Laser Blended Vision for Presbyopia: An Eight-in-one procedure

Laser Blended Vision for Presbyopia:

An Eight-in-one procedure

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)


Laser Blended Vision: 8-in-1 Mechanism

5. Retinal image processing [edge detection]

6. Neural summation

7. Blur adaptation

8. Neural suppression

1. Monovision principle

2. Depth of field to reduce anisometropia

3. Spherical aberration control

[DOF without decrease quality of vision]

4. Vertex centration of spherical aberration

[OSA coma, on-axis symmetry of image blur]




6. Neural summation

7. Blur adaptation









Presbyopia: Ideal Solution

Near

Intermediate

Distance

Far Distance

Right Eye Left Eye


Influence of Spherical Aberration on Depth of Field

without spherical aberration

with spherical aberration

Slides courtesy Hartmut Vogelsang, PhD


Influence of Spherical Aberration on Depth of Field

0.00 D -0.50 D -1.00 D -1.50 D -2.00 D

without spherical aberration

withspherical aberration



0.00 D -0.50 D -1.00 D -1.50 D -2.00 D

@ 7 mm

@ 4 mm

Influence of Pupil Diameter on Depth of Field



0.00 D -0.50 D -1.00 D -1.50 D -2.00 D

@ 7 mm

withspherical aberration@ 4 mm

Influence of Pupil Diameter & Spherical Aberration on Depth of Field



Non-Linear Aspheric Presbyopic Ablation Profiles

• New Presbyopic Profile

• Increases depth of field

• Based on non-linear changes in asphericity

Linear Aspheric Non-Linear Aspheric


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




6. Neural summation

7. Blur adaptation









Presbyopia: Ideal Solution

Near

Intermediate

Distance

Far Distance

Right Eye Left Eye


Current Possible Depth of Field Increase

Near

Intermediate

Distance

Far Distance

Right Eye Left Eye

1.50 D 1.50 D




6. Neural summation

7. Blur adaptation









Laser Blended Vision – Micro-Monovision

Near

Intermediate

Distance

Far Distance

Dominant Eye Non-Dominant Eye

“Blend Zone”

1.50 D 1.50 D


Contact Lens Monovision

Near

Intermediate

Distance

Far Distance


“Blend Zone”“Blur Zone”

1.50 D

1.50 D


Contact Lens Monovision

Near

Intermediate

Distance

Far Distance


“Blur Zone”

“In contact lens monovision, there is a need for a third focal length, for example with computer screens at intermediate distances”

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


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.


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




6. Neural summation

7. Blur adaptation








Online Feb 2010

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

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

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


Binocular Vision: Neural Summation

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Distance UCVA After All Treatments

Cu

mu

lati

ve

Pe

rce

nta

ge

Ey

es

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

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%


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




6. Neural summation

7. Blur adaptation









Blur Adaptation

Wore glasses except for VA measurement

No glasses throughout

Wore glasses throughout

No change in Rx




6. Neural summation

7. Blur adaptation









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


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




6. Neural summation

7. Blur adaptation








Wavefront-Guided Treatment

of Spherical Aberration


How Effective are Wavefront Repair Treatments?

Repair Group

Complaining NVDs post LASIK

Wavefront-Guided Repair Treatment

Control Group

Not Complaining NVDs post LASIK

16 eyes in study

4:1 matched for sphere & cyl

• Aberrations Pre-op• Aberrations Post-op

Compare Aberrations

• Aberrations Pre-repair• Aberrations Post-

repair


Control Pre Control PostPre CRS-M

RepairPost CRSM-

Repair

Sph Ab Area 122 276 563 410

0100200300400500600700800900

µm

2

Average RAWS ParameterBefore & After Routine LASI K with the MEL80

Before & After CRS-Master Wavefront Guided Repair

3 cpd 6 cpd 12 cpd 18 cpd

Control 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

No

rma

lize

d C

on

tra

st

Se

ns

itiv

ity

Ra

tio

Normalized Contrast Sensitivity RatioBefore & After Routine LASIK with the MEL80


Correlation of Contrast with Wavefront

Spherical Aberration Contrast Sensitivity


Control Pre Control PostPre CRS-M

RepairPost CRSM-

Repair

Sph Ab Area 122 276 563 410

0100200300400500600700800900

µm

2

Average RAWS ParameterBefore & After Routine LASI K with the MEL80


3 cpd 6 cpd 12 cpd 18 cpd

Control 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

No

rma

lize

d C

on

tra

st

Se

ns

itiv

ity

Ra

tio

Normalized Contrast Sensitivity RatioBefore & After Routine LASIK with the MEL80


Correlation of Contrast with Wavefront

Spherical Aberration Contrast Sensitivity

• 27% Gross Reduction

• 53% Net Reduction (cf tolerable level)

• Tolerable level ~0.56 µm @ 6mm




6. Neural summation

7. Blur adaptation









Centration: Visual Axis vs Entrance Pupil

Ph

oro

pto

r Len

s

No Angle Kappa

Phoroptor Manifest Refraction Excimer Laser Ablation

Large Angle Kappa

Ab

lation

Pro

file

Ph

oro

pto

r Len

s




6. Neural summation

7. Blur adaptation








Outcomes

Measurement of Effective

Depth of Field

Example: Emmetropic Patient


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


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

2025

32

40

50

63

80

100

125

160

-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

tan

ce U

CV

A (

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


2025

32

40

50

63

80

100

125

160

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


Dis

tan

ce U

CV

A (

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


2025

32

40

50

63

80

100

125

160

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


Dis

tan

ce U

CV

A (

log

Mar

)

Expected Near Addition – 56 yo Female


Age Add

50-52 +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


2025

32

40

50

63

80

100

125

160

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


Dis

tan

ce U

CV

A (

log

Mar

)

Depth of Field – 56 yo Female


Age Add

50-52 +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


Blended Vision: Methods

Myopia Hyperopia Emmetropia

# Patients 136 111 119

SEQ-3.58 ± 1.80 D

up to -8.50 D

+2.58 ± 1.17 D

up 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 63

median 56 yrs

44 to 66

median 54 yrs

43 to 71


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


Blended Vision: Efficacy – Distance Eye

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Distance Eye Distance UCVA After All Treatments

Cu

mu

lati

ve

Pe

rce

nta

ge

Ey

es

Myopia 13% 49% 98% 99% 99% 99%

Hyperopia 6% 37% 86% 99% 100% 100%

Emmetropia 8% 47% 92% 96% 99% 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


0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Near Eye Distance UCVA After All Treatments

Cu

mu

lati

ve

Pe

rce

nta

ge

Ey

es

Myopia 0% 4% 20% 31% 48% 60% 87% 94% 98%

Hyperopia 0% 2% 15% 25% 38% 45% 80% 94% 99%

Emmetropia 2% 3% 8% 14% 22% 27% 74% 84% 94%

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

20/80 or better

20/100 or better

Blended Vision: Efficacy – Near Eye

Better than expected distance vision in the near eye


Blended Vision: Efficacy – Binocular Distance

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Binocular Distance UCVA After All Treatments

Cu

mu

lati

ve

Pe

rce

nta

ge

Ey

es

Myopia 18% 61% 98% 99% 100% 100%

Hyperopia 9% 47% 95% 99% 100% 100%

Emmetropia 11% 51% 96% 97% 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


Binocular Vision: Neural Summation

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%


Cu

mu

lati

ve

Pe

rce

nta

ge

Ey

es

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

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%


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


0%

10%

20%

30%

40%

50%

60%

70%

Pre-op BSCVA compared to Post-op UCVA (Lines Difference)

Pe

rce

nta

ge

Dis

tan

ce

Ey

es

Myopia 0.7% 1.5% 27.9% 47.1% 22.1% 0.7%

Hyperopia 1.8% 7.3% 19.1% 60.0% 10.9% 0.9%

Emmetropia 2.5% 5.9% 25.2% 55.5% 10.1% 0.8%

3 worse 2 worse 1 worse Same 1 better 2 better

Blended Vision: Pre BSCVA vs Post UCVA

“SUCCESS!”

All Groups:

94% eyes in the box


Blended Vision: Efficacy – Near Vision

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Binocular Near UCVA After All Treatments

Cu

mu

lati

ve

Pe

rce

nta

ge

Ey

es

Myopia 96% 99% 100% 100% 100%

Hyperopia 81% 94% 100% 100% 100%

Emmetropia 95% 99% 100% 100% 100%

J2 or better J3 or better J5 or better J7 or better J8 or better


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


Blended Vision: Accuracy

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Accuracy to Intended Spherical Equivalent Refraction (D)

Cu

mu

lati

ve

Pe

rce

nta

ge

Ey

es

Myopia 66% 91% 96% 99% 100% 100% 100%

Hyperopia 58% 79% 92% 95% 98% 100% 100%

Emmetropia 68% 88% 97% 99% 100% 100% 100%

Within 0.25D

Within 0.50D

Within 0.75D

Within 1.00D

Within 1.25D

Within 1.50D

Within 2.00D


Blended Vision: Safety

0%

10%

20%

30%

40%

50%

60%

70%

Lines Change in BSCVA

Pe

rce

nta

ge

Ey

es

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


Emmetropia BV: Contrast Sensitivity

*

Statistically significant improvement (p<0.05)

** *

* *

Myopia Hyperopia Emmetropia


Achieving Excellent Results

Stereo Acuity


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 D

up to -2.25 D

Agemedian 57 yrs

45 to 69


• 4-5% of patients with excellent pre-op stereo acuity (40-50 sec) lost 1 patch

• Post-op near-corrected stereo acuity equivalent to pre-op for ≥60 sec

• No statistically significant difference (p=0.376)

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

40 50 60 80 100 140 200 400 800Pre-Corrected 72% 87% 95% 98% 100% 100% 100% 100% 100%Post-Corrected 68% 83% 94% 98% 99% 99% 100% 100% 100%

72%

87%

95% 98% 100% 100% 100% 100% 100%

68%

83%

94%98% 99% 99% 100% 100% 100%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Cum

ulati

ve P

erce

nata

ge P

atien

ts

Stereo Acuity (seconds)

All Patients - Stereo Acuity - Safety


• Post-op uncorrected stereo acuity lower than pre-op near-corrected (p<0.001)

• But, majority of patients maintained functional stereo acuity– 68% achieved 100 secs– 93% achieved 200 secs

40 50 60 80 100 140 200 400 800Pre-Corrected 72% 87% 95% 98% 100% 100% 100% 100% 100%Post-Uncorrected 23% 38% 46% 57% 68% 77% 93% 96% 100%

72%

87%

95% 98% 100% 100% 100% 100% 100%

23%

38%

46%

57%

68%

77%

93%96%

100%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Cunm

ulati

ve P

erce

nata

ge P

atien

ts

Stereo Acuity (seconds)

All Patients - Stereo Acuity - Efficacy

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

Non-linear Aspheric Micro-Monovision:

Summary


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 for Presbyopia:

An Eight-in-one procedure

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

Documents

Laser Blended Vision for Presbyopia: An Eight-in-one procedure