OCT-guided Femtosecond Laser for LASIK and Presbyopia Treatment

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1 Shinagawa LASIK Center OCT-guided Femtosecond Laser for LASIK and Presbyopia Treatment Minoru Tomita, MD, Ph.D 1) Executive Medical Director at Shinagawa LASIK Center, Tokyo, Japan 2) Clinical Professor at the Department of Ophthalmology, Wenzhou Medical College, Wenzhou, China Financial Disclosure Dr. Tomita is a consultant for SCHWIND Eye-Tech-Solutions, Ziemer Ophthalmic Systems AG, and AcuFocus Inc.

D 1) Executive Medical Director at Shinagawa LASIK Center, Tokyo, Japan 2) Clinical Professor at the

2 Shinagawa LASIK Center in Tokyo, JAPAN 1,149,036 Femto LASIK cases since being established in Shinagawa LASIK Center in Tokyo with 5 branch clinics. We have a total of 131 doctors. Our clinics perform approx. 70% of the LASIK procedures in Japan.

Shinagawa LASIK Center in Tokyo with 5 branch clinics.

3 Laser Systems at Shinagawa LASIK Center FEMTO LDV, Crystal Line & Z6 (9 units) (Ziemer, Switzerland) 23 Units IntraLase FS60 & ifs (AMO, USA) Refractive Suite (Alcon, US) 1 Unit AMARIS (SCHWIND, Germany) Visx star S4 IR (AMO, USA) 14 Units ALLEGRETTO Wave Eye-Q (Alcon, USA) 13 Units 19 Units Other procedures also available: Surface ablation (PRK, LASEK, EpiLASIK) Intrastromal corneal ring segments Phakic IOLs Multi-focal IOLs KAMRA Intracorneal Inlays CK (Conductive Keratoplasty) 3 Units

ALLEGRETTO Wave Eye-Q (Alcon, USA) 13 Units 19 Units Other procedures also available: Surface ablation (PRK, LASEK,

4 Customer FS Laser Preference at Shinagawa IntraLase FS60 or ifs 2.8% FS % Ziemer FEMTO LDV, Crystal Line & Z6 97.2% Data obtained : August 2013 LASIK using Ziemer FEMTO LDV is the choice for 97% of our patients. Although the price is higher, patients are choosing the benefits of Crystal Line, or Z6 Technology.

2% Data obtained : August 2013 LASIK using Ziemer FEMTO LDV is the choice for

5 Total LASIK Surgeries using FEMTO LDV systems: Monthly and Accumulated Accumulated Monthly Number Since we started using FEMTO LDV in February 2009 through February 2013, the number of eyes treated using either FEMTO LDV or Crystal Line has reached 470,796.

FEMTO LDV in February 2009 through February 2013, the number of

6 Purpose 1) To evaluate the safety and efficacy of an Optical Coherence Tomography (OCT) guided femtosecond laser (Ziemer Z6) in Sub-Bowman s LASIK and corneal inlay implantation. 2) To report and evaluate the clinical outcomes of Sub Bowman s LASIK and corneal inlay implantation using Ziemer FEMTO LDV Z6. 3) To evaluate the benefits of this new OCT-Guided femtosecond laser.

2) To report and evaluate the clinical outcomes of Sub Bowman s LASIK and corneal inlay

7 What will we need in the Future? The Optical Coherence Tomography (OCT) is necessary for refractive surgeons desiring the safest and most efficient surgeries. The latest Z Model now provides this OCT guidance! The OCT guidance is used for : Sub Bowman s LASIK Corneal inlay implantation Corneal ring segment implantation Corneal transplantation 1) Lamellar keratoplasty (LKP) 2) Deep lamellar keratplasty (DLKP) 3) Penetrating keratoplasty (PKP) OCP interface

surgeries. The latest Z Model now provides this OCT guidance!

8 Why is OCT guidance needed? There are RISKS for surgeons while performing Sub-Bowman s LASIK, and corneal inlay implantation for post-lasik eyes. 1) Sub-Bowman s LASIK : button holes, flap tears 2) Corneal inlay implantation for Post-LASIK eyes : perforation from the new pocket to the original Using the Ziemer Z6 with its new OCT technology, surgeons can now visually verify the depth before and during LASER ablation. *This technology brings greater safety to thin flap and pocket creation!

1) Sub-Bowman s LASIK : button holes, flap tears 2) Corneal inlay implantation for Post-LASIK eyes : perforation from the

9 Video: Flap Tear During LASIK Flap Creation

10 Video: Perforation During Pocket Creation

11 Method Corneal Flap / Pocket Ziemer Z6 Lowest pulse energy (nj range) combined with the highest repetition rate (>5 MHz). Small spot technology preserves tissue and is free of edema. Focuses on the x, y, and z axis Enables surgeons to be able to change the flap configuration such as position, diameter, hinge position and length, thickness, side cut angle (30º to 150º), and shape. New features added to Z6! Corneal inlay implantation Corneal ring implantation Corneal transplantation + Built-in OCT system Swept source domain Scans in x, y, and z directions OCT images are captured after suctioning

Focuses on the x, y, and z axis Enables surgeons to be able to change the flap configuration such as position, diameter, hinge position and length,

12 Sub-Bowman s LASIK Sub-Bowman s LASIK surgery was performed on 300 eyes of 152 patients using the OCT guided application that is built in the new Ziemer Z6. Refractive correction was performed using Schwind AMARIS 750S. Target flap thickness was μm. Preoperative data : (Operations conducted: September-October 2012) Patients Age Sub-Bowman s LASIK Patients 300 eyes of 152 patients ± 7.69 years UDVA (Snellen) 20/250 CDVA (Snellen) 20/12.5 MRSE (D) -4.41

13 OCT Image: Sub-Bowman s LASIK Pre-OP Bowman s Layer Estimated LASIK Flap Line Vertical OCT-Scan Post-OP Bowman s Layer LASIK Flap For Sub-Bowman s LASIK, we confirm a 30 μm distance between Bowman s layer and the estimated flap line before laser disruption.

Flap For Sub-Bowman s LASIK, we confirm a 30 μm distance between

14 Visual Acuity : Sub-Bowman s LASIK Achievement (%) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 14.3% 11.3% 88.7% 89.7% 0.0% 0.0% 0.0% 20/10 or better Cumulative UDVA (Snellen) 20/16 or better 98.7% 96.7% 20/20 or better Pre-Op (n=300) 1W (n=300) 3M (n=300) For UDVA, 96.7% of the eyes achieved 20/20 or better at 3 months postoperatively.

7% 96.7% 20/20 or better Pre-Op (n=300) 1W (n=300) 3M (n=300) For UDVA, 96.

15 MRSE : Sub-Bowman s LASIK Cumulative MRSE (D) Achievement (%) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 92.7% 100% 91.0% 72.3% 70.0% 0.0% 0.3% 2.0% ±0.25 ±0.50 ± % Pre-Op (n=300) 1W (n=300) 3M (n=300) For MRSE, 91.0% of the eyes achieved results within ±0.50 D and 97.7% of the eyes achieved results within ±1.00 D at 3 months postoperatively.

7% Pre-Op (n=300) 1W (n=300) 3M (n=300) For MRSE, 91.

16 KAMRA Corneal Inlay Implantation using FEMTO LDV Z6

17 KAMRA Corneal Inlay 8,400 holes ( 5 to 11 micron) 3.8mm Total diameter 1.6mm Aperture Made from Polyvinylidene Fluoride (PVDF) 5 microns Thick

18 With Inlay Inlay KAMRA Corneal Inlay (-cont.) The central aperture increases the depth of field. The patient is able to achieve improved vision for near and intermediate with minimal affect on distance vision. (Data source : AcuFocus, Inc.) Presbyopia Lens cannot accommodate Several published reports showed the KAMRA intracorneal inlay is an effective method for the treatment of presbyopia ) Yilmaz et al, Intracorneal inlay to correct presbyopia:long-term results Jul;37(7): ) Seyeddain et al, Small-aperture corneal inlay for the correction of presbyopia: 3-year follow-up. J Cataract Refract Surg Jan;38(1): ) Waring GO 4 th, Correction of presbyopia with a small aperture corneal inlay. J Refract Surg Nov;27(11): ) Tomita et al, Simultaneous corneal inlay implantation and laser in situ keratomileusis for presbyopia in patients with hyperopia, myopia, or emmetropia: sixmonth results. J Cataract Refract Surg Mar;38(3):

) Presbyopia Lens cannot accommodate Several published reports showed the KAMRA intracorneal inlay is an effective method for the treatment of presbyopia 1-4.

19 Post-LASIK Corneal Inlay Implantation Corneal inlay implantation was performed on 300 eyes of 300 Post- LASIK patients with pocket creation using the OCT guided application that is built in the new Ziemer Z6. Preoperative data : (Operations conducted: June ~ September 2012) Post-LASIK Patients Patients 300 eyes of 300 patients Age ± 5.35 years UDVA (Snellen) 20/16 UNVA (Jaeger) MRSE (D) J6

20 How OCT Guidance Works

21 OCT Image: Post-LASIK Corneal Inlay Implantation Pre-OP Bowman s Layer Original LASIK Flap Estimated Pocket Line Post-OP Vertical OCT-Scan Bowman s Layer Original LASIK Flap Pocket For pocket creation, we confirmed a safe distance between the original LASIK flap and the estimated pocket line before laser disruption.

22 Post-LASIK KAMRA Inlay Implantation: Surgical Video

23 Post-LASIK KAMRA Inlay Implantation OCT-Scan Image showing that the previous LASIK flap was made at a depth of 100 μm and the new pocket at a depth of 200 μm. *The OCT (Casia SS-1000, Tomey Corporation, Nogoya, Japan) was used.

24 Visual Acuity (UDVA) of the Implanted Eye: Post-LASIK Corneal Inlay Implantation Cumulative UDVA (Snellen) Achievement (%) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 93.0% 81.3% 77.7% 20/16 or better 95.3% 96.7% 93.3% 87.0% 91.7% 85.3% 20/20 or better 20/30 or better Pre-Op (n=300) 1M (n=300) 3M (n=300) Mean UDVA was 20/20 at 3 months postoperatively. For UDVA, 85.3% of the eyes achieved 20/20 or better at 3 months postoperatively.

25 Visual Acuity (UNVA) of the Implanted Eye: Post-LASIK Corneal Inlay Implantation Cumulative UNVA (Jaeger) Achievement (%) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 37.3% 6.0% 46.0% J1 or better 67.3% 61.3% 11.3% J2or better 81.0% 74.7% 16.7% J3 or better 89.7% 85.7% 23.7% J4or better 96.0% 91.7% 34.3% J5 or better Pre-Op (n=300) 1M (n=300) 3M (n=300) Mean UNVA was J2 at 3 months postoperatively. For UNVA, 81.0% of the eyes achieved J3 or better at 3 months postoperatively.

26 Conclusion 1) Using the OCT guided system, surgeons are able to visualize and confirm safe surgical parameters for thin flap and corneal pocket. 2) The clinical outcomes of Sub Bowman s LASIK and corneal inlay implantation using Ziemer FEMTO LDV Z6 were excellent. 3) Using OCT, surgeons are able to prevent intraoperative complications and increase the safety and accuracy of corneal surgery.

What now, when Presbyopia sets in? Minoru Tomita, MD, PhD Executive Director Shinagawa LASIK Center, Tokyo, JAPAN

What now, when Presbyopia sets in? Minoru Tomita, MD, PhD Executive Director, Tokyo, JAPAN Financial disclosure Travel expenses for the ASCRS meeting were paid by Ziemer and AcuFocus, Inc. Presbyopia: