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The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax Dan Z Reinstein MD MA(Cantab) FRCSC FRCOphth 1,2,3,4 1. London Vision Clinic, London, UK 2. St. Thomas’ Hospital - Kings College, London, UK  3. Weill Medical College of Cornell University, New York, 4. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche) , Paris, France
Financial Disclosure The author (DZ Reinstein) acknowledges a financial interest in Artemis™ VHF digital ultrasound ( ArcScan Inc , Morrison, CO) The author (DZ Reinstein) is a consultant for  Carl Zeiss Meditec AG  (Jena, Germany)
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],VisuMax  Femtosecond System   0.1  µJ  500 kHz ~1 µm Pulse Rate Precise Focusing Spot Energy
[object Object],VisuMax Femtosecond System   ▼ low  Numerical aperture  high  ▲ ▼ large  Spot diameter  small  ▲ ▼ low  Depth accuracy  high  ▲ ▼ high  Single pulse energy small  ▲
The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Assessment of VisuMax Flap Thickness ,[object Object],[object Object],J Refract Surg. Online Pre Release.
Artemis very high-frequency digital ultrasound arc-scanner ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Surface localization: 0.87 µm ArcScan Inc Evergreen, Colorado
Flap Thickness Measurement ,[object Object],+ Pre-op Post-op 3 months Epithelial thickness Stromal Flap thickness ,[object Object],Thickness of the stromal component of the flap  measured 3 months after surgery   +  Preoperative epithelial thickness
Artemis B-Scan: 6 Months Post LASIK  Artemis B-Scan (above) of VisuMax Flap 6 months post LASIK. Edge detection by I-scan digital signal processing (red outline, below) based on raw scan data
RESULTS: Central Flap Thickness ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
RESULTS: Central Flap Thickness  ,[object Object],[object Object],[object Object]
Flap Thickness Reproducibility: Published ,[object Object],Author Microkeratome Accuracy (µm) SD (µm) Pachymetry Method Pachymetry Instrument Stahl 2007 IntraLase FS60 +12.0 5.0 1 Mo Post-op OCT Visante Pietila 2009 Femto LDV -20.0 5.0 Intra-op US SP-3000 Alio 2008 IntraLase FS30 +6.0 6.2 1 Mo Post-op VHFU Artemis-2 Hu 2007 IntraLase FS30 +13.9 7.1 3 Mo Post-op CMTF NR Reinstein 2009 VisuMax  +2.3 7.9 Pre and 3 Mo Post-op VHFU Artemis-1 Li 2007 IntraLase (Pulsion) +35.0 9.0 1 Wk Post-op OCT CAS-OCT Holzer 2006 Femtec -0.4 9.1 Micrometer Digimatic Sutton 2008 IntraLase FS30 -1.0 9.8 Intra-op US Corneo-Gage Plus Binder 2006 IntraLase FS10 +35.8 10.1 Intra-op US Cornea Scan II 50 MHz Binder 2006 IntraLase FS15 +21.1 10.2 Intra-op US Cornea Scan II 50 MHz Holzer 2006 Femtec +3.7 10.7 Micrometer Digimatic Binder 2006 IntraLase FS15 +25.8 10.8 Intra-op US Cornea Scan II 50 MHz Sutton 2008 IntraLase FS15 +11.8 10.8 Intra-op US Corneo-Gage Plus Li 2007 IntraLase (Pulsion) +30.0 11.0 Intra-op US Corneo-Gage 2 50 MHz Li 2007 IntraLase (Pulsion) +36.0 11.0 1 Wk Post-op OCT CAS-OCT (Visante prototype) Holzer 2006 Femtec -7.9 11.1 Micrometer Digimatic Hu 2007 IntraLase FS15 +16.8 11.1 3 Mo Post-op CMTF NR Binder 2006 IntraLase FS15 +20.1 11.8 Intra-op US Cornea Scan II 50 MHz Binder 2004 IntraLase FS +2.4 11.9 Intra-op US NR Binder 2004 IntraLase FS +15.0 12.0 Intra-op US NR Talamo 2006 IntraLase FS +9.0 12.0 Intra-op US Pachette II Binder 2006 IntraLase FS10 +29.2 12.4 Intra-op US Cornea Scan II 50 MHz Kim 2008 IntraLase FS60 +8.9 13.6 3 Mo Post-op OCT Visante Pfaeffl 2008 IntraLase FS30 +0.4 13.6 Intra-op OCP Online OCP Kezirian 2004 IntraLase FS -16.0 14.0 Intra-op US Pachette 50/60 KHz pachymeter Binder 2006 IntraLase FS10 +29.7 14.3 Intra-op US Cornea Scan II 50 MHz Neuhann 2008 IntraLase FS30 +11.7 14.7 Intra-op OCP Online OCP Binder 2006 IntraLase FS10 +17.4 15.2 Intra-op US Cornea Scan II 50 MHz Binder 2004 IntraLase FS -1.3 16.6 Intra-op US NR Binder 2006 IntraLase FS10 -0.4 17.1 Intra-op US Cornea Scan II 50 MHz Kim 2008 IntraLase FS60 +4.8 17.6 3 Mo Post-op OCT Visante Binder 2004 IntraLase FS -7.5 18.5 Intra-op US NR Binder 2006 IntraLase FS10 -9.4 19.0 Intra-op US Cornea Scan II 50 MHz Li 2007 IntraLase (Pulsion) +40.0 19.0 Intra-op US Corneo-Gage 2 50 MHz Binder 2006 IntraLase FS10 +13.4 22.1 Intra-op US Cornea Scan II 50 MHz
Validity of Measurement Instrument
Validity of Measurement Instrument 95% values within 2 standard deviations
Validity of Measurement Instrument 95% values within 2 standard deviations Precision: 1  µm 95% within: 108-112  µm
Validity of Measurement Instrument 95% values within 2 standard deviations Precision: 10  µm 95% within: 90-130  µm
Validity of Measurement Instrument 95 104 105 106 114 115 116 125 Value 1 Value 2 Valid Invalid Instrument 1 Instrument 2
Validity of Measurement Instrument Required Precision: 2.5  µm Reproducibility: 5  µm
Validity of Measurement Instrument Ideal Precision: 1.66  µm Reproducibility: 5  µm
Validity of Measurement Instrument Artemis  Flap Thickness Repeatability: 1.14  µm Therefore, the Artemis  is capable  of measuring a flap thickness reproducibility of  7.89  µm  as found in this study
Validity of Measurement Instrument Artemis  Flap Thickness Repeatability: 1.14  µm The Artemis is capable of measuring a flap thickness reproducibility  as small as   3.42  µm
The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
VisuMax  Femtosecond System : Patient Comfort ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Cross section of the contact glass
IOP Comparison: VisuMax vs IntraLase Comparison of typical curves plotted on the same scale Ref:  Grabner G. Femtosecond to fully replace microkeratome. Ophthalmology Times, 2008 0 50 100 150 200 250 300 350 0 20 40 60 80 100 time (sec) IOP (mmHg) IntraLase VisuMax
IOP Comparison: VisuMax vs IntraLase VisuMax flap creation time reduced to  ~20 seconds  with software v 2.4.0 Comparison of typical curves plotted on the same scale Ref:  Grabner G. Femtosecond to fully replace microkeratome. Ophthalmology Times, 2008
Questionnaire: Patient Experience  VisuMax vs Hansatome
Questionnaire :  Claustrophobia
Questionnaire :  Discomfort from Pressure
Questionnaire :  Length of Time With Pressure
The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],VisuMax  Femtosecond System : Centration
Flap Centration on Corneal Vertex
Flap Centration on Corneal Vertex Corneal vertex Flap edge Dye pooling in ablation zone
The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Ultra Thin Flap LASIK:  No Need For PRK ,[object Object],[object Object],[object Object],[object Object],[object Object],Flap thickness: 84 µm
The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Flap Creation with Previous PRK Thick epithelium after hyperopic PRK Flap underneath epithelium Epithelium Post PRK for +3.00 D
Recutting Flaps: Measure Twice, Cut Once! Incomplete Flap: Hansatome zero compression microkeratome
Recutting Flaps: Measure Twice, Cut Once! Second flap  created under the  half flap  using the VisuMax femtosecond laser
Recutting Flaps: Measure Twice, Cut Once! ,[object Object],[object Object],Flap Thickness Profile
Recutting Flaps: Measure Twice, Cut Once! ,[object Object],[object Object],[object Object],VisuMax Micro-Bubble Layer Creation
Recutting Flaps: Measure Twice, Cut Once! ,[object Object],[object Object]
The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
VisuMax when Hansatome not Possible Hansatome VisuMax Forced to switch to PRK Retreatment as VisuMax
VisuMax Flap in RK Patient
VisuMax Flap in Deep Lamellar Keratoplasty
The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
VisuMax Population ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Attempted vs Achieved: 6 Months
Accuracy 6 Months: Within Range of Intended
Efficacy 6 Months: Binocular Vision
Efficacy 6 Months: Monocular Vision
Safety 6 Months: Lines Change BSCVA
Stability: Change in Spherical Equivalent Pre Op 1 Day 1 Month 3 Months 6 Months Avg SEQ -4.06 +0.37 -0.08 -0.15 -0.17 SD SEQ 1.85 0.36 0.43 0.42 0.41 # eyes 232 228 223 203 222
The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
VisuMax Unsurpassed Future Potential ,[object Object],[object Object],[object Object],[object Object]
The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax Dan Z Reinstein MD MA(Cantab) FRCSC FRCOphth 1,2,3,4 1. London Vision Clinic, London, UK 2. St. Thomas’ Hospital - Kings College, London, UK  3. Weill Medical College of Cornell University, New York, 4. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche) , Paris, France Thank You
Comparison with IntraLase
IntraLase Claims vs VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IntraLase Claims vs VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IntraLase Claims vs VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IntraLase Claims vs VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IntraLase Claims vs VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IntraLase Claims vs VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IntraLase Claims vs VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IntraLase Claims vs VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IntraLase Claims vs VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IntraLase Claims vs VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IntraLase Claims vs VisuMax ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Reinstein visumax

  • 1. The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax Dan Z Reinstein MD MA(Cantab) FRCSC FRCOphth 1,2,3,4 1. London Vision Clinic, London, UK 2. St. Thomas’ Hospital - Kings College, London, UK 3. Weill Medical College of Cornell University, New York, 4. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche) , Paris, France
  • 2. Financial Disclosure The author (DZ Reinstein) acknowledges a financial interest in Artemis™ VHF digital ultrasound ( ArcScan Inc , Morrison, CO) The author (DZ Reinstein) is a consultant for Carl Zeiss Meditec AG (Jena, Germany)
  • 3.
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  • 10. Artemis B-Scan: 6 Months Post LASIK Artemis B-Scan (above) of VisuMax Flap 6 months post LASIK. Edge detection by I-scan digital signal processing (red outline, below) based on raw scan data
  • 11.
  • 12.
  • 13.
  • 15. Validity of Measurement Instrument 95% values within 2 standard deviations
  • 16. Validity of Measurement Instrument 95% values within 2 standard deviations Precision: 1 µm 95% within: 108-112 µm
  • 17. Validity of Measurement Instrument 95% values within 2 standard deviations Precision: 10 µm 95% within: 90-130 µm
  • 18. Validity of Measurement Instrument 95 104 105 106 114 115 116 125 Value 1 Value 2 Valid Invalid Instrument 1 Instrument 2
  • 19. Validity of Measurement Instrument Required Precision: 2.5 µm Reproducibility: 5 µm
  • 20. Validity of Measurement Instrument Ideal Precision: 1.66 µm Reproducibility: 5 µm
  • 21. Validity of Measurement Instrument Artemis Flap Thickness Repeatability: 1.14 µm Therefore, the Artemis is capable of measuring a flap thickness reproducibility of 7.89 µm as found in this study
  • 22. Validity of Measurement Instrument Artemis Flap Thickness Repeatability: 1.14 µm The Artemis is capable of measuring a flap thickness reproducibility as small as 3.42 µm
  • 23.
  • 24.
  • 25. IOP Comparison: VisuMax vs IntraLase Comparison of typical curves plotted on the same scale Ref: Grabner G. Femtosecond to fully replace microkeratome. Ophthalmology Times, 2008 0 50 100 150 200 250 300 350 0 20 40 60 80 100 time (sec) IOP (mmHg) IntraLase VisuMax
  • 26. IOP Comparison: VisuMax vs IntraLase VisuMax flap creation time reduced to ~20 seconds with software v 2.4.0 Comparison of typical curves plotted on the same scale Ref: Grabner G. Femtosecond to fully replace microkeratome. Ophthalmology Times, 2008
  • 27. Questionnaire: Patient Experience VisuMax vs Hansatome
  • 28. Questionnaire : Claustrophobia
  • 29. Questionnaire : Discomfort from Pressure
  • 30. Questionnaire : Length of Time With Pressure
  • 31.
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  • 33. Flap Centration on Corneal Vertex
  • 34. Flap Centration on Corneal Vertex Corneal vertex Flap edge Dye pooling in ablation zone
  • 35.
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  • 38. Flap Creation with Previous PRK Thick epithelium after hyperopic PRK Flap underneath epithelium Epithelium Post PRK for +3.00 D
  • 39. Recutting Flaps: Measure Twice, Cut Once! Incomplete Flap: Hansatome zero compression microkeratome
  • 40. Recutting Flaps: Measure Twice, Cut Once! Second flap created under the half flap using the VisuMax femtosecond laser
  • 41.
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  • 45. VisuMax when Hansatome not Possible Hansatome VisuMax Forced to switch to PRK Retreatment as VisuMax
  • 46. VisuMax Flap in RK Patient
  • 47. VisuMax Flap in Deep Lamellar Keratoplasty
  • 48.
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  • 51. Accuracy 6 Months: Within Range of Intended
  • 52. Efficacy 6 Months: Binocular Vision
  • 53. Efficacy 6 Months: Monocular Vision
  • 54. Safety 6 Months: Lines Change BSCVA
  • 55. Stability: Change in Spherical Equivalent Pre Op 1 Day 1 Month 3 Months 6 Months Avg SEQ -4.06 +0.37 -0.08 -0.15 -0.17 SD SEQ 1.85 0.36 0.43 0.42 0.41 # eyes 232 228 223 203 222
  • 56.
  • 57.
  • 58. The Great Femtosecond Face-off: Carl Zeiss Meditec VisuMax Dan Z Reinstein MD MA(Cantab) FRCSC FRCOphth 1,2,3,4 1. London Vision Clinic, London, UK 2. St. Thomas’ Hospital - Kings College, London, UK 3. Weill Medical College of Cornell University, New York, 4. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche) , Paris, France Thank You
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Notas do Editor

  1. I acknowledge a financial interest in the Artemis technology and am a consultant for Carl Zeiss Meditec
  2. In order for the reproducibility results to be valid, the precision of the measuring instrument needs to be smaller than the reproducibility of the data set being measured.
  3. For example, considering that 95% of measurements will be contained within a range of two standard deviations from the mean,
  4. if an instrument with a precision of 1 µm were to be used to repeatedly measure the same flap, known to be exactly 110 µm in thickness, 95% of the measurements would fall between 108-112 µm (2 standard deviations from the mean).
  5. On the other hand, if an instrument with a precision of 10 µm were to be used to repeatedly measure the same 110 micron flap, 95% of the measurements would fall between 90 and 130 µm.  
  6. Therefore, the validity of a flap thickness study is compromised if the precision of the measuring instrument is too large to be able to distinguish between two data points. And really, it’s the rule of 3 times – as 99.5% of data points are to be found within 3 standard deviations of the mean
  7. For a claim of let’s say, a flap thickness reproducibility of 5 microns, the precision of the measuring tool needs to be at least half, …
  8. preferably a third of 5 microns, or 1.66 microns.
  9. So for example, the Artemis, with a 1.14 micron precision is perfectly capable of proving a flap thickness reproducibility of 7.89 microns
  10. In fact, the Artemis, with a 1.14 micron precision, can be expected to distinguish flaps that are at least 3.42 microns different in thickness and therefore can legitimately be used to study the flap reproducibility of a system as long as the flap reproducibility is not better than 3.42 microns.
  11. All experiments were performed in New zealand white rabbits of both sexes, anesthetized with PENTOPARBITAL. Since the laser doppler system is a sensitive motion detector the animals were paralysed with FLEXADIL to avoid measurement artefacts by movement. The rabbits were artificially respired. exspired CO2 levels were kept around 42 milimeters of mercury. body temperature was maintained by a heating pad. H ydrolic occluders were placed around the abdominal aorta and the inferior caval vein to manipulate mean arterial pressure and thereby change the perfusion pressure of the target tissue over a wide range. During the occlussion of the abdominal aorta blood flow to the lower half of the body is redirected to the upper half which increases blood pressure at the level of the ciliary body. During a caval occlusion venous return is decreased which in turn decreases blood pressure in the whole animal.
  12. All experiments were performed in New zealand white rabbits of both sexes, anesthetized with PENTOPARBITAL. Since the laser doppler system is a sensitive motion detector the animals were paralysed with FLEXADIL to avoid measurement artefacts by movement. The rabbits were artificially respired. exspired CO2 levels were kept around 42 milimeters of mercury. body temperature was maintained by a heating pad. H ydrolic occluders were placed around the abdominal aorta and the inferior caval vein to manipulate mean arterial pressure and thereby change the perfusion pressure of the target tissue over a wide range. During the occlussion of the abdominal aorta blood flow to the lower half of the body is redirected to the upper half which increases blood pressure at the level of the ciliary body. During a caval occlusion venous return is decreased which in turn decreases blood pressure in the whole animal.