LASIK Xtra and Higher fluence CXL

Transcription

1 LASIK Xtra and Higher fluence CXL A. John Kanellopoulos, MD Director, Laservision.gr Institute, Athens, Greece Clinical Professor NYU Medical School, NY Kanellopoulos MD 1

2 Financial interests Avedro Alcon/Wavelight Bausch & Lomb Revision Optics Seros Medical Ocular Therapeutix Keramed Revision Optics

3 Decrease of UV-intensity courtesy E. Spoel MD 3.00 mw/cm² 1.49 mw/cm² 0.74 mw/cm² 0.36 mw/cm² 0.18 mw/cm² 0.09 mw/cm²

4 The Athens Protocol: Simultaneous surface ablation and CXL for correction of Refractive error in eyes with early keratoconus ISRS/AAO keynote Kanellopoulos MD 4

5 J Cornea August 2007 CXL followed 6 months later by a partial tprk Kanellopoulos MD 5

6 The Athens Protocol: same day PTK > topoprk > MMC > CXL (7mW/cm2 x 15 min) now Avedro KXL 10mW X 10

7 UV light blockage by normal corneal structures Kolozsvári et al IOVS 2002;43: Ambrosio: Athens Protocol eyes appear superior to CXL alone in biomechanical testing Kanellopoulos MD 7

8 Topo-guided partial PRK 1-Topolyzer:Placido disc topography 2-Pentacam (Oculyzer) 3-Pentacam HD (oculyzer II)-Refractive suite 4-Vario (placido disc +pupil sensor+iris recognition+limbal landmarks recognition) WaveLight FS200 Femtosecond Laser WaveLight EX500 Excimer Laser WaveLight Refractive Suite Kanellopoulos MD 8

9 JRS Sept 2009 UCVA LogMar BSCVA LogMar Mean Decrease MRSE Mean K Decrease Mean Haze Score PreOp PostOp 0.9 ± ± ± ± ± ± ±0.5 Mean CCT 465±45 395±25 UCVA LogMar BSCVA LogMar Mean Decrease MRSE Mean K Decrease Mean Haze Score Pre op Post op 0.96 ± ± ± ±0.16 (p<0.001) 3.2±1.4 (p<0.005) 3.50±1.3 (p<0.005) 0.5±0.3 (p< Mean CCT 475±55 405±35 Kanellopoulos MD 9

10 Final treatment plan partial myopic PRK and partial hyperopic PRK Kanellopoulos MD 10

11 Athens Protocol: Keratometric change over 24 months, progressive flattening this finding makes challenging the prediction of refractive correction 11

12 Little change in keratometry BSCVA 20/50 to 20/20 Kanellopoulos MD 12

13 Topometric improvement: Significant reduction in IHD Topometric parameter improvement: IHD Kanellopoulos MD 13

14 Topometric improvement: Significant reduction in IHD Average K from 48.5 to 44 Refraction @155 (20/70) to @10 (20/20) Kanellopoulos MD 14

15 Topometric improvement: Significant reduction in IHD In oblique KCN: AveK from 44.6 to just 44.3! Flattest K steeper by 1D refraction @160(20/60) to -1.5D (20/20) Kanellopoulos MD 15

16 Athens Protocol: Some improvement in UCVA, dramatic improvement in BSCVA: 98% of cases at least 20/40!) 16

17 Safety Athens Protocol: safety 17

18 Topometric improvement: Significant reduction in IHD Myopia induction!: Refraction from (20/60) to @170 (20/20) due to improvement of the topometric parameters Kanellopoulos MD 18

19 Topometric improvement: Significant reduction in IHD 2 year follow up in a 15 y/o Kanellopoulos MD 19

20 Conclusions Combine CXL with topo-guided partial PRK= The Athens Protocol Not a refractive treatment-rather therapeutic The refractive result is unpredictable Higher fluence CXL safe and effective The improvement of BSCVA is very predictable Synergistic effect with CXL No other current treatment can improve predictably tomometric cornea parameters with long follow-up Kanellopoulos MD 20

21 Cornea remodeling without tissue removal Avedro, Keraflex first reports Kanellopoulos, Herakar:TRXL 21

22 Introduction of riboflavin in a femto-pocket 22

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24 Dresden protocol 3mw/cm2 24

25 We introduced: Higher fluence CXL: 6 mw/cm2 AAO 2008: CXL for 15 minutes utilizing 7mW/cm2 fluence Kanellopoulos MD 25

26 Same patient 4 years p PRK -4D, which was Xtra? 26

27 Prophylactic CXL in high risk LASIK AAO 2009 A. John Kanellopoulos, MD Professor of Ophthalmology, NYU Medical School

28 Purpose: In our long experience with cross-linking since 2002 we have treated over 100 ectasia cases and over 700 KCN cases We have subsequently employed CXL as a prophylactic measure in over 150 primary refractive surgery cases (PRK and LASIK) In this study we evaluated the safety and efficacy of ultraviolet A irradiation (UVA) cross-linking (CCL) combined at the completion for high risk myopic LASIK cases

29 Methods 25 LASIK cases treated with a FS micron Intralase flap and the Wavelight excimer Pentacam guided platform were evaluated peri-operatively for UCVA, BSCVA, refraction, keratometry (K), topography(t), total and flap pachymetry (tp & fp), endothelium(ecc). All eyes at the completion LASIK were CCL with 7mW/cm2 for 10 minutes following a single instillation of 0.1% riboflavin in the flap interface. Mean follow up was 1.5 years (1 to 3)

30 Case example 31y/o: Pre-(537um) > BSCVA 20/30 Immediately and next day 1 month (383um) > 5 months(408um) UCVA 20/20 >

31 Video

32 Results Mean values: UCVA changed from 0.2 to 1.0, BSCVA 0.9 to 1.2, spherical equivalent -7.5D to -0.2D, Cyl to K: 44.5D to 36.25D, Flap P: 105, Total P: 525 to 405, ECC: 2750 to No ectasia 1 1/2 year follow-up (1-2.5)

33 Conclusions Prophylactic collagen cross-linking (CCL) for high risk LASIK cases appears to be a safe and effective adjunct treatment against potential ectasia. This application may be viewed as the prophylactic customization of the biomechanic behavior of the cornea collagen. It appears not to affect our treatment nomogram as all cases were within treatment goal as with this novel technique we did not encountered any refractive surprises This adjunct cross-linking technique may have wider application in LASIK surgery in the future and potentially in therapeutic LASIK surgery under 18 years of age Not tested- but may make flap re-opening difficult.

34 PRK and LASIK xtra Biomechanical stability Additive effect in epithelial healing (biomechanical stability or keratocyte modulation may inhibit epithelial overgrowth in the optical zone) 34

35 4 years LASIK Xtra Kanellopoulos MD 35

36 36 Every day practice LASIK Xtra

37 37 LASIK Xtra within the Alcon Refractive Suite

38 Trans epi 0.25% Ribo + 30mW X 3 min Untreated Treated 38

39 Transepi 30mW X % ribo 39

40 High Fluence Transpethelial CXL early findings There is significant CXL effect The epithelium does not seem to absorb significant riboflavin Extremely comfortable, no recoup time Long term data neccessary 40

41 41 Hyperopic LASIK xtra

42 CXL and long term Hyperopic LASIK stability. Initial clinical findings in a contralateral eye study Purpose: The evaluation of the safety and efficacy of the application of intrastromal CXL in a contralateral eye study in routine hyperopic LASIK Methods: 27 consecutive hyperopic and hyperopic astigmatic bilateral topography-guided LASIK patients were randomized to receive 5 minutes of 10mW/cm2 CXL after in-the-flap administration of a single drop of 0.1% sodium phosphate riboflavin solution. All cases were treated with the Allegretto 400Hxz Eye-Q excimer laser and femtosecond laser flap creation. Peri-operative refractive error, keratometric, topographic and topometric measurements were evaluated with a mean follow-up of 23 months (22-35). Results: Mean sphere was +3.25D, Cyl: -1.75D. The CXL cases demonstrated a mean regression from treatment of +0.22D (diopters), the non-cxl cases: D, showing a very strong statistically significant difference even in the first 6 patients despite the expected flattening effect of CXL. Conclusions: These preliminary data suggest that the combination of CXL in hyperopic LASIK may offer a very significant synergy in efficacy, suggesting that hyperopic LASIK long term regression may be more related to cornea biomechanical changes, than just residual accommodation. 42

43 Current UVA Cross-linking Systems

44 Conclusions Should be viewed as a biomechanical stromal modulator May prevent regression in hyperopia May become the standard of care for PRK (resuce scarring, epithelial hyperplasia) CXL can sterilize the stroma higher fluence and higher riboflavin % may be useful The apoptosis of keratocytes may have unknown benefit to epithelial hyperplasia and risks Potential endothelial toxicity Potential limbal cell cell and/or goblet cell toxicity Kanellopoulos MD 44

45 AAO/ISRS meeting in Athens! December 17 th The ISRS didactic course Live surgery and commentary in LASIK, Athens Protocol, CXL and femto cataract surgery Please contact: Kanellopoulos MD