1

American Society of Cataract

and Refractive Surgery

06-10 May, 2016

New Orleans, Louisiana Ernest N. Morial Convention Center

Course 10-105 Room 228-230

“Best of the Best : Advanced New Technologies

Cataract Surgery”

Senior Instructor:

Richard L Lindstrom MD Instructor:

Eric Donnenfeld MD Jack Holladay MD MSEE

Stephen S Lane MD Matteo Piovella MD

Steven C Schallhorn MD

Tuesday, May 10, 2016 8.30 AM – 9.30 AM

2

INDEX

Femto Laser Assisted cataract Surgery: Virtuosity or

Frontier?

Matteo Piovella MD

Pag. 3

Multifocal Accommodative and Toric IOL Implantation in

Advanced cataract Surgery: 8 Years Up to date

Matteo Piovella MD

Pag. 8

What’s New in Multifocal IOLs

Eric Donnenfeld MD

Pag. 19

Delivering Improved Outcomes for Today's Cataract Patient

Stephen S Lane

Pag. 25

Preliminary Results of Intrastromal Femtosecond

Astigmatism keratotomy

Steve C. Schallhorn MD

Pag. 31

The Promise of No Glasses or Contact Lenses! Jack T Holladay MD, MSEE, FACS

Pag. 34

ADDRESSES Pag. 43

3

“Femto Laser Assisted cataract Surgery: Virtuosity or Frontier?”

Matteo Piovella MD

4

5

6

7

8

“Multifocal Accommodative and Toric IOL Implantation in Advanced

cataract Surgery: 9 Years Up to date”

Matteo Piovella MD

9

10

11

12

13

14

15

16

17

18

19

“What’s New in Multifocal IOLs”

Eric D. Donnenfeld MD

20

21

22

23

24

25

“Delivering Improved Outcomes for Today's Cataract Patient”

Stephen S Lane MD

Delivering Improved Outcomes for

Today's Cataract Patient

Stephen Lane, MD

1

DISCLOSURE• Alcon

• ClarVista

• Bausch and Lomb

• Ivantis

• i-Veena

• Kala

• Lifecore

• Mati

• Ocular Therapeutics

• Omeros

• PowerVision

• PRN

• RPS

• Shire

• TearLab

• TearScience

• VisionCare

• WaveTec

Cataract Surgery Outcomes***

CRS15001SK 1

• Patient expectations are at an all-time

high for refractive surgery

• Positive experiences with LASIK have

produced high expectations

– 92.6% of LASIK patients achieve vision of

20/40 or better*

– 95.4% of patients were satisfied with their

outcome after LASIK surgery**

• Cataract surgery outcomes may not be meeting the target of 0.5D that is

considered the standard

41%

55%

97%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

±0.25D ±0.5D ±1.0D

Cataract Surgery Outcomes

*“LASIK Surgery Statistics.” Docshop.com. http://www.docshop.com/education/vision/refractive/lasik/statistics

**Solomon, K et al. (2009) “LASIK world literature review: quality of life and patient satisfaction.” Ophthalmology. 16(4):691-701

***Graph: Data from Dr. Warren Hill & Behndig A, et al. Aiming for emmetropia after cataract surgery: Swedish National Cataract Register study. J Cataract Refract Surg. 2012;38(7):1181-6.

What are the issues that affect hitting

the refractive target?

Pre-operative

• Biometry

• Managing astigmatism

• Transcription errors

• Cyclorotation

• Manual marking

Intra and Post Operative

• Rhexis shape and size?

• Posterior corneal

astigmatism

• Alignment, centration

• A-constant optimization

4

Cataract Refractive Diagnostics

Image Guidance

5

Manual Toric Marking

6

26

Removing Ink From the Entire Process

7

Courtesy of Michael Jones, MD

The Verion™ Image Guided System

Designed to help you consistently achieve your refractive target.

The VERION™ Image Guided System is designed to add greater accuracy and

efficiency during surgical planning and execution. Consisting of the VERION™

Reference Unit and the VERION™ Digital Marker, it is designed to help you

perform cataract surgery.

8

Introducing the VERION™ Image Guidance

VERION™ Reference Unit

IMAGE. PLAN. GUIDE.

9

VERION™ Microscope Integrated Display

Capturing the Reference Image

10

Comprehensive

Astigmatism Planner

11

Closing the Loop: Optimization

12

27

VERION™ DIGITAL MARKER

Digital Marker Guidance

13

Registration Process at the LenSx® Laser- Digital Marker L

14

Image Guided System and Centration

Visual Axis Center

Limbus Center

15

MICROSCOPE INTEGRATED DISPLAY

Location of Incisions Marker Rhexis Marker

Centration Marker Toric Alignment Marker

16

Verion Digital Marker M

17

Intraoperative Surgical

Aberrometry

18

28

“Yardstick” to measure Cataract Surgery

Success

• Driven by LASIK outcomes– Refractive component and Visual Acuity component

• > 95% of outcomes within 0.50 D of nomogrampredicted refractive target

• 90% of eyes achieving UDVA of 20/20 or better

• <3% enhancement rates expected

* Intraoperative aberrometry may help refractive cataract surgery reach the next level by Richard L. Lindstrom, MD, Ocular Surgery News U.S. Edition, December 25, 2010

Outcomes in Modern Cataract Surgery-

Literature • Narvaez / Stulting JCRS Dec. 2006

– 46 % within 0.50 D of formula predicted target

– Mean prediction error: 0.52 D +/- 0.44 D

• Gale et al, Eye Aug. 2007– 55 % of eyes within 0.50 D of formula predicted target

– 85% of eyes within 1.00 D of formula predicted target• Findings considered the benchmark for the NHS in the UK

– Enhancement Rates on Premium IOL cases (Presbyopicand Toric IOLs)

• Range from 10% to 35%

Outcomes in Modern Cataract Surgery

Recent Literature

• Andrs Behndig, M.D., Ph.D.,et al, J

Cataract Refract Surg. (July) 2012 (Swedish

National Cataract Registry.)

–17,056 procedures

–Emmetropia (spherical equivalent −0.5 to

+0.5D and <1.0 D astigmatism) achieved in

55% of eyes planned for emmetropia.

Conventional IOL Power Determination

Approach• Various characteristics of the eye are measured preoperatively

• Axial Length

• Corneal Power

• Other measurements that may be used (formulae dependent)

– Anterior Chamber Depth

– Lens Thickness

– White to White

– Formula applied

ORA System™ by WaveTec

(Optiwave™ Refractive Analysis)

• Provides intraoperative refractive information

• Attaches to most surgical microscopes for on-demand intraoperative measurements of sphere, cylinder and axis

• Enables real-time surgical course correction

• “Get it right – right on the table” the first time

• Every ORA System connects live to WaveTec servers to capture every procedure and push software upgrades

The ORA System® with VerifEye®

24

29

Overview• The ORA System® uses wavefront aberrometry data in the

measurement and analysis of the refractive power of the eye (i.e.

sphere, cylinder, and axis measurements) to support cataract surgical

procedures.

• Accounts for contribution of anterior and posterior corneal astigmatism

in its measurements

• Real-time, intraoperative refractometer plus a working algorithm

supported by a large clinical database (100k+ cases), and a platform

for additional enhancements.

25

Improve astigmatic outcomes for your patients

with real-time intraoperative Validation1

• Provides streaming refractive information to determine power, cylindrical magnitude and axis, even for post-refractive-procedure eyes.

• Accounts for contribution of anterior and posterior corneal astigmatism in its measurements.

• Reduces risk of residual postoperative astigmatism.

26

Primary Efficacy Result

Residual Refractive Cylinder at 3 Months

31,4

39,2

71,6

90,296,1

3.90102030405060708090

100

0 ≤ 0.25 ≤ 0.50* ≤ 0.75 ≤ 1.00 > 1.00

Pe

rce

nt

Pa

tie

nts

Diopters* 95% CI: 61.8 - 80.1%

Primary Efficacy Result

Residual Refractive Cylinder at 3 Months

1

53,3

81

91,4 92,4

6,7

31,4

39,2

71,6

90,296,1

3,90

10

20

30

40

50

60

70

80

90

100

0 ≤ 0.25 ≤ 0.50 ≤ 0.75 ≤ 1.00 > 1.00

Pe

rce

nt

Pa

tie

nts

Diopters

Anticipated Residual Cylinder based upon Preoperative Calculation

88.4%

from

target

Secondary Efficacy Result

Postoperative MRSE Accuracy at 3 Months

0

40,2

69,6

87,391,2

7,80

102030405060708090

100

0 ≤ 0.25 ≤ 0.50* ≤ 0.75 ≤ 1.00 > 1.00

Pe

rce

nt

Pa

tie

nts

Diopters* 95% CI: 59.7 – 78.3%

Improved astigmatic outcomes with VerifEye®

2. Standard of Care: Conventional biometry measurement of the pre-op corneal astigmatism and toric calculator determination of IOL cylinder power.

3. Results are statistically significant based on McNemar’s test (p=0.006).

This carefully controlled clinical study confirms that the ORA

System® with VerifEye® provides better astigmatic outcomes in

cataract surgery.

Percent of Patients Within ≤ 0.50 D of Intended Target at One Month; n = 111 patients, p = .006

30

30

Improved astigmatic outcomes with VerifEye®

*Based on seeing 100 post-op patients per month

53.8% fewer patients were outside the intended target.

31

Synergism of Guidance with

Aberrometry and Femtosecond

Cataract Surgery

• Paired with the VERION™ Image Guided System

aberrometry provides the opportunity to address

potential sources of error at each procedural step

imaging, planning, guidance and verification.

• Aberrometry gives you the confidence to effectively

treat astigmatism for toric IOL patients.

32

How I use the systems together

• Toric case– Establish initial plan with Verion guidance

• K’s will help establish initial cylinder power and axis – registration will help identify this axis during surgery

• Pre-op will supply preliminary spherical power for the toric lens

– Obtain consistent VerifEye aberrometry aphakic measurements intraoperatively

• Will provide the actual spherical power of the lens, cylinder power and the target axis of placement

– Use Verion guidance to locate axis obtained during pre-op

– Place lens and use VerifEye’s toric pseudophakic aberrometryapplication to refine axis of placement by rotating as directed

33

Refractive Cataract Suite

Conclusions

• Aberrometry and Guidance are complimentary

• Using both together results in refined IOL power

selection and astigmatic treatment

35

31

“ Preliminary Results of Intrastromal Femtosecond Astigmatism keratotomy”

Steve C. Schallhorn MD

32

33

34

“ The Promise of No Glasses or Contact Lenses!”

Jack T. Holladay MD, MSEE, FACS

35

36

37

38

39

40

41

42

43

ADDRESSES

RICHARD L LINDSTROM MD Minnesota Eye Consultants,PA Ste 200 9801 Dupont Ave S Bloomington MN 55431-3200

Ph.: 952-567-6051 Fax: 952-567-6182 e-mail: rllindstrom@mneye.com

ERIC DONNENFELD MD Ophthalmic Consultants of

Long Island

Garden City, New York

Clinical Professor of Ophthalmology NYU

Trustee Dartmouth Medical School

Ph.: 516-766-2519

e-mail:ericdonnenfeld@gmail.com

JACK T HOLLADAY MD MSEE FACS 5108 Braeburn DR, BALLAIRE TX 77401-4902

Ph.: (713) 668 7337 Fax: (713) 669 9153 e-mail: holladay@docholladay.com

STEPHEN S LANE MD Adjunct Clinical Professor, University of Minnesota Minnesota USA

e-mail: sslane@associatedeyecare.com

MATTEO PIOVELLA MD C. M. A. Centro Microchirurgia Ambulatoriale Via Donizetti, 24 - 20900 Monza- Italy

Ph.: +39 039389498 Fax:+39 0392300964 e-mail: piovella@piovella.com

STEVEN C. SCHALLHORN MD 5 Deerdykes Road Westfield Industrial Estate Cumbernauld

Glasgow G68 9HF

Ph.: 01236 795 010

e-mail: scschallhorn@yahoo.com