Zeiss VisuMax/MEL for LASIK and Keratoplasty. William W. Culbertson, MD; Bascom Palmer Eye Institute, Miami, FL

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1 Zeiss VisuMax/MEL for LASIK and Keratoplasty William W. Culbertson, MD; Bascom Palmer Eye Institute, Miami, FL 1

2 VisuMax Femtosecond Laser Precision Low IOP Low energy Gentle on patient Minimal applanation SMILE LASIK flaps Keratoplasty ICR 2

3 Femtosecond Technology Spherical contact interface to cornea Corneal fixation assures a better fixation than scleral fixation designs Precise treatment positioning Different sizes to adapt to individual cornea dimension Low suction pressure Minimal applanation Minimal IOP increase No vision loss during suction* Page 3

4 VisuMax Femtosecond System Features of Visumax Flap: Predictable and accurate flap thickness (80 µm 220 µm) and dimension Flap bed parallel to corneal surface (Diameter 10.7 mm, applanated) Step side cut angle (selectable between 45 degree to 135 degree) Better fit for flap repositioning Increased safety

5 VisuMax Femtosecond System OCT flap imaging Homogeneous flap thickness Regular interface Visante OCT HD OCT

6 History of the Zeiss excimer laser 1986 MEL 50 introduced Zeiss has been in the refractive laser business for 27+ years 1989 MEL MEL MEL International launch of MEL

7 MEL-80 MEL-80 Excimer laser Smart Pulse technology Developed to control every laser pulse at high speed repetition rate (250Hz) Peripheral Pulse Control to compensate for energy reflection Very small spot size (0.7mm) Gaussian Beam Profile Closed Loop Controlled Energy Beam Delivery System Active Eye Tracking (1060 Hz) Optics Shielded and Vacuum Flushed 110V Page 7

8 MEL 80 Best FDA clinical results (August 2006) 93% 20/20 41% 20/15 Myopic approval -7D sphere Hyperopic approval +5D sphere Astigmatism approval 3D cylinder MRSE -8 D We can treat 95% of population base with current approvals Page 8

9 MEL 90 Excimer Technology The MEL 90 is the only flying spot excimer laser that builds on a legacy of 10 years of technical experience and excellent clinical outcomes The reliability of MEL 80 + the high clinical performance = MEL 90 Fastest intraoperative ablation on the market with its 500 Hz capability Carl Zeiss Meditec, Inc., Amy Wong, MarComm 8/6/2014 9

10 POWER, ACCURACY, TIME MEL 90 power With its unique FLEXIQUENCE switch function (250 Hz and 500 Hz operation) and additional configuration options the MEL 90 is a true customized power package. (FLEXIQUENCE - Frequency switch function 250 Hz/ 500 Hz) MEL 90 accuracy The Triple-A profile enables fast, safe and highly precise treatments. Its excellent predictability, even with astigmatism and higher ametropias, offers additional safety. (Triple-A Advanced Ablation Algorithm) MEL 90 time When performing LASIK for myopia at 500 Hz, MEL 90 can intra-operatively ablate 1 diopter as little as 1.3 seconds. Intuitive system guidance and speedy treatment planning allow for additional time savings. (Intra-operative speed of 1.3 seconds per diopter (Myopia, LASIK, 500 Hz, OZ: 6 mm)) Carl Zeiss Meditec, Inc., Amy Wong, MarComm 8/6/

11 INTELLIGENCE, ATMOSPHERE, OUTCOMES MEL 90 intelligence The Triple-A profile is based on an intelligent combination of refractive correction and clever energy distribution. It enables an aspherically optimized design with minimal ablation depth. As a result, treatments are faster and save tissue. MEL 90 atmosphere The unique, sensor-controlled CCA+ plume removal system supports optimal atmospheric conditions around the patient s eye thereby also significantly improving the predictability of the results.. MEL 90 outcomes The MEL 90 can be precisely tailored to the individual needs of the modern refractive surgical practice. Its preinstalled functions also offer surgeons optimal support for achieving excellent treatment results. Carl Zeiss Meditec, Inc., Amy Wong, MarComm 8/6/

12 Combination with VisuMax Fastest excimer-femtosecond combo on the market Real time bilateral femto-lasik using VisuMax and MEL: 8:30 minutes No platform extension required 90 and 180 setup Seamless data transfer Carl Zeiss Meditec, Inc., Amy Wong, MarComm 8/6/

13 Clinical Trial Results for MEL 90 Highly accurate and predictable outcomes for all ranges 13

14 LASIK with Visumax with MEL - 80

15 VisuMax Keratoplasty

16 VisuMax Femtosecond System Keratoplasty range of clinical applications Surgical procedures PTK ALK DLK PKP PLK Phototherapeutic Keratomileusis (excimer laser domain) Anterior Lamellar Keratoplasty Deep (Anterior) Lamellar Keratoplasty Penetrating Keratoplasty Posterior Lamellar Keratoplasty DSEK Descemet Stripping Endothelial Keratoplasty DALK

17 Corneal Structure vs Bubble Formation The upper layer collagen is denser, thinner and more compact The lower layer collagen is less dense, thicker and less compact

18 Corneal Structure vs Bubble Formation 100um Thickness 200um Thickness 300um Thickness 450um Thickness

19 Recommended Energy Setting for Keratoplasty ALK & DALK (Transparent Cornea) 100um Thickness: 110nJ-130nJ (3.0/3.0/1.5) 200um Thickness: 130nJ-150nJ (3.0/3.0/1.5) 300um Thickness: 200nJ-230nJ (1.6/1.6/1.5) 400um Thickness: 230nJ-280nJ (1.6/1.6/1.5) PKP Standard Mode: 280nJ - 300nJ (1.5/1.5) Fast Mode: 320nJ - 340nJ (2.0/2.0)

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21 Circumferential deep folds caused by applanation

22 Engagement/Attachment: Intralase

23 Engagement/Attachment: FS - 200

24 Engagement/Attachment: Visumax Cross section of the contact glass

25 Interface and Transparency Outcomes

26 VisuMax Femtosecond System User programmable parameters for Keratoplasty Lamellar intrastromal cut parallel to the anterior surface of the cornea Lamellar incisions ranging from 50 µm up to 650 µm depth for anterior lamellar keratoplasty PKP: Penetrating Keratoplasty (sidecut) Max. appro 700 8mm Diameter range: mm Straight sidecut with adjustable sidecut angle Individual programming of all treatment parameters for donor and recipient treatment

27 VisuMax Femtosecond System Keratoplasty treatment planning user interface

28 VisuMax Femtosecond System Donor cornea handling easy and flexible solution Adapter to headrest of patient bed Cover plate can be sterilized

29 VisuMax Femtosecond System Corneal interface designed donor cornea preparation Donor cornea Special KP treatment pack No suction ring Designed to avoid mechanical interference with most artificial anterior chambers models Patient eye Regular Treatment Pack as used for flap (S/M/L) Artificial anterior chamber Dynamic pressure control -BSS Model Barron (katena, inc) is recommended

30 VisuMax Femtosecond System Impressions on clinical performance VisuMax workstation setup in sterile OR VisuMax microscope for manual surgery and suturing

31 VisuMax Femtosecond System Keratoplasty treatment planning user interface PKP (Donor & Receipient) Donor Curvature: 7.7mm (default) Receipient: individual K reading Donor Diameter > Receipient (+0.2mm) Actual Diameter = Nominal (+ 0.4mm) Outer diameter > Inner diameter (1mm) Side cut angle: 90 (less astigmatism) Cornea should be transparent Thickness > pachy approx micron Donor uses KP treatment pack Receipent uses normal treatment pack

32 VisuMax Femtosecond System Sidecut angle of PKP

33 VisuMax Femtosecond System Example Penetrating KP Separation and removal of donor button

34 VisuMax Femtosecond System Example Deep anterior lamellar KP 480 µm deep lamellar incision in the course of DALK

35 VisuMax Femtosecond System Visante OCT scans post-op DALK ant. lam. KP DSEK post. lam. KP

36 VisuMax Femtosecond System Histology of femtosecond incision Penetrating graft Incision depth: 715 µm Laser settings: 360 / 1.8 Incision time: 48 sec. Deep lamellar graft Incision depth: 450 µm Laser settings: 340 / 1.8 Incision time: 97 sec.

37 ALK with Visumax Anterior scar 6 months post infectious keratitis Pre-op Vision: 20/200

38 ALK Visumax

39 ALK with Visumax Anterior scar 6 months post infectious keratitis Post-op Vision: 20/40 sc

40 Zeiss VisuMax/MEL for LASIK and Keratoplasty