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ENTER RELEX-GOODBYE
EXCIMER
Dr. Rupal Shah
Clinical Director, New Vision Laser Centers, India
www.drrupalshahlasik.com
EXCIMER LASER
 Technology has been around since at least 20
  years
 Stable Technology

 Excellent results (>95% of all eyes are within +/-
  0.5D)
 Ability to customize treatments

 High Patient Awareness and Acceptance
CONVENTIONAL LASIK


   Mechanical Microkeratome to create a hinged flap
   Flap is lifted to one side and excimer laser ablation
    is carried out
   In excimer Laser ablation a lens is ablated from the
    cornea, equivalent to the correction achieved
   Lens material is removed in the shape of a gas
    plume from the corneal surface
FEMTOSECOND LASER

 Wellestablished Safety Profile for making
  LASIK Flaps
 Several Advantages
     “Locked In” Flap
     Fully Sterile
     Tight control of Flap thickness
     Thin Flaps possible
     More Predictability and better complication profile relative
      to mechanical microkeratome flaps
   Preferred choice for making LASIK flaps
RELEX
 Uses only the femtosecond laser for completing the
  entire LASIK procedure
 No need for an excimer laser

 Possible only with the VisuMax Laser from Carl Zeiss

 Two Procedures
     FLEx=Femtosecond   Lenticule Extraction
     SMILE-Small Incision Lenticule Extraction
Surgical steps of the ReLeX Procedure

1




2




3
WHY RELEX?
STABILITY OF THE LASER
 Excimer Laser is a gas based laser. Even after
  many improvements, it is not as stable as a fiber
  based femtosecond laser
 In a study we did, our MEL 80 excimer laser
  required about six interventions in the year
  ended February 2011 (including gas bottle
  changes)
 Our VisuMax Femtosecond Laser required only
  two interventions (of which one was for software
  upgradation)
CORNEAL RESHAPING WITHOUT
ABLATION
 An excimer laser performs photoablation
 The photoablation rate increases linearly with
  fluence beyond a certain threshold
 Excimer Laser fluence and photoablation rate
  gets influenced by various factors –corneal
  hydration levels, humidity levels, the presence of
  organic vapors, the depth of ablation
 This results in a scatter, especially for the
  treatment of high myopia
RELEX
 Uses cutting instead of ablation
 A binary process instead of linear

 Much less influence of any external factors

 Reflected in the tremendous accuracy achieved,
  even in the first 1500-2000 eyes treated
  worldwide
 Results are especially interesting for high
  myopia, a group in which excimer lasers don’t
  fare as well
RESULTS OF REFRACTIVE
CORRECTION USING RELEX WITH A
500 KHZ VISUMAX
                                             month (eyes)
                                                                                 97%   98%
                          100%                                                94%
                                               1 m (410)       3 m (377)
                                                                                    95%
                          90%                   6 m (261)      1 y (64)


                          80%


                          70%


                          60%


                          50%


                          40%


                          30%
 CZM-Application Pujara




                          20%


                          10%
                                                                   2% 2%                        1% 1%
                                        1% 1% 1% 2%                      3%                           1%          1% 0%
                                                                                                                          0%
                           0%
                                         -2




                                                                    -1




                                                                                                  +1




                                                                                                                   +2
                                                                                ,5
                                                                                 0
                                        to




                                                                   to




                                                                                                to




                                                                                                                  to
                                                                              +-
                                  01




                                                             51




                                                                                                             01
                                                                                             51
                                    ,




                                                               ,
                                                            -0




                                                                                            ,




                                                                                                              ,
                                 -1




                                                                                         +0




                                                                                                           +1
                                                    Refractive outcome - Percentage within Attempted
SCATTER PLOT OF RELEX WITH A
500 KHZ LASER (AT 3 MONTHS)
    Achieved [D]                                  Scatter: Attempted vs. Achieved SEQ 'PREDICTABILITY'     377 eyes

                             15

                             14

                             13       overcorrected
                             12

                             11

                             10

                             9

                             8

                             7

                                                                                             y = 0.99x + 0.02
                             6
                                                                                                 R2 = 0.98
                             5

                             4

                             3
                                                                           undercorrected
                             2
    CZM-Application Pujara




                             1

                             0
                                  0   1   2   3   4    5      6      7     8      9     10     11     12        13    14   15

                                                                          Attempted delta SR equiv. [D]
RESULTS OF RELEX FOR HIGH
MYOPIA (>-5D UPTO -10D)
RELEX AND INFLAMMATION
 Total amount of energy input into the eye with
  ReLEx is less than with Femto LASIK
 Results in less inflammation and higher stability
  of the treatment
RELEX-STABILITY AFTER TREATMENT
WITH A 500 KHZ LASER
 1.00           -0.02                 -0.02
                                                            -0.03   -0.03


 0.00
    pre op       1m                   3m                    6m      1y
-1.00


-2.00


-3.00

        -4.43
-4.00




                                                                            CZM-Application Pujara
-5.00


-6.00

        422       410                   377                  261
                                                                    64
-7.00
                 Achieved Correction SEQ over Time 'STABILITY'
STABILITY AFTER RELEX FOR THE
TREATMENT OF HIGH MYOPIA (>-
5D)
 1.00
                              0.07         0.08    0.06
                 0.14
 0.00
    pre op          1w           1m           3m     6m
 -1.00


 -2.00


 -3.00


 -4.00


 -5.00


 -6.00
         -6.41
 -7.00

         123            118          113    83      43
 -8.00
                               Time
POTENTIAL FOR MINIMALLY
INVASIVE TREATMENT
   One can easily remove the lenticule from a 3 mm
    incision. We are working on techniques to reduce
    this to less than 1.5 mm
VIDEO
SMALL INCISIONS
 No risk of flap displacements (There is a cap.
  There is no flap!!!)
 Small Incision results in minimal cutting of
  corneal nerves – less dry eyes, smaller reduction
  in corneal sensitivity
 Less discomfort for the patient for a smaller
  period
 Possible better biomechanical stability relative to
  Femto-LASIK
INDUCTION OF ABERRATIONS
   Excimer lasers suffer from peripheral fluence
    loss
     Fresnel reflection losses at a high angle of incidence
     Increase in spot size in the periphery
   Leads to an increase in spherical aberrations
     Minimized   by newer ablation profiles
   However, with ReLEx, this problem is essentially
    not there
     Should  lead to less induction of spherical aberration
     In our study, there was an induction of less than 0.12
      microns of spherical aberration (5 mm pupil)
WORKFLOW IMPROVEMENTS
 No need to change stations
 No need to keep placing and removing the
  speculum
 In a study we conducted,
     SMILE  (2 Eyes) took an average of 12.9 minutes
     Femto LASIK (2 Eyes) took an average of 21 minutes
   At our volume, doing ReLEx on all patients
    would result in a net saving of 120 hours a year,
    or half an hour every working day
PATIENT ACCEPTANCE
 Patients really like the idea of a flap less
  procedure without the pain and slow visual
  recovery of surface procedures
 In my experience, ReLEx is an easier “sell” to
  patients than Femto-LASIK
COSTS
 Only one laser needed instead of 2
 Capital cost is reduced by nearly 50%

 Consumables of only one laser

 Maintenance contract of only one laser
SO WHEN IS AN EXCIMER NEEDED
 Wavefront Guided Procedures (< 5% of a normal
  refractive practice)
 Retreatments (< 1% in ReLEx procedures- In
  over 1000 eyes treated, I have actually retreated
  only 3 eyes)
 Hyperopia (Latest results of ReLEx for
  Hyperopia are quite encouraging)
GOODBYE EXCIMER
Enter ReLEx
drrupalshahlasik.com

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Enter ReLEx-goodbye excimer

  • 1. ENTER RELEX-GOODBYE EXCIMER Dr. Rupal Shah Clinical Director, New Vision Laser Centers, India www.drrupalshahlasik.com
  • 2. EXCIMER LASER  Technology has been around since at least 20 years  Stable Technology  Excellent results (>95% of all eyes are within +/- 0.5D)  Ability to customize treatments  High Patient Awareness and Acceptance
  • 3. CONVENTIONAL LASIK  Mechanical Microkeratome to create a hinged flap  Flap is lifted to one side and excimer laser ablation is carried out  In excimer Laser ablation a lens is ablated from the cornea, equivalent to the correction achieved  Lens material is removed in the shape of a gas plume from the corneal surface
  • 4. FEMTOSECOND LASER  Wellestablished Safety Profile for making LASIK Flaps  Several Advantages  “Locked In” Flap  Fully Sterile  Tight control of Flap thickness  Thin Flaps possible  More Predictability and better complication profile relative to mechanical microkeratome flaps  Preferred choice for making LASIK flaps
  • 5. RELEX  Uses only the femtosecond laser for completing the entire LASIK procedure  No need for an excimer laser  Possible only with the VisuMax Laser from Carl Zeiss  Two Procedures  FLEx=Femtosecond Lenticule Extraction  SMILE-Small Incision Lenticule Extraction
  • 6. Surgical steps of the ReLeX Procedure 1 2 3
  • 8. STABILITY OF THE LASER  Excimer Laser is a gas based laser. Even after many improvements, it is not as stable as a fiber based femtosecond laser  In a study we did, our MEL 80 excimer laser required about six interventions in the year ended February 2011 (including gas bottle changes)  Our VisuMax Femtosecond Laser required only two interventions (of which one was for software upgradation)
  • 9. CORNEAL RESHAPING WITHOUT ABLATION  An excimer laser performs photoablation  The photoablation rate increases linearly with fluence beyond a certain threshold  Excimer Laser fluence and photoablation rate gets influenced by various factors –corneal hydration levels, humidity levels, the presence of organic vapors, the depth of ablation  This results in a scatter, especially for the treatment of high myopia
  • 10. RELEX  Uses cutting instead of ablation  A binary process instead of linear  Much less influence of any external factors  Reflected in the tremendous accuracy achieved, even in the first 1500-2000 eyes treated worldwide  Results are especially interesting for high myopia, a group in which excimer lasers don’t fare as well
  • 11. RESULTS OF REFRACTIVE CORRECTION USING RELEX WITH A 500 KHZ VISUMAX month (eyes) 97% 98% 100% 94% 1 m (410) 3 m (377) 95% 90% 6 m (261) 1 y (64) 80% 70% 60% 50% 40% 30% CZM-Application Pujara 20% 10% 2% 2% 1% 1% 1% 1% 1% 2% 3% 1% 1% 0% 0% 0% -2 -1 +1 +2 ,5 0 to to to to +- 01 51 01 51 , , -0 , , -1 +0 +1 Refractive outcome - Percentage within Attempted
  • 12. SCATTER PLOT OF RELEX WITH A 500 KHZ LASER (AT 3 MONTHS) Achieved [D] Scatter: Attempted vs. Achieved SEQ 'PREDICTABILITY' 377 eyes 15 14 13 overcorrected 12 11 10 9 8 7 y = 0.99x + 0.02 6 R2 = 0.98 5 4 3 undercorrected 2 CZM-Application Pujara 1 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Attempted delta SR equiv. [D]
  • 13. RESULTS OF RELEX FOR HIGH MYOPIA (>-5D UPTO -10D)
  • 14. RELEX AND INFLAMMATION  Total amount of energy input into the eye with ReLEx is less than with Femto LASIK  Results in less inflammation and higher stability of the treatment
  • 15. RELEX-STABILITY AFTER TREATMENT WITH A 500 KHZ LASER 1.00 -0.02 -0.02 -0.03 -0.03 0.00 pre op 1m 3m 6m 1y -1.00 -2.00 -3.00 -4.43 -4.00 CZM-Application Pujara -5.00 -6.00 422 410 377 261 64 -7.00 Achieved Correction SEQ over Time 'STABILITY'
  • 16. STABILITY AFTER RELEX FOR THE TREATMENT OF HIGH MYOPIA (>- 5D) 1.00 0.07 0.08 0.06 0.14 0.00 pre op 1w 1m 3m 6m -1.00 -2.00 -3.00 -4.00 -5.00 -6.00 -6.41 -7.00 123 118 113 83 43 -8.00 Time
  • 17. POTENTIAL FOR MINIMALLY INVASIVE TREATMENT  One can easily remove the lenticule from a 3 mm incision. We are working on techniques to reduce this to less than 1.5 mm
  • 18. VIDEO
  • 19. SMALL INCISIONS  No risk of flap displacements (There is a cap. There is no flap!!!)  Small Incision results in minimal cutting of corneal nerves – less dry eyes, smaller reduction in corneal sensitivity  Less discomfort for the patient for a smaller period  Possible better biomechanical stability relative to Femto-LASIK
  • 20. INDUCTION OF ABERRATIONS  Excimer lasers suffer from peripheral fluence loss  Fresnel reflection losses at a high angle of incidence  Increase in spot size in the periphery  Leads to an increase in spherical aberrations  Minimized by newer ablation profiles  However, with ReLEx, this problem is essentially not there  Should lead to less induction of spherical aberration  In our study, there was an induction of less than 0.12 microns of spherical aberration (5 mm pupil)
  • 21. WORKFLOW IMPROVEMENTS  No need to change stations  No need to keep placing and removing the speculum  In a study we conducted,  SMILE (2 Eyes) took an average of 12.9 minutes  Femto LASIK (2 Eyes) took an average of 21 minutes  At our volume, doing ReLEx on all patients would result in a net saving of 120 hours a year, or half an hour every working day
  • 22. PATIENT ACCEPTANCE  Patients really like the idea of a flap less procedure without the pain and slow visual recovery of surface procedures  In my experience, ReLEx is an easier “sell” to patients than Femto-LASIK
  • 23. COSTS  Only one laser needed instead of 2  Capital cost is reduced by nearly 50%  Consumables of only one laser  Maintenance contract of only one laser
  • 24. SO WHEN IS AN EXCIMER NEEDED  Wavefront Guided Procedures (< 5% of a normal refractive practice)  Retreatments (< 1% in ReLEx procedures- In over 1000 eyes treated, I have actually retreated only 3 eyes)  Hyperopia (Latest results of ReLEx for Hyperopia are quite encouraging)

Editor's Notes

  1. We are of course all familiar with conventional LASIK, wherein a mechanical microkeratome is used to create a flap, and an excimer laser is used to ablate a lenticule equivalent to the refractive error.
  2. In recent years, the Femtosecond Laser has established itself as an excellent alternative to the mechanical microkeratome. The numerous advantages of the Femtosecond Laser as a flapmaker are well known, and its safety profile for the use on a human eye is well established. It is worth reminding though, that the Femtosecond laser is usually used only as a means of flap making, and the lenticule is still ablated using an excimer laser.
  3. The Femtosecond Laser, as all of you are aware is an elegant tissue separation tool.. It can separate two layers of the cornea with incredible precision. Therefore in the FLEx procedure, first the Femtosecond laser is scanned in a manner to separate the posterior lenticule surface. It is then scanned in a manner to create the roof of the lens, which is also the posterior surface of the flap. The flap sidecut is then made, the flap lifted, and lenticule is then mechanically extracted from the stromal bed. The flap is then replaced in the usual manner.