian 49 yrs

43 to 63median 56 yrs

44 to 66median 54 yrs

43 to 71

©DZ Reinstein [email protected]

Routine LASIK Procedure

• Hansatome 160• CRS-Master custom programming

– Non-linear aspheric ablation profile DOF• MEL80 excimer laser• Micro-monovision:

– Dominant: “plano” [plano to -0.75] – Non-dominant: “-1.50 D” [-0.75 to -2.25]

• >90% follow up at 1 year• Results presented including enhancements

©DZ Reinstein [email protected]

Laser Blended Vision: Results

Emmetropic Population

(In Press)Online Feb 2010

Myopia20/20 & J5

98.5%

Hyperopia20/20 & J5

94.5%

Emmetropia20/20 & J5

97.7%

20/20J5

upto -8.50 D upto +5.75 D

Page 18: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

©DZ Reinstein [email protected]

Blended Vision: Safety

0%

10%

20%

30%

40%

50%

60%

70%

Lines Change in BSCVA

Perc

enta

ge E

yes

Myopia 0.0% 8% 55% 36% 1%

Hyperopia 0.0% 17% 62% 19% 2%

Emmetropia 0.0% 13% 64% 22% 1%

Loss 2 or More Loss 1 No Change Gain 1 Gain 2 or More

Range: -8.50 D – plano – +5.75 D

©DZ Reinstein [email protected]

Laser Blended Vision: Contrast Sensitivity

*

Statistically significant improvement (p<0.05)

* * ** *

MyopiaUpto -8.50D, n=272

HyperopiaUpto -8.50D, n=222

Emmetropian=142

Stereo Acuity

©DZ Reinstein [email protected]

Stereo Acuity: Patients & Methods• 22 myopes, 38 hyperopes, 16 emmetropes

• Stereo acuity measurements (4-dot test)– Pre-op: near-corrected– Post-op: near-corrected– Post-op: uncorrected

• Analysis– Safety: post-op near corrected – pre-op near

corrected– Efficacy: post-op uncorrected – pre-op near

corrected

# Patients 76

SEQ-0.40 ± 2.69 D

-7.13 to +3.75 D

Cylinder-0.73 ± 0.54 Dup to -2.25 D

Agemedian 57 yrs

45 to 69

©DZ Reinstein [email protected]

• All eyes retained BCSA of 100 arcsec or better post-operatively• No statistically significant difference between pre-op best-corrected

stereaoacuity and post-op best-corrected stereoacuity (p>0.185)

Stereo Acuity: Safety(near-corrected pre vs near-corrected post)

Fawcett et al demonstrated a loss of best-corrected stereo after monovision LASIK/PRK (J.AAPOS. 2001;5(6):342-7)

Control Monovision <1.50D Monovision ≥1.50D

Stereo (median) 40 sec 100 sec 150 sec

Time in monovision14.5 months (6-47m)

©DZ Reinstein [email protected]

Stereo Acuity: Efficacy(near-corrected pre vs near-uncorrected post)

• All eyes retained UCSA of 400 arcsec or better post-operatively

Page 19: CORNEAL ACCOMODATION How does the cornea focus at … · 2019-07-11 · range of vision Normal Presbyopia With ACI Increasing Depth of Field ! Universitätsaugenklinik Salzburg Surgical

Non-linear Aspheric Micro-Monovision:Summary

©DZ Reinstein [email protected]

Summary

• Non-linear aspheric micro-monovision– Correction of pure presbyopia (distance normal)– Wide range of refractive error: +5.00 to -9.00– Simultaneous accurate correction of cylinder– Easily enhanced in future if required– Centration on visual axis– Minimal compromise to contrast sensitivity and night

vision disturbances– Tolerated by >95% of patients– Functional stereo acuity maintained– Performed as bilateral simultaneous 10 minute

procedure with fast recovery

Laser Blended Vision with MEL80

Dan Z Reinstein MD MA(Cantab) FRCSC1,2,3,4

1. London Vision Clinic, London, UK2. St. Thomas’ Hospital - Kings College, London, UK 3. Weill Medical College of Cornell University, New York, USA4. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche), Paris, France

Thank YouThis indication for use is not cleared by the FDA for distribution in the United States

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1

• The Lens is implanted into the corneal stroma of the non-dominant eye, inside a pocket created using femtosecondlaser

Intracorneal Inlays for Presbyopia

Figure 1: The Flexivue Microlens™ is a transparent, hydrophilic disc with 3 mm diameter and approximately 15 μm edge thickness. The central 1,8 mm diameter of the disc is plano and the peripheral zone has an add power. The base power available range from +1,25 D to +3,50 D in 0,25 D increments. At the center of the disc there is a hole of 0,5mm diameter that permits the transfer of oxygen and nutrients of the cornea through the lens.

15 µm 3 mm

Refractive Power:

+1,25D to +3,50D

No Refractive

Power

1,8 mm

Flexivue Micro-Lens (Presbia)

Intracorneal Inlays - During Far Vision

Figure 2: During far vision the rays pass through the central zone of the implant (blue line) and through the free peripheral corneal tissue (interrupted blue line) without the Lens add refractive effect and will be sharply focused on the retina, whereas the rays which pass through the refractive peripheral zone (red line) will be focused in front of the retina.

Flexivue Micro-Lens (Presbia)

Figure 3: During near vision the rays pass through the central zone of theLens (blue line) will be out of focus behind the retina and the rays passing through the peripheral clear cornea will be blocked by the pupil (interrupted blue lines). The rays passing through the peripheral refractive zone (red lines) will be focus on the retina.

Intracorneal Inlays - During Near Vision

Flexivue Micro-Lens (Presbia)

Femtosecond-assisted Corneal Pocket

Femto parameters:•iPockets software

–Depth: 280-300–Diameter: 4 mm–Bed energy:0.60-0,70–Spot-Line Sep: 2-2 (or 3-3)–Side cut energy: 1.6-1.7–Side cut angle: 160

•Deactivate pocket•Suction-applanation

Flexivue Micro-Lens (Presbia)

The Four Principal Phases

Create the corneal

pocket

Implant the Lens Check the position of

the Lens

Mark the center of the

visual axes

1 2

3 4

Flexivue Micro-Lens (Presbia) Flexivue Micro-Lens (Presbia)