LASIK Surgery. Thin planar flaps created predictably and economically without compromise

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1 LASIK Surgery Thin planar flaps created predictably and economically without compromise

2 1 One Use-Plus SBK: reliably creates thin planar LASIK flaps Moria One Use-Plus SBK Microkeratome: Predictably Thin, Smooth, Planar Flaps for Faster Visual Recovery PART 1 of 2 Richard J. Duffey, MD (Mobile, AL, USA) 26 th ESCRS Fall 2008, Berlin, Germany Purpose: To assess outcomes when using One Use-Plus SBK. Participants: 50 eyes of 25 consecutive myopic patients: Flap thickness: 103 ± 9 [83 to 123] µm Vertical flap diameter: 9.3 ± 0.3 mm Pupil tracking successful in 100% of eyes No intraop complications: no epithelial defects, no epithelial slides No postop complications: no slipped flaps, microstriae, DLK, or flap complications OCT: planar profile in all flaps along the horizontal, vertical, and oblique meridia. UCVA at 1 day postoperative N=50 eyes N=50 eyes /16 or better 20/20 or better 20/25 or better 0 % eyes One Use-Plus SBK - Dr. Duffey (Mobile, AL, USA) 1 Femto-SBK - Dr. Durrie (Overland Park, KS, USA) Pain score at 1 to 5 hours post surgery N=10 eyes N=10 eyes 0,80 4, One Use-Plus SBK - Dr. Duffey 1 Femto-SBK - Dr. Duffey 1 0 = no pain 10 = worst imaginable pain «The pain occurred at a much lower frequency and intensity with One Use-Plus SBK in the first one to five hours after surgery than with IntraLase SBK.» Richard J. Duffey, MD One Use-Plus SBK: Gentle on epithelium Efficient, accurate and predictible for creation of 100-µm flaps Creates planar flaps Compares favorably to femtosecond lasers.

3 2 Smoother stromal surface than with FemtoLASIK Moria One Use-Plus SBK Microkeratome: Predictably Thin, Smooth, Planar Flaps for Faster Visual Recovery PART 2 of 2 Richard J. Duffey, MD (Mobile, AL, USA) 26 th ESCRS Fall 2008, Berlin, Germany Purpose: To compare quality of flap bed smoothness by Scanning Electron Microscopy (SEM) at different magnifications: x20, x40, x80, and x160 of One Use-Plus SBK vs IntraLase 60kHz targeted to create100-µm flaps Design: Laboratory study Material: Human corneas not suitable for transplantation SEM pictures of intended 100-micron flaps: Top: 20x magnification Bottom: 160x magnification Left: One Use-Plus SBK Right: IntraLase 60kHz One Use-Plus SBK creates a much smoother surface compared to velcro-like rough surface when using a FS laser. «Flap thickness predictability, speed of visual recovery, high order aberrations in custom treated eyes, and smoothness of stromal bed as determined by scanning electron microscopy in eyes undergoing SBK (thin flap LASIK) using the Moria One Use-Plus SBK microkeratome all compare favorably or equally to femtosecond laser SBK flap technology at a fraction of the cost and with less postoperative pain and potentially fewer postoperative complications.» Richard J. Duffey, MD One Use-Plus SBK creates smoother, more consistent stromal beds Smoother stromal bed smoother backside surface of the flap allows a faster healing process for faster visual recovery than with velcro-like FemtoLASIK surface

4 3 SBK without compromise Comparison of the One Use-Plus SBK vs.femtosecond Laser in SBK Richard A. Norden, MD (Ridgewood, NJ, USA) ASCRS 2009, San Francisco Purpose: To compare the efficacy and safety of different technologies for SBK Materials: One Use-Plus SBK vs IntraLase 60kHz Both devices set to create 100-µm flaps Participants: 2 matched patient groups presenting similar preop characteristics 50 eyes of 25 myopic patients in each group Moria SBK IntraLase Flap thickness (µm) 98.2 ± ± 15.4 Flap range Suction time 21.9 ± ± 13.9 Time of procedure 7 46 ± ± 1 48 Stromal bed 100% very good velcro-like surface Intraop flap complications Postop complication None None OBL:18.9% AC gas bubbles: 3% Incomplete flaps: 3% Photophobia (TLS syndrome): 11% «I think we can actually get closer to Bowman s with a mechanical microkeratome than with a femtosecond laser. I have used both technologies for SBK and, in my hands [ ] I have not seen any advantage in centration, visual outcome, or the precision of the flap cut. And there are some real disadvantages to the femtosecond laser, including longer suction time and increased discomfort for patients.» Richard A. Norden, MD One Use-Plus SBK and IntraLase FS laser achieve equivalent degrees of flap thickness accuracy and equivalent visual outcomes. Patients treated with One Use-Plus SBK, however, experience less discomfort and fewer complications.

5 4 SBK at a reasonable price SBK LASIK with a manual microkeratome Gustavo E. Tamayo, MD (Bogota, Colombia) ASCRS 2009, San Francisco Purpose: To compare the efficacy and safety of different technologies for SBK Materials: One Use-Plus SBK vs IntraLase 60kHz Both devices set to create 100-µm flaps Participants: 2 matched patient groups presenting similar preoperative characteristics 20 eyes of 10 myopic patients in each group Moria SBK IntraLase Flap thickness (µm) Flap range Vertical flap diameter (mm) Loss of corneal hysteresis (CH) Loss of corneal resistance factor (CRF) 9.1 [ ] 9.1 [ ] -10.0% -5.7% -20.8% -12% «[Sub-Bowman s keratomileusis] thin-flap LASIK is of particular interest because the biomechanical properties of the cornea must be preserved. There is less risk of ectasia, of course. It [One Use-Plus SBK] produces comparable flaps to femtosecond technology, almost planar, a smooth bed and certainly highly reproducible thinness around 100 µm. It can be reproduced, and it can be compared with an IntraLase flap. It s easy to use. The Moria One Use-Plus SBK is an excellent answer to femtosecond technology, at a much lower price.» Gustavo E. Tamayo, MD One Use-Plus produces SBK flaps, comparable to those created with femto: flaps are planar, smooth, and highly reproducible with thickness approximately 100µm. Biomechanics decrease with both keratomes. One Use-Plus SBK is an excellent alternative to the FS technology at a much lower price.

6 5 SBK without «Femto-Furrow» Unanticipated stromal tissue loss following femtosecond flap creation James S. Lewis, MD (Elkins Park, PA, USA) 28 th ESCRS 2010, Paris, France Purpose: To compare the morphology of SBK flaps created by two keratomes Setting: 2 high-volume private practice LASIK surgeons Materials: One Use-Plus SBK vs IntraLase 150kHz Both devices set to create 100-µm flaps Participants: 2 matched patient groups presenting similar preoperative characteristics 60 virgin eyes of 30 patients in each group Outcome measures: OCT measurements immediately after flap creation OCT pictures compared by a third masked observer FS group: 80% of eyes demonstrated stromal tissue gap or furrow between the distal flap edge and the peripheral stroma in the horizontal meridian. OUP SBK group: No furrow was seen; 100% perfect alignment between the flap stroma and the stromal peripheral bed OCT pictures immediately after SBK flap creation: Left: IntraLase 150kHz // Right: OUP SBK We wanted to see the geometry, the anatomy of the flap edge. [ ] I was expecting the FS angle to be well defined, as these arguments have been made that it s so much better and so much more stable. In actuality, I found discontinuity, a total absence of stroma and possibly stromal tissue loss. A week later you don t see the gap in the OCT. What you see is an epithelial plug filling the furrow with a slightly different tissue density. We do not see the well-defined edges that are theorized to make enhancement safer and epithelial ingrowth a thing of the past. In fact, what we see may be the first sign that the femtosecond laser is not a panacea. [ ] Nothing suggestive of tissue loss was found in the Moria SBK cases.» James S. Lewis, MD Ophthalmology Management, Sept 2010; 14(9): IntraLase furrow (stromal tissue loss) ranging from 10µm to 62µm observed in the majority of IntraLase flaps. Discovery of early post-op stromal furrow nullifies any benefit of the 150 inverted-bevel side cut. Concept of tongue-in-groove tissue alignment can have no merit if there is no stromal apposition. Theory of improved flap adhesion, enhanced biomechanical stability, and reduced risk of epithelial ingrowth are highly suspect.

7 6 SBK superior to PRK Prospective study comparing SBK with PRK Talal Al-Thomali, MD (Taif University, Saudi Arabia) 28 th ESCRS 2010, Paris, France Purpose: To determine the differences in the visual outcomes in eyes undergoing either PRK or SBK, at months after surgery Materials: SBK group: One Use-Plus SBK for 100-µm and 8.5-mm diameter flaps PRK group: 8.5-mm ethanol-assisted PRK Participants: 2 matched patient groups presenting similar preoperative characteristics 100 virgin eyes of 50 patients in each group All eyes underwent customized laser ablation using same excimer laser Pain response: SBK group had mild pain for 2 hours after surgery PRK group: 100% of eyes had pain: 44% severe for 2 days (photophobia, excessive tearing and headache). 38% mild 18% low Visual outcomes at 1 and 3 months postop: UCVA results showed statistically significant difference in favor of SBK SBK group had lower HOA (coma & spherical aberration; p 0.05) UCVA: 20/20 or better month 3 months 0 % eyes One Use-Plus SBK PRK One Use-Plus SBK safe and effective modality for SBK. At 1-month follow-up, the SBK group demonstrated clinically and statistically significant better visual acuity than the PRK group. At 3 months, the SBK eyes continued to have better vision.

8 7 One Use-Plus SBK: comparable flap architecture to FS laser Comparison of flaps made by FS laser and automated keratome for SBK Zhai et al. (Beijing, China) ARVO 2011, Fort Lauderdale, FL, USA Invest Ophthalmol Vis Sci 2011;52: E-Abstract 5787 Purpose: To analyze the reproducibility, uniformity, regularity, and accuracy of LASIK flaps. Materials: MK group: One Use-Plus SBK (and M2SU90 by Moria not shown here) FS group: IntraLase 60kHz FS laser Participants: 2 matched patient groups presenting similar preoperative characteristics MK group: 44 eyes FS group: 59 eyes Outcome measures: OCT measurements flap thickness at 20 specified locations OCT measurements at 1 month postoperatively Mean flap thickness: MK group: ± 4.90 μm FS group: ± 2.26 μm Average flap thickness in different locations: Flap profile in MK and FS groups Flaps created by One Use-Plus SBK and IntraLase FS laser are uniform, regular, accurate and reproducible. Both technologies create precise flapsf or Sub-Bowman Keratomileusis (SBK).

9 8 SBK with metallic and singleuse options SBK with a mechanical microkeratome Daniel Casado, MD (Madrid, Spain) 27 th ESCRS 2009, Barcelona, Spain Purpose: To assess the safety and efficacy of One Use-Plus SBK microkeratome for thin-flap LASIK. Material and methods: one single surgeon (Dr Casado) 1350 virgin eyes 1 microkeratome head was used for each patient (2 eyes) Mean central flap thickness: ± µm, from 74 to 130 microns. Mean vertical flap diameter: 9.26 ± 0.34 mm. Mean hinge width: 3.15 ± 0.91 mm. Flaps all planar and of good quality. No complications: no free caps, no buttonholes, no abrasions, no DLK, nor infection. Selection of 200 eyes (SECOIR 2008, Madrid, Spain) 8 Flap thickness (µm) Flap diameter (mm) Mean ± Sd [min-max] Metal rings (100 eyes) 99.7 ± 13.2 [73-135] 9.5 ± 0.2 [ ] Plastic rings (100 eyes) 98.1 ± 10.7 [77-122] 9.0 ± 0.3 [ ] «Using the Moria One Use-Plus SBK, I have been very impressed with the smoothness of the stromal bed. I think this is a combination of advanced microkeratome technology and the more superficial location of the flap [ ]. In any case, there are no peaks, lines or other irregularities on the stroma like we used to see with other microkeratomes. We have even stopped tracking bed quality in our outcomes database now because it is always of a perfect smoothness.» Daniel Casado, MD One Use-Plus SBK microkeratome is: safe, reliable and efficient, effectively produces good quality, effectively produces thin planar flaps.

10 9 Intra-flap LASIK with One Use- Plus Intra-flap LASIK : a new procedure for LASIK enhancement; a case report José L. Güell, MD (Barcelona, Spain) 27 th ESCRS 2009, Barcelona, Spain Purpose: To report a case of successful LASIK enhancement by using the One Use-Plus to create a 100-µm SBK flap inside the previous thicker flap. Method: 35-year-old man who had previous LASIK surgery 8 years ago reported poor UCVA and quality of vision due to residual refractive defect thin pachymetry: OD 440µm and OS 412µm OCT showed flap thickness of: OD 170µm and OS 185µm as there was no enough tissue to perform further ablation, the One Use-Plus SBK was used to create a 100-µm planar flap inside the former flap wavefront-guided treatment using an excimer laser. RESULTS AT 1 MONTH POSTOP: UCVA : OD 20/20 and OS 20/25. Refraction: plano OD and 170º OS. High order root mean square (HO RMS) improved from: OD: 1.02 µm to 0.68 µm, OS: 1.67 µm to 0.72 µm. OCT showed both the old and the newer thinner flap. Concept of an Intra-Flap LASIK (courtesy of Dr. Gauthier, St-Jean de Luz, France) 2 nd ablation 2 nd cut 1 st old flap stromal bed «Interestingly, I am now retreating some high myopes who had their primary LASIK procedure a decade ago. Some of these early flaps were very thick. Now we can actually cut more superficially and improve their myopic correction without taking any more tissue, something that can t be done with a femtosecond laser.» Laurent Gauthier-Fournet, MD Intra-flap LASIK by creating a thin 100-µm Sub Bowman s planar flap with the Moria One Use-Plus SBK represents a promising approach for LASIK wavefront-guided enhancements to improve both quality of vision and UCVA in eyes with thin residual stromal bed and a thick previous LASIK flap.

11 10 One Use-Plus SBK equivalent to FemtoLASIK Comparative study between One Use-Plus SBK and FemtoLASIK flaps Ahmed El-Massry, MD (Alexandria, Egypt) 15 th ESCRS Winter 2011, Istanbul, Turkey Purpose: To compare One Use-Plus SBK and femtosbk flaps. Material and methods: 3 matched patient groups presenting similar preoperative characteristics Group 1: 132 eyes with One Use-Plus SBK microkeratome Group 2: 112 eyes with IntraLase 60kHz FS laser Group 3: 112 eyes with VisuMax 500kHz FS laser Group 1: Moria SBK Group 2: IntraLase Group 3: VisuMax Nb of eyes Intended flap thickness 100 µm Obtained flap thickness 108 ± ± ± 8 Flap range Anterior chamber gas None Occasionally bubbles Opaque Bubble Layer None Often Pupil tracking Easy Difficult «The One Use-Plus SBK microkeratome is: simple, easy to use and safe comparable to FemtoSBK (accuracy and predictability) without intraop and postop femtolasers complications and at a significant less cost.» Ahmed El-Massry, MD One Use-Plus SBK is safe and effective; stromal bed are of excellent quality. Flaps are highly predictable and consistent in terms of: thickness, shape, diameter, and hinge size. Flaps are superior to conventional flaps and as good as Femto flaps. One Use-Plus advantages: speed, visibility, clarity (no gas bubbles), and lower cost to the patient.

12 11 One Use-Plus SBK: oval flaps for better outcomes Corneal flaps individualized with precise mechanical microkeratome Bai Ji, MD, PhD (Chongqing, China) 29 th ESCRS 2011, Vienna, Austria Purpose: To demonstrate safety and effectiveness of SBK with oval suction ring in Asian patients To compare flaps created by oval and circular suction rings for One Use-Plus. Participants: 428 eyes of 214 myopic Asian patients Method: Preop corneal shape: oval cornea when horizontal diameter (Dh) is at least 1mm more than vertical diameter (Dv) circular cornea when Dh is less than 1mm more than Dv. OD or OS patient eyes evenly distributed in 2 groups not considering their initial corneal shape: Group A: randomized, creation of circular flap with circular ring, Group B: randomized, creation of oval flap with oval ring for the other eye. Group A: circular ring Group B: oval ring Nb of eyes 214 eyes of 214 patients Flap thickness (µm) 96 ± ± 8.9 Flap shape Circle flap as expected Oval flap as expected Edge defects 15.4% 3.8% Bleeding 17.3% 5.1% UCVA recovery depending on flap shape ,5 93,4 95, month 3 months 80 % eyes ROUND flap OVAL flap One Use-Plus SBK using an oval suction ring effectively and safely creates oval flaps in eyes of Asian patients. Significantly reduces risk of edge irregularities compared to circular suction ring. Oval flap creation provides better surgical outcomes.

13 Routinely creates planar flaps of approximately 100-microns Linear automated microkeratome Safety and reliability of 2 independent motors Design of suction rings makes the use of a speculum unnecessary on small lid apertures Choice of single-use or metallic reusable suction rings Translucent single-use suction rings enable visual confirmation of suction Adjustable stops for customized hinge length Optimal intraoperative visibility Reduced suction time, quick procedure Much more economical than Femto-LASIK REFERENCES: 1. Duffey RJ. Moria One Use-Plus SBK Microkeratome: Predictably Thin, Smooth, Planar Flaps for Faster Visual Recovery. Paper presented at: 26 th annual meeting of the ESCRS; Sept ; Berlin, Germany. 2. Norden RA. Comparison of the One Use-Plus SBK vs the femtosecond laser in SBK. Paper presented at: annual meeting of the ASCRS; Apr ; San Francisco, CA, USA. 3. Tamayo GE. SBK LASIK with a manual microkeratome: new Moria One Use-Plus. Paper presented at: annual meeting of the ASCRS; Apr ; San Francisco, CA, USA. 4. Lewis JS. Unanticipated stromal tissue loss following femtosecond flap creation. Paper presented at: 28 th annual meeting of the ESCRS; Sept ; Paris, France. 5. Al-Thomali T. Prospective study comparing One Use-Plus SBK with PRK. Paper presented at: 28 th annual meeting of the ESCRS; Sept ; Paris, France. 6. Changbin Zhai, Lei Tian, Yuehua Zhou. Comparison of the flaps made by femtosecond laser and automated keratome for thin-flap LASIK. Invest Ophthalmol Vis Sci 2011;52: E-Abstract Presented at: annual meeting of the ARVO, May 2011; Fort Lauderdale, FL, USA. 7. Casado D. SBK with a mechanical microkeratome: prospective clinical study after 1350 eyes. Paper presented at: 27 th annual meeting of the ESCRS; Sept , Barcelona, Spain. 8. Casado D. LASIK Sub-Bowman con el nuevo microqueratomo Moria One-Use Plus SBK. Paper presented at: 23 rd annual meeting of the SECOIR; May , Madrid, Spain 9. Güell JL. Intra-flap LASIK: a new procedure for LASIK enhancement; a case report. Paper presented at: 27 th annual meeting of the ESCRS; Sept , Barcelona, Spain. 10. El-Massry A. Comparative study between One Use-Plus SBK and FemtoLASIK flaps. Paper presented at: 15 th annual meeting of the ESCRS Winter session; Feb ; Istanbul, Turkey. 11. Bai Ji. Corneal flaps individualized with precise mechanical microkeratome. Paper presented at: 29 th annual meeting of the ESCRS; Sept ; Vienna, Austria. FINANCIAL DISCLOSURE: None of the authors has financial interest in the One Use-Plus SBK microkeratome or is a paid consultant for Moria. TRADEMARKS AND COPYRIGHT: One Use-Plus SBK and M2SU90 are products and registered trademarks of Moria SA (Antony, France). IntraLase is a product and registered trademark of Abbott Medical Optics, Inc (Irvine, CA, USA). VisuMax is a product and registered trademark of Carl Zeiss Meditec (Jena, Germany).

14 To obtain more information MORIA SA 15, rue Georges Besse Antony FRANCE Phone: +33 (0) Fax: +33 (0) MORIA Inc 1050 Cross Keys Drive Doylestown, PA USA Phone: (800) Fax: + 1 (215) MORIA JAPAN KK Inami Bldg. 6F Hongo Bunkyo-ku Tokyo JAPAN Phone: Fax: MORIA in CHINA Moria Commercial (China) Co. Ltd Rm H, I, 6FL, Kai Li Building N 432 Huai Hai West Road Shanghai CHINA Phone: Fax: Non contractual document. MORIA #66083EN-B

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