the author has a financial interest in the matter under presentation dr. rupal shah, new vision...

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The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

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Page 1: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

The author has a financial interest in the matter under presentationDr. Rupal Shah, New Vision Laser Centers, India

Page 2: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

Uses only the femtosecond laser for completing the entire LASIK procedure

No need for an excimer laserPossible only with the VisuMax Laser

from Carl ZeissTwo Procedures

FLEx=Femtosecond Lenticule Extraction SMILE=Small Incision Lenticule Extraction

Page 3: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

All-Femto Lasik Integrated Solution

Benefits and Advantages

Advantages for the patient

Vision correction w/o corneal ablation• Result quality independent of external conditions• High refractive correction with less induced aberration

Fast single-step treatment• Short period of stress and fear• No need to change stations

Potential for minimal-invasive procedure• Better and faster healing (small incisions)• Preserved biomechanical stability of the cornea• Potential for correction of higher myopes• Lower incidence of Dry-Eye syndrome

(to be proven)

Advantages for the surgeon Differentiation from other LVC providers• Uniqueness of AIO procedure (marketing, positioning)

Workflow improvements• Fast bilateral treatment w/o need to change to excimer

higher patient throughput• Less space requirement

Increased profitability • Premium procedure provides higher margin potential

(ex.: Intralase, Wavefront)• Minimal-invasive treatment may increase demand• Only one laser, with the investment, consumables and

service costs for only laser

Page 4: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

683 eyes treated between Aug 2008 and February 2010

Includes eyes treated with both FLEx and SMILE

All consecutive eyes- All eyes treated have been included

Video Illustrates technique of All in One (AiO) Femtosecond Laser Refractive Surgery

Page 5: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

Subject Demographics

Mean Range

Age 25 y 18 y to 50y

MR SEQ -4.56 D ± 2.04 D -0.75 D to -10.38 D

MR Sphere -4.22 D ± 1.95 D -0.50 D to -10.00 D

MR Cylinder -0.68 D ± 0.72 D up to -4.50 D

Pre-operative: 683 eligible eyes (339 OD, 344 OS)

429 female eyes, 254 male eyes

Page 6: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

Postoperative Results

Mean Range

MR SEQ 0.00 D ± 0.26 D 1.00 D to -1.25 D

MR Sphere 0.00 D ± 0.21 D 1.00 D to -1.25 D

MR Cylinder -0.10 D ± 0.26 D up to -1.75 D

6 month 423 eyes

Page 7: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

AiO Safety Change in CDVA

Change in CDVA

13%

54%

8%6%

1%

18%

4%

17%

4%2%

25%

64%

1%4%

33%

57%

11%

<1%2%

31%

58%

8%7%2%2%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

lost > 2 lost 2 lost 1 unchanged gained 1 gained 2 gained > 2

Per

cen

tag

e E

yes

[%]

0.25 (638) 1 (558) 3 (502) 6 (423) 12 (109)month (eye)

@3 month 92% unchanged/gained

Page 8: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

AiO Stability Achieved correction (MR SEQ) over time

Time

-4.49

0.12 0.08 0.04 0.05 0.03

110423502558639683-7.00

-6.00

-5.00

-4.00

-3.00

-2.00

-1.00

0.00

1.00

pre op 1 w 1 m 3 m 6 m 1 y

Highly stable refraction over time!

Page 9: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

R2 = 0.97

0

1

2

3

4

5

6

7

8

9

10

11

12

0 1 2 3 4 5 6 7 8 9 10 11 12

Attempted delta SR equiv. [D]

Achieved [D]

overcorrected

undercorrected

R2 = 0.98

0

1

2

3

4

5

6

7

8

9

10

11

12

0 1 2 3 4 5 6 7 8 9 10 11 12

Attempted delta SR equiv. [D]

Achieved [D]

overcorrected

undercorrected

AiO Refractive Outcome MR SEQ Percent within Attempted@1w and @6m

1 week (639) 6 month (423)

High predictability for early and late follow-ups!

Page 10: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

Refractive outcome - Percentage within Attempted

2%

90%

7%3%

93%

4%

94%

3%<1% 2% 2%2%

97%

1%1%0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

-1.01 to -2.00 -0.51 to -1.00 +- 0.50 +0.51 to +1.00 +1.01 to +2.00

1 w (639) 1 m (558) 3 m (502) 6 m (423) 1 y (110)

AiO Refractive Outcome MR SEQ Percent within Attempted

@1w 99% ± 1.00 D@3m100% ± 1.00 D

Page 11: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

preOP CDVA vs. postOP UDVA - Percentage

67% 69%

43%

22%

44%

<1%

94%

84%

65%

99%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

20/16 orbetter

20/20 orbetter

20/25 orbetter

20/32 orbetter

20/40 orbetter

20/50 orbetter

20/63 orworse

preSCVA (575) 1 d (572) 1 w (537)

month (eyes)

Only 94% are 20/25 or better preOP

Page 12: The author has a financial interest in the matter under presentation Dr. Rupal Shah, New Vision Laser Centers, India

AiO-Astigmatism CorrectionNormalized Double Angle Minus Cylinder – Scatter Plot ►only eyes with myopic astigmatism

preOP (485 eyes with myopic astigmatism)

High predictability in cylinder correction after 1 week!

-5

-4

-3

-2

-1

-0

-1

-2

-3

-4

-5

-5 -4 -3 -2 -1 -0 -1 -2 -3 -4 -5

Mean Cyl -0.95 @ 0.0°CZM-Applikation Gehmlich

45°

90°

135°

1 week (460 eyes with myopic astigmatism)

-5

-4

-3

-2

-1

-0

-1

-2

-3

-4

-5

-5 -4 -3 -2 -1 -0 -1 -2 -3 -4 -5

Mean Cyl -0.02@ 167.2°CZM-Applikation Gehmlich

45°

90°

135°