See Clearly Vision Group

Incorporating Lasik Xtra into Standard Lasik Surgery

1.  VibeX Riboflavin is applied to the flap bed for 1 minute

3. The cornea is then illuminated with UVA for 1.25 minutes with the KXL System

2.  The flap is repositioned

Following excimer laser ablation in the flap bed

3

Interna'onal  Experience  -­‐  LASIK  Xtra  

• Omer  Faruk  Yilmaz,  Turkey  

– Pilot  Study  in  2010,  Published  JCRS  

• Gustavo  Tamayo,  Colombia  

– >200  Eyes,  1  Year  Follow  Up,  0%  Enh  Rate  

• Howard  Gimble,  Canada  

– Offered  to  All  Pa'ents,  24%  Conversion  Rate  

– 419  cases  (158  LASIK  Xtra,  261  PRK  Xtra)  Being  Followed  

• Minoru  Tomita,  Japan  

– >9,000  Pa'ents  Treated  

Personal Experience with Lasik Xtra™ in a High Volume LASIK Clinic

Minoru Tomita, MD, PhD, Medical Director Shinagawa LASIK Center, Tokyo, Japan

Laser Systems at Shinagawa LASIK Center

Other  procedures  also  available:  Surface  abla'on  (PRK,  LASEK,  EpiLASIK)  Intracorneal  Ring  Segment  Phaikic  IOL  Mul'-­‐focal  IOL  KAMRA  ®  Intracorneal  Inlay  CK  (Conduc've  Keratoplasty)  

ALLEGRETTO    wave  Eye-­‐Q  (Alcon,  USA)

Visx  star  S4  IR  (AMO,  USA)

13 Units

3  Units

AMARIS    (SCHWIND,  Germany)

IntraLase  FS60™  &      iFS  (AMO,  USA)

19  Units

FEMTO  LDV™  &  Crystal  Line™    

(Ziemer,  Switzerland)

21  Units

Refrac've  Suite  (Alcon,  US)

1  Unit

14  Units

1,007,915 Femto LASIK cases since being established in 2004.

We recommend this procedure for patients with…

  Borderline topography between LASIK and PRK   Strong refractive errors -High refractive correction leads to a weaker corneal structure

  Atopic dermatitis -One of the major risk factors for keratoconus and keratoectasia

  Thin corneas, less than 480µm preoperatively

Who are LASIK Xtra™ candidates at our clinic?

11

LASIK Xtra™ Cases at Shinagawa LASIK Center

14 43 69 125 251 381 544

1,151 2,086

3,458

4,947

6,540

8,418

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

Feb, '11

Apr, '11

May, '11

Jun, '11

Jul, '11

Aug, '11

Sept, '11

Oct, '11

Nov, '11

Dec, '11

Jan, '12

Feb, '12

Mar, '12

(eyes)

Monthly Accumulation*

Total clinical cases

*The data is Tokyo only

Patients   24 myopic candidates with mean age: 30.4±5.3 (range:19 to 40

y.o.) were enrolled in this study with sufficient informed consent before participation.

  Patients had bilateral LASIK, then KXL had performed but only on their non-dominant eye.

Methods

Dominant

ＬＡＳＩＫ VS

Non-dominant

ＬＡＳＩＫ

KXL

LASIK Xtra™

Preoperative Data

UDVA (LogMAR)  

CDVA (LogMAR)  

SE(D) Mean ± SD

(Range)  

K Ave. (D) Mean ± SD

(Range)  

ECD （cells/mm2) Manual

Mean ± SD

LASIK Xtra™

(non-dominant)

1.10   -0.20   -4.45 ± 2.22 (-11.88 to -1.25)

44.33 ± 1.26 (41.50 to 45.75)

　3,078.5 ±285.9 　(2,232 to 3,534)  

LASIK Only

(dominant)

1.08 -0.19   -4.43 ± 2.26 (-11.25 to -1.00)

44.40 ± 1.30 (41.25 to 46.00)

　3,048.8 ± 336.3 　(2,105 to 3,509)  

NS NS NS NS NS

Mann-Whitney’s U-test （NS: No statistically significant difference）

No statistically significant differences observed between the 2 groups preoperatively.

①Seamlessly after LASIK

②1 minute riboflavin soak for the corneal bed of the LASIK Xtra™ eyes

③The flap was then rinsed completely and returned to the original position

④75 seconds of Ultraviolet A (UVA)　light was applied (UVA : 30mW/cm2) KXL system

(Avedro, Inc, MA, USA)

Surgical technique, LASIK Xtra™ by Avedro

Confocal Microscope 5 months postoperative HRT image for same patients

LASIK Xtra™

LASIK Only

Pt.A OS:130µm

Pt.A OD: 131µm

Pt.B OS: 130µm

Pt.B OD: 129µm

Using confocal microscope examination, we found increased reflectivity in the stroma cells which is normally observed after conventional CXL.

　No statistically significant differences observed between the 2 groups.

-4.45

0.03 0.11 0.19 0.18 0.14

-4.43

0.13 0.13 0.13 0.21 0.12

-5.00

-4.00

-3.00

-2.00

-1.00

0.00

1.00

Pre (n=24) 1D (n=24) 1W (n=24) 1M (n=24) 3M (n=24) 6M（n=23)

■MRSE (D)

LASIK Xtra

LASIK only

Refractions

NS

NS NS NS NS NS

Mann-Whitney’s U-test （NS: No statistically significant difference）

ECD

No statistically significant differences were observed between the 2 groups.

Post operative ECD was converted using a certain formula taking pre and post K values and pachmetries into account.2

Mann-Whitney’s U-test （NS: No statistical significance）　

2.Nawa, Y. , et al.: Journal of Cataract & Refractive Surgery, 2003; 29(8), 543-1545.

NS NS NS NS

Mann-Whitney’s U-test （NS: No statistically significant difference ）　

1000

1500

2000

2500

3000

3500

4000

Pre (n=24) 1M (n=24) 3M (n=24) 6M（n=23)

3,079 3,220 2,987 3,040 3,049 3,131

2,980 3,005

(cells/mm2)

■Longitudinal Change in ECD LASIK Xtra LASIK only

Higher volume study

  　1,319 eyes of 689 patients underwent LASIK Xtra™ between 　 　　　February and November 2011.   　Preoperative and postoperative (1Day, 1Week, 1Month, 3Months and 　　　 　　　6Months)　UDVA, CDVA, Sphere, Cylinder and MRSE were evaluated.

Age UDVA CDVA Sphere(D) Cylinder(D) MRSE(D) (years old)

(Range) (LogMAR) (LogMAR) Mean ± SD (Range)

Mean ± SD (Range)

Mean ± SD (Range)

LASIK Xtra™ 32.4±7.46 1.28 -0.16 -5.75 ± 2.60 1.14 ± 0.93 -6.32 ± 2.58

(n=1,319 eyes) ( 18 to 63 ) (-13.00 to 5.75)   (-6.00 to 0)   (-14.13 to 4.63)  

Higher volume study cont’d

 Result

1.28

-0.08

-0.14 -0.16 -0.14 -0.14 -0.40

0.00

0.40

0.80

1.20

1.60

■UDVA:LogMAR

LASIK Xtra

-0.16

-0.11

-0.16

-0.18 -0.18 -0.19

-0.20

-0.10

0.00 ■CDVA: LogMAR

LASIK Xtra

The visual outcome in this high-volume study was consistent with the outcome of standard LASIK over time.

The refractive change in this high-volume study also demonstrated similar result with standard LASIK.

Higher volume study cont’d

-5.75

0.14 0.15 0.15 0.07 0.01

-7.00

-6.00

-5.00

-4.00

-3.00

-2.00

-1.00

0.00

1.00

■Sphere (D)

LASIK Xtra -1.14

-0.06 -0.09 -0.09 -0.12 -0.10

-1.20

-1.00

-0.80

-0.60

-0.40

-0.20

0.00

■Cylinder（D)

LASIK Xtra

Higher volume study cont’d

-6.32

0.11 0.11 0.11 0.01 -0.04

-7.00

-6.00

-5.00

-4.00

-3.00

-2.00

-1.00

0.00

1.00

Pre(n=1319) 1D(n=1319) 1W(n=1227) 1M(n=1142) 3M(n=903) 6M（n=240)

■MRSE（D)

LASIK Xtra

The MRSE refractive change in this high-volume study also demonstrated similar result with standard LASIK.

Conclusions

  There were no statistically significant differences between the LASIK Xtra™ and the LASIK only groups at 6 months for UDVA, keratometric reading, and ECD changes.

  The six months results suggest that LASIK Xtra™ surgery is as safe and effective as standard LASIK.

  We found changes in the corneal stroma cells similar to the changes in conventional CXL using confocal microscope examination.

  The safety of LASIK　Xtra™ is further confirmed with the high-volume study.

  Further long term follow-up studies are necessary to confirm these results and to evaluate the effects of LASIK　Xtra™.

Interna'onal  Experience  -­‐  LASIK  Xtra  

• A.  John  Kanellopoulos,  Greece  – >5  Year  Follow  Up  

– Lower  Enhancement  Rate  

– OCT  Demonstra'ng  Hyperreflec'vity  at  Flap  

Interface  

– Greater  Difficulty  Liling  Flaps  for  Enhancement  

Interna'onal  Experience  -­‐  LASIK  Xtra  • A.  John  Kanellopoulos,  Greece  

– Hyperopic  LASIK  Xtra  

– Sta's'cally  Significant  Reduc'on  in  Hyperopic  

Regression  

LASIK  Xtra  –  Interna'onal  Results  

• Results  Demonstrate:  

– No  Increase  in  Risk  

– Refrac've  Outcome  Predictable  

LASIK  Xtra,  A  Good  Idea?  

• Procedure  Rela'vely  Easy  to  Perform  

• Cross  Linking  Treats  Ectasia  • Results  Demonstrate:  

– No  Increase  in  Risk  

– Refrac've  Outcome  Predictable  

• What  Addi'onal  Evidence  is  Required  

• Ethical  to  Not  Offer  to  All  Refrac've  Pa'ents?